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عتمادتعليم وان جودة الية لضما الهيئة القومUniversity: Alexandria Faculty: Medicine Programme Specifications (Academic year: 2016/2017 ) A. Basic Information: 1. Program title: Master degree in clinical pharmacology 2. Department(s) offering the program: Department of clinical pharmacology 3. Date of program specifications approval: /1 /2016 B. Professional Information 1- Program Aims 1.1 prepare graduates who are able to share in improving the quality of patient care through optimal medication management based on sound pharmaco-therapeutic principles 1.2 Encourage the student to be capable of working confidently and adopting a mature, professional and safe attitude to their work 1.3 Increase the depth of the student’s knowledge, technical and transferable skills in an integrated manner to enhance their current and future roles 1.4Encourage the student to develop independent and self-critical learning to maximize their own potential 1.5 Enhance critical, analytical problem-solving skills, evidence-based decision making skills and the use of information technology 1.6 Develop a deep understanding of human pharmacology, including its application in the clinical setting, as well as its relevance in the drug development process. 1.7 To develop students’ skills in experimental design, evaluation and interpretation of experimental data, literature searches, scientific writing, oral presentations, poster presentations and team working. 1.8 Develop an advanced understanding of how clinical, safety and regulatory principles underpin human trials 1.9 Develop the ability to critically review the scientific literature, critically analyze information, synthesize and summarize conclusions 3- Benchmarks: 3.1 Department of Pharmacology University of Oxford (http://www.pharm.ox.ac.uk/) 3.2 Department of Clinical Pharmacology. Medical University of Vienna (http://klpharm.meduniwien.ac.at/) 3.3 American board of clinical pharmacology http://www.abcp.net/instructions.pdf 3.4 The Irish Committee on Higher Medical Training Curriculum For Higher Specialist Training In Clinical Pharmacology. October, 2002. http://www.rcpi.ie/EducationAndTraining/HMT%20%20Specialties%20Library/ICHMT%20- %20Clinical%20Pharmacology%20Therapeutics%20-%20October%202002.pdf 3.5 Specialty training curriculum for clinical pharmacology And therapeutic by Joint Royal Colleges Of Physicians Training Board-UK; May 2007 http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLOG Y_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf
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Page 1: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

الهيئة القومية لضمان جودة التعليم واالعتماد

University: Alexandria

Faculty: Medicine

Programme Specifications

(Academic year: 2016/2017 )

A. Basic Information:

1. Program title: Master degree in clinical pharmacology

2. Department(s) offering the program: Department of clinical pharmacology

3. Date of program specifications approval: /1 /2016

B. Professional Information

1- Program Aims

1.1 prepare graduates who are able to share in improving the quality of patient care through optimal medication

management based on sound pharmaco-therapeutic principles

1.2 Encourage the student to be capable of working confidently and adopting a mature, professional and safe attitude to their work

1.3 Increase the depth of the student’s knowledge, technical and transferable skills in an integrated manner to enhance their

current and future roles

1.4Encourage the student to develop independent and self-critical learning to maximize their own potential

1.5 Enhance critical, analytical problem-solving skills, evidence-based decision making skills and the use of information

technology

1.6 Develop a deep understanding of human pharmacology, including its application in the clinical setting, as well as its relevance

in the drug development process.

1.7 To develop students’ skills in experimental design, evaluation and interpretation of experimental data, literature searches,

scientific writing, oral presentations, poster presentations and team working.

1.8 Develop an advanced understanding of how clinical, safety and regulatory principles underpin human trials

1.9 Develop the ability to critically review the scientific literature, critically analyze information, synthesize and summarize

conclusions

3- Benchmarks:

3.1 Department of Pharmacology University of Oxford (http://www.pharm.ox.ac.uk/)

3.2 Department of Clinical Pharmacology. Medical University of Vienna (http://klpharm.meduniwien.ac.at/)

3.3 American board of clinical pharmacology http://www.abcp.net/instructions.pdf

3.4 The Irish Committee on Higher Medical Training Curriculum For Higher Specialist Training In Clinical

Pharmacology. October, 2002.

http://www.rcpi.ie/EducationAndTraining/HMT%20%20Specialties%20Library/ICHMT%20-

%20Clinical%20Pharmacology%20Therapeutics%20-%20October%202002.pdf

3.5 Specialty training curriculum for clinical pharmacology And therapeutic by Joint Royal Colleges Of

Physicians Training Board-UK; May 2007

http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLOG

Y_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf

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الهيئة القومية لضمان جودة التعليم واالعتماد

Domain Academic

Reference

Standards

ILOs

A. Knowledge

and

understandin

g

A1. Review the fundamental principles of pharmacology, drug

discovery and drug development.

A2. Discuss the sources of individual variations in drug response

A3. Explain in depth the molecular mechanisms underlying

pharmacokinetics and pharmacodynamics and their relations to

manifestations and therapy of drug toxicity;

A4. Elucidate the cellular signaling pathways relevant to drug

discovery and disease; considering the associated molecular and

genetic techniques.

A5. Discuss and appraise the clinical management of various clinical

cases, illustrating their related problems; such as adverse drug

reactions, interactions, contraindications, carcinogenicity and

teratogenicity.

A6. Summarize the drug use and management of diseases of special

populations

A7. Review Research ethics and reporting to research ethics

committees (REC).

A8. Describe in details clinical trials, and compare between its

different phases.

A9. Outline the concept of pharmacoeconomics.

A10. Classify types of pharmacoeconomic analysis

A11. Recognize Portfolio and Project Planning and Management in the

Drug Discovery, Evaluation, Development, and Regulatory Review

Process

B. Intellectual

skills

B1. Apply the pharmacokinetic information to justify drug plasma

concentrations according to number of doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based treatment strategies for a specific

clinical cases in the light of studied pharmacological information to

minimize medication errors

B3. Write a report to research ethics committees (REC).

B4. Design Non-Clinical Drug Development

B5. Perform Preclinical Prediction of Human Pharmacokinetics

B6. Design Phase I Clinical Studies

B7. Construct Design of Clinical drug Development Programs

B8. Review Role of the Administration (e.g. FDA) in Guiding Drug

Development

B9. Compare different types of pharmacoeconomic analysis.

B10. Discuss future perspectives.

B11. apply problem solving skills in experimental and clinical issues

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الهيئة القومية لضمان جودة التعليم واالعتماد

C. Professional

skills

C1. Assess drug pharmacokinetics (solubility, absorption/

bioavailability and bioequivalence, distribution and protein binding,

biotransformation, renal excretion), and pharmacodynamics.

C2. work effectively and safely in a clinical and laboratory environment

C3.Recommend the drug (S) of choice for a particular clinical

presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific situations

C6.Criticize the Non-Clinical Drug Development

C7.Design a pharmacoeconomic study.

C8. Outline suggestions to improve patients adherence to prescribed

drugs

C9. Communicate basic information about drug therapy to patients and

their families, including purpose of medication, how it works, possible

adverse drug reactions, potential drug interactions, cost, and necessary

follow-up

C10. Identify and recommend appropriate corrections of prescription

errors

C11. Recognize drug compliance and administrations errors and

communicate effectively with patients about them

C12. Recognize patient preferences for treatment, patient concerns and

goals about disease and treatment

D. General and

transferrable

skills

D1. Hold skills of class discussion and critical evaluation of evidence

presented by publications or industry.

D2- Write reports, design poster presentation and give oral presentations

D3- Use web browsing to locate and use online data bases.

D4. Apply effective listening skills and elicit and provide information

using nonverbal, explanatory, and questioning skills.

D5. Integrate effectively with others as a member or leader of a health

care team.

D6. Participate in community and professional organizations.

D7. Report attended seminars, conferences and workshops for further

development.

D8. Plan training courses to improve practice and enhance

performance of juniors.

E. Attitudes and

ethical

behavior

E1. Apply regulations and ethics that govern physicians in promotion

and detailing of drugs.

E2. Explain to patients the possible participation as human research

subjects in clinical trials,

E3. Integrate essential elements for informed consent

E4. Obtain consent that is truly informed

E5. Manage special challenges of performing clinical research in

vulnerable populations

E6. Manage confusion of roles in academic medical centers and

problems with duplicative, interactive, or conflicting drug treatment

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الهيئة القومية لضمان جودة التعليم واالعتماد

plans

E7. Integrate with other members of medical team to provide the

patients the appropriate medical care

E8. Apply regulations and ethics during laboratory work on

experimental animals

E9. Show respect to professors, colleagues, other members of medical

team and to patients.

Matrix of Program ILOs/Courses ILO Course

A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11

Clinical pharmacokinetics × × × Basic Pharmacology-I × × × × × Basic Pharmacology –II × × × × × × Drug discovery and development-I × × × ×

Drug discovery and development-II × × × × ×

Optimizing and evaluative patient therapy and assessment of

drug effects × × ×

Pharmacotherapy (Rational use of drugs) × × × × × × Basic Pharmacoeconomics × × Drug metabolism and transport × × × × ×

Applied internal medicine × × × × × × × Applied emergency medicine × × ',,,,Clinical pediatrics × × × × × × Clinical geriatrics × × × × × × Drug poisoning × . ×

ILO Course

B1 B2 B3 B4 B5 B6 B7 B8 B9 B10 B11

Clinical pharmacokinetics × × Basic Pharmacology-I × × Basic Pharmacology –II × × × × Drug discovery and development-I × × × × Drug discovery and development-II × × × × Optimizing and evaluative patient therapy and assessment of drug

effects × × ×

Pharmacotherapy (Rational use of drugs) × × × Basic Pharmacoeconomics × ×

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الهيئة القومية لضمان جودة التعليم واالعتماد

Drug metabolism and transport × × × × × Applied internal medicine × × × × Applied emergency medicine × × Clinical pediatrics × × Clinical geriatrics × × Drug poisoning ×

ILO Course

C1 C2

C3 C4 C5 C6 C7 C8 C9 C10 C11 12

Clinical pharmacokinetics × × × × × Basic Pharmacology-I × × × × × × × × Basic Pharmacology –II × × × × × × × × Drug discovery and development-I × Drug discovery and development-II × Optimizing and evaluative patient therapy and assessment of drug

effects × × × ×

Pharmacotherapy (Rational use of drugs) × × × × × × × × Basic Pharmacoeconomics × × Drug metabolism and transport × × × × Applied internal medicine × × × × × × × × × Applied emergency medicine × × × × Clinical pediatrics × × × × Clinical geriatrics × × × Drug poisoning × ×

Page 6: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

الهيئة القومية لضمان جودة التعليم واالعتماد

ILO Course

D1-

D2

D3 D4 D5 D6 D7 D8

Clinical pharmacokinetics × × × × × Basic Pharmacology-I × × × × × × Basic Pharmacology –II × × × × × × Drug discovery and development-I × × × × × Drug discovery and development-II × × × × × Optimizing and evaluative patient therapy and assessment of

drug effects × × × ×

Pharmacotherapy (Rational use of drugs) × × × × × × × ×

Basic Pharmacoeconomics × Drug metabolism and transport × Applied internal medicine × Applied emergency medicine × Clinical pediatrics × × × × × × Clinical geriatrics × × × Drug poisoning ×

Page 7: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

الهيئة القومية لضمان جودة التعليم واالعتماد

ILO Course

E1 -E2 E3

E4 -E5 E6 E7 E8 -E9

Clinical pharmacokinetics × ×

Basic Pharmacology-I × × × × ×

Basic Pharmacology –II × × × × ×

Drug discovery and development-I × × Drug discovery and development-II × × Optimizing and evaluative patient therapy and assessment of drug effects × × Pharmacotherapy (Rational use of drugs) × × × × Basic Pharmacoeconomics × Drug metabolism and transport × × Applied internal medicine × × × × × × × × × Applied emergency medicine × × × × × × × × × Clinical pediatrics × × × × × × × × × Clinical geriatrics × ×

Drug poisoning ×

5- Curriculum Structure and Contents:

5.1 Programme duration: 40 credit hours

5.2 Programme structure: …………………………………………………………..

Programme courses:

Obligatory:

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الهيئة القومية لضمان جودة التعليم واالعتماد

Course Code Course Title Number

of Units

No of Hours/Week

Lectures Practical Clinical

05500801 Basics of research 3

05060801 Clinical pharmacokinetics 2 1 1

05060802 Basic Pharmacology-I 3 2.5 0.5

05060803 Basic Pharmacology –II 3 2 1

05060804 Drug discovery and

development-I

2 2

05060805 Drug discovery and

development-II

2 2

05060806 Optimizing and

evaluating patient's

therapy and assessment of

drug effects

1 0.5 0.5

05060807 Pharmacotherapy

(Rational use of drugs)

4 2 2

05060808 Basic

Pharmacoeconomics

1 1

05060809 Drug metabolism and

transport

1 0.5 0.5

05060810 Applied internal medicine 3 2.5 0.5

05060811 Applied emergency

medicine

1 0.5 0.5

05060812 Clinical pediatrics 2 1 1

05060813 Clinical geriatrics 1 0.5 0.5

05060814 Drug poisoning 3 2 1

6- Curricular Contents:

Clinical pharmacokinetics

Code Course credit hours 2 Pre-requisites

05060801

Theoretical 1 Practical 1 05500801

This course aims at helping the student to acquire advanced knowledge and problem solving skills

to guide drug prescribing based on pharmacokinetic properties of drugs.

Basic Pharmacology-I

Code Course credit hours 3 Pre-requisites

05060802 Theoretical 2.5 Practical 0.5 05500801

Page 9: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

الهيئة القومية لضمان جودة التعليم واالعتماد

This course aims to provide the student with the basic knowledge of the essential principles in

pharmacology, To build up the ability of applying this knowledge in recognizing the basic

pharmacology of drugs targeting inflammation, autonomic nervous system, blood components, body

fluid balance, hemostasis, renal system and skin disorders.To enable the student to apply these

pharmacological knowledge in clinical situations in the field of therapeutics And to provide the

student with essential practical skills in pharmacology

Basic Pharmacology-II

Code Course credit hours 3 Pre-requisites

05060803 Theoretical 2 Practical 1 05500801

The course includes knowledge about the essentials of basic pharmacology. Aiming to help students

recognizing the basic pharmacology of drugs targeting infection, autoimmune diseases, cancer, central

nervous, cardiovascular, gastrointestinal, pulmonary, and endocrine systems and to apply these

knowledge in clinical situations in the field of therapeutics. Also it tends to provide the student with

essential practical skills in pharmacology.

Drug discovery and development-I

Code Course credit hours 2 Pre-requisites

05060804 Theoretical 2 Practical 05500801

This course helps the student to acquire advanced knowledge and apply recent techniques that help in

exploring Drug discovery and Development, implement Project Planning and Management in the

Drug Discovery, Evaluation, Development, and Regulatory Review Process

Drug discovery and development-II

Code Course credit hours 2 Pre-requisites

05060805 Theoretical 2 Practical 05500801

This course helps the student to Acquire advanced knowledge and apply recent techniques that help in

exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the

Administration (e.g. FDA) in Guiding Drug Development

Optimizing and evaluating patient's therapy and assessment of drug effects

Code Course credit hours 1 Pre-requisites

05060806 Theoretical 0.5 Practical 0.5 05500801

This course helps student to Acquire advanced knowledge enabling the student to assess drug

effect, evaluate and optimize drug therapy.

.

Pharmacotherapy (Rational use of drugs)

Code Course credit hours 4 Pre-requisites

Page 10: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

الهيئة القومية لضمان جودة التعليم واالعتماد

05060807 Theoretical 2 Clinical 2 05500801

This Course Aims To enable the student to recognize factors that make patients unique

To build up the ability of applying basic pharmacology knowledge in drug use in common medical

diseases, To provide the student with the essentials of rules and regulation that govern prescribing

To enable the students to identify medication errors, adverse drug reactions and drug interactions.

To develop in the students the skills of Good communication with patients and families, Obtaining

accurate drug history, Developing a sound drug therapy plan, Using information technology and

Finding evidence-based information

Basic Pharmacoeconomics

Code Course credit hours 1 Pre-requisites

05060808 Theoretical 1 Practical 05500801

At the end of the course the student will be able to Define pharmacoeconomic concepts and

terminology. Compare different types of pharmacoeconomic analysis. Apply knowledge to provide

healthcare decision-makers with valuable information and allowing optimal allocation of limited

resources, and discuss future perspectives.

Drug metabolism and transport

Code Course credit hours 1 Pre-requisites

05060809 Theoretical 0.5 Practical 0.5 05500801

This course helps student to Acquire advanced knowledge related to variable types of drug transport

and drug metabolic pathways.

Applied internal medicine

Code Course credit hours 3 Pre-requisites

05060810 Theoretical 2.5 Clinical 0.5 05500801

This course is designed To enable the student to recognize factors that make patients unique

To build up the ability of applying basic pharmacology knowledge in drug use in common medical

diseases, To provide the student with the essentials of rules and regulation that govern prescribing

To enable the students to identify medication errors, adverse drug reactions, drug interactions and

overdosage and To develop in the students the skills of Good communication with patients and

families, Obtaining accurate drug history, Developing a sound drug therapy plan, Using information

technology and Finding evidence-based information

Applied emergency medicine

Code Course credit hours 1 Pre-requisites

05060811 Theoretical 0.5 Clinical 0.5 05500801

The course Discussess basic and advanced measures for management of emergency situations.

Recognize important pharmacokinetic and pharmacodynamic changes in critically ill patients. Gain

advanced knowledge and apply recent guidelines to construct effective management plan in

emergency room

Page 11: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

الهيئة القومية لضمان جودة التعليم واالعتماد

Clinical pediatrics

Code Course credit hours 2 Pre-requisites

05060812 Theoretical 1 Clinical 1 05500801

The course aims to help the student to Gain advanced knowledge in optimizing use of medications for

individual children and provide advanced clinical training in the areas of pediatric pharmacotherapy.

The primary emphasis of the course is to develop independent problem-solving skills in pediatrics

pharmacotherapy. This includes the establishment of a firm knowledge base in pediatric

pharmacology and pharmacokinetics; and the ability to provide therapeutic interventions to enhance

the management of pediatric patients.

Clinical geriatrics

Code Course credit hours 1 Pre-requisites

05060813 Theoretical 0.5 Clinical 0.5 05500801

The course aims to help the student to Acquire advanced knowledge and problem solving skills to

guide prescribing in geriatric disorders based on updated guidelines and evidence-based practices.

Drug poisoning

Code Course credit hours 3 Pre-requisites evaluation

05060814 Theoretical 2 Practical 1 05500801

Gain advanced knowledge and apply recent laboratory techniques that helps in understanding the

pharmacokinetic aspects of different therapeutic agents and its implications in the field of drug

poisoning and toxicology with exploration of recent guidelines in their evaluation and management

aiming to improve outcome and decrease in both drug related morbidity and mortality

7- Programme Admission Requirements: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University

(annex).

8- Regulations for Progression and Programme Completion: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University

(annex).

10- Methods of student assessment:

Methods Intended Learning outcomes to be

assessed

1. Essay A1-11, B1-11

2. Case studies A1-11, B1-11, C2-5, C7

3. Assignment A1-11, B1-11, D1-12, E1-9

4. Objective questions A1-11, B1-11, C1-12

5. OSCE/OSPE A1-11, B1-11, C1-12, D1-8, E1-9

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الهيئة القومية لضمان جودة التعليم واالعتماد

11- Methods of programme evaluation:

Evaluator Tool Sample

1. Questionnaires

2. Alumni

3. Stakeholders (Employers)

4. External Evaluator (s)

5. Others:

Programme Director: Prof Dr Samya Mohamed Ali Signature:

Programme coordinator: Prof. Dr Maged Misheal Signature:

Date: / /

Page 13: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060801 Course Name: Clinical Pharmacokinetics

Program in which the Course is Given MSc in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Acquire advanced knowledge and problem solving skills to guide drug prescribing based on

pharmacokinetic properties of drugs.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Review the fundamental principles

of pharmacology, drug discovery and

drug development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying

pharmacokinetics and

pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A1.Define pharmacokinetics and

pharmacodynamics

A2. Discuss drug Clearance.

A4. Explain Volume of distribution

A5. State Half-life and elimination rate

constant

A6. Explain Michaelis-menten (saturable or

nonlinear pharmacokinetics)

A7. Outline factors affecting Drug Absorption,

Bioavailability and Bioequivalence

A8. Review the effects of Renal and Liver

Disease on Pharmacokinetics

A9. Compare between Noncompartmental

and Compartmental Approaches to

1 1

Page 14: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Pharmacokinetic Analysis

A10. Describe the effects of liver and renal

diseases on pharmacokinetics

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design a evidence-based treatment

strategies for a specific clinical cases in

the light of studied pharmacokinetic

information to minimize medication

errors

B1. Apply the pharmacokinetic equations

for drug single dose administration

B2. Apply the pharmacokinetic equations

for drug multiple doses administration

B3. Apply the pharmacokinetic equations to

adjust timing to reach steady state situation

B4. Adjust drug dosing in renal and hepatic

impairment.

B5. Design individualized dosage regimens

using one-compartment and Multi-

compartment model equations.

B6. Calculate of clearance, volume of

distribution, and half-life in

pharmacokinetic research studies.

C.Professional

and Practical

Skills

C1. Recommend the drug (S) of choice for

a particular clinical presentation

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs

C8. Outline suggestions to improve

patients adherence to prescribed drugs

C1. Apply update pharmacokinetic knowledge

to select the best drug for a particular clinical

case

C2.Solve problems of variations of drug

concentration in diseases of organs of

elimination.

C3. Appraise the cardioprotective,

neuroprotective and renoprotective effects of

some drug classes that favor their use over

other counterparts.

C4. Criticize medication errors in some

prescriptions and recommend changes to

improve safety and efficacy of drug therapy.

D. General

Skills

D1. Hold skills of class discussion and

critical evaluation of evidence presented by

publications or industry.

D2- Write reports and give oral

d1. Demonstrate competent presentation and

knowledge in class and respect questions and

inquires from colleagues and professors.

d2. Prove efficient skills in searching databases

and evidence-based guidelines.

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presentations

D3- Use web browsing to locate and

use online data bases.

D4. Communicate basic information about

drug therapy to patients and their families,

including purpose of medication, how it

works, possible adverse drug reactions,

potential drug interactions, cost, and

necessary follow-up

D5. Apply effective listening skills and

elicit and provide information using

nonverbal, explanatory, and questioning

skills.

d3. Demonstrate clinical cases and Display good

time-management during talk, case

presentation and discussion.

D4. Communicate basic information about drug

pharmacokinetics to patients and their families

D5. Apply effective listening skills during

lectures and seminars.

E. Attitudes and ethical behavior

E8. Apply regulations and ethics during

laboratory work on experimental animals

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

E1. Apply regulations and ethical behavior

toward experimental animals during

laboratory work.

E2. Show respect during listening,

providing oral presentations and

experimental work towards other team

members.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Introduction to pharmacokinetics (Clinical pharmacokinetics vs pharmacodynamics)

Page 16: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

2. Clearance, Volume of distribution, Half-life and elimination rate constant

3. Michaelis-menten (saturable or nonlinear pharmacokinetics)

4. Drug Absorption, Bioavailability and Bioequivalence

5. One-compartment model equations for linear pharmacokinetics (Single dose, Multiple-Dose and Steady-State Equations

✓ ✓

6. Designing individualized dosage regimens using one compartment model equations

✓ ✓

7. Multicompartment models ✓ ✓

8. Calculation of clearance, volume of distribution, and half-life in pharmacokinetic research studies

✓ ✓

9. Effects of Renal Disease on Pharmacokinetics

✓ ✓ ✓

10. Effect of Liver Disease on Pharmacokinetics

✓ ✓ ✓

11. Noncompartmental versus Compartmental Approaches to Pharmacokinetic Analysis

✓ ✓ ✓

12. Study problems ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 40 %

End of term 60 %

Distribution of Marks

Written Exam 80 %

Practical/Clinical Exam 20 %

Others (attendance/Assignment)

✓ ✓

✓ ✓

Page 17: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

List of Textbooks and References

Lecture Notes

Manuscripts of Assignment Topics prepared

by candidates and revised by supervising

professors.

Course Text Books

Suggested Extra Reading

1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic

Pharmacology.

Journals and Periodicals, others

Review articles on pubmed and Medscape on

pharmacokinetics

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 18: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060802 Course Name: Basic Pharmacology I

Program in which the Course is Given MS in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

To provide the student with the basic knowledge of the essential principles in pharmacology

To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs

targeting inflammation, autonomic nervous system, blood components, body fluid balance, hemostasis,

renal system and skin disorders.

To enable the student to apply these pharmacological knowledge in clinical situations in the field of

therapeutics

To provide the student with essential practical skills in pharmacology

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

0.5 2.5

Page 19: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response A3- Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

a1.Describe in depth principles and facts

related to the pharmacodynamics of drugs

a2.Identify the detailed pharmacology of

drugs affecting the autonomic nervous

system and their applications in the medical

field

a3.State the pharmacological aspects of

different autacoids and their targeting by

drugs

a4.List drugs used in different types of

anemia

a5.Point different diuretics and their site of

action and adverse effects

a6.Outline vitamins and intravenous fluids

replacement therapy

a7. List drugs used in different

dermatological diseases.

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors

B1.Describe the mechanism of action and

drug interactions related to the autonomic

nervous system, inflammation and

homeostasis

B2.Classify diuretics and discuss their side

effects in relation to their mechanism of

action

B3.Describe vitamins and relate their

physiological aspects to their use in

different clinical states.

Page 20: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

C.

Professional

and Practical

Skills

C1. Assess drug pharmacokinetics

(solubility, absorption/ bioavailability and

bioequivalence, distribution and protein

binding, biotransformation, renal

excretion), and pharmacodynamics.

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations

C8. Outline suggestions to improve

patients adherence to prescribed drugs

C9. Communicate basic information about

drug therapy to patients and their

families, including purpose of medication,

how it works, possible adverse drug

reactions, potential drug interactions,

cost, and necessary follow-up

C10. Identify and recommend appropriate

corrections of prescription errors

C1.Compare different diuretics and put a

recommendation of the use of each group in

specific clinical conditions

C2.Organize a plan for therapeutic

management of patients with coagulation

disorders with different comorbidities

C3.Apply the pharmacological knowledge

in management of gout and other rheumatic

disorders

C4.Design systematic approaches for fluid

replacement in different clinical conditions

of fluid imbalance

C5.Use practical experiments to evaluate

the action of analgesics and autonomic

drugs.

C6.Identify examples of recently published

advances in treatment of collagen disorders

C7.Dicuss guidelines of different societies

for the management of thrombotic

disorders, rheumatoid arthritis and

intravenous fluid replacement therapy

C8. Identify problems causing failure of

therapy, and Outline suggestions to avoid or

correct them.

C9. Communicate basic information (purpose of

medication, how it works, possible adverse

drug reactions, potential drug interactions,

cost, and necessary follow-up) about drug

therapy for anemia, renal and inflammatory

diseases, to patients and their families.

D. General

Skills D1. Hold skills of class discussion and D1.Perform practice-based improvement

Page 21: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

critical evaluation of evidence presented

by publications or industry.

D2- Write reports, design poster

presentation and give oral presentations

D3- Use web browsing to locate and use

online data bases.

D4. Apply effective listening skills and

elicit and provide information using

nonverbal, explanatory, and questioning

skills.

D7. Report attended seminars,

conferences and workshops for further

development.

D8. Plan training courses to improve

practice and enhance performance of

juniors.

activities using a systematic methodology

D2.Appraise evidence from scientific

studies

D3.Participate in one audit related to

pharmacology

D4. Write two reports about two attended

conferences

D5. Use online data bases to identify the

proper guidelines for certain clinical cases

D6. Apply effective listening skills and elicit

and provide information using nonverbal,

explanatory, and questioning skills during

lectures and during oral presentations

D7. Plan experimental and clinical training

courses to improve practice.

.

E. Attitudes and ethical behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs

E6. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E7. Integrate with other members of

medical team to provide the patients the

appropriate medical care

E8. Apply regulations and ethics during

laboratory work on experimental animals

E9. Show respect to professors,

colleagues, other members of medical

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of the

studied drugs

E2. Manage confusion of roles in academic

medical centers and problems with duplicative,

interactive, or conflicting drug treatment plans

related to anemia, gout and dermatological

diseases

E3. Integrate with other members of medical

team to provide the renal, hepatic and cardiac

patients the appropriate medical care

E4. Apply regulations and ethics during

laboratory work on experimental animals

E5. Show respect to professors, colleagues

Page 22: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

team and to patients. during lectures and oral presentations, and to

other members of medical team and to

patients during patient counselling.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. General principles of drug action ✓

2. Drugs acting on the autonomic

nervous system

✓ ✓ ✓

3. Autacoids and ergots ✓ ✓

4. Antiinflammatory agents and drugs

used in treatment of gout and

hyperuricemia

✓ ✓

5. Drugs used in anemia and

disorders of haemostasis

✓ ✓

6. Drugs acting on the renal system ✓ ✓

7. Fluids used in the intravenous fluid

therapy

✓ ✓

8. Vitamins ✓ ✓

9. Drugs used in dermatologic

diseases

10. Disinfectants and antiseptics ✓ ✓

Page 23: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

11. Practical:

• Effect of drugs on the eye

• Dose-response curve and

drug antagonism

• Evaluation of analgesic

activity of NSAIDs

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 60 %

Practical/Clinical Exam 20 %

Others: essays (assignments) 20%

List of Textbooks and References

Lecture Notes

Course Text Books

• Katzung Basic and Clinical

Pharmacology

• Goodman and Gilmen’s the

Pharmacological Basis of Therapeutics

Suggested Extra Reading

--

✓ ✓

Page 24: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Journals and Periodicals, others

• British journal of Pharmacology

Pharmacological review

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 25: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060803 Course Name: Basic Pharmacology II

Program in which the Course is Given MS in Clinical Pharmacology

Number of Credit Hours Theoretical Practical

Course Aims

To develop a deep knowledge of the essentials of basic pharmacology.

To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs

targeting infection, autoimmune diseases, cancer, central nervous, cardiovascular, gastrointestinal,

pulmonary, and endocrine systems.

To enable the student to apply these pharmacological knowledge in clinical situations in the field of

therapeutics.

To provide the student with essential practical skills in pharmacology.

Program ILO (refer to program

matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

A1. Classify drugs acting on CVS, CNS,

Pulmonary and endocrinal systems

A2. Identify the detailed pharmacology of

drugs Acting on CVS, CNS, Pulmonary and

endocrinal systems

A3. Discuss drugs Used in Treatment of

Infectious Diseases.

A4. State the pharmacological aspects of

different Drugs Used in Cancer Chemotherapy A5. Review recent guidelines for treatment of common cardiovascular, pulmonary, neurological and endocrinal diseases.

1 2

Page 26: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

disease; considering the associated

molecular and genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

A6. Summarize the drug use and

management of diseases of special

populations

A6. Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics of drugs acting on CVS, CNS, Pulmonary and endocrinal systems and anticancer drugs. and their relations to adverse drug reactions A7. Discuss the sources of individual variations in response to drugs acting on CVS, CNS, Pulmonary and endocrinal systems and to anticancer drugs

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to optimize

plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors B8. Review Role of the Administration (e.g.

FDA) in Guiding Drug Development

B11. apply problem solving skills in

experimental and clinical issues

B1.Describe the mechanisms of action and

drug interactions related to the CVS, CNS,

Pulmonary and endocrinal systems

B2.Classify Immunosuppressant Drugs and

discuss their side effects in relation to their

mechanism of action

B3.Compare between different anticancer

drugs regarding their mechanisms of action,

therapeutic uses and adverse drug reactions.

B4. Identify appropriate method to optimize

plasma drug concentration during treatment of

common cardiovascular, pulmonary,

neurological and endocrinal diseases.

B5. Review Role of the Administration (e.g.

FDA) in Guiding Development of anticancer

drugs and other pharmacological agents.

Page 27: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

C.

Professional

and Practical

Skills

C1. Assess drug pharmacokinetics

(solubility, absorption/ bioavailability and

bioequivalence, distribution and protein

binding, biotransformation, renal

excretion), and pharmacodynamics.

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations

C8. Outline suggestions to improve

patients adherence to prescribed drugs

C9. Communicate basic information about

drug therapy to patients and their

families, including purpose of medication,

how it works, possible adverse drug

reactions, potential drug interactions,

cost, and necessary follow-up

C10. Identify and recommend appropriate

corrections of prescription errors

C11. Recognize drug compliance and

administrations errors and communicate

effectively with patients about them

C1.Apply the pharmacological knowledge

in management of clinical cases related to

cardiovascular, respiratory, endocrinal

C2. Select the appropriate drug for common

clinical cases taking into considerations the

causes of individual variations

C3. Recommend drug therapy for common

cardiovascular, infectious, endocrinal and

respiratory diseases, using evidence based

medicine.

C4.Compare available classes of the studied

drugs, and select specific drugs for each clinical

case.

C5.Criticize specific drugs in specific situations.

C6. Identify problems causing failure of

therapy, and Outline suggestions to avoid or

correct them.

C7. Conduct laboratory experiments to

evaluate anticonvulsant activity of drugs,

applying effective, safe and ethical

measures. C8. Conduct laboratory experiments to

Evaluate bronchodilators and

Bronchoconstrictors applying effective, safe

and ethical measures

C9. Communicate basic information (purpose of

medication, how it works, possible adverse

drug reactions, potential drug interactions,

cost, and necessary follow-up) about drug

therapy for common cardiovascular, infectious,

endocrinal and respiratory diseases, to patients

and their families.

D. General

Skills

D1. Hold skills of class discussion and

critical evaluation of evidence presented

D1.Perform practice-based improvement

activities using a systematic methodology

Page 28: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

by publications or industry.

D2- Write reports, design poster

presentation and give oral presentations

D3- Use web browsing to locate and use

online data bases.

D4. Apply effective listening skills and

elicit and provide information using

nonverbal, explanatory, and questioning

skills.

D7. Report attended seminars,

conferences and workshops for further

development.

D8. Plan training courses to improve

practice and enhance performance of

juniors.

.

D2.Appraise evidence from scientific

studies

D3.Participate in one audit related to

pharmacology

D4. Write two reports about two attended

conferences

D5. Use online data bases to identify the

proper guidelines for certain clinical cases

D6. Apply effective listening skills and elicit

and provide information using nonverbal,

explanatory, and questioning skills during

lectures and during oral presentations

D7. Plan experimental and clinical training

courses to improve practice.

E. Attitudes and ethical behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs

E6. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E7. Integrate with other members of

medical team to provide the patients the

appropriate medical care

E8. Apply regulations and ethics during

laboratory work on experimental animals

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of the

studied drugs

E2. Manage confusion of roles in academic

medical centers and problems with duplicative,

interactive, or conflicting drug treatment plans

related to cardiovascular, neurological and

endocrinal disease

E3. Integrate with other members of medical

team to provide the cancer patients the

appropriate medical care

E4. Apply regulations and ethics during

Page 29: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

laboratory work on experimental animals

E5. Show respect to professors, colleagues

during lectures and oral presentations, and to

other members of medical team and to

patients during patient counselling.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Drugs acting on central nervous system.

✓ ✓ ✓

2. Drugs acting on cardiovascular system.

✓ ✓

3. Drugs acting on gastrointestinal system.

4. Drugs acting on pulmonary system. ✓ ✓

5. Drugs acting on endocrine system. ✓ ✓

6. Drugs used in cancer chemotherapy

✓ ✓

7. Immunosuppressant drugs ✓

8. Drugs used in treatment of infectious disease.

✓ ✓ ✓

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

✓ ✓

Page 30: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Distribution of Marks

Written Exam 80 %

Practical/Clinical Exam 20 %

Others %

List of Textbooks and References

Lecture Notes

Course Text Books

• Katzung Basic and Clinical

Pharmacology

• Goodman and Gilmen’s the

Pharmacological Basis of Therapeutics.

Suggested Extra Reading

Journals and Periodicals, others

• British journal of Pharmacology

• Pharmacological review

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 31: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060804 Course Name: Drug discovery and Development –I

Program in which the Course is Given MSc in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and

Development, and implement Project Planning and Management in the Drug Discovery, Evaluation,

Development, and Regulatory Review Process

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

2

Page 32: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques

A7. Review Research ethics and report

to research ethics committees (REC).

A11. Recognize Portfolio and Project

Planning and Management in the Drug

Discovery, Evaluation, Development,

and Regulatory Review Process.

a.1 Review Research ethics and report

to research ethics committees (REC).

a.2 Discuss Project Planning and

Management?

a.3 Define Project planning and

management

a.4 Discuss Project planning and

management tools

a.5 Distinguish Project team

management and decision-making.

a.6 Discuss Drug discovery

philosophies and definition of drug

targets

a.7 Explain Generating diversity

a.8 Describe lead structures

a.9 Identify Qualifying leads for

transition to early trials

a.10 Identify Components of non-clinical

drug development

a.11 Distinguish Translational research in

oncology drug development

a.12 Discuss Microdosing

a.13 Identify Allometry

a.14 Distinguish Physiologic

pharmacokinetics

a.15 Recognize Preclinical

Prediction of Human

Pharmacokinetics

Page 33: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B. Intellectual

skills

B3. Write a report to research ethics

committees (REC). B4. Design Non-Clinical Drug Development

B5. Perform Preclinical Prediction of

Human Pharmacokinetics

B7. Construct Design of Clinical drug

Development Programs

b1. Design a report to research ethics

committees (REC).

b2. Report on and interpret Project

Planning and Management?

b3. Build Project planning and

management

b4. Construct Project planning and

management tools

b5. Relate Project team management

and decision-making

b6. Relate Drug discovery philosophies

and definition of drug targets

b7. Report Generating diversity

b8. Build Definition of lead structures

b9. Relate Qualifying leads for

transition to early trials

b10. Describe Components of

non-clinical drug development

b11. Construct Translational

research in oncology drug

development

b12. interpret Microdosing

b13. Analyze Allometry

b14. Analyze Physiologic

pharmacokinetics

Page 34: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

C.Professional

and Practical

Skills

C6.Criticize the Non-Clinical Drug

Development

C1. Apply update to predict and develop

Components of non-clinical drug

development

C2. Solve problems of Translational

research in oncology drug

development...etc.

D. General

Skills

d1. Hold skills of class discussion and

critical evaluation of evidence

presented by publications or industry.

D2- Write reports, design poster

presentation and give oral presentations

D3- Use web browsing to locate and use

online data bases.

D4. Apply effective listening skills and elicit

and provide information using nonverbal,

explanatory, and questioning skills.

D7. Report attended seminars,

conferences and workshops for further

development.

d1. Demonstrate competent presentation

and knowledge in class and respect

questions and inquires from colleagues and

professors.

d2. Prove efficient skills in searching

databases and evidence-based guidelines.

d3. Display good time-management during

talk, case presentation and discussion.

D4. Report two attended conferences

D5. Apply effective listening skills during

lectures and oral presentations

E. Attitudes and ethical behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs.

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

E1. Apply regulations and ethics that govern

physicians in designing pre-clinical and clinical

drug development.

E9. Show respect to professors, colleagues,

other members of medical team and to

patients.

Page 35: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Research ethics and reporting to

research ethics committees (REC).

[in collaboration with Department of

Forensic Medicine]

2. Portfolio and Project Planning and

Management in the Drug Discovery,

Evaluation, Development, and

Regulatory Review Process.

▪ What Is Project Planning and

Management?

▪ Project planning and

management

▪ Project planning and

management tools

▪ Project team management and

decision-making

3. Drug Discovery ✓

▪ Drug discovery philosophies and

definition of drug targets

▪ Generating diversity ✓

▪ Definition of lead structures ✓

▪ Qualifying leads for transition to

early trials

4. Non-Clinical Drug Development ✓

▪ Components of non-clinical drug

development

▪ Translational research in

oncology drug development

5. Preclinical Prediction of Human

Pharmacokinetics

▪ Microdosing ✓

▪ Allometry ✓

▪ Physiologic pharmacokinetics ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment Essay Objective questions ✓ ✓

Page 36: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 40 %

End of term 60 %

Distribution of Marks

Written Exam 60 %

Practical/Clinical Exam %

Others (attendance/Assignment) 40 %

List of Textbooks and References

Lecture Notes

Manuscripts of Assignment Topics prepared

by candidates and revised by supervising

professors.

Course Text Books

Drug Discovery and Development

UNDERSTANDING THE R&D

PROCESS (by innovation.org)

Biopharmaceutical Research &

Development: The Process Behind New

Medicines (www.phrma.org)

Suggested Extra Reading

1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic

Pharmacology.

Journals and Periodicals, others

Review articles on pubmed and Medscape on

Drug discovery and Development

Course Instructor

Name: Signature:

✓ ✓

Page 37: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 38: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060805 Course Name: Drug discovery and Development –II

Program in which the Course is Given MSc in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and

Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in

Guiding Drug Development.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

2

Page 39: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles

of pharmacology, drug discovery and

drug development.

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques.

A7. Review Research ethics and

reporting to research ethics committees

(REC).

A8. Describe in details clinical trials, and

compare between its different phases.

A11. Recognize Portfolio and Project

Planning and Management in the

Drug Discovery, Evaluation,

Development, and Regulatory

Review Process

a.1 Define Phase I Clinical Studies

a.2 Explain drug toxicity.

a.3 Define Monoclonal antibodies

a.4 Assay of macromolecules

a.5 Describe Interspecies scaling of

macromolecules: predictions in humans

a.6 Explain Pharmacokinetic characteristics

of macromolecules

a.7 Describe Pharmacodynamics of

macromolecules

a.8 Discuss Principles of clinical

development

a.9 Distinguish Legal and regulatory

requirements

a.10 discuss Evidence-based, goal-directed

clinical development

a.11 Review Specific design issues in clinical

development programs

a.12 Review Personalized Medicine, Elderly

and Pediatric Populations, Orphan Drugs,

Comparative Effectiveness, Combination

Treatments, Transparency)

a.13 Recognize The role of the FDA office of

clinical pharmacology.

Page 40: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B. Intellectual

skills

B3. Write a report to research ethics

committees (REC). B6. Design Phase I Clinical Studies

B7. Construct Design of Clinical drug

Development Programs

B8. Review Role of the Administration

(e.g. FDA) in Guiding Drug Development

b1. interpret Monoclonal antibodies

b2. Review methods of Assay of

macromolecules

b3. Construct Interspecies scaling of

macromolecules: predictions in humans

b4. Explain Pharmacokinetic characteristics

of macromolecules

b5. Discuss Legal and regulatory requirements

b6. Analyze Evidence-based, goal-directed

clinical development

b7. interpret Specific design issues in clinical

development programs

b8. Describe Evidence-based, goal-directed

clinical development

b9. Analyze Specific design issues in clinical

development programs

b10. compose Specific design issues in

clinical development programs

b11. Relate Conduct of clinical development

b12. Interpret how does the FDA guide drug

development?

Page 41: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

C.Professional

and Practical

Skills

C6.Criticize the Non-Clinical Drug

Development

C1. Apply update in Personalized Medicine,

C2. Appraise update pharmacologic knowledge

to select the best drug for a particular Elderly

and Pediatric Populations

C3. Solve problems of Orphan Drugs,

Comparative Effectiveness, Combination

Treatments, Transparency...etc.

D. General

Skills

d1. Hold skills of class discussion

and critical evaluation of evidence

presented by publications or industry.

D2- Write reports, design poster

presentation and give oral presentations

D3- Use web browsing to locate and use

online data bases.

D4. Apply effective listening skills and

elicit and provide information using

nonverbal, explanatory, and questioning

skills.

D7. Report attended seminars,

conferences and workshops for further

development.

d1. Demonstrate competent presentation and

knowledge in class and respect questions from

colleagues and professors.

d2. Prove efficient skills in searching databases

and evidence-based guidelines.

d3. Display good time-management during talk,

case presentation and discussion.

D4. Report two attended conferences

D5. Apply effective listening skills during lectures

and oral presentations

E. Attitudes and ethical behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs.

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

E1. Apply regulations and ethics that govern

physicians in designing pre-clinical and clinical drug

development.

E9. Show respect to professors, colleagues, other

members of medical team and to patients.

Teaching/Learning Methods

Page 42: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Content (Units/Topics)

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Phase I Clinical Studies ✓ ✓

▪ Introduction ✓ ✓

▪ Disease-specific considerations ✓ ✓

▪ Beyond toxicity ✓ ✓

2. Pharmacokinetic and

Pharmacodynamic

Considerations in the

Development of Biotechnology

Products and Large Molecules

✓ ✓

▪ Monoclonal antibodies ✓ ✓

▪ Assay of macromolecules ✓ ✓

▪ Interspecies scaling of

macromolecules: predictions in

humans

✓ ✓

▪ Pharmacokinetic characteristics

of macromolecules

✓ ✓

▪ Pharmacodynamics of

macromolecules

✓ ✓

3. Design of Clinical Development

Programs

▪ Principles of clinical development ✓

▪ Legal and regulatory requirements ✓

▪ Evidence-based, goal-directed

clinical development

▪ Specific design issues in clinical

development programs

▪ Specific design issues in clinical

development programs

▪ Conduct of clinical development ✓

▪ Special topics (Personalized

Medicine, Elderly and Pediatric

Populations, Orphan Drugs,

Comparative Effectiveness,

Combination Treatments,

Transparency)

4. Role of the Administration (e.g. ✓

Page 43: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

FDA) in Guiding Drug

Development

▪ Why does the FDA get involved

in drug development?

▪ When does the FDA get involved

in drug development?

▪ How does the FDA guide drug

development?

▪ What are FDA guidances? ✓

▪ The role of the FDA office of

clinical pharmacology

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam %

Others (attendance/Assignment) 30%

List of Textbooks and References

Lecture Notes

Manuscripts of Assignment Topics prepared

by candidates and revised by supervising

professors.

Course Text Books

Drug Discovery and Development

UNDERSTANDING THE R&D

PROCESS (by innovation.org)

Biopharmaceutical Research &

Development: The Process Behind New

Medicines (www.phrma.org)

✓ ✓

✓ ✓

Page 44: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Suggested Extra Reading

1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic

Pharmacology.

Journals and Periodicals, others

Review articles on pubmed and Medscape on

Drug discovery and Development

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 45: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060806 Course Name: Optimizing and evaluating patient's therapy and assessment of drug effects

Program in which the Course is Given MSc in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Acquire advanced knowledge enabling the student to assess drug effect, evaluate and optimize drug

therapy.

.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques.

A1. Discuss Physiological and Laboratory Markers of Drug Effect A2.Review the role of Imaging in Drug Development A3. Enumerate Methods of Analysis of Drugs

and Drug Metabolites

A4. Discuss Dose–Effect and Concentration–Effect Analysis

A5. Explain Time Course of Drug Response

A6. State the Pharmacokinetic differences between Men and Women

0.5 0.5

Page 46: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors

B11. apply problem solving skills in

experimental and clinical issues

B1. Review Physiological and Laboratory Markers of Drug Effect B2. Compare between pharmacokinetics in male and female B3. Classify drugs according to their use in pregnancy and lactation

C.Professional

and Practical

Skills

C1. Assess drug pharmacokinetics

(solubility, absorption/ bioavailability and

bioequivalence, distribution and protein

binding, biotransformation, renal

excretion), and pharmacodynamics.

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C1. Apply update pharmacologic knowledge to

select the best drug combinations for a

particular indication

C2. Solve problems of polypharmacy, drug

interactions, decline of function of elimination

organs, drug adherence...etc especially in cases

of pregnancy and lactation.

C3. Criticize medication errors in prescriptions

in pregnancy and lactation

D. General

Skills

D1. Hold skills of class discussion and

critical evaluation of evidence presented

by publications or industry.

D2- Write reports and give oral

presentations

D3- Use web browsing to locate and

use online data bases.

D4. Apply effective listening skills and

elicit and provide information using

nonverbal, explanatory, and questioning

d1. Demonstrate competent presentation and

knowledge in class and respect questions

and inquires from colleagues and

professors.

d2. Prove efficient skills in searching databases

and evidence-based guidelines.

d3. Display good time-management during

talk, case presentation and discussion.

Page 47: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

skills.

E. Attitudes and ethical behavior

E8. Apply regulations and ethics during

laboratory work on experimental animals

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

E1. Apply regulations and ethical behavior

toward experimental animals during

laboratory work.

E2. Show respect during listening,

providing oral presentations and

experimental work towards other team

members.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Physiological and Laboratory Markers of Drug Effect

✓ ✓

2. Imaging in Drug Development. ✓ ✓

3. Dose–Effect and Concentration–Effect Analysis

✓ ✓ ✓

4. Time Course of Drug Response ✓ ✓

5. Disease Progress Models

✓ ✓

6. Pharmacokinetic differences between Men and Women

7. Drug Therapy in Pregnant and Nursing Women

✓ ✓

8. Clinical Analysis of Adverse Drug Reactions

✓ ✓

9. Quality Assessment of Drug Therapy

✓ ✓

Page 48: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 40 %

End of term 60 %

Distribution of Marks

Written Exam 60 %

Practical/Clinical Exam 40 %

Others (attendance/Assignment)

List of Textbooks and References

Lecture Notes

Manuscripts of Assignment Topics prepared

by candidates and revised by supervising

professors.

Course Text Books

1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic

Pharmacology.

Suggested Extra Reading

Journals and Periodicals, others

Review articles on pubmed and Medscape on

drug metabolism

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

✓ ✓

Page 49: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Program Director (Head of Department)

Name: Signature:

Page 50: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060807 Course Name: Pharmacotherapy (Rational use of drugs)

Program in which the Course is Given MS in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

To enable the student to recognize factors that make patients unique

To build up the ability of applying basic pharmacology knowledge in drug use in common medical

diseases.

To provide the student with the essentials of rules and regulation that govern prescribing

To enable the students to identify medication errors, adverse drug reactions and drug interactions.

To develop in the students the skills of:

• Good communication with patients and families

• Obtaining accurate drug history

• Developing a sound drug therapy plan

• Using information technology

• Finding evidence-based information

Intended Learning Outcomes (ILOs)

Program ILO (refer to program matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

A1.Review recent guidelines in

management of common diseases.

A2.Identify Principles of rational drug use A3.Discuss Clinical Use Of Antimicrobial Drugs A4.Outline Management of Rheumatoid Arthritis A5. Define Drug Therapy

2 2

Page 51: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

toxicity;

A4. Elucidate the cellular signaling pathways

relevant to drug discovery and disease;

considering the associated molecular and

genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

A6. Summarize the drug use and

management of diseases of special

populations

Individualization. A6. Explain Clinical Use of Antiepileptic Drugs A7. State lines of pain management

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to optimize

plasma drug concentration.

B2. Design an evidence-based treatment

strategies for a specific clinical cases in

the light of studied pharmacological

information to minimize medication

errors B11. apply problem solving skills in

experimental and clinical issues

B1.Describe the mechanism of action and

drug interactions related to the

management of common medical diseases

B2.Classify therapeutic approaches for

management of: Heart Failure, Ischemic

Heart Disease, Acute Coronary Syndromes,

Atrial Fibrillation, Hyperlipidemia

B3.Describe emergency management of

acute hepatic failure and acute coronary

syndrome

B4. Differentiate therapeutic guidelines

for treatment of Essential Hypertension,

Hypertensive emergency and Hypertension

in pregnancy

B5. Formulate therapeutic strategies for

common acute and chronic

gastrointestinal, neurologic,

immunologic, hematologic, infectious

and endocrinal disorders, taking into

Page 52: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

consideration the special precautions

needed in pediatric and geriatric patients.

C.

Professional

and Practical

Skills

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations

C8. Outline suggestions to improve patients

adherence to prescribed drugs

C9. Communicate basic information about

drug therapy to patients and their families,

including purpose of medication, how it

works, possible adverse drug reactions,

potential drug interactions, cost, and

necessary follow-up

C10. Identify and recommend appropriate

corrections of prescription errors

C11. Recognize drug compliance and

administrations errors and communicate

effectively with patients about them

C12. Recognize patient preferences for

treatment, patient concerns and goals about

disease and treatment

C1.Criticize different therapeutic

approaches for common medical

problems

C2.Organize a plan for therapeutic

management of patients with common

disorders with comorbidities

C3.Apply the pharmacological

knowledge in finding common medical

errors

C4.Design systematic approaches

management of hepatic patients

C5.Use trials to compare the

appropriateness of different therapeutic

approaches in specific populations..

C6. Compare available classes of available

drugs, regarding their efficacy, safety,

suitability and cost.

C7. Communicate effectively with patients

about them

D. General

Skills

D1. Hold skills of class discussion and critical

evaluation of evidence presented by

publications or industry.

D2- Write reports, design poster presentation

d1. Demonstrate competent presentation

and knowledge in class and respect

questions and inquires from colleagues and

professors.

Page 53: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

and give oral presentations

D3- Use web browsing to locate and use

online data bases.

D4. Apply effective listening skills and elicit

and provide information using nonverbal,

explanatory, and questioning skills.

D5. Integrate effectively with others as a

member or leader of a health care team.

D6. Participate in community and

professional organizations.

D7. Report attended seminars, conferences

and workshops for further development.

D8. Plan training courses to improve practice

and enhance performance of juniors..

d2. Prove efficient skills in searching

databases and evidence-based guidelines.

d3. Demonstrate clinical cases and Display

good time-management during talk, case

presentation and discussion.

D4. Communicate basic information about

drug pharmacokinetics and

pharmacodynamics to patients and their

families

D5. Apply effective listening skills during

lectures and seminars and during

communication with patients.

Attitudes and ethical behavior

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of

drugs.

E6. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E7. Integrate with other members of

medical team to provide the patients the

appropriate medical care

E9. Show respect to professors, colleagues,

other members of medical team and to

patients.

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of

drugs and in communication with patients

and other medical team members.

E2. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E3. Integrate with physicians and nurses to

provide the patients the appropriate medical

care

E4. Show respect to professors, colleagues

during lectures and oral presentations, other

members of medical team and to patients

during drug councelling.

Page 54: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Recent guidelines in management

of common diseases

✓ ✓ ✓

2. Principles of rational drug use ✓ ✓

3. Clinical Use Of Antimicrobial Drugs ✓ ✓

4. Clinical Use of HCV & HIV Drugs ✓ ✓ ✓

5. Management of Rheumatoid Arthritis

✓ ✓

6. Drug Therapy Individualization in Patients with Hepatic Disease or Genetic Alterations in Drug Metabolizing Activity

✓ ✓ ✓

7. Clinical Use of Antiepileptic Drugs ✓ ✓ ✓

8. Drug Therapy Individualization for Patients with Renal Insufficiency

✓ ✓ ✓ ✓

9. Pain Management ✓ ✓

10. C.V.S. Disorders – I Essential Hypertension

Hypertensive emergency

Hypertension in pregnancy

Heart Failure

✓ ✓ ✓ ✓

11. C.V.S. Disorders - II Ischemic Heart Disease

Acute Coronary Syndromes

Atrial Fibrillation

Hyperlipidemia

✓ ✓

12. Respiratory Disorders: Bronchial Asthma

✓ ✓

Page 55: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Community Acquired Pneumonia

Nosocomial Pneumonia

Tuberculosis

GIT Disorders:

Chronic Inflammatory Bowel Disease

Peptic Ulcer Disease

Portal Hypertension and Cirrhosis

Viral Hepatitis

Traveler’s Diarrhea

✓ ✓

Neurologic Disorders:

Ischemic Stroke

Generalized Tonic-Clonic Seizures.

Parkinson’s Disease

Migraine

✓ ✓

Endocrinology, Metabolism, and Diabetes

Disorders- I:

Diabetes Mellitus (NIDDM)

Diabetes Mellitus (IDDM)

Hyperthyroidism

Hypothyroidism

✓ ✓

Immunologic And Rheumatologic

Disorders:

Rheumatoid Arthritis

Osteoarthritis

Gout and Hyperuricemia

Solid-Organ Transplantation

✓ ✓ ✓

Page 56: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Hematologic Disorders:

Iron Deficiency Anemia

Megaloplastic Anemia

Acute Leukemia

Human Immunodeficiency Virus Infection

✓ ✓

Infectious Disease-I:

Bacterial Meningitis

Typhoid fever

Osteomyelitis

Urinary Tract Infections

✓ ✓

Infectious Disease-II:

Cellulitis

Infective Endocarditis

Intraabdominal Infections

Gonorrhea

✓ ✓ ✓

Pediatric Disorders:

Pediatric Gastroenteritis

Rheumatic fever

Meningitis in childhood

Acute childhood leukemia

✓ ✓ ✓

Geriatric Disorders:

Dementia

Urinary Incontinence

Osteoporosis

✓ ✓ ✓

Page 57: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Emergency:

Cardiopulmonary Arrest

Anaphylactic shock

Sepsis and Septic Shock

Diabetic ketoacidosis

✓ ✓ ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam 30 %

Others:

List of Textbooks and References

Lecture Notes

Course Text Books

• Katzung Basic and Clinical

Pharmacology

• Martindale: The Extrapharmacopoeia

✓ ✓

Page 58: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

• JM Ritter, LD Lewis, TG Mant & A

Ferro (Eds.), A Textbook of Clinical

Pharmacology and Therapeutics.

• Harrison’s Principles of Internal

Medicine

Suggested Extra Reading

--

Journals and Periodicals, others

• British journal of Pharmacology

• The Journal of Clinical Pharmacology

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 59: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05160801 Course Name: Basic Pharmacoeconomics

Program in which the Course is Given MD in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Define pharmacoeconomic concepts and terminology. Compare different types of pharmacoeconomic

analysis. Apply knowledge to provide healthcare decision-makers with valuable information and

allowing optimal allocation of limited resources, and discuss future perspectives.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix)

Course ILOs

A. Knowledge

and

Understanding

A9. Outline the concept of

pharmacoeconomics.

A10. Classify types of

pharmacoeconomic analysis.

A1. Define pharmacoeconomic concepts.

A2. Enumerate the sources and data needed

for pharmacoeconomic studies.

A3. Define cost-of-illness, and cost-

minimization analysis.

A4. Discuss cost-benefit , cost utility

analysis

A5. Explain cost effectiveness and

incremental analysis.

A6. Compare Define sensitivity analysis.

1

Page 60: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B. Intellectual

skills

B9. Compare different types of

pharmacoeconomic analysis.

B10. Discuss future perspectives.

B1. Compare different types of

pharmacoeconomic analysis.

B2. Differentiate between cost

effectiveness and incremental analysis.

B3. Explain how pharmacoeconomics can

enhance clinical practice.

C.Professional

and Practical

Skills

C7.Design a pharmacoeconomic study.

C8. Outline suggestions to improve

C1. Apply pharmacoeconomic analysis on

6 case studies.

C2. Interpret policy decisions for selected

cas studies.

D. General

Skills

D1. Hold skills to critically evaluate

evidence presented by publications or

industry.

D1. Write scientific article under the basics

of scientific research.

D2. Work in a multi-disciplinary team.

A. Attitudes and ethical behavior

E9. Show respect to professors,

colleagues, other members of medical

team and to patients

E1. Show respect to professors, colleagues,

during lectures, seminars and oral

presentations

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

Concept of pharmacoeconomics ✓

Examples of researches and published

data

✓ ✓

Data source for PE ✓

Enhancement of clinical practice by PE

studies

Types of PE analysis ✓ ✓

Page 61: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Objectives and research outcomes ✓

Cost effectiveness and incremental

analysis

✓ ✓

Perspectives in PE And sensitivity

analysis

✓ ✓

Application for 6 case studies ✓

Analysis of data ✓ ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam

Others 30 %

List of Textbooks and References

Lecture Notes

Course Text Books

• Arnold R. (2010), Pharmacoeconomics

From Theory to Practice. CRC Press,

Taylor & Francis Group

• Bootman JL, Townsend RJ, McGhan WF.

Principles of Pharmacoeconomics, 3rd ed.

Cincinnati, OH: Harvey Whitney Books,

✓ ✓

✓ ✓

Page 62: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

2005.

• Barner J, Rascati K. Cost-benefit analysis.

In Grauer D, Lee J, Odom T, et al., eds.

Pharmacoeconomics and Outcomes, 2nd

ed. Kansas City, MO: American College of

Clinical Pharmacy, 2003:115–132.

Suggested Extra Reading

Drummond MF, O’Brien BJ, Stoddart GL,

Torrance GW (1997). Basic types of economic

evaluation. In: Drummond MF, O’Brien BJ,

Stoddart GL, Torrance GW (eds). Methods for

the Economic Evaluation of Health Care

Programmes. Oxford University Press: New

York, pp. 6–26.

Journals and Periodicals, others

PharmacoEconomics Journal.

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 63: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060809 Course Name: Drug metabolism and transport

Program in which the Course is Given MSc in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Acquire advanced knowledge related to variable types of drug transport and drug metabolic

pathways

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

0.5 0.5

Page 64: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

A1. Identify Basics of genetics

A2. Discuss mechanisms and Genetics of drug

transport.

A3.Define drug metabolism

A4.Review different pathways of drug

metabolism

A5. Illustrate instruments used in analysis

(Chromatographic Separations, Absorption

and Emission Spectroscopy, Immunoaffinity

Assays, Mass Spectrometry, etc)

A6. Enumerate Methods of Analysis of Drugs

and Drug Metabolites

A7. Discuss the role of liver and kidney in drug

metabolism

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors B5. Perform Preclinical Prediction of

Human Pharmacokinetics

B10. Discuss future perspectives.

B11. apply problem solving skills in

experimental and clinical issue

B1. Solve problems of dose adjustment in

renal and hepatic impairment

B2. Report on and interpret:

- Drug-drug interactions

- Drug-disease interaction

- Drug- food interactions.

B3. Design therapeutic plan for specific

clinical cases, avoiding drug

interaction at the level of drug

metabolism and transport .

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C.Professional

and Practical

Skills

C1. Assess drug pharmacokinetics

(solubility, absorption/ bioavailability and

bioequivalence, distribution and protein

binding, biotransformation, renal

excretion), and pharmacodynamics.

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C1. Apply update pharmacologic knowledge to

select the best drug combinations for a

particular indication

C2. Solve problems of polypharmacy, drug

interactions, decline of function of elimination

organs, drug adherence...etc.

C3. Criticize medication errors in some

prescriptions.

D. General

Skills

D1. Hold skills of class discussion and

critical evaluation of evidence

presented by publications or

industry.

d1. Demonstrate competent presentation and

knowledge in class and respect questions

and inquires from colleagues and

professors.

d2. Prove efficient skills in searching databases

and evidence-based guidelines.

d3. Display good time-management during

talk, case presentation and discussion.

E. Attitudes and ethical behavior

E8. Apply regulations and ethics during

laboratory work on experimental animals

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

E1. Apply regulations and ethical behavior

toward experimental animals during

laboratory work.

E2. Show respect during listening,

providing oral presentations and

experimental work towards other team

members.

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Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Basics of genetics ✓

2. Pathways of Drug Metabolism. ✓

3. Methods of Analysis of Drugs and Drug Metabolites

4. Clinical Pharmacogenetics ✓

5. Mechanisms and Genetics of Drug Transport

6. Drug Interactions ✓

7. Basis of instruments used in analysis, etc

✓ ✓

8. (Chromatographic Separations ✓ ✓

9. Absorption and Emission Spectroscopy

✓ ✓

10. Immunoaffinity Assays ✓ ✓

11. Mass Spectrometry ✓ ✓

Page 67: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 40 %

End of term 60 %

Distribution of Marks

Written Exam 80 %

Practical/Clinical Exam 20%

Others (attendance/Assignment)

List of Textbooks and References

Lecture Notes

Manuscripts of Assignment Topics prepared

by candidates and revised by supervising

professors.

Course Text Books

1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic

Pharmacology.

Suggested Extra Reading

Journals and Periodicals, others

Review articles on pubmed and Medscape on

drug metabolism

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

✓ ✓

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Program Director (Head of Department)

Name: Signature:

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Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060810 Course Name: Applied Internal Medicine

Program in which the Course is Given MS in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

To enable the student to recognise factors that make patients unique

To build up the ability of applying basic pharmacology knowledge in drug use in common medical

diseases.

To provide the student with the essentials of rules and regulation that govern prescribing

To enable the students to identify medication errors, adverse drug reactions, drug interactions and

overdosage.

To develop in the students the skills of:

• Good communication with patients and families

• Obtaining accurate drug history

• Developing a sound drug therapy plan

• Using information technology

• Finding evidence-based information

Intended Learning Outcomes (ILOs)

Program ILO (refer to program matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

A1.Describe the clinical picture of

common cardiovascular, hepatic,

pulmonary, GIT, endocrine and

rheumatic diseases.

A2.Identify the laboratory

investigations required in diagnosing

such disorders

A3.List drugs used in these common

0.5 2.5

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toxicity;

A4. Elucidate the cellular signaling pathways

relevant to drug discovery and disease;

considering the associated molecular and

genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

A6. Summarize the drug use and

management of diseases of special

populations

A8. Describe in details clinical trials, and

compare between its different phases

disorders

A5.Outline approaches in management

of anemias.

A6. . Elucidate the cellular signaling

pathways mediating the

pharmacological actions of drugs used

in common cardiovascular, hepatic,

pulmonary, GIT, endocrine and

rheumatic diseases.

A7. Discuss types of adverse drug

reactions.

A7. Summarize the drug use and

management of diseases of hepatic and

renal patients

A8. Describe in details phases of clinical

trials.

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to optimize

plasma drug concentration.

B2. Design an evidence-based treatment

strategies for a specific clinical cases in

the light of studied pharmacological

information to minimize medication

errors B10. Discuss future perspectives.

B11. apply problem solving skills in

experimental and clinical issues

B1.Describe the mechanism of action

and drug interactions related to the

management of common medical

diseases

B2.Classify therapeutic approaches for

management of: viral hepatitis,

anemia, diabetes mellitus,

inflammatory bowel disease,

arrhythmia, rheumatoid a & gouty

arthritis, and systemic lupus

erythematosis

B3.Describe emergency management

of acute hepatic failure and acute

coronary syndrome

Page 71: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B4. Differentiate therapeutic

guidelines for treatment of: liver

cirrhosis, osteoarthritis, adrenocortical

disorders, peptic ulcer, gastro-

intestinal infections, heart failure,

hypertension, dyslipidemia,

pneumonias and tuberculosis.

C. Professional

and Practical

Skills

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations

C6.Criticize the Non-Clinical Drug

Development

C9. Communicate basic information about

drug therapy to patients and their families,

including purpose of medication, how it

works, possible adverse drug reactions,

potential drug interactions, cost, and

necessary follow-up

C10. Identify and recommend appropriate

corrections of prescription errors

C11. Recognize drug compliance and

administrations errors and communicate

effectively with patients about them

C12. Recognize patient preferences for

treatment, patient concerns and goals about

disease and treatment

C1.Criticize different therapeutic

approaches for common medical

problems

C2.Organize a plan for therapeutic

management of patients with common

disorders with comorbidities

C3.Apply the pharmacological

knowledge in finding common

medical errors

C4.Design systematic approaches

managrmrnt of hepatic patients

C5.Use trials to compare the

appropriateness of different

therapeutic approaches in specific

populations..

C6.Identify examples of recently

published advances in treatment of

diabetes

C7. Communicate basic information

about drug therapy of common internal

medicine cases, to patients and their

families, including purpose of medication,

how it works, possible adverse drug

reactions, potential drug interactions,

cost, and necessary follow-up

Page 72: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

C8. Identify and recommend appropriate

corrections of prescription errors for

diabetes mellitus

C9. Recognize preferences of diabetic

patient for treatment

D. General Skills

D1. Hold skills to critically evaluate

evidence presented by publications.

D1.Perform practice-based

improvement activities using a

systematic methodology

D2.Appraise evidence from scientific

studies

D3.Participate in one audit related to

pharmacology

E. Attitudes and

ethical behavior

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of

drugs.

E2. Explain to patients the possible

participation as human research subjects in

clinical trials,

E3. Integrate essential elements for

informed consent

E4. Obtain consent that is truly informed

E5. Manage special challenges of performing

clinical research in vulnerable populations

E6. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E7. Integrate with other members of

medical team to provide the patients the

appropriate medical care

E8. Apply regulations and ethics during

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs used in common

internal medicine diseases.

E2. Explain to patients the possible

participation as human research

subjects to participate in phase III

clinical trials,

E3. Integrate essential elements for

informed consent taken from the

patient before incorporation in clinical

trial

E4. Obtain consent from patients

tending to participate in clinical trials,

that is truly informed

E5. Manage special challenges of

performing clinical research in

vulnerable populations, like elderly,

diabetic and patients with renal failure

E6. Manage confusion of roles in

academic medical centers and

problems with duplicative, interactive,

or conflicting drug treatment plans

E7. Integrate with other members of

medical team to provide the diabetic,

renal and hepatic patients the

Page 73: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

laboratory work on experimental animals

E9. Show respect to professors, colleagues,

other members of medical team and to

patients.

appropriate medical care

E8. Show respect to professors,

colleagues during lectures, seminars and

oral presentation and to other members

of medical team and to patients in clinical

practice.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Viral hepatitis ✓ ✓ ✓

2. Liver cirrhosis & Acute hepatic

failure

✓ ✓

3. Degenerative joint disease

(osteoarthritis)

✓ ✓

4. Rheumatoid arthritis ✓ ✓ ✓

5. Systemic lupus erythematosus ✓ ✓

6. Gouty arthritis ✓ ✓ ✓

7. Approach to anemia ✓ ✓ ✓

8. Diabetes mellitus: type1 & type 2 ✓ ✓ ✓ ✓

9. Chronic adrenocortical

insufficiency (Addison’s disease) &

hypercorticolism (Cushing’s

syndrome)

✓ ✓

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10. Peptic ulcer disease

✓ ✓ ✓ ✓

11. Inflammatory bowel disease

✓ ✓

12. Gastrointestinal infections ✓ ✓

13. Acute coronary syndromes ✓ ✓

14. Disturbances in rate and rhythm ✓ ✓

15. Heart failure ✓ ✓

16. Systemic hypertension ✓ ✓ ✓

17. Lipid and lipoprotein disorders ✓ ✓

18. Tuberculosis ✓ ✓

19. Pneumonias ✓ ✓ ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks Written Exam 70 %

✓ ✓

Page 75: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Practical/Clinical Exam 30 %

Others:

List of Textbooks and References

Lecture Notes

Course Text Books

• Katzung Basic and Clinical

Pharmacology

• Martindale: The Extrapharmacopoeia

• JM Ritter, LD Lewis, TG Mant & A

Ferro (Eds.), A Textbook of Clinical

Pharmacology and Therapeutics.

• Harrison’s Principles of Internal

Medicine

Suggested Extra Reading

--

Journals and Periodicals, others

• British journal of Pharmacology

• The Journal of Clinical Pharmacology

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 76: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060811 Course Name: Applied Emergency Medicine

Program in which the Course is Given MD in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Discuss basic and advanced measures for management of emergency situations. Recognize important

pharmacokinetic and pharmacodynamic changes in critically ill patients. Gain advanced knowledge and

apply recent guidelines to construct effective management plan in emergency room.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A1. discuss the pharmacodynamic and

pharmacokinetic concepts.

A2. discuss the effect of renal and/or

hepatic dysfunction on the dynamic

characteristics of commonly used drugs in

emergency situations.

A3. Discuss changes in sensitivity to some

drugs in liver diseases (Benzodiazepines, β-

Adrenergic blockers, β-Lactam antibiotics).

0.5 0.5

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B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors

.

B1. Recommend the appropriate use of

different drugs used in myocardial

infarction.

B2. Formulate evidence-based treatment

strategies for patients with acute

decompensated heart failure.

B3. Select the appropriate use of fluids,

vasopressors, antibiotics, and

corticosteroids in patients with sepsis, or

septic shock.

B4. Choose alternative drugs to avoid

potential drug interactions.

B5. Classify patients, assess control, and

select and monitor appropriate acute and

preventive treatments for pediatric and adult

patients with asthma.

B6. Classify factors that influence the

dosing of antibiotics in critical illness (Drug

factors, Patient factors).

C.

Professional

and Practical

Skills

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations

C1. Apply the appropriate calculations for

drug dosing in patients with renal diseases.

C2. Acquire the ability to recognize errors

in prescribing multidrug therapy which may

have significant, life threatening drug

interactions.

D. General

Skills

D1. Hold skills to critically evaluate

evidence presented by publications.

D1. Write scientific article under the basics

of scientific research.

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D2. Work in a multi-disciplinary team.

E. Attitudes

and ethical

behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs.

E2. Explain to patients the possible

participation as human research subjects

in clinical trials,

E3. Integrate essential elements for

informed consent

E4. Obtain consent that is truly informed

E5. Manage special challenges of

performing clinical research in vulnerable

populations

E6. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E7. Integrate with other members of

medical team to provide the patients the

appropriate medical care

E8. Apply regulations and ethics during

laboratory work on experimental animals

E9. Show respect to professors,

colleagues, other members of medical

team and to patients.

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs used in common internal

medicine diseases.

E2. Explain to patients the possible

participation as human research subjects to

participate in phase III clinical trials,

E3. Integrate essential elements for

informed consent taken from the patient

before incorporation in clinical trial

E4. Obtain consent from patients tending to

participate in clinical trials, that is truly

informed

E5. Manage special challenges of

performing clinical research in vulnerable

populations, like elderly, diabetic and

patients with renal failure

E6. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

E7. Integrate with other members of

medical team to provide the diabetic, renal

and hepatic patients the appropriate medical

care

E8. Show respect to professors, colleagues

during lectures, seminars and oral presentation

and to other members of medical team and to

patients in clinical practice.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Pharmacokinetic and ✓ ✓

Page 79: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

pharmacodynamic concepts

2. The altered pharmacokinetics

and pharmacodynamics of drugs

commonly used in critically ill

patients.

✓ ✓

3. Management of severe Sepsis

and Septic Shock.

✓ ✓

4. Management of myocardial

infarction.

✓ ✓

5. The use of antimicrobials in

the treatment of infection in

critically ill patient.

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam 30 %

Others %

List of Textbooks and References

Lecture Notes

✓ ✓

Page 80: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Text Books

• Ritter J, Lewis L, Mant T, Ferro A.

(2008) A text book of Clinical

pharmacology and therapeutics, 5th ed.,

Charon Tec Ltd (A Macmillan

Company).

• Park G, and Shelly M. (2001)

Pharmacology of the critically ill. J W

Arrowsmith Ltd, Bristol.

Suggested Extra Reading

• Craig C, Stitzel R. Modern pharmacology

with clinical applications, 6th ed,

Journals and Periodicals, others

• Ann. Rev. Pharmacol

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 81: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060812 Course Name: Clinical Pediatrics

Program in which the Course is Given MS in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Gain advanced knowledge in optimizing use of medications for individual children and provide

advanced clinical training in the areas of pediatric pharmacotherapy. The primary emphasis of the

course is to develop independent problem-solving skills in pediatrics pharmacotherapy. This includes

the establishment of a firm knowledge base in pediatric pharmacology and pharmacokinetics; and the

ability to provide therapeutic interventions to enhance the management of pediatric patients.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

1 1

Page 82: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

A6. Summarize the drug use and

management of diseases of special

populations

A1.Describe of the developmental changes

in newborns, infants, and children

A2.Discuss age-related changes in

pharmacokinetics (PK) and

pharmacodynamics (PD ) for several

commonly used classes of drugs.

A3.Identify areas of active research on

pediatric pharmacology

A4Explain pediatric clinical trials and

methods of improvement of pediatric drug

study designs

A5. Discuss pathophysiology and

pharmacologic management of pediatric

diseases

A6. Review guidelines for pediatric disease

management

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors

B1. Implicate changes in pharmacokinetics

and pharmacodynamics for dose selection

and assessment of benefits and risks of

drugs used in treating different pediatrics

diseases.

B2. Select most appropriate drugs to treat

pediatric diseases in children with renal or

hepatic impairment

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B3. Apply knowledge of drug

pharmacokinetics to select safe drugs to be

given to a lactating child.

C.

Professional

and Practical

Skills

C2. work effectively and safely in a clinical

and laboratory environment

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations

C1. work effectively and safely in a clinical

environment

C2 Recommend rational use of drugs in

pediatrics

C3 Practice pediatric case study, analysis,

drug selection and dose adjustment

C4. Practice methods to promote adherence of

parents to prescribed drugs

D. General

Skills

D1. Hold skills of class discussion and

critical evaluation of evidence presented

by publications or industry.

D2- Write reports, design poster

presentation and give oral presentations

D3- Use web browsing to locate and use

online data bases.

D4. Apply effective listening skills and elicit

and provide information using nonverbal,

explanatory, and questioning skills.

D5. Integrate effectively with others as a

member or leader of a health care team.

. D7. Report attended seminars,

conferences and workshops for further

development

D1. Criticize the challenges inherent in

pediatric clinical trials and awareness of

ongoing efforts to improve on pediatric drug

study designs

D2.Hold skills to critically evaluate

evidence presented by publications

concerning pediatric pharmacology..

D3- Use web browsing to locate and use online

data bases to summarize guidelines for

common pediatric diseases

D4. Report three attended seminars,

conferences related to pediatric medicine

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Attitudes and ethical behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs

E9. Show respect to professors,

colleagues, other members of medical

team and to patients

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of drugs

used in pediatrics

E9. Show respect to professors, colleagues,

other members of medical team and to

patients in clinical practice

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Developmental

Pharmacodynamics

2. Pharmacometabolomic

Implications for Clinical

Pharmacology

3. Pediatric Pharmacogenetics:

Discovery to Clinical

Implementation

4. How Physiologic Changes in

the child Influence Drug

pharmacokinetics

✓ ✓

5. Optimal Study Design in

Pediatric Clinical

Pharmacology Research

6. Pharmacokinetic Modeling and

Trial Desig

✓ ✓ ✓

7. Pharmacotherapy of CNS ✓ ✓ ✓

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diseases in pediatrics

8. Pharmacotherapy of Pediatric

Cardiovascular diseases

✓ ✓ ✓

9. Pharmacotherapy of Pediatric

Infectious diseases

✓ ✓ ✓

10. Pharmacotherapy of Pediatric

endocrine disorders

✓ ✓ ✓

11.Pharmacotherapy of Pediatric

cancer and blood disorders

✓ ✓ ✓

12. Pharmacotherapy of Pediatric

respiratory disorders

✓ ✓ ✓

13. Safe use of drugs for a lactating

child

✓ ✓ ✓

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14. Extemporaneous Formulations -

Problems and Solutions

✓ ✓ ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam 30 %

Others %

List of Textbooks and References

Lecture Notes

Course Text Books

• .Nelson Textbook of Pediatrics

Suggested Extra Reading

• Textbook on Pediatric Clinical

Pharmacology. The basis of rational drug

therapy in children. Edited by S M

MacLeod.....

Journals and Periodicals, others

• WHO medication handbook in Pediatrics

Course Instructor

Name: Azza Baraka Signature:

✓ ✓

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Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Samia Mohammed Ali Signature:

Page 88: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 05060813 Course Name: Clinical Geriatrics

Program in which the Course is Given MSc in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Acquire advanced knowledge and problem solving skills to guide prescribing in geriatric disorders

based on updated guidelines and evidence-based practices.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

0.5 0.5

Page 89: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A2. Discuss the sources of individual

variations in drug response

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A4. Elucidate the cellular signaling

pathways relevant to drug discovery and

disease; considering the associated

molecular and genetic techniques.

A5. Discuss and appraise the clinical

management of various clinical cases,

illustrating their related problems; such as

adverse drug reactions, interactions,

contraindications, carcinogenicity and

teratogenicity.

A6. Summarize the drug use and

management of diseases of special

populations

A1.Discuss theories of aging process

A2. Mention the physiological changes of

aging

A3. Review the special health needs for this

cohort of population.

A4. Discuss the changes in liver and kidney

functions with aging and impact of these on

plasma drug levels and drugs' half-lives.

A5. Explain the pharmacodynamic changes in

geriatric patient and alterations in

magnitude of drug effects.

A6. Discuss pathophysiology, clinical features,

diagonsis , non-pharmacologic and

pharmacologic management of geriatric

disorders affecting different body systems.

A7. Review updates on guidelines and

evidence-based practices for prescribing.

A8. Discuss nutrition and exercises that can

be prescribed to geriatric patients in

the ambulatory setting as part of their

health maintenance. A9. Discuss the impact of natural products and

herbal medicines used by elderly for

possible interactions with drugs.

A10. Identify principles for appropriate

prescription of drugs in geriatric patients to

avoid adverse effects, drug interactions and

minimize polypharmacy.

A11. Discuss how to promote adherence to a

prescribed drug regimen

Page 90: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B. Intellectual

skills

B1. Apply the pharmacokinetic

information to justify drug plasma

concentrations according to number of

doses given to the patient and to

optimize plasma drug concentration.

B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of studied

pharmacological information to

minimize medication errors .

B1. Perform a comprehensive assessment

of clinical case presentation.

B2. Design a treatment plan for the

clinical diagnosis.

B3. Solve problems of dose adjustment in

renal and hepatic impairment.

B4. Incorporate evidence-based medicine

into geriatric medicine.

B5. Report on and interpret:

- Drug history

- previous or current adverse drug

reactions.

- Drug-drug interactions

- Drug-disease interaction

- Drug- food interactions.

B6 Design appropriate methods improve

adherence to a prescribed drug

regimen.

C.Professional

and Practical

Skills

C3.Recommend the drug (S) of choice for a

particular clinical presentation.

C4.Compare available classes of drugs.

C5.Criticize specific drugs in specific

situations .

C1. Apply update pharmacologic knowledge to

select the best drug for a particular indication

C2. Solve problems of polypharmacy, drug

interactions, decline of function of elimination

organs, drug adherence...etc.

C3. Apprise the cardioprotective,

neuroprotective and renoprotective

effects of some drug classes that favor

their use over other counterparts.

C4. Criticize medication errors in some

prescriptions.

D. General

Skills

D1. Hold skills of class discussion and

critical evaluation of evidence

presented by publications or

d1. Demonstrate competent presentation and

knowledge in class and respect questions

and inquires from colleagues and

professors.

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industry.

D2- Write reports, design poster

presentation and give oral presentations

D3- Use web browsing to locate and use

online data bases.

d2. Prove efficient skills in searching databases

and evidence-based guidelines.

d3. Display good time-management during

talk, case presentation and discussion.

Attitudes and ethical behavior

E1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs.

E9. Show respect to professors,

colleagues, other members of

medical team and to patients.

E1. Apply regulations and ethics that govern

physicians in promotion and detailing of drugs

used for treatment of common geriatric

diseases.

E2. Show respect to professors, colleagues, other members of medical team and to patients during drug councelling.

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Aging biology ✓

2. Altered pharmacokinetics and Pharmacodynamics in aging population.

✓ ✓ ✓

3. Managing diabetes mellitus and thyroid disease in the elderly

✓ ✓ ✓

4. Issues concerning common infections in elderly.

✓ ✓ ✓

5. Issues in geriatric dermatology ✓ ✓ ✓

6. Dealing with dementia, Alzheimer's disease and depression.

✓ ✓ ✓

7. Pharmacotherapy issues of managing chronic pain in the

✓ ✓ ✓

Page 92: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

geriatric population

8. Nutrition and exercise in the elderly

9. Natural medicines used by the elderly

10. Ethical prescribing in the geriatric patient

11. Improving medication use in the elderly and enhancing medication adherence

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 40 %

End of term 60 %

Distribution of Marks

Written Exam 60 %

Practical/Clinical Exam 20 %

Others (attendance/Assignment) 20 %

List of Textbooks and References

Lecture Notes

Manuscripts of Assignment Topics prepared

by candidates and revised by supervising

professors.

Course Text Books

Geriatric Pharmacology - The

Principles of Practice & Clinical

Recommendations (by Steven Atkinson)

Suggested Extra Reading

1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic

Pharmacology.

✓ ✓

✓ ✓

Page 93: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Journals and Periodicals, others

Review articles on pubmed and Medscape on

geriatric pharmacology

Course Instructor

Name: Madiha Abdel-Halim Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:

Page 94: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Specifications

University: Alexandria

Faculty: Medicine

Department: Clinical pharmacology

Course Information

Course Code: 05060814 Course Name: Drug poisoning

Program in which the Course is Given Ms in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Gain advanced knowledge and apply recent laboratory techniques that helps in understanding

the pharmacokinetic aspects of different therapeutic agents and its implications in the field of

drug poisoning and toxicology with exploration of recent guidelines in their evaluation and

management aiming to improve outcome and decrease in both drug related morbidity and

mortality.

Intended Learning Outcomes (ILOs)

Program ILO (refer to program

matrix) Course ILOs

1 2

Page 95: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

A. Knowledge

and

Understanding

A1. Review the fundamental principles of

pharmacology, drug discovery and drug

development.

A3. Explain in depth the molecular

mechanisms underlying pharmacokinetics

and pharmacodynamics and their relations

to manifestations and therapy of drug

toxicity;

A1. Define the therapeutic agents most involved

in increased toxic effects.

A2. Discuss their pharmacokinetics in details.

A3. review their recoded toxic effects.

A4. describe recent advances in methods for

clinical assessment of patient with drug

poisoning.

A5. review recent laboratory investigation

involved in drug related adverse reaction.

A6. Discuss in detail the specific diagnostic tool

for each drug related toxicity.

A7. Discuss general lines of management of

intoxication patient.

A8. explain that specific measures of each agent

with the specific antidote if available.

A10. Discuss different categories of teratogenic

drugs.

A11. Discuss optimal drug choice in pregnancy.

A12. Identify drugs with high carcinogenic

potentials

A13. Discuss in measures to reduce the risk.

Page 96: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

B. Intellectual

skills

. B2. Design an evidence-based

treatment strategies for a specific

clinical cases in the light of

studied pharmacological

information to minimize

medication errors

B1. Compare pharmacokinetic aspects of

different alternative.

B2. Select optimal drug suitable to each patient

with specific conditions.

B3. Select optimal drug in patient with

increased activity of drug metabolizing enzyme.

B4. Select optimal drug in patient receiving

other drugs which inhibit or stimulate

metabolizing enzymes.

C.Professional

and Practical

Skills

C5.Criticize specific drugs in specific

situations

C10. Identify and recommend appropriate

corrections of prescription errors

C1. Apply recent laboratory techniques in

clinical and analytical toxicology.

C2. Implement the quantitative evaluation of

plasma drug level in drug discovery and

development

C3. Design kinetics of different therapeutic

agents.

C4. Apply the mathematical calculations for

Steady State Analysis of plasma drug level.

D. General

Skills

D1. Hold skills to critically evaluate

evidence presented by publications

or industry.

D1. Identify examples of Pharmacologically

Interesting recent advances in manipulating

drugs with high toxic risk.

D2. Acquire the ability to recognize errors in

prescribing multidrug therapy which may

interact and to correct these errors.

Attitudes and ethical behavior

E9. Show respect to professors,

colleagues, other members of

medical team and to patients

E1. Show respect to professors, colleagues,

Page 97: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Pharmacology, kinetics, toxic effects of different drugs.

✓ ✓

2. Recent guidelines for evaluation of patient with drug toxicity.

✓ ✓

3. General and specific lines in management of drug toxicity.

✓ ✓

4. Pharmacokinetic and dynamic aspects of intoxication in vulnerable groups.

✓ ✓

5. Carcinogenic and teratogenic agents, how to minimize the risk

✓ ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam 30 %

Others %

List of Textbooks and References

Lecture Notes

Course Text Books

• Michael J. Derelanko (2014), Handbook of

✓ ✓

Page 98: University: Alexandria Faculty: Medicine Programme ...exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding

toxicology, 3nd ed., Wiley, New York.

• Abou-Donia Mohamed B (2015), Mammalin

toxicology, 1st ed., Wiley, New York.

Suggested Extra Reading

Journals and Periodicals, others

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature: