CLINICAL & PHARMACEUTICAL BIOTECHNOLOGY [As per Choice Based Credit System (CBCS) scheme] SEMESTER –VIII Sub. Code : 15BT 81 I.A Marks : 20 Hours/week : 4 Exam Hrs. : 3 Total Hours : 50 Exam Marks : 80 CREDITS – 04 Course objectives: The objective of this course is to educate students about drug design, formulation; importance of pharmacokinetics & pharmacodynamics study. To list the applications & advantages of Pharmaceutical & Clinical Biotechnology MODULES TEACHING HOURS REVISED BLOOM’S TAXONOMY (RBT) LEVEL MODULE – 1 DRUG MANUFACTURE AND FORMULATION Introduction to pharma industry, Biotechnology and Drug design, Basic concepts and applications, composition, preparation, physicochemical considerations in manufacture of current biotech products & herbal medicines. Need of formulation and formulation development considerations. Concept & testing of preformulation & their parameters. Tablets: compressed, granulation, coatings, pills, capsules. Parental preparations, herbal extracts, Oral liquids, Ointments. Analytical methods and tests for various drugs, packaging techniques- Glass containers, plastic containers, film wrapper, bottle seals; storage and stability of biotech products. 10 L1, L2, L3 MODULE –2 PHARMACOKINETICS AND PHARMACODYNAMICS Pharmacodynamics and Pharmacokinetics of protein based drugs. Disease target identification and selection, receptor-based approaches, agonists, antagonists, enzyme inhibitors Basic concepts, ADME definitions, Need of pharmacokinetic study; Interpretations from pharmacokinetics parameters, Examples of Pharmacodynamic parameters of various drugs; Evolution of Drug Metabolism Phase I Metabolism (microsomal oxidation, hydroxylation, dealkylation) Phase II 10 L1, L2, L3
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CLINICAL & PHARMACEUTICAL BIOTECHNOLOGY
[As per Choice Based Credit System (CBCS) scheme]
SEMESTER –VIII
Sub. Code : 15BT 81 I.A Marks : 20
Hours/week : 4 Exam Hrs. : 3
Total Hours : 50 Exam Marks : 80
CREDITS – 04
Course objectives: The objective of this course is to educate students about drug design,
formulation; importance of pharmacokinetics & pharmacodynamics study. To list the
applications & advantages of Pharmaceutical & Clinical Biotechnology
MODULES TEACHING
HOURS
REVISED
BLOOM’S
TAXONOMY
(RBT) LEVEL
MODULE – 1
DRUG MANUFACTURE AND FORMULATION
Introduction to pharma industry, Biotechnology and Drug
design, Basic concepts and applications, composition,
preparation, physicochemical considerations in
manufacture of current biotech products & herbal
medicines. Need of formulation and formulation
development considerations. Concept & testing of
preformulation & their parameters. Tablets: compressed,
Research Institutes, Data Management, Clinical Research
from Pharmaceutical Industry.
10 L1, L2, L3
COURSE OUTCOMES:
After studying this course, students will be able to:
Explain the significance of pharmaco-kinetic models, pharmaco-dynamic principles,
various dosage forms and formulation
Understand the specific techniques used in biotherapy & clinical Biotechnology
Comprehend specific applications of pharmaceutical & clinical Biotechnology
Graduate Attributes (as per NBA):
Engineer and society
Professional Ethics.
Lifelong learning.
Question paper pattern:
The question paper will have ten questions.
Each full question consists of 16 marks.
There will be 2full questions (with a maximum of four sub questions) from each
module.
Each full question will have sub questions covering all the topics under a module.
The students will have to answer 5 full questions, selecting one full question from
each module.
TEXT BOOKS
1. Biochemistry and Biotechnology by Gary Walsh, John Wiley & Sons Ltd.
2. Principles and Practice of Clinical Research by J. I. Gallin and F. P. Ognibene,
Elsevier Publication.
3. Hematology by William J. Williams, Ernest Beutler, Allan JU. Erslev, Marshall A.
Lichtman, IK Publishers.
4. Stem Cell Biology by Marshak, Cold Spring Harbour Symposium Pulblications.
5. Current Trends in Pharmacology by Arunabha Ray & Kavitha Gulati, IK Intl.
6. An Introduction to Synthetic Drugs by Singh & Rangnekar, Himalaya publishing
House.
7. Biopharmaceuticals, Biochemistry and Biotechnology by Gary Walsh, Wiley Pub.
8. Principles of Medicinal Chemistry by Foye, Lippincott Williams & Wilkins
Publishers.
9. Industrial Pharmaceutical Biotechnology by Heinrich Klefenz, Wiley-VCH edition. 10. Biopharmaceutical Drug Design and Development by S Wu-Pong, Y Rojanasakul,
and J Robinson.
11. Pharmaceutical Biotechnology by K Sambamurthy & Ashutosh Kar, New Age.
12. Pharmaceutical Biotechnology by S P Vyas and V K Dixit, CBS Publishers.
REFERENCE BOOKS
1. Basic & Clinical Pharmacology by Bartram G. Katzung, Mc Graw Hill.
2. The Theory & Practice of Industrial Pharmacy by Leon Lachman, Herbert A.
Lieberman & Joseph & Kanig, Vergese Publishing House Bombay.
3. Enzyme Technologies for pharmaceutical and biotechnological applications by
Herbert A Kirst, Wu-Kuang Yeh, Milton J. Marcel Dekker Publications.
4. Developmental Biology, by Scott F. Gilbert, Wiley Publications.
5. Current Trends in Pharmacology by Arunabha Ray & Kavitha Gulati, IK Intl.
6. Developmental Biology, Scott F. Gilbert, Cambridge University Press.
7. Molecular Biology of the Cell, by Bruce Alberts, Dennis Bray, Julian Lewis, Martin
Raff, Keith Roberts, James D. Watson, Garland Science.
8. Text book of Medical Biochemistry by R L Nath, New Age Publishers.
9. Pharmaceutical Biotechnology by K Sambamurthy & Ashutosh Kar, New Age
Publishers.
10. ICH guideline Q6B, Freelance Publishing.
11. Basic & Clinical Pharmacology by Bartram G. Katzung, Mc Graw Hill.
REGULATORY AFFAIRS IN BIOTECH INDUSTRY
[As per Choice Based Credit System (CBCS) scheme]
SEMESTER –VIII
Sub. Code : 15BT82 I.A Marks : 20
Hours/week : 4 Exam Hrs. : 3
Total Hours : 50 Exam Marks : 80
CREDITS – 04
Course objectives: The objective of this course is to educate students about regulatory rules and
guidelines that specify parameters of the safety and quality standards in the biotech industry.
MODULES TEACHING
HOURS
REVISED
BLOOM’S
TAXONOMY
(RBT) LEVEL
MODULE – 1
INTRODUCTION
Validation and Regulatory Affairs in Bio (Pharmaceutical)
Manufacturing: An Introduction to FDA Operations &
Industry Compliance Regulations, The Fundamentals of
Regulatory Compliance with respect to Good Clinical
Practice (GCP), Good Manufacturing Practice (GMP) &
Good Laboratory Practice (GLP). An Introduction to the
Basic Concepts of Process Validation & how it Differs from
Qualification (IQ, OQ & PQ) Procedures, A Review of