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Health & Medicine Introduction to pharmacology and drug metabolism

1. Introduction to Pharmacology and Drug MetabolismLuke Lightning, PhD 2. Outline of topics to be discussed: Introduction Quantitative aspects of drug-receptor interactions…

Documents Clinical Pharmacology OverviewFrom the Antiviral Perspective

1. Clinical Pharmacology Overview From the Antiviral Perspective 2. Outline Terminology Bioequivalence Scenarios with antiretroviral drugs New formulations Alternative dosing…

Documents Equivalence Tests in Clinical Trials Chunqin Deng, PhD PPD Development Research Triangle Park, NC...

Slide 1Equivalence Tests in Clinical Trials Chunqin Deng, PhD PPD Development Research Triangle Park, NC 27560 Slide 2 Traditional Hypothesis Test Test for Difference: H…

Documents Statistical Methods for Assessment of Individual/Population Bioequivalence Shein-Chung Chow, Ph.D......

Slide 1Statistical Methods for Assessment of Individual/Population Bioequivalence Shein-Chung Chow, Ph.D. Biostatistics and Clinical Data Management Millennium Pharmaceuticals,…

Documents Bioequivalence Studies Anoop Agarwal. Basic Assumptions Drug effect depends upon drug concentration....

Slide 1Bioequivalence Studies Anoop Agarwal Slide 2 Basic Assumptions Drug effect depends upon drug concentration at the site of action Drug concentration at the site is…

Documents Ruth E. Stevens, PhD, MBA Chief Scientific Officer, Executive Vice President Camargo Pharmaceutical....

Slide 1Ruth E. Stevens, PhD, MBA Chief Scientific Officer, Executive Vice President Camargo Pharmaceutical Services ACPU: October 19, 2010 Phase 1 Bioavailability(BA)/Bioequivalence(BE)…

Health & Medicine Pharmacodynamics PPT

1.PHARMACODYNAMICS 2. • In Greek Pharmacon = Drug Dynamics = Action/Power It covers all the aspects relating to “What a drug does to the body” Mechanism of action 3.…

Health & Medicine Bioequivalence experimental study design By Vishnu Datta M

1. - Vishnu Datta.M 2. Bioavailability1 Defined as the rate and extent (amount) of absorption of unchanged drug from its dosage form 3. Bioeqivalence* “The absence of a…

Science Regulatory requirements-BA/BE Studies

Bioavailability & Bioequivalence studies General Considerations for Orally Administered Drugs KIREETI BHEEMAVARAPU MSc (IPSc), MSc (Chemistry) CONTENTS • Background…

Documents Work Sample#1Regulatory_Requirements-BABE-Studies

Bioavailability & Bioequivalence studies General Considerations for Orally Administered Drugs KIREETI BHEEMAVARAPU MSc (IPSc), MSc (Chemistry) CONTENTS • Background…