Pharmacokinetic/Pharmacodynamic Approach and Drug Development: Utility and Regulatory Implications

20/04/99


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Table of Contents

Pharmacokinetic/Pharmacodynamic Approach and Drug Development: Utility and Regulatory Implications

Outline

Background

Background (contd.)

Objectives

Possible uses of PK/PD in drug development

Example 1

Example 1 (Contd.)

Example 2

Possible uses of PK/PD in drug development (contd.)

Possible uses of PK/PD in drug development (contd.)

Possible uses of PK/PD in drug development (contd.)

Example 3

Example 3 (Contd.)

Possible uses of PK/PD in drug development (contd.)

Incorporation of PK/PD in clinical trial design

Incorporation of PK/PD in trial design (contd.)

PK/PD Parameters - Examples

PK/PD Parameters - Examples (contd.)

Potential Advantages of PK/PD Approach

Potential Advantages of PK/PD Approach (contd.)

“Difficulties” of PK/PD

“Difficulties” of PK/PD (contd.)

“Difficulties” (contd.)

“Difficulties” (contd.)

Summary

Summary (contd.)

Summary (contd.)

Acknowledgement

 Author: kofi Amoa Kumi

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Home Page: http://www.isap.org/Rockville-1999.htm