PK/PD: The point of view of EU regulators

10th ISAP Symposium
Pharmacokinetics and Pharmacodynamics (PK/PD) : towards definitive criteria

Milan, Italy -  April 27th-28, 2002


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Table of Contents

- “The point of view of EU regulators “–

EU regulatory view on PK/PD in drug development

PPT Slide

CPMP PK/PD guideline 2000 Regulatory expectations

CPMP PK/PD guideline 2000 Regulatory expectations

CPMP PK/PD guideline 2000 Regulatory expectations

“Normal “ populations/pathogens

“Special” populations/pathogens

Summary

PPT Slide

EU activities in the context of antimicrobial resistance

EU activities in the context of antimicrobial resistance

EU activities in the context of antimicrobial resistance

CPMP PK/PD guideline 2000 Concepts

EU activities in the context of antimicrobial resistance

Author: Bo Aronsson

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