8th ISAP Symposium
Developments in Pharmacokinetics and Pharmacodynamics (PK/PD):
optimizing efficacy and prevention of resistance
Nijmegen, The Netherlands, July 4th-6th, 2001


FUTURE of PHASE 1, 2, and 3 TRIALS

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Table of Contents

FUTURE of PHASE 1, 2, and 3 TRIALS

FDA Review Division Organization

OUTLINE

CAUTION !

General Overview: Phase 1 PK Studies

Phase 1 Clinical Pharmacology

Phase 1 Clinical Pharmacology

Phase 2 Trials 

Phase 2 Trials (cont.)

Phase 2 Trials (cont.)

Phase 3 Trials 

Phase 3 Trials (cont.)

Phase 3 Trials (cont.)

EXAMPLE

EXAMPLE

EXAMPLE

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

Ab-X: PK/PD in Phase 3 Trials for Respiratory Infections

EXAMPLE

Ab-X: Meta Analysis of QTc

Ab-X: Regression Analyses of QTc

Ab-X: Regression Analyses of QTc

Ab-X: Regression Analyses of QTc

Ab-X: Exposure-QTc Response

Ab-X: Exposure-QTc Response

Future of Clinical Trials: Key Considerations

Future of Clinical Trials: Key Considerations (cont.)

Future of Clinical Trials: Key Considerations (cont.)

Future of Clinical Trials: Key Considerations (cont.)

Future of Clinical Trials: Other Considerations/Tools

Future of Clinical Trials: Other Considerations/Tools

Future of Clinical Trials: Other Considerations/Tools

 Author: P. Colangelo 

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