Summary of Public Response and Regulatory Perspective

2/7/01


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Table of Contents

Summary of Public Response and Regulatory Perspective

Presentation Outline

Defining Terms

Defining Terms

Summary of Responses: Patient Population

Summary of Responses: Patient Population

Summary of Responses: Study Regimen

Summary of Responses: Study Duration

Summary of Responses: Virologic Endpoints:

Summary of Responses: Clinical Endpoints

Summary of Responses: Study Designs

Summary of Responses: Historical-controlled

Summary of Responses: Historical-controlled

Summary of Responses: Blinded vs. Open Label

Summary of Responses: Blinded vs. Open Label

Summary of Responses: Intensification

Summary of Responses: Concentration-controlled and Dose-response

Response from Public: Concentration-controlled and Dose-response

Dose Response vs. Strain Susceptibility

Response from Public: Concentration-controlled and Dose-response

Summary of Responses: Factorial

Three Examples for Discussion

#1: Add-on to OBR

#2: Two-Part Hybrid Design

#2: Two-Part Hybrid Design

#2: Two Part Hybrid Design

#3: Modified Factorial Design

Regulatory Conclusions

Regulatory Conclusions

Regulatory Conclusions

Author: CDER User