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
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