Table of Contents
Role of Pharmacokinetic Data in the Evaluation of Alternative Antiretroviral Dosing Regimens
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Reasons/Advantages of Post-Approval Changes
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“Substantial Evidence”
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Guidance For Industry (May 1998): Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
Exposure-Response Understood
Exposure-Response Not Understood
Current DAVDP Recommendation
Pros and Cons of this Approach
Meeting Objectives
Review of Relevant Data
Agenda
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Author: Heidi Jolson, M.D., M.P.H.
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