Table of Contents
Guidance Update: Average, Population, and Individual Approaches to Establishing Bioequivalence
Statistical Guidances on Bioequivalence
The 1999 Draft Guidance
Regulatory Application
Statistical Guidance Outline
Types of Bioequivalence
Bioequivalence Criteria
Distance Concept
General Form
Constraint on Mean Difference
Guidance Status
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Author: FDA\CDER
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