Guidance Update: Average, Population, and Individual Approaches to Establishing Bioequivalence

4/16/01


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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The 1999 Draft Guidance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

Author: FDA\CDER