ANDA Bioequivalence Studies That Fail to Meet FDA’s Current Bioequivalence Criteria

4/16/01


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Table of Contents

ANDA Bioequivalence Studies That Fail to Meet FDA’s Current Bioequivalence Criteria

Introduction -- BE Studies

Examples of BE Results

Introduction

Background

Background

Reasons for “Failure” of BE Studies

Reasons for “Failure” of BE Studies

Example 1 - Drug X Oral Liquid

Example 2 - Drug Y Solid Oral MR

Example 3 “Outlier” Response Example

Questions

Author: Dale Conner