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
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Author: Dale Conner
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