Individual Bioequivalence

12/3/01


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Table of Contents

Individual Bioequivalence

Average Bioequivalence (ABE)

Individual Bioequivalence (IBE)

Recommendation of ACPS

Focus

Comparison of BA Measures in BE Studies (Section IV)*

Implementation of Guidance Recommendations

Discussion Topic #1

Discussion Topic #1: Background

Discussion Topic #2

Discussion Topic #2: Constraints

Discussion Topic #3

Discussion Topic #3: Background

Discussion Topic #4

Discussion Topic #4: Background

Agenda

Author: Lawrence J. Lesko, Ph.D.