Current Bioequivalence Issues

4/15/02


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Table of Contents

Current Bioequivalence Issues

Introduction

PPT Slide

BA/BE Guidance

Draft Food-Effect BE Guidance

Draft Food-Effect BE Guidance

Draft Food-Effect BE Guidance - Comments

Reserve Sample Retention

Date of Implementation of Guidances

DPK Guidance

Biopharmaceutics Classification System (BCS)

“Failed” Studies

Pharmacokinetic Reassays

Selection of Appropriate Assay Standard Curve Range

Standard Curve Example

 Author: Dale P Conner

Home Page: http://www.fda.gov/cder/ogd