Regulatory Guidance: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations

From the U.S. Food and Drug Administration,
Center for Drug Evaluation and Research (CDER)

CDER has issued a new guidance, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products.

Table of Contents

I. Introduction

II. Background

A. General
B. Bioavailability
C. Bioequivalence

III. Methods To Document BA and BE

A. Pharmacokinetic Studies
B. Pharmacodynamic Studies
C. Comparative Clinical Studies
D. In Vitro Studies

IV. Comparison Of Ba Measures In Be Studies

V. Documentation Of BA and BE

A. Solutions
B. Suspensions
C. Immediate-Release Products: Capsules and Tablets
D. Modified-Release Products
E. Miscellaneous Dosage Forms

VI. Special Topics

A. Food-Effect Studies
B. Moieties To Be Measured
C. Long Half-Life Drugs
D. First Point Cmax
E. Orally Administered Drugs Intended For Local Action
F. Narrow Therapeutic Range Drugs

Appendix 1: List Of Guidances That Will Be Replaced

Appendix 2: General Pharmacokinetic Study Design and Data Handling

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