Waiver of In Vivo Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

4/26/01


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Table of Contents

Waiver of In Vivo Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

Timeline

BCS Guidance 2000

BCS a tool for risk management (discussion on risk management is based on R.F. Griffith. Dealing with risk. 1981)

Differences in Drug Dissolution: Primary Reason for Bio-in-equivalence(?)

FDAs Bioequivalence Hearing (1986)

Bioequivalence: IR Products

Dissolution specifications and Bioequivalence

Dissolution tests: Debates

Failure of Dissolution Tests to Signal Bio-in-equivalence

Typical Physiologic Parameters: Single Dose Fasting BE Study

BCS Class Boundaries: Objectives

BCS Class Membership: Risk Management

Acceptance of BCS based biowaivers

Next Steps

Author: Ajaz S Hussain