Methods for Assessing Bioequivalence of Topical Products: How should FDA Redirect its Research Program?

4/16/01


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Table of Contents

Methods for Assessing Bioequivalence of Topical Products: How should FDA Redirect its Research Program?

Bioavailability of Topical Drugs

Bioequivalence of Topical Products

How should FDA Redirect its Research Program?

Current DPK Research Activities

DPK Approach for Bioequivalence: Concerns

Key Questions

Rephrasing the Concerns with DPK

Role of follicular transport on BE assessment?

Role of follicular transport

Mechanistic evidence plus distribution and imaging approaches?

Body of Evidence?

Vaginal Products

Desired Distribution Profile of Certain Vaginal Formulations

PPT Slide

Pre-Coital Forces Acting on a Bolus of Gel in Vagina

Mechanistic Analysis of Sub-processes (Squeezing)

SLIDING THEORY

Viscosity vs. Shear Rate

Vaginal Gel Thickness Distribution (Advantage)

Vaginal Gel Thickness Distribution (Conceptrol)

Axial and Angular Dependence of Coating Thickness Distribution

Author: CDER USER