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
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?
Desired Distribution Profile ofCertain Vaginal Formulations
Pre-Coital Forces Acting on a Bolus of Gel in Vagina
Mechanistic Analysis of Sub-processes (Squeezing)
Viscosity vs. Shear Rate
Vaginal Gel Thickness Distribution (Advantage)
Vaginal Gel Thickness Distribution (Conceptrol)
Axial and Angular Dependenceof Coating Thickness Distribution