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In Vitro Characterization Based Approaches for Demonstrating Equivalence of Locally Acting Complex Generic Drug Products

Monday, November 8, 2021

1:00 p.m. - 2:30 p.m.

It is often challenging to demonstrate bioequivalence of locally acting complex generic products.  Pharmacokinetic (PK) end points may not capture the rate and extent of drug availability at the site of action for these products. The clinical endpoint studies are challenging to conduct due to the large sample size requirement and may present challenges with demonstrating sensitivity to quantify product differences. Therefore, the agency has started to recommend in vitro characterization based approaches to demonstrate equivalence of these products. These involve demonstrating no difference in qualitative (Q1) and quantitative (Q2) composition as well as the microstructure (Q3) of the proposed test and reference drug product formulations for topical dermatological products. This session will focus on opportunities and challenges in using in vitro characterization-based approaches to demonstrate the equivalence of locally acting complex generics.

Moderator: April Braddy, PhD, RAC
Acting Director, Division of Bioequivalence III, OB, OGD, CDER, FDA

Suman Dandamudi, PhD
Reviewer, Division of Bioequivalence III, Office of Bioequivalence (OB), OGD, CDER, FDA

Darby Kozak, PhD
Deputy Director, Division of Therapeutic Performance I, Office of Research and Standards (ORS), OGD, CDER, FDA

Likan Liang, PhD
Branch Chief, Division of Liquid-Based Products II, Office of Lifecycle Drug Products, OPQ, CDER, FDA

Ahmed Zidan, PhD
Senior Staff Fellow, Division of Product Quality Research, Office of Testing and Research, OPQ, CDER, FDA

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