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The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

The next FDA Grand Rounds is scheduled for October 8, 2020. (Webcast only)

FDA Grand Rounds: Bioequivalence of Complex Topical Generics: In Vitro and In Vivo

Thursday, October 8, 2020
12:00 p.m. - 1:00 p.m. EST
Webcast Only

Presented by:

Sam Raney, PhD
Lead for Topical and Transdermal Drug Products
Office of Generic Drugs, CDER
US Food and Drug Administration

About the Presentation:

This presentation summarizes a series of FDA-coordinated, GDUFA-funded research studies included in a strategic multi-year, multi-million dollar research program to develop new, more efficient approaches by which to evaluate bioequivalence (BE) for topical generics. These studies characterized solution, gel, ointment, lotion and cream topical products containing a range of drugs including acyclovir, metronidazole, nystatin, triamcinolone acetonide, lidocaine, prilocaine, and diclofenac.

Frequently, BE assessments with the same set of products are conducted in vitro and in vivo, under matched conditions. In vitro studies typically include physical and structural (Q3) product characterizations as well as in vitro release (IVRT) and in vitro permeation test (IVPT) studies. In vivo BE studies utilize pharmacokinetic endpoints (e.g., dermal micro dialysis) or clinical endpoints. Collectively, the results of such research have established a remarkably clear, consistent, and substantial body of evidence supporting the utility of sensitive and efficient in vitro BE methods for topical products as an alternative to (or in support of) an in vivo BE assessment.

Based upon this research program, revolutionary new paradigms have been developed to establish topical BE more efficiently via in vitro BE and cutaneous PK approaches, which can be more accurate, sensitive and reproducible than traditional BE approaches for topical products. These advances have enabled FDA to be responsive to numerous product development communications with prospective generic drug applicants, through controlled correspondences, Pre-ANDA meeting requests, product-specific guidances, and internal consultations with review divisions which have directly supported the review (and approval) of ANDAs submitted to the FDA involving novel BE approaches

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