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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.

About the Speaker:

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

Bio:

Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience producing numerous research manuscripts, review articles, book chapters and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub investigator on over 400 pharmaceutical product studies, has held senior management roles in industry, serves as an expert panel member in the U.S. Pharmacopeia, and is the Lead for Topical and Transdermal Drug Products in the FDA’s Office of Generic Drugs. Dr. Raney's regulatory responsibilities involve the development of FDA guidances related to topical and transdermal generic products, as well as pre-ANDA meetings, controlled correspondences, and citizen petitions involving FDA’s Office of Generic Drugs. Dr. Raney's responsibilities also include serving as a subject matter expert on topical and transdermal drug products within FDA, as well as overseeing the development of regulatory science research initiatives related to topical and transdermal generic drug products, notably, several FDA-funded collaborations with research institutions around the world. Dr. Raney holds a Bachelor’s degree in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.

Event Materials:

Continuing Education (CE) Announcement

Webcast:

Webcast recording

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