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Thursday, October 8, 2020
12:00 p.m. - 1:00 p.m. EST
Webcast Only
12:00 p.m. - 1:00 p.m. EST
Webcast Only
Register here for webcast (public attendees and FDA staff)
CE Credit Available
Presented by:
Sam Raney, PhD
Lead for Topical and Transdermal Drug Products
Office of Generic Drugs, CDER, FDA
Sam Raney, PhD
Lead for Topical and Transdermal Drug Products
Office of Generic Drugs, CDER, FDA
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 characterize solution, gel, ointment, lotion and cream topical products containing a range of drugs including acyclovir, metronidazole, nystatin, triamcinolone acetonide, lidocaine, prilocaine, and diclofenac.
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 characterize 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.
What you’ll learn from this FDA Chemist:
o The criteria that should be satisfied for a complex generic topical product to be considered bioequivalent and therapeutically equivalent to a brand name reference product.
o Why it was historically challenging to develop topical generics.
o The relationship between the limited availability of topical generics and extraordinary increases in prices for topical products.
o Evidence indicating the sensitivity of in vitro methods, and the correlation with in vivo bioequivalence.
o Why it was historically challenging to develop topical generics.
o The relationship between the limited availability of topical generics and extraordinary increases in prices for topical products.
o Evidence indicating the sensitivity of in vitro methods, and the correlation with in vivo bioequivalence.
(adobe link for webcast)
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