Poster: Meeting the Draft Guidance for Bioequivalence for Topical Products
A recent analysis by the US Government Accountability Office of drug pricing showed that topical generic drug prices had increased by an average of 276%, whereas for all other routes of delivery there had been no significant change. This was directly related to lack of generic competition and the height of barriers to entry for new topical generic products. To further facilitate generic product availability, the FDA published product-specific guidance describing the Agency’s
current thinking and expectations on how to develop and test generic drug products therapeutically equivalent to specific reference listed drugs (RLDs).
The aim of this study was to investigate the applicability of IVRT and IVPT methods from the FDA’s Draft Guidance on Acyclovir in demonstrating BE of TEST and RLD products. Gel formulations of three different drugs were evaluated; Drugs A , B, and C.