Dermatologic Corticosteroid BE Guidance

FDA has published a draft guidance, Topical Dermatologic Corticosteroids: In Vivo Bioequivalence, to assist applicants who submit ANDAs for the products. The document has recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids.

When finalized, the draft will replace a 6/1995 guidance, FDA says. It says the revision will provide clarity for potential ANDA applicants on the appropriate pilot and pivotal studies and other recommendations for a pharmacodynamic approach to assess the bioequivalence of the products. The recommendations have evolved since the 1995 guidance, FDA says.

The draft has recommendations for the study design, method qualification, data analysis, and data reporting for the pilot dose-duration vasoconstrictor response study and pivotal vasoconstrictor bioequivalence study used to demonstrate bioequivalence of topical corticosteroids. It also discusses considerations and approaches for estimating key study parameters.