Skin stripping adequate as bioequivalence determinant in topicals -- draft guidance.
This article was originally published in The Tan Sheet
Executive Summary
SKIN STRIPPING ADEQUATE FOR DERMATOLOGIC BIOEQUIVALENCE STUDIES for most topical drugs, an FDA draft guidance states. "Skin strip-ping," or dermatopharmacokinetics (DPK), "principles should be generally applicable to all topical dermatological drug products including antifungal, antiviral, anti-acne, antibiotic, corticosteroid and vaginally applied drug products," the draft guidance states. The draft, "Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies," was published in the Federal Register June 18.