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Skin stripping adequate as bioequivalence determinant in topical drugs -- FDA guidance.

This article was originally published in The Rose Sheet

Executive Summary

SKIN STRIPPING ADEQUATE FOR DERMATOLOGIC BIOEQUIVALENCE PRIMARY STUDIES for most topical dermatological drugs, an FDA draft guidance states. "Skin stripping," or dermatopharmacokinetics (DPK) "principles should be generally applicable to all topical dermatological drug products including antifungal, antiviral, anti-acne, antibiotic, corticosteroid and vaginally applied drugs products," the draft guidance states.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 June 18 in the Federal Register.
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