Skin stripping not yet viable replacement for comparative clinical trials -- FDA cmte.
This article was originally published in The Rose Sheet
Executive Summary
SKIN STRIPPING SHOULD NOT REPLACE TOPICAL CLINICAL BIO STUDIES for topical generic drug products because dermatopharmacokinetics "is very risky without more validation," and "I do not think it is time to use [DPK] as a replacement" for in vivo comparative clinical trials, committee member Lynn Drake, MD, University of Oklahoma, said at FDA's Dermatologic & Ophthalmic Drugs Advisory Committee meeting March 20 in Gaithersburg, Md. Speaking for the committee, Drake said she is "unwilling to accept this test as a replacement for what we do in patients and see in patients."