TRETINOIN BIOEQUIVALENCE PILOT STUDIES BASED ON WATER LOSS
Executive Summary
TRETINOIN BIOEQUIVALENCE PILOT STUDIES BASED ON WATER LOSS and days-to-skin peeling surrogate end-points were introduced at FDA's Generic Drugs Advisory Committee meeting Sept. 13. FDA's Dermatological Drags Advisory Committee was also represented. Division of Topical Drugs Products Medical Officer Thomas Franz, MD, said the studies measure skin absorption of retinoic acid cream formulations at concentrations of .025%, .05% and .1% compared to placebo and innovator creams.