DPK Method Should Be Confirmed By Three-Arm BE Studies - FDA's Wilkin
This article was originally published in The Tan Sheet
Executive Summary
The dermatopharmacokinetics methodology being proposed for dermatological bioequivalence by FDA should first undergo validation through a three-way comparison of reference product to bioequivalent and bioinequivalent products, according to FDA Division of Dermatological & Dental Drug Products Director Jonathan Wilkin, MD.