Currently, FDA approval for topical generic drugs requires a clinical endpoint study to show bioequivalence (BE). Standard blood PK studies are not useful for BE tests of topical dermal generics. dOFM allows a PK based BE approach directly in the skin.
FDA-Project: Bioequivalence of drugs in the skin
A cost- and time-saving standardized OFM set-up is being developed to test dermatological generics in cooperation with US FDA.