ppt课件-bioequivalenceof topical drug products（bioequivalenceof局部药物产品）.pptVIP

Bioequivalence of Topical Drug Products Dale P. Conner, Pharm.D. Division of Bioequivalence Office of Generic Drugs CDER, FDA connerd@cder.fda.gov Introduction Products applied locally to the skin to treat diseases of the skin Types of products Creams Ointments Gels Solutions Suspensions NOT transdermals Evolution of Scientific Thinking Early regulatory approaches to generic topicals Pharmaceutical equivalents Waivers of in vivo studies Evidence of non-therapeutically equivalent generic topical corticosteroid products Stoughton, Arch Dermatol 1987;123:1312-4 Change to in vivo BE testing Guidan