FDA CDER Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs – Drug Information Update

FDA CDER Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs

For many drugs applied to the skin, a traditional bioequivalence approach based on measuring the concentrations achieved in the blood stream is inappropriate, and developers of generics often needed to rely on clinical outcomes in large trials. This has limited the availability of generics in this class. A clinical study by FDA and international researchers showed that a method called dermal open-flow microperfusion can be used to measure concentrations of drugs in the skin. This research opens the door for developers to use a bioequivalence approach to develop generics for many important topical dermatological products. To learn more, please visit: FDA CDER Impact Story.