Topical antifungal bioequivalence
Executive Summary
Studies will require a "significantly higher" number of patients than originally anticipated, FDA says. According to one FDA official, the agency had initially estimated that only 60 patients would be adequate. An FDA topical antifungal guidance, issued March 15, suggested that the number of patients needed in clinical trials to show bioequivalence should be determined with "statistical consultation." FDA is planning a workshop in the fall to discuss what will be required to show bioequivalence to reference topical antifungal products.