Bioequivalence and Bioavailability Forum

The Applicant has preplanned for a 2-stage sequential design and such is principally acceptable. The Applicant has prespecified to follow the approach as outlined in Potvin et al. (2007), where the type I error control is based on simulations and a small inflation (of 0.2%, one-sided) was considered acceptable by the authors. However, this would mean that the trial would be allowed a larger type I error than in a more conventional design. This general consideration could in principle turn out to be critical in the case the bioequivalence criteria are met only sharply. However, as the study was stopped for inequivalence, any further considerations on type I error control become obsolete.