Adaptive two-stage bioequivalence trials with early stopping and sample size re-estimation
Adaptive two-stage bioequivalence trials with early stopping and sample size re-estimation
Bioequivalence between two products has to be demonstrated as an essential part of the generic approval process (new formulation vs. innovator product), bridging an innovator’s product from the formulation used in clinical phase III to the marketed formulation, or in case of major variations of an approved product. The most …