Bioequivalence and Bioavailability Forum

❝ Exactly! Just saw a presentation by FDA's Mehul Mehta. The food effect study should be powered for the 80-125% acceptance range and 90% CIs. If lacking food effect is not shown, the efficacy/safety data (from phase III) will be reviewed by the FDA in order to assess whether the observed difference is considered clinically relevant (depending on that the wording in the label will differ). Having data in both fasting/fed state in the phase III programme greatly helps. The FDA doesn't expect an additional „PD food effect study“.