Bioequivalence and Bioavailability Forum

Hi Brus!

Generally Helmut's remark is acceptable considering you are not drawing any conclusion from different BE studies. But as you are using it for new molecule, kindly consider below scenario.
Scenario 1: A bridging study requiring BE for phase 1 formulation with TBM formulation in fasting condition, along with fed arm for TMB

Scenario 2: Two separate study of phase 1 formulation vs TBM formulation in fasting condition and TBM fasting vs Fed condition.

Though you may find BE for phase 1 and TBM formulation, the food effect needs to be consider for label. There is a possibility that as per scenario 2- the fasting levels in your (a) phase 1 formulation vs TMB and (b) Fasting TBM vs Fed TBM could be different. So why there is difference in both the separate study? Is it due to subject change or due to bioanalytical method? In such scenario, the cross validation can play a crucial role in drawing a conclusion of food effect.

Divyen