Bioequivalence and Bioavailability Forum

Dear Helmut and Akif,

❝ My personal ranking:

❝

❝ 1. Overly optimistic assumptions about the T/R-ratio leading to a too small sample size.

❝ 2. Assuming a unrealistically low CV.

❝ 3. Design issues (too short washout, metabolite instead of parent drug,…).

The first reason I would put on the list, whether it is the most frequent one or not, is that the test and the reference formulations are simply not bioequivalent.

I think this is important to state, because one of the root causes behind the cases of data manipulation which were reported over the last years appears to be that sponsors consider by default that their product is perfect and that it is the CRO's fault if the study failed. The CRO is under pressure to make the study pass if they want to retain the sponsor for future business. Some education and key messages are needed there.