Bioequivalence and Bioavailability Forum

Hi Oiinkie,

❝ In the end I am the sponsor so they will do as I tell them to, but it would help to put an end to this misery and to convince them if anyone would have a reference (to an article or guideline, preferably EMA) or a solid justification on especially the GMR to take into account when planning a BE study... I am running out of justifications, rationales, creativity, energy and persuasive power with these guys

As the sponsor your word is indisputable. You have done what you can, it seems.

Never argue with a fool - they will drag you down to their level, then beat you with experience    NN.

So just let it go. There's a ton of threads on this forum about it, and surely the CRO has been visiting them or reading books or papers about BE from time to time. If they won't listen to common sense, perhaps it is your choice of CRO that needs further consideration rather than an improvement of your persuasive powers.

In perspective, I work a lot on inhalation drugs where ivivc's are outright terrible. There is no in vitro method that provides assurance that the GMR is not worse than 0.95 or even 0.90. But the guys who fund the stuff refuse to understand that. Armani suits do strange things to people. 80% of equivalence studies for inhalation drugs tend to fail for that reason.