Bioequivalence and Bioavailability Forum

Hi Averroes and Dr_Dan,

❝ Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this?

It is a situation that is not covered by the guideline. And as such I am not sure there is one solution that is guaranteed to work with a high probability across man agencies.
Therefore, get scientific advice and apply lots of common sense in the briefing document. I know the issue of common sense is subject to much debate and confusion but in this regard I think it should imply scientifically balanced views and not just quick and cheap approval.