Bioequivalence and Bioavailability Forum

Hi John,

Valid points! However, generic companies do sometimes have to make formulation changes (e.g. problems with a functional coating in a modified-release tablet) and if they happen to be SUPAC level 3, then the BE studies would be required by the USFDA in the absence of an acceptable IVIVC. I'm not very clear on how the EMA assesses such changes but if an IVIVC is not submitted, then it means that 3 BE studies have to be submitted for a modified-release oral solid dosage form? This seems like a lot but I guess generic companies may consider the risks of such formulation problems to be fairly low?

I am asking out of academic interest - I have not come across IVIVCs performed in this part of the world so far and there is no push for this to change anytime soon.