Bioequivalence and Bioavailability Forum

Hi kumarnaidu,

I have been discussing this with regulators a few times.
The opinions apparently differ between agencies and quite possibly also from regulator to regulator within specific agencies.
The hardliners and most statisticians, like you indicate, will not accept it. The softliners will accept it on ethical grounds (it is almost unnecessary and unethical to test the stuff again if you know reasonably know the outcome).
Lack of ISR is a showstopper however. I am not convinced that you can get easily away with it. It will require additional stability studies beforehand, won't it?

For future purposes take a scientific advice. And pick your country for sc. advice and submission well - do not (and I really mean not) just pick the country where your EU subsidiary is headquartered or where the most important market is.