Bioequivalence and Bioavailability Forum

Hi yatish gosai
and all posters on this thread,

to be honest I think this is a great, great question and it is one that made me think very hard for a prolonged moment.

The mere fact that such a question is asked should give rise to a lot of reflection on the part of regulators. What is obvious to a regulator or someone from one geographical region is obviously not obvious to others. At the end of the day guidelines are not intended solely for regulators but for all involved parties.

So here's something to work with.