Bioequivalence and Bioavailability Forum

Hi Doc!

Talking about EU? And BCS-based biowaivers?

The EU Guideline is crystal clear, for different salts: Both have to be BCS-class I.

Do you have all data necessary to prove? Otherwise, maybe a waste of time. That's why biowaivers are not so easy, in my opinion, you need some (non-standard) data like solubility over pH (and at pKa) and maybe some permeability data not at hand (at sufficient detail) for generics from published literature...

I think often people go the "known" way, BE-study, end of game. Instead of investing time (!) and money for a task with unknown outcome. On the other hand, if you have enough data before going for a SA you might be able to convince authorities.

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Edit: Please don’t shout! [Helmut]