Bioequivalence and Bioavailability Forum

Hi nobody

❝ Talking about EU? And BCS-based biowaivers?

Yes Sir!

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

Yes, for different salts, but my question was, do they regard the cocrystal as a salt?
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states: Biowaiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of an active substance from that of the reference product, since these differences may lead to different bioavailabilities not deducible by means of experiments used in the BCS-based biowaiver concept.

❝ 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.

Yes, the unknown outcome is the killing point. You can not predict what will be asked and sometimes the objections are so ......