Bioequivalence and Bioavailability Forum

Thanks Helmut for your feed-back!

❝ Without digging into guidelines: No. What we have in Phase I/II is sometimes not what I would call a ‘formulation’ in the biopharmaceutical sense at all. Anything goes: Manually filled capsules, lab-scale tablet-presses, etc.

Indeed.

❝ Doesn’t matter because we are interested in PK (I) and safety (II).

OK but then how to justify in the dossier the extrapolation of some early phase outcomes, e.g. a food effect or an efficacy and/or safety exposure signal... should these key findings be evaluated/demonstrated again with the final formulation?

❝ Once you move to phase III you are bound to cGMP (though still in pilot-scale). Only when you move from III to the to be marketed formulation, the applicable SUPAC guidance (IR, MR, SS) cut in and very likely you need a BE study.

Yep.

Thank you!