Bioequivalence and Bioavailability Forum

Hi Fabrice,

❝ Is FDA requiring a formal BE demonstration for bridging the early phase with the Phase 3 formulations?

❝ If so, what would be the required actions in case the Phase 3 formulation is not perfectly bioequivalent to the previously used formulation?

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