no BE between early phase and Phase 3 formulations [Regulatives / Guidelines]
❝ 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).
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.
- FDA: required BE between early phase and Phase 3 formulations? fno 2020-01-22 15:38 [Regulatives / Guidelines]
- no BE between early phase and Phase 3 formulations Helmut 2020-01-22 16:15
- FDA: required BE between early phase and Phase 3 formulations? Achievwin 2020-01-27 20:06