FDA: required BE between early phase and Phase 3 formulations? [Regulatives / Guidelines]

posted by Achievwin – US, 2020-01-27 19:06 (509 d 17:36 ago) – Posting: # 21087
Views: 1,717

Typically it is not needed, because your approval is based on Two identical Phase III studies, all early development studies (such as FIH, ADME, DDI Dose escalation etc.) are conducted on a preliminary dosage form which leads to refinement of the dosage form at the end of Phase 2 program typically companies present the data to regulatory agencies and formalize the dosage form and Phase 3 study design. Work done for Phase 3 programs forms pivotal/basis for NDA approval. Sponsor routinely performs a relative BA study (not a must) between the Phase 2 dosage form and phase III IMP do document only minor changes in formulation exist as a process optimization and these changes have no consequence on the bioavailability. IMHO it is a risk mitigation step for the NDA.

Hope other members agree with my reasoning.



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