Bioequivalence and Bioavailability Forum

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

posted by fno  – Belgium, 2020-01-22 15:38 (273 d 09:49 ago) – Posting: # 21078
Views: 2,482

Dear All,

Sorry for the naive and quite basic question, but I did not succeed in finding a clear and definite answer in any of the FDA guidances :

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?

Many thanks in advance!

Complete thread:

• 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
    • no BE between early phase and Phase 3 formulations fno 2020-01-22 17:11
      • relax Helmut 2020-01-23 11:59
        • Thanks! fno 2020-01-23 14:48
  • FDA: required BE between early phase and Phase 3 formulations? Achievwin 2020-01-27 20:06