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

posted by fno Homepage – Belgium, 2020-01-22 16:38 (1553 d 10:25 ago) – Posting: # 21078
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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 :confused::

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!

Kind regards,
Fabrice

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