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

posted by fno Homepage – 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 :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

Complete thread:

Activity
 Admin contact
21,174 posts in 4,412 threads, 1,477 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Thursday 02:27 CEST (Europe/Vienna)

It is not so much that I have confidence in scientists being right,
but that I have so much in nonscientists being wrong.    Isaac Asimov

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5