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

posted by fno Homepage – Belgium, 2020-01-22 15:38 (250 d 06:55 ago) – Posting: # 21078
Views: 2,412

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,

Complete thread:

 Admin contact
21,084 posts in 4,398 threads, 1,468 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time: Monday 23:33 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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