no BE between early phase and Phase 3 formulations [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-01-22 17:15 (1550 d 22:34 ago) – Posting: # 21079
Views: 2,546

Hi Fabrice,

❝ 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?


Without digging into guidelines: No. What we have in Phase I/II is sometimes not what I would call a ‘formulation’ in the biopharmaceutical sense at all. Anything goes: Manually filled capsules, lab-scale tablet-presses, etc. Doesn’t matter because we are interested in PK (I) and safety (II). Once you move to phase III you are bound to cGMP (though still in pilot-scale). Only when you move from III to the to be marketed formulation, the applicable SUPAC guidance (IR, MR, SS) cut in and very likely you need a BE study.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,649 registered users;
37 visitors (0 registered, 37 guests [including 7 identified bots]).
Forum time: 16:49 CEST (Europe/Vienna)

As soon as we abandon our own reason, and are content
to rely upon authority, there is no end to our troubles.    Bertrand Russell

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