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

posted by fno Homepage – Belgium, 2020-01-22 17:11 (612 d 11:14 ago) – Posting: # 21080
Views: 2,111

Thanks Helmut for your feed-back!

» 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.

Indeed.

» Doesn’t matter because we are interested in PK (I) and safety (II).

OK but then how to justify in the dossier the extrapolation of some early phase outcomes, e.g. a food effect or an efficacy and/or safety exposure signal... should these key findings be evaluated/demonstrated again with the final formulation?

» 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.

Yep.

Thank you!

Kind regards,
Fabrice

Complete thread:

Activity
 Admin contact
21,699 posts in 4,537 threads, 1,542 registered users;
online 12 (0 registered, 12 guests [including 3 identified bots]).
Forum time: Sunday 05:25 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
HTML5