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

posted by fno Homepage – Belgium, 2020-01-22 17:11 (410 d 13:19 ago) – Posting: # 21080
Views: 1,734

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
21,371 posts in 4,463 threads, 1,496 registered users;
online 7 (0 registered, 7 guests [including 2 identified bots]).
Forum time: Monday 06:31 CET (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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