ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by MSimoes – Portugal, 2020-09-17 15:56 (488 d 17:30 ago) – Posting: # 21924
Views: 762

Dear dshah,

Many thanks for your feedback. I suppose that orthogonal methods are also not required as we are not referring to complex formulations (IR only).

The CC/meeting is also crucial from the practical point of view.

Thanks, once again!
Marta

Regards,
MSimoes

Complete thread:

Activity
 Admin contact
21,831 posts in 4,567 threads, 1,553 registered users;
online 8 (0 registered, 8 guests [including 7 identified bots]).
Forum time: Wednesday 08:27 CET (Europe/Vienna)

Research under a paradigm must be a particularly effective way
of inducing paradigm change.    Thomas S. Kuhn

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