Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by MSimoes – Portugal, 2020-09-17 17:56 (1315 d 15:48 ago) – Posting: # 21924
Views: 1,231

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:

ICH M9 - reverse engineering? MSimoes 2020-09-16 16:01 [Regulatives / Guidelines]
- ICH M9 - reverse engineering? dshah 2020-09-17 06:46
  - ICH M9 - reverse engineering?MSimoes 2020-09-17 15:56
    - ICH M9 - reverse engineering? dshah 2020-09-30 07:27

Admin contact
22,993 posts in 4,828 threads, 1,656 registered users;
111 visitors (0 registered, 111 guests [including 4 identified bots]).
Forum time: 09:45 CEST (Europe/Vienna)

Never never never never use Excel.
Not even for calculation of arithmetic means. Martin Wolfsegger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz