Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2021-10-21 16:51 (213 d 05:58 ago) – Posting: # 22651
Views: 1,046

Dear Ohlbe,


» You can very well write in your SOP acceptance criteria of 2/3 and 50% at each level of concentration. By the way, the ICH M10 draft guideline (step 2, public consultation now ended) has dropped the awkward 67% criterion and replaced it with 2/3. We'll see what is decided in the final guideline.
»

Yes. Will update the SOP and then when ICH M10 will be finalized our SOP already in line with the guideline.:cool:

Regards,
Qualityassurance

Complete thread:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 38 (0 registered, 38 guests [including 37 identified bots]).
Forum time: Sunday 22:50 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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