ICH guideline M10 on BA method validation [Regulatives / Guidelines]

posted by PSU – Thailand, 2022-05-03 15:53 (24 d 02:34 ago) – Posting: # 22956
Views: 323

Dear all experts,

Referring to ICH guideline M10 on BA method validation step2b (line no.413-414, p.11), CC and QCs should be prepared from separate stock solution in order to avoid biased estimations which are not related to the analytical performance of the method.

Can you explain how separate stock solution can avoid biased estimations? and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?

Thank you so much


Complete thread:

UA Flag
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Friday 18:28 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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