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

posted by PSU – Thailand, 2022-05-03 17:53 (210 d 16:26 ago) – Posting: # 22956
Views: 673

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

PSU

Complete thread:

UA Flag
Activity
 Admin contact
22,418 posts in 4,693 threads, 1,598 registered users;
7 visitors (0 registered, 7 guests [including 4 identified bots]).
Forum time: 09:19 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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