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

posted by PSU – Thailand, 2022-05-03 17:53 (658 d 10:35 ago) – Posting: # 22956
Views: 1,325

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


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