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RegisterICH guideline M10 on BA method validation [Regulatives / Guidelines]
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
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:
- ICH guideline M10 on BA method validationPSU 2022-05-03 15:53 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Stock solutions for CCs and QCs Helmut 2022-05-04 14:48
- ICH guideline M10 on BA method validation paulhurleyuk 2022-05-05 11:47
Ing. Helmut Schütz