Publication of the final ICH M10 guideline [BE/BA News]

posted by qualityassurance – 2022-06-12 14:31 (537 d 13:36 ago) – Posting: # 23052
Views: 1,734

❝ The ICH M10 guideline "Bioanalytical method validation and study sample analysis" has been adopted on 24 May 2022 and published on the ICH web site.


Thank you Mr. Ohlbe for the update.

Dear Members,

The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required.

Should we start submitting 100% chromatograms now.

Regards

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