20% of randomly chosen chromatograms - In any Guideline? [Bioanalytics]

posted by Obinoscopy  – USA, 2018-06-03 22:50 (1332 d 23:03 ago) – Posting: # 18850
Views: 6,213

Hi ElMaestro,

Thanks for your response.

» It is in the guidelines to the same extent as the requirement for cherry-picking the 20%.

Lol @ cherry-picking. But yeah, that should be a concern for the Sponsor or even the Regulator as the CRO site could cherry-pick runs of samples with wonderfully looking Chromatogram. However I noticed the FDA Guideline did state that chromatogram for NDAs and BLAs be randomly selected while chromatogram for ANDAs be serially selected. Which is great. I hope EMA considers this in subsequent reviews.

» Make sure to have an SOP which gives an objective way to select them.

Yea, the draft FDA Guideline did state that. But it was not stated in the final FDA guideline.....strange.



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