Not blinding sampling times [Bioanalytics]

posted by Obinoscopy  – USA, 2018-08-19 20:20 (796 d 15:44 ago) – Posting: # 19177
Views: 2,353

Hi Helmut,

» Even if substantial carry-over is not apparent in method validation (which would call for injecting mobile phase between samples), it exists. The EMA’s GL tells us [...]

Going by that guideline, will it be safe to say that the converse it also true. That is:

If it appears there is no carry-over, study samples should be randomised

Well, just as you said, carryover is always very likely. Thus complete randomisation will not be the reasonable path to follow.

Thanks guys, at least I am glad I let my thoughts out and not get drowned in them.


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