Different sampling time points and Blinding [Bioanalytics]

posted by ElMaestro  – Denmark, 2020-12-11 21:57 (612 d 16:37 ago) – Posting: # 22146
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Hi Helmut,

» Evidently, my dear Dr Watson. But: Sooner or later a smart analyst would start to wonder why in one period the last two samples are always BLQ.

Fantastic... you are right. :-)

We could put anything into the last two samples like sample 21 = "sample 20 diluted x.95" and sample 22 ="sample 20 diluted x.90" or something.
The smart analyst you refer to may then look at the two profiles to check if the Cmax occurs on sample X in one series and on sample Y in another and try to work out something from the design. Perhaps one should make an effort ascertain that the sample number that corresponds to Cmax occurs at the same spot in the two series.

But speculation and cleverness aside, how could one rock-solidly assure analyst-blindedness in those trials, in your opinion?

Pass or fail!
ElMaestro

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