Reanalysis for Pharmacokinetic Reason [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-16 14:30 (103 d 22:50 ago) – Posting: # 21713
Views: 2,453

Dear All,

I am trying to get my head around why reanalyzing a blank sample because it had values above LLOQ in the initial analysis is not considered reanalysis for pharmacokinetic reason.

My thinking is...if a pre-dose sample gives a detectable peak area on analysis and on evaluation, there seem to be no explanation for this, why is it okay to reanalyze it again? Isn't it not considered reanalysis based on PK? Could it be because the concentration at time t = 0 is not used in calculating AUC? I don't know.

Also please what are the examples of reanalysis that are considered reanalysis due to PK reasons?

Thanks.

Scopy

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