Reanalysis for Pharmacokinetic Reason [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-16 14:30 (188 d 01:23 ago) – Posting: # 21713
Views: 2,698

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

Complete thread:

Activity
 Admin contact
21,308 posts in 4,444 threads, 1,489 registered users;
online 14 (1 registered, 13 guests [including 5 identified bots]).
Forum time: Wednesday 14:54 CET (Europe/Vienna)

Power: That which is wielded by the priesthood of
clinical trials, the statisticians, and a stick which they use
to beta their colleagues.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5