Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by dshah  – India/United Kingdom, 2020-07-17 08:40 (866 d 09:47 ago) – Posting: # 21729
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Greetings team!

I believe that Helmut is correct and without a predefined SOP for repeat analysis, repeat would not be acceptable!

If we are focusing on root cause, I believe that for pre-dose concentration even in period-I would not cause a significant issue to final BE out come as it may only impact AUC and it would not be significant. :-D If the value is MT 5% of Cmax, the subject would by default not considered for statistical evaluation :-). And for Root cause- most of CRO are not able to identify and thus there would not be a CAPA. :confused:


Thanks,
Dshah


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

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