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

posted by Obinoscopy  – USA, 2020-07-18 02:27 (1364 d 10:16 ago) – Posting: # 21737
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Hi dshah

❝ 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 :-).


How can you be so sure that its effect on AUC won't be significant? The removal/or inclusion of a subject from a statistical evaluation is enough is change the outcome especially if the result is borderline.

Scopy

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