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

posted by Obinoscopy  – USA, 2020-07-17 22:27 (100 d 00:12 ago) – Posting: # 21737
Views: 2,132

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

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,475 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Sunday 22:40 UTC (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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