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

posted by Obinoscopy  – USA, 2020-07-18 00:27 (548 d 05:15 ago) – Posting: # 21737
Views: 3,725

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
21,829 posts in 4,566 threads, 1,554 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Monday 04:43 CET (Europe/Vienna)

Discovery consists of seeing what everybody has seen
and thinking what nobody has thought.    Albert Szent-Györgyi

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