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

posted by Obinoscopy  – USA, 2020-07-18 00:27 (23 d 13:46 ago) – Posting: # 21737
Views: 1,640

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
20,992 posts in 4,375 threads, 1,460 registered users;
online 25 (0 registered, 25 guests [including 13 identified bots]).
Forum time: Monday 14:14 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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