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

posted by Obinoscopy  – USA, 2020-07-20 14:12 (92 d 19:07 ago) – Posting: # 21761
Views: 1,827

Hi Dshah

» time concentration 1 concentration 2 concentration 3 concentration 4
» AUC      826.125         826.375         826.625         826.75

» I believe that such small change in AUC can be considered non-significant. :-)

I agree with you that these changes are very little. But you'd be amazed at how the difference between 826.125 and 826.375 is enough to make a study that failed (eg CI of T/R: 79.99 - 111.11) to pass (eg CI of T/R: 80.02 - 111.11).

Regards,

Scopy

Complete thread:

Activity
 Admin contact
21,170 posts in 4,411 threads, 1,475 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Wednesday 09:19 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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