Positive pre-dose [Bioanalytics]

posted by Ohlbe – France, 2020-07-20 14:43 (432 d 17:02 ago) – Posting: # 21762
Views: 3,034

Dear Dshah,

» Pls note that over here, we are only taking for pre-dose concentration. If the predose concentration>5%, the subject would be excluded from analysis as per most of the guideline.

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

The change in AUC is indeed extremely limited, and unless the study outcome is just at the boundary it will indeed not have any influence in itself. But excluding or including a subject, depending on whether his pre-dose concentration is > or < 5% of Cmax, can have dramatic consequences.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,699 posts in 4,537 threads, 1,542 registered users;
online 5 (1 registered, 4 guests [including 4 identified bots]).
Forum time: Sunday 07:45 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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