Positive pre-dose [Bioanalytics]

posted by Ohlbe – France, 2020-07-20 14:43 (20 d 23:15 ago) – Posting: # 21762
Views: 1,354

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
20,992 posts in 4,375 threads, 1,460 registered users;
online 22 (1 registered, 21 guests [including 11 identified bots]).
Forum time: Monday 13:58 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