Positive pre-dose [Bioanalytics]

posted by Ohlbe – France, 2020-07-20 14:43 (709 d 22:28 ago) – Posting: # 21762
Views: 3,820

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:

UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 10 (1 registered, 9 guests [including 8 identified bots]).
Forum time: Thursday 13:12 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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