Sereng
☆    

USA,
2022-05-12 19:14
(707 d 23:46 ago)

Posting: # 22974
Views: 1,334
 

 BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both? [Regulatives / Guidelines]

Post reply
Dear colleagues, for BE determination, in addition to Cmax, do we need to meet the 90% CI for both AUCt and AUCinf? Regards, Sereng
—
Biostatistically Challenged CEO
 
ElMaestro
★★★

Denmark,
2022-05-13 00:14
(707 d 18:46 ago)

@ Sereng
Posting: # 22979
Views: 1,029
 

 BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both?

Post reply
Hi Sereng,

❝ ....do we need to meet the 90% CI for both AUCt and AUCinf?


Yes.
—
Pass or fail!
ElMaestro
 
UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,661 registered users;
84 visitors (1 registered, 83 guests [including 4 identified bots]).
Forum time: 19:00 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