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

posted by Sereng  – USA, 2022-05-12 19:14 (1103 d 03:58 ago) – Posting: # 22974
Views: 2,562

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

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,682 registered users;
82 visitors (0 registered, 82 guests [including 12 identified bots]).
Forum time: 23:13 CEST (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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