AUCrefTmax [Regulatives / Guidelines]

posted by raghup – India, 2021-05-28 14:44 (1283 d 08:51 ago) – Posting: # 22376
Views: 2,763

For an NSAID immediate release Soft gelatin capsules with two way crossover study although if AUCt and Cmax are with in acceptance limits and there is no difference in median Tmax of both Test and Reference, but for AUCrefTmax 90% CI is not within 80-125% (will Health Canada accept the BE study). No outliers detected in the study.


Edit: Please follow the Forum’s Policy[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,328 posts in 4,898 threads, 1,660 registered users;
79 visitors (0 registered, 79 guests [including 12 identified bots]).
Forum time: 22:35 CET (Europe/Vienna)

Satisfaction of one’s curiosity is one of the greatest sources
of happiness in life.    Linus Pauling

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