AUCrefTmax [Regulatives / Guidelines]

posted by raghup – India, 2021-05-28 14:44 (1423 d 23:24 ago) – Posting: # 22376
Views: 3,565

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
23,424 posts in 4,927 threads, 1,671 registered users;
24 visitors (0 registered, 24 guests [including 12 identified bots]).
Forum time: 14:08 CEST (Europe/Vienna)

The combination of some data and an aching desire
for an answer does not ensure that a reasonable answer
can be extracted from a given body of data.    John W. Tukey

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