AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-05-28 12:58 (121 d 16:20 ago) – Posting: # 22377
Views: 667

Hi raghup,

» 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).

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,700 posts in 4,538 threads, 1,542 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Monday 05:19 CEST (Europe/Vienna)

In the beginner’s mind there are many possibilities.
In the expert’s mind there are few.    Shunryu Suzuki

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