AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-05-28 12:58 (23 d 19:25 ago) – Posting: # 22377
Views: 288

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
21,530 posts in 4,499 threads, 1,524 registered users;
online 12 (0 registered, 12 guests [including 4 identified bots]).
Forum time: Monday 08:24 CEST (Europe/Vienna)

Young man, in mathematics you don’t understand things.
You just get used to them.    John von Neumann

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