AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-05-28 14:58 (1049 d 21:46 ago) – Posting: # 22377
Views: 1,506

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,979 posts in 4,821 threads, 1,661 registered users;
27 visitors (0 registered, 27 guests [including 12 identified bots]).
Forum time: 12:45 CEST (Europe/Vienna)

Never, never, never use any software!
Never, never, never trust any computer!    Detlew Labes

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