AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-05-28 13:23 (487 d 18:43 ago) – Posting: # 22379
Views: 1,082

Hi raghup,

» https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/comparative-bioavailability-standards-formulations-used-systemic-effects.html
» section 2.1.1.5, reads about AUCrefTmax and its relative mean area of Test and Ref to be in 80-125%. Correct me if I am wrong. Here I understood 90% CI is not required. Only point estimate has to be with in 80 to 125%

THX, I missed that. You are right.

» Protocol is slient on AUCrefTmax.

;-)

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
22,391 posts in 4,685 threads, 1,595 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time: Wednesday 08:06 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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