Bioequivalence and Bioavailability Forum

AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2021-05-28 15:23 (1845 d 02:03 ago) – Posting: # 22379
Views: 4,226

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! 
Helmut Schütz


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

Complete thread:

• AUCrefTmax raghup 2021-05-28 12:44 [Regulatives / Guidelines] 
  • AUCrefTmax (Health Canada) Helmut 2021-05-28 12:58
    • AUCrefTmax (Health Canada) raghup 2021-05-28 13:16
      • AUCrefTmax (Health Canada)Helmut 2021-05-28 13:23
      • AUCrefTmax (Health Canada) dshah 2021-05-31 10:15