AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-05-28 15:23 (1436 d 04:09 ago) – Posting: # 22379
Views: 2,872

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.


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