AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-05-28 13:23 (62 d 12:50 ago) – Posting: # 22379
Views: 460

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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