AUCrefTmax (Health Canada) [Regulatives / Guidelines]

posted by raghup – India, 2021-05-28 13:16 (151 d 20:28 ago) – Posting: # 22378
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  • Rapid onset of effect is important. According to the guidance AUCrefTmax should be reported. IMHO, a statistical comparison is not required.
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  • What does you protocol say?

Hi Helmut,

Thank you for the note.
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%

Protocol is slient on AUCrefTmax.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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