Canada Implementation of ICH M13A BE guideline [Regulatives / Guidelines]

posted by jag009  – NJ, 2025-08-14 16:55 (293 d 15:21 ago) – Posting: # 24430
Views: 2,358

Hi folks,

As per notice from Canada on June 27, BE criteria will require 90%CI for both Cmax and AUC if a submission is to occur after Dec 27/2025. See details in link below.

Implementation of ICH M13A

J

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