jag009
★★★

NJ,
2025-08-14 16:55
(319 d 19:19 ago)

Posting: # 24430
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 Canada Implementation of ICH M13A BE guideline [Regulatives / Guidelines]

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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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