HC: open label studies acc. to ICH M13A [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2026-02-12 10:03 (111 d 19:37 ago) – Posting: # 24569
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Hi bebacrk,

❝ is open label study acceptable for Canada after implementation of ICH M13A guidelines.

Yes, since ICH M13A was implemented on 27 December 2025.

❝ Outlier tests are acceptable?

No – that’s different from the 2018 Canadian guidance.

❝ if so in full replicate design, if any subject found outlier in particular period for Cmax and AUC, is that subject data should be removed from perticulaer period or from all the periods when calculating pharmacokinetic and statistical analysis?

ICH M13A does not cover replicate design (M13C will). Therefore, Section 2.3.5 of Health Canada’s guidance is still applicable.
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