Health Canada
NOTICE
Notice to stakeholders on implementing ICH M13B: Bioequivalence for immediate release solid oral dosage forms: Additional strengths biowaiver
Published: 11/4/2026Detected: 11/5/2026
Summary preview
Implements ICH M13B to support regulatory decisions on bioequivalence for immediate-release solid oral dosage forms, including use of additional-strength biowaivers.
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#Health Canada
#ICH M13B
#bioequivalence
#additional strengths biowaiver
#immediate-release
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