Description

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is [i.e.], new drug and abbreviated new drug submissions) of changes in Health Canada's comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).

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Name	Format	Description	Link
Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-policy-bioequivalence-standards-highly-variable-drug-products.html
Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-politique-normes-bioequivalence-produits-pharmaceutiques-haute-variabilite.html

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