Description

To provide sponsors of new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations (Regulations) with respect to comparative bioavailability studies used in support of the safety and efficacy of a drug.

Resources

Name	Format	Description	Link
Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.html
Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/biodisponibilite-bioequivalence/conduite-analyse-etudes.html

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