Description

To ensure that sponsors of new drug submissions have 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 with respect to comparative bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug.

Resources

Name	Format	Description	Link
Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/comparative-bioavailability-standards-formulations-used-systemic-effects.html#a1.1
Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/biodisponibilite-bioequivalence/normes-matiere-etudes-biodisponibilite-comparatives-formes-pharmaceutiques-medicaments-effets-systemiques.html#a1.1

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