Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects

Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects 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. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentcomparative bioavailability standardscomparative pharmacodynamic studiesFood and Drug Regulationssafety of a drug Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic EffectsHTML 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 EffectsHTML 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

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.

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