Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies

Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies 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. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentconduct and analysiscomparative bioavailability studiespharmaceutically equivalentdata requirements and criteria Guidance Document: Conduct and Analysis of Comparative Bioavailability StudiesHTML 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 StudiesHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/biodisponibilite-bioequivalence/conduite-analyse-etudes.html

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.

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