Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice

Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice Good Laboratory Practice (GLP) covers the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, archived and reported. It is intended to promote the quality and validity of test data and improve the international acceptance of data generated in adherence to its principles 2021-07-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance documentnon-clinical laboratory studydata supporting drug product applications and submissionsgood laboratory practicenon-clinical health and environmental safety studiesquality and validity of test datainternational acceptance of data principles Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory PracticeHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/non-clinical-laboratory-study-data-supporting-drug-product-applications-submissions-adherence-good-laboratory-practice.html#a1 Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory PracticeHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/donnees-etudes-non-cliniques-laboratoire-appui-demandes-presentations-drogues-respect-bonnes-pratiques-laboratoire.html

Good Laboratory Practice (GLP) covers the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, archived and reported. It is intended to promote the quality and validity of test data and improve the international acceptance of data generated in adherence to its principles

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