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

Description

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

Resources

Name Format Description Link
21 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
21 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

Tags

Topics

Categories