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

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Title (French)	Ligne directrice : données d'études non cliniques en laboratoire à l'appui des demandes et des présentations de drogues: respect des bonnes pratiques de laboratoire
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Sensitivity Level	unrestricted
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Open Canada Date Published	2010-04-30 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["Document d'orientation", "étude de laboratoire non clinique", "données à l'appui des demandes et soumissions de produits pharmaceutiques", "bonnes pratiques de laboratoire", "études non cliniques sur la santé et la sécurité environnementale", "qualité et validité des données d'essai", "acceptation internationale des principes de données"], "en": ["Guidance document", "non-clinical laboratory study", "data supporting drug product applications and submissions", "good laboratory practice", "non-clinical health and environmental safety studies", "quality and validity of test data", "international acceptance of data principles"]}
Open Canada Collection	publication
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