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.

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Dernière modification avril 17, 2026, 17:36 (TU)
Créé le avril 17, 2026, 17:36 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2018-09-01 00:00:00
open_canada_keywords {"fr": ["document d'orientation", "conduite et analyse", "études comparatives de biodisponibilité", "équivalent pharmaceutique", "exigences en matière de données et critères"], "en": ["guidance document", "conduct and analysis", "comparative bioavailability studies", "pharmaceutically equivalent", "data requirements and criteria"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice : Conduite et analyse des études de biodisponibilité comparatives
update_frequency as_needed