Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format

The purpose of this guidance is to define the Common Technical Document (CTD) format of drug submissions which rely on comparative bioavailability studies to establish safety and efficacy. This guidance also references some of the technical requirements related to the conduct and analysis of such studies.

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Champ Valeur
Dernière modification avril 17, 2026, 22:11 (TU)
Créé le avril 17, 2026, 22:11 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2011-01-27 00:00:00
open_canada_keywords {"fr": ["directives pour l'industrie", "biodisponibilité comparative", "présentations de médicaments", "document technique commun", "format CTD", "sécurité et efficacité", "Règlement sur les aliments et drogues"], "en": ["guidance for industry", "comparative bioavailability", "drug submissions", "common technical document", "CTD format", "sfety and effectiveness", "Food and Drug Regulations"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ébauche ligne directrice à l'intention de l'industrie: Préparation de données comparatives de biodisponibilité pour les présentations de drogues dans le format CTD
update_frequency as_needed