Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format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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Title (French) Ébauche ligne directrice à l'intention de l'industrie: Préparation de données comparatives de biodisponibilité pour les présentations de drogues dans le format CTD
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Open Canada Date Published 2011-01-27 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
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"]}
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