Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects

To ensure that sponsors of new drug submissions have 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 with respect to comparative bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug.

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Title (French) Ligne directrice - Normes en matière d'études de biodisponibilité comparatives : Formes pharmaceutiques de médicaments à effets systémiques
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Open Canada Date Published 2018-03-01 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["document d'orientation", "normes de biodisponibilité comparatives", "études pharmacodynamiques comparatives", "Règlement sur les aliments et drogues", "innocuité d'un médicament"], "en": ["guidance document", "comparative bioavailability standards", "comparative pharmacodynamic studies", "Food and Drug Regulations", "safety of a drug"]}
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