Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document

This information will help sponsors comply with the Food and Drug Regulations (Regulations), with respect to comparative studies, with emphasis on in vivo comparative pharmacokinetic studies, used in support of the safety and efficacy of subsequent-entry orally inhaled drug products (OIPs).

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Title (French) Études pharmacocinétiques comparatives sur les produits administrés par inhalation orale: Lignes Directrices
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Open Canada Date Published 2021-06-23 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["études pharmacocinétiques comparatives", "produits médicamenteux inhalés par voie orale"], "en": ["comparative pharmacokinetic studies", "orally inhaled drug-products"]}
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