Description

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).

Resources

Name	Format	Description	Link
Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/comparative-pharmacokinetic-studies-orally-inhaled-products-2020.html
Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/etudes-pharmacocinetiques-comparatives-produits-administres-inhalation-orale-2020.html

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