Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document

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). 2023-10-28 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetycomparative pharmacokinetic studiesorally inhaled drug-products Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance DocumentHTML 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 DocumentHTML 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

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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