Description

The purpose of this document is to provide sponsors of new drug submissions and abbreviated new drug submissions with 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 pharmacokinetic studies, with emphasis on in vivo comparative pharmacokinetic studies.

Resources

Name	Format	Description	Link
Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/notice-draft-guidance-comparative-pharmacokinetic-studies-orally-inhaled-products.html
Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/medicaments/avis-ebauche-ligne-directrice-etudes-pharmacocinetiques-comparatives-produits-administres-inhalation-orale.html

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