Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products

Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products The purpose of this document is to provide sponsors of new drug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. 2021-06-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydraft guidanceconsultationcomparative pharmacokinetic studiesorally inhaled productssponsors of new drug submissionsabbreviated new drug submissionsFood and Drug Regulations Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled ProductsHTML 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Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled ProductsHTML 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

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.

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