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).

Data and Resources

Additional Info

Field Value
Last Updated April 17, 2026, 22:00 (UTC)
Created April 17, 2026, 22:00 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2021-06-23 00:00:00
open_canada_keywords {"fr": ["études pharmacocinétiques comparatives", "produits médicamenteux inhalés par voie orale"], "en": ["comparative pharmacokinetic studies", "orally inhaled drug-products"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Études pharmacocinétiques comparatives sur les produits administrés par inhalation orale: Lignes Directrices
update_frequency as_needed