00000nam 2200000zi 4500 9.893026 CaOODSP 20221107173331 m o d f cr cn||||||||| 201029t20202020onc o f000 0 eng d 9780660364803 CaOODSP eng rda CaOODSP n-cn--- H164-302/2020E-PDF Guidance document : comparative pharmacokinetic studies for orally inhaled products. Comparative pharmacokinetic studies for orally inhaled products Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (11 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. Issued also in HTML format. "Effective date: 2020/12/21." Issued also in French under title: Ligne directrice : études pharmacocinétiques comparatives sur les produits administrés par inhalation orale. "Comparative pharmacokinetic studies should be conducted in accordance with generally accepted clinical practices. These practices are designed to ensure the protection of the rights, safety and well-being of subjects. Good Clinical Practices are referred to in Division 5 of the Regulations, and described in the International Council for Harmonisation (ICH) Guidance (Topic E6) on Good Clinical Practice. To ensure compliance with the Regulations, follow the recommendations included in this guidance respecting study design and the conduct of comparative pharmacokinetic studies involving subsequent-entry orally inhaled drug products (OIPs)"--Policy statement, page 5. Pharmacokinetics. Oral medication Government policy Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.893028 PDF 250 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-302-2020-eng.pdf HTML N/A 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 200255