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| 02317cam 2200385zi 4500 |
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| 001 | 9.893026 |
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| 003 | CaOODSP |
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| 005 | 20221107173331 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 201029t20202020onc o f000 0 eng d |
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| 020 | |a9780660364803 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-302/2020E-PDF |
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| 245 | 00|aGuidance document : |bcomparative pharmacokinetic studies for orally inhaled products. |
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| 246 | 10|aComparative pharmacokinetic studies for orally inhaled products |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020. |
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| 264 | 4|c©2020 |
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| 300 | |a1 online resource (11 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aCover title. |
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| 500 | |aIssued also in HTML format. |
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| 500 | |a"Effective date: 2020/12/21." |
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| 500 | |aIssued also in French under title: Ligne directrice : études pharmacocinétiques comparatives sur les produits administrés par inhalation orale. |
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| 520 | |a"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. |
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| 650 | 0|aPharmacokinetics. |
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| 650 | 0|aOral medication|xGovernment policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.893028 |
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| 856 | 40|qPDF|s250 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-302-2020-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/comparative-pharmacokinetic-studies-orally-inhaled-products-2020.html |
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