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| 02136cam 22003738a 4500 |
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| 001 | 9.852795 |
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| 003 | CaOODSP |
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| 005 | 20221107154654 |
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| 007 | cr ||||||||||| |
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| 008 | 180302s2018 onc ob f000 0 eng d |
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| 020 | |a9780660255149 |
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| 040 | |aCaOODSP|beng |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/7-2018E-PDF |
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| 245 | 00|aGuidance document |h[electronic resource] : |bcomparative bioavailability standards : formulations used for system effects. |
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| 246 | 30|aComparative bioavailability standards : |bformulations used for system effects |
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| 260 | |aOttawa : |bHealth Canada, |c2018. |
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| 300 | |a16 p. |
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| 500 | |aIssued also in French under title: Ligne directrice : normes en matière d’études de biodisponibilité comparatives : formes pharmaceutiques de médicaments à effets systémiques. |
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| 500 | |aCover title. |
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| 500 | |a"Date adopted: 2012/12/08. Revised date: 2018/06/08. Effective date: 2018/07/01 (for submissions filed on or September 1, 2018)." |
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| 500 | |a"Publication date: June 2018." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (p. 14). |
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| 520 | |a"Policy objectives: To ensure that sponsors of new drug submissions have 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 bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug"--Introd., p. 9. |
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| 693 | 4|aDrug approval |
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| 693 | 4|aDrugs--Bioavailability |
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| 693 | 4|aDrugs--Therapeutic equivalency |
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| 693 | 4|aStandards |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tLigne directrice |w(CaOODSP)9.852796 |
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| 856 | 40|qPDF|s287 KB|uhttps://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-7-2018-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/bioavailability-bioequivalence/comparative-bioavailability-standards-formulations-used-systemic-effects.html |
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