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| 01504nas 2200229za 4500 |
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| 001 | 9.506920 |
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| 003 | CaOODSP |
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| 005 | 20200331213158 |
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| 007 | cr ||||||||||| |
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| 008 | 150406d19971997xxc|| m o||||f| |0eng|d |
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| 040 | |aCaOODSP|beng |
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| 043 | |an-cn--- |
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| 086 | 1 |aH42-2/2E-PDF |
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| 110 | 1 |aCanada.|bHealth Canada. |bTherapeutic Products Directorate. |
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| 245 | 10|aTherapeutic Products Directorate guidelines |h[electronic resource] |
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| 260 | |aOttawa - Ontario : |bHealth Canada. |
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| 520 | 3 |a"The ICH harmonised tripartite guideline: "General Considerations for Clinical Trials" has been developed by an ICH Expert Working Group and has been subject to consultation, in accordance with the ICH process, by regulatory parties which include Canada. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan, and the USA. [...] The Therapeutic Products Directorate of Health Canada has adopted this international guideline in order to provide a comprehensive document that relates the clinical phases of drug development to specific topic-related harmonized guidelines."--Foreword. |
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| 690 | 07|aDrugs|2gcpds |
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| 775 | 08|tDirectives de la Direction des produits thérapeutiques |w(CaOODSP)9.503316 |
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| 776 | 0#|tTherapeutic Products Directorate guidelines |w(CaOODSP)9.514729 |
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| 785 | 00|tGuidance for industry |w(CaOODSP)9.506921 |
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