Research on compassionate use program from a quality management perspective
| Project/Area Number |
26860353
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Applied pharmacology
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| Research Institution | The University of Tokyo |
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Principal Investigator |
Miayji Tempei 東京大学, 医学部附属病院, 特任助教 (70709568)
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥3,120,000 (Direct Cost: ¥2,400,000、Indirect Cost: ¥720,000)
Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2014: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Keywords | コンパッショネート・ユース制度 / CU制度 / 未承認薬 / カンナビノイド / 医療用大麻 / 品質管理 / 品質マネジメント / レギュラトリーサイエンス / アクセス / 有害事象報告 / 医療大麻 / 大麻医薬品 |
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| Outline of Final Research Achievements |
The compassionate use (CU) program is a system that allows official access to unapproved drugs for the purpose of treatment of patients with serious diseases or patients without approved alternative drugs. It allows exceptional use of unapproved drugs for therapeutic purposes under a certain rule from an ethical point of view. The quality management and safety report system is critical for operating CU program safely. This research investigated the operation of medical cannabis under the CU program in the United States from a quality management perspective as a case study. The patient advocacy groups have taken the initiative, establishing a third-party certification system in terms of the standardization of cultivation, manufacturing, laboratory test and distribution of medical cannabis.
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Report
(4 results)
Research Products
(3 results)
