| Project/Area Number |
24659244
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| Research Category |
Grant-in-Aid for Challenging Exploratory Research
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| Allocation Type | Single-year Grants |
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| Research Field |
Medical sociology
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| Research Institution | Sapporo Medical University |
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Principal Investigator |
MASAHO Ishino 札幌医科大学, 医学部, 教授 (30232325)
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| Co-Investigator(Kenkyū-buntansha) |
IIDA Kaori 東京医科歯科大学, 産学連携推進本部, 教授 (90570755)
NISHIMURA Norihiro 三重大学, 大学院医学系研究科, 教授 (30402689)
ONODERA Rie 札幌医科大学, 医学部, 講師 (60393328)
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| Co-Investigator(Renkei-kenkyūsha) |
ANDO Tsuyoshi 東京大学, 医学部, 特任講師
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| Project Period (FY) |
2012-04-01 – 2014-03-31
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| Project Status |
Completed (Fiscal Year 2013)
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| Budget Amount *help |
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2013: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2012: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
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| Keywords | 先端医療 / 再生医療 / 薬事 / 共通評価指標 / バリデーション / ガイドライン / 開発 / 国際情報交換 / イギリス / フランス / アメリカ / ベルギー |
|---|
| Research Abstract |
Development of state-of-the-art medical technologies, strategy of which differs from those conventional approaches conducted by drug companies, are forwarded gropingly by universities and venture businesses. For the promotion of utilizing these medical technologies, construction of common infrastructures for supporting medicine evaluation process is very important. First of all, political investments are inevitable for that purpose. At the same time, bringing transparency and speed to the process in amendment of Japanese Pharmacopoeia and establishment of new guidelines is necessary, although too much dependence on them also leads to the fault of causing technical fixation. Therefore, formulation of the framework for adopting rational pliability to the evaluation process of drug safety and efficacy is also considered to be very important.
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