2009 Fiscal Year Final Research Report
Regulation Gap Management in Advanced Medicines : A Comparative Institutional Analysis between US and Japan
| Project/Area Number |
19330087
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| Research Category |
Grant-in-Aid for Scientific Research (B)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Business administration
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| Research Institution | Shibaura Institute of Technology |
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Principal Investigator |
KANO Shingo Shibaura Institute of Technology, 大学院・新領域創成科学研究科, 特任教授 (20439293)
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| Co-Investigator(Kenkyū-buntansha) |
KODAMA Fumio 芝浦工業大学, 大学院・工学マネジメント研究科, 教授 (20016538)
SUNAMI Atsushi 政策研究大学院大学, 科学技術・学術政策博士プログラム, 准教授 (20361884)
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| Research Collaborator |
NAKANO Sohrei 財団法人医療機器センター, 研究開発部, 主任研究員
HAYASHI Yuko 山口大学, 大学院・技術経営研究科, 非常勤講師
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| Project Period (FY) |
2007 – 2009
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| Keywords | レギュレトリーサイエンス / 遺伝子治療 / イノベーション / レギュレーションギャップ / 再生医療 / テーラーメード医療 / ドラッグラグ / プリンシバルエージェント理論 |
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| Research Abstract |
The concept of "Regulation Frontier" that is Authority's threshold to able to generate rules was introduced to construct analytical framework for explanation of "Regulation Gap" which is non-rules status for occurred medical innovation. Using this analytical framework, comparative case study on DNA chip diagnosis device between US and Japan was conducted and clarified the difference of both Authorities. The main differences are in the structure of Authorities and R&D activities to make rules.
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