Study on regulatory science of dental devices
| Project/Area Number |
22592179
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Dental engineering/Regenerative dentistry
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| Research Institution | Tokyo Medical and Dental University |
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Principal Investigator |
HARADA NAOKO 東京医科歯科大学, 医歯(薬)学総合研究科, 助教 (70372448)
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| Co-Investigator(Kenkyū-buntansha) |
TAGAMI Junji 東京医科歯科大学, 大学院医歯学総合研究科, 教授 (50171567)
TAKAHASHI Hidekazu 東京医科歯科大学, 歯学部口腔保健学科, 教授 (90175430)
TAKAGI Yuzo 東京医科歯科大学, 医学部医学科, 非常勤講師 (30124697)
SONODA Hidekazu 東京医科歯科大学, 歯学部, 非常勤講師 (40302880)
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| Co-Investigator(Renkei-kenkyūsha) |
HARASAWA Hideki 東京医科歯科大学, 歯学部附属病院, 薬剤部長
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| Project Period (FY) |
2010-04-01 – 2014-03-31
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| Project Status |
Completed (Fiscal Year 2013)
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| Budget Amount *help |
¥3,250,000 (Direct Cost: ¥2,500,000、Indirect Cost: ¥750,000)
Fiscal Year 2013: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2012: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2011: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2010: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
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| Keywords | レギュラトリー・サイエンス / 歯学 / 歯科医療機器 / リスク・ベネフィット / 医歯工連携 / 薬事法 / 機械材料・材料力学 / 生体材料 |
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| Research Abstract |
Safety and performance of dental devices and effectiveness of dental technology should be assured based on appropriate scientific evidences. In this study, we considered to plan an education program on Pharmaceutical Affairs Act, and provided lectures for students to help them to gain fundamental knowledge of Pharmaceutical Affairs Act which is required for development and application of dental devices and technologies. And also we tried to perform the objective evaluation of the risk and benefit of dental treatment. With the use of QALY (Quality Adjusted Life Years) concept and Monte Carlo simulation, we could compare the risks and the benefit quantitatively. Thus the effectiveness of the suggested method was demonstrated for risk analysis of dental treatment.
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Report
(5 results)
Research Products
(27 results)
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[Presentation] 歯科医療機器の評価の現状
Author(s)
原田 直子
Organizer
日本機械学会第２５回バイオエンジニアリング講演会
Place of Presentation
（独）産業技術総合研究所 つくば研究センター
Related Report
Invited
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