2013 Fiscal Year Final Research Report
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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| 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 |
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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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