Study of risk assessment of drug-induced liver injury using chimeric mice with highly humanized liver and large-scale adverse drug reactions databese
| Project/Area Number |
26460220
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | Nagasaki University |
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Principal Investigator |
NAKASHIMA Mikiro 長崎大学, 医歯薬学総合研究科(薬学系), 教授 (00260737)
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| Co-Investigator(Renkei-kenkyūsha) |
SASAKI Hitoshi 長崎大学, 病院(医学系), 教授 (00170689)
SAKAEDA Toshiyuki 京都薬科大学, 薬学部, 教授 (00304098)
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| Research Collaborator |
SHIMADA Takashi
NAGATSUKA Shin-Ichiro
TACHIKI Hidehisa
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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 |
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2016: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2015: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2014: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
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| Keywords | 後発医薬品 / 薬剤性肝障害 / ヒト肝キメラマウス / ファーマコビジランス / 製剤品質評価 / トキシコゲノミクス / T-LEX / Ｔ-ＬＥＸ |
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| Outline of Final Research Achievements |
A novel method for risk prediction of drug-induced liver injury in human using toxicogenomic analyses and chimeric mice with highly humanized liver has been developed, and was named the Toxicity of Liver Examination method (T-LEX method). In this study, it was established by relating a result of the toxicogenomic experiment in chimeric mice with highly humanized liver after administration of statins to clinical information based on a large-scale drug reactions databese. Various safety information about liver injury induced by generic drugs were possible to indicate as a result of study of T-LEX method.
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Report
(4 results)
Research Products
(14 results)
