2013 Fiscal Year Final Research Report
Development of a system to predict the bioequivalency of risk of drug-induced hepatotoxicity in humans in the case of using generic and counterpart drug formulations
| Project/Area Number |
23590187
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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, 教授 (00260737)
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| Co-Investigator(Renkei-kenkyūsha) |
SHIMADA Takashi 株式会社フェニックスバイオ, 研究員
NAGATSUKA Shin-ichiro 積水メディカル株式会社, 薬物動態研究所, 研究員
TACHIKI Hidehisa 東和薬品株式会社, 研究開発本部, 研究員
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| Project Period (FY) |
2011 – 2013
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| Keywords | 後発医薬品 / 薬剤性肝障害 / ヒト肝細胞キメラマウス / トキシコゲノミクス / 品質試験 / 薬剤反応性 / T-LEX / 安全性試験 |
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| Research Abstract |
We examined changes in hepatic gene expression induced by administration of a generic drug, such as statin, and its brand name counterpart using chimeric mice with highly humanized liver, in order to develop a system to predict the bioequivalency of risk of drug-induced hepatotoxicity in humans in the case of using different drug formulations. As a result, bioequivalency of risk of drug-induced human hepatotoxicity with generic and counterpart formulations of various drugs was clarified. The present system which is not a human clinical test was named the Toxicity of Liver Examination method (T-LEX method), and the industrial property rights were acquired.
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