Study of risk assessment of drug-induced liver injury using chimeric mice with highly humanized liver and large-scale adverse drug reactions databese

2016 Fiscal Year Final Research Report

• Project/Area Number: 26460220
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: Nagasaki University
• Principal Investigator: NAKASHIMA Mikiro 長崎大学, 医歯薬学総合研究科(薬学系), 教授 (00260737)
• 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)
• Research Collaborator: SHIMADA Takashi ; NAGATSUKA Shin-Ichiro ; TACHIKI Hidehisa
• Project Period (FY): 2014-04-01 – 2017-03-31
• 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

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.

Free Research Field

医療系薬学