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

我们利用具有高度人源化肝脏的嵌合小鼠，检测了给予非专利药物(如他汀类药物)及其品牌对应药物引起的肝脏基因表达的变化，以开发一种系统，以预测在使用不同药物配方的情况下，药物诱导的肝毒性风险在人类中的生物等效性。结果，药物引起的人体肝毒性风险与各种药物的仿制药和对应制剂的生物等效性被阐明。目前的非人体临床试验系统被命名为肝脏毒性检测方法(T-Lex法)，并获得了工业产权。

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.