药物肝毒性评价技术指导原则.pdf

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1、药物肝毒性评价技术指导原则2007年10月美国FDA发布草案2009年6月药审中心组织翻译安斯泰来制药有限公司翻译北核协会审核药审中心最终核准目录I.前言...........................................................................................................................1II.背景：..........................................................

2、............................................................1III.药物肝毒性的信号和海氏法则.............................................................................3IV.药物肝毒性的临床评价.........................................................................................6A.一般考虑

3、.............................................................................................................61.肝功能异常或肝病患者.............................................................................62.药物肝毒性的检测.......................................................

4、..............................73.确认.............................................................................................................74.密切观察.....................................................................................................85.决定停药......

5、...............................................................................................86.评价其他原因的资料.................................................................................97.随访至消除.....................................................................

6、..........................108.再暴露.......................................................................................................109.研究机会...................................................................................................11B.病例报告表.............

7、........................................................................................12C.药物肝毒性的信号或急性肝功能衰竭的解释.............................................121.肝脏AT异常的频率和强度....................................................................122.转氨酶和胆红素联合升高..........

8、.............................................................13D.药物肝毒性信号的分析......................................................................