细胞毒类抗肿瘤药物非临床评价技术指导原则VIP免费

细胞毒类抗肿瘤药物非临床研究 技术指导原则 二○○六年十一月 目 录 一、概述.....................................................................................................2 二、有效性研究.........................................................................................3 （一）体外试验......................................................................................3 （二）体内试验......................................................................................4 （三）药代动力学 .................................................................................7 三、安全性研究.........................................................................................7 （一）急性毒性试验 .............................................................................8 （二）长期毒性试验 .............................................................................8（三）一般药理学试验 .......................................................................10（四）局部刺激性试验 .......................................................................10 （五）遗传毒性、生殖毒性和致癌性试验 .......................................10 （六）毒代动力学 ...............................................................................10 四、非临床研究结果向临床试验的过渡 ..............................................11 （一）关于临床试验起始剂量 ...........................................................11 （二）关于临床适应症 .......................................................................11 五、结语...................................................................................................12 六、注释...................................................................................................12 七、参考文献...........................................................................................13 八、著者...................................................................................................14 1一、概述...