中药、天然药物长期毒性研究技术指导原则

指导原则编号:【Z】GPT3-1中药、天然药物长期毒性研究技术指导原则二OO五年三月目录一、概述···················································································································································1二、基本原则········································································································································2（一）实验管理································································································································2（二）具体问题具体分析···········································································································2（三）整体性······································································································································2（四）试验·································································································································2三、基本内容·········································································································································3（一）受试物······································································································································3（二）试验动物·································································································································3（三）给药途径································································································································3（四）给药频率································································································································4（五）给药期限································································································································4（六）给药剂量································································································································5（七）观察指标································································································································6（八）观察指标的时间和次数································································································8（九）结果及分析···························································································································8（十）综合评价································································································································9（十一）其他考虑·························································································································10四、不同情况的中药、天然药物长期毒性试验的要求···········································10五、参考文献······································································································································12六、附录·····&