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指导原则编号：【H 】 GPT5-1
化学药物非临床药代动力学研究
技术指导原则
二○○五年三月
目
录
一、概述 ··························································································· 1 二、基本原则 ··························································································· 2
三、试验设计 ········································································································· 2
（一）总体要求·································································································· 2 （二）生物样本的药物测定方法······································································3 （三）研究项
目·········································································································4 四、数据处理与分析 · ··· ···· ··· ·· ··· ··· ··· ··· ···· ··· ··· ··· ···· ··· ··· ··· ···· ··· ··· ··· ··· ···· ··· ··· ··· ··· · 9 五、结果与评价 ·································································································· 9 六、常见问题与处理思路···························································································10 七、参考文献······························································································································13
八、附录（生物样品的分析方法）·············································································15
九、著者·····································································································································21