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