化学药物长期毒性试验技术指导原则资料.pdfVIP

指导原则编号: 【 H 】 G P T 2 - 1 化学药物长期毒性试验 技术指导原则 二○○五年三月 1 目 录 一、概述 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · 1 二、立题原则··· ·· ·· · ··· ·· ··· ·· ·· ··· ·· ··· ·· ··· ·· ·· ··· ·· ··· ·· ··· ·· ··· ·· ·· ··· ·· ··· ·· ··· ·· ·· ··· ·· ··· ·· ··· ··2 三、基本原则··································································································2 四、基本内容··································································································3 五、结果分析和评价···························································································7 六、结语·······················································································································10 七、参考文献················································································································10 八、附录················································································································12 九、著者·······················································································································14 2 化学药物长期毒性试验技术指导原则 一、概述 长期毒性试验 （重复给药毒性试验）是药物非临床安全性评价的 核心内容，它与急性毒性、生殖毒性以及致癌性等毒理学研究有着密 切的联系，是药物从药学研究进入临床试验的重要环节。 在药物开发的过程中，长期毒性试验的目的是通过重复给药的动物 试验表征受试物的毒性作用，预测其可能对人体产生的不良反应，降低 临床试验受试者和药品上市后使用人群的用药风险。具体包括以下五个 方面：①预测受试物可能引起的临床不良反应，包括不良反应的性