化学药物刺激性、过敏性和溶血性研究技术指导原则.pdf

指导原则编号: 【 H】G P T 4 - 1




化学药物刺激性、过敏性和溶血性
研究技术指导原则




















二○○五年三月
目录
一、概述····················································································································································1
二、总则····················································································································································1
(一)刺激性试验·································································································································2
1、目的···········································································································································2
2、刺激性试验设计中应考虑的问题············································································3
3、皮肤刺激性试验·················································································································4
4、注射给药部位的刺激性试验······················································································4
5、眼刺激性试验······················································································································5
6、其他途径给药部位刺激性试验·················································································5
(二)过敏性试验·································································································································5
1、目的············································································································································5
2、过敏性试验设计中应考虑的问题············································································6
3、经皮给药过敏性试验·······································································································7
4、注射给药过敏性试验········································································································7
5、其他途径给药过敏性试验·························································