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中药、天然药物免疫毒性过敏性、光变态反应)研究技术指导原则1).pdf
指导原则编号: 【Z 】 G P T 5 - 1
中药、天然药物免疫毒性(过敏性、光过敏反应)
研究的技术指导原则
二○○五年三月
目 录
一、概述·····················································································································································1
二、基本内容·········································································································································2
····························································································································2
(一)基本原则
··················································································································3
(二)过敏反应试验
1、试验中应考虑的问题······································································································3
2、I 型过敏反应试验·············································································································4
3、II、Ⅲ型过敏反应试验··································································································6
4、Ⅳ型过敏反应试验···········································································································6
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(三)光过敏反应试验
············································································································7
(四)结果分析及评价
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(五)常见问题及处理
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