药物制剂安全性评价及常见问题分析
Evaluation of drug local tolerance testing and analysis of common problems
陈美灵 1王庆利 1光红梅 1崔岚 1张晓东1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100022
- 折叠
摘要
非口服途径给药制剂开展制剂安全性试验对评估药物的临床用药风险具有重要的意义.尽管国内外相关指导原则对如何开展制剂安全性试验进行了详细的介绍,但在审评中发现仍有部分产品的申报资料存在缺陷,影响了药物的研发效率.本文对近年来国内外药物制剂安全性相关指导原则信息进行了梳理,并结合具体审评案例对常见的问题进行阐述,以期为相关工作提供参考.
Abstract
Conducting local tolerance testing on parentaral drugs is of great significance for evaluating the clinical medication risks of drugs.Although relevant domestic and international guidelines provide detailed instructions on how to conduct local tolerance testing,it was found that some products still provide non-standard application materials,which affects the efficiency of drug development.This article summarizes the information on domestic and international guidance related to the local tolerance testing and elaborates on common problems based on specific application cases,with the aim of of providing reference for related work.
关键词
非口服途径给药制剂/制剂安全性试验/刺激性/过敏性/溶血性Key words
parentaral drugs/local tolerance testing/irritation/hypersensitivity/hemolysis引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据