中国临床药理学杂志2024，Vol.40Issue(1)：139-143,5.DOI:10.13699/j.cnki.1001-6821.2024.01.029
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
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分类
医药卫生引用本文复制引用
陈美灵,王庆利,光红梅,崔岚,张晓东..药物制剂安全性评价及常见问题分析[J].中国临床药理学杂志,2024,40(1):139-143,5.
