Evaluation of drug local tolerance testing and analysis of common problems
10.13699/j.cnki.1001-6821.2024.01.029
- VernacularTitle:药物制剂安全性评价及常见问题分析
- Author:
Mei-Ling CHEN
1
;
Qing-Li WANG
;
Hong-Mei GUANG
;
Lan CUI
;
Xiao-Dong ZHANG
Author Information
1. 国家药品监督管理局 药品审评中心,北京 100022
- Keywords:
parentaral drugs;
local tolerance testing;
irritation;
hypersensitivity;
hemolysis
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(1):139-143
- CountryChina
- Language:Chinese
-
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.
