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.
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.
陈美灵;王庆利;光红梅;崔岚;张晓东
国家药品监督管理局 药品审评中心,北京 100022
药学
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
parentaral drugs;local tolerance testing;irritation;hypersensitivity;hemolysis
《中国临床药理学杂志》 2024 (001)
139-143 / 5
10.13699/j.cnki.1001-6821.2024.01.029
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