药物眼毒性非临床安全性评价的关注要点  

Major concerns about non-clinical safety evaluation of ocular toxicity of pharmaceuticals

作　　者：邵雪 刘斌 岑小波 王庆利 黄芳华 SHAO Xue;LIU Bin;CEN Xiao-bo;WANG Qing-li;HUANG Fang-hua(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;National Chengdu New Drug Safety Evaluation Center,Chengdu 610041,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]国家成都新药安全性评价中心,四川成都610041

出　　处：《中国药理学与毒理学杂志》2020年第8期616-622,共7页Chinese Journal of Pharmacology and Toxicology

摘　　要：眼毒性非临床安全性评价对指导后续临床试验和药物上市后的应用至关重要。本文在调研已上市药物在非临床研究、临床研究及上市后眼毒性的基础上,通过介绍代表性案例中针对眼毒性发现的非临床研究策略,从动物种属、给药频率、给药剂量、眼毒性的检测手段和判断标准、检测时间和频率、样本采集和检测等方面,对药物眼毒性的非临床安全性评价的关注要点进行分析和探讨,供研究者参考和借鉴。Non-clinical safety evaluation of ophthalmological toxicity can help assess the potential ocular toxicity of pharmaceuticals,which is crucial to subsequent clinical trials and the application of pharmaceuticals after marketing.Based on literature review and investigation of some approved drugs which were reported with ocular toxicity during non-clinical studies,clinical trials and post-market appli⁃cation,this article introduced non-clinical research strategies for discovering ocular toxicity in represen⁃tative cases,listed major concerns about non-clinical safety evaluation of ocular toxicity,including the selection of relevant animal species,treatment schedule and dosage,examination methods and criteria of ocular toxicity,detection frequency and timing,sample collection and detection,hoping to draw atten⁃tion from and provide reference for researchers.

关 键 词：药物 眼毒性 非临床安全性评价 

分 类 号：R988.1[医药卫生—药品] R951[医药卫生—药学]