生物技术药物开展非临床安全药理学评价的考虑  

Consideration of non-clinical safety pharmacology evaluation of biopharmaceutics

作　　者：尹茂山 李峥 尹华静 王寅 吴爽 张晓东 张旻 戴学栋 于冰 孙涛 王庆利 YIN Mao-shan;LI Zheng;YIN Hua-jing;WANG Yin;WU Shang;ZHANG Xiao-dong;ZHANG Min;DAI Xue-dong;YU Bing;SUN Tao;WANG Qing-li(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2022年第24期3049-3055,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：生物技术药物开展非临床安全药理学评价是非临床评价的重要组成部分。本文系统梳理了生物技术药物安全药理学研究的相关技术要求和评价策略,回顾了部分已批准上市生物技术药物采用的安全药理学研究案例及策略;结合审评工作实践,对生物技术药物伴随开展安全药理学研究存在的问题及原因进行了分析,并对开展相关试验研究的关键考虑点进行了梳理总结,以期为相关工作提供参考。Objective Non clinical safety pharmacology evaluation of biotechnology-derived pharmaceuticals or biopharmaceuticals(BPs) is an important part of non-clinical evaluation of drugs. This paper systematically combs the relevant technical requirements and evaluation strategies for the safety pharmacology research of biotechnological drugs, and reviews the safety pharmacology research cases and strategies adopted by some approved biotechnological drugs. Combined with the review practice, the problems and reasons of safety pharmacology research of biotechnological drugs were analyzed, and the key considerations of relevant experimental research were summarized, with a view to providing reference for relevant work.

关 键 词：生物技术药物 心血管系统 中枢神经系统 呼吸系统 安全药理学 国际人用药品注册技术协调会 

分 类 号：R259[医药卫生—中西医结合]