摘要
采用计算机化系统进行数据采集和分析是目前药物临床前安全性评价研究的趋势,由此产生的计算机化系统安全性问题成为GLP机构以及行政管理监督部门关注的重点。作者从计算机化系统安全性的概念及范围、安全要素以及安全事件的管理等方面进行了简要阐述,以期为我国药物临床前安全性评价GLP机构中计算机化系统的广泛应用提供支持和帮助,从而促进我国药物研发以及安全性评价策略与国际接轨。
The use of computerized system for data acquisition and analysis is currently the trend of preclinical safety evaluation of drugs,so the security of computerized system has become the focus of GLP institutes and administrative supervision department.The author of the paper briefly introduces the concept,scope,security elements of computerized system and management of security incidents so as to provide supports and help for the wide application of computerized system in GLP institutes for preclinical safety evaluation of drugs in China,and thus promoting the research and development and safety evaluation strategy of drugs in line with international standards.
作者
张頔
李芊芊
霍桂桃
屈哲
杨艳伟
李琛
张曦
吕建军
林志
ZHANG Di;LI Qianqian;HUO Guitao;QU Zhe;YANG Yanwei;LI Chen;ZHANG Xi;LV Jianjun;LIN Zhi(National Center for Safety Evaluation of drugs,National Institutes for Food and Drug Control,Beijing 100176,China)
出处
《药物评价研究》
CAS
2020年第1期153-156,共4页
Drug Evaluation Research
基金
十三五重大新药创制专项(2018ZX09201-017).
关键词
临床前安全性评价
计算机化系统
药物安全
药物临床前评价
preclinical safety evaluation
computerized system
security of drug
preclinical evaluation of drug
