[关键词]
[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。
[Key word]
[Abstract]
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.
[中图分类号]
R951
[基金项目]
十三五重大新药创制专项(2018ZX09201-017)