Article(id=1236342821821674287, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1659024000000, acceptedDateStr=2022-07-29, onlineDate=1772696698860, onlineDateStr=2026-03-05, pubDate=1677513600000, pubDateStr=2023-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772696698860, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772696698860, creator=13701087609, updateTime=1772696698860, updator=13701087609, issue=Issue{id=1236342820131361209, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='4', pageStart='329', pageEnd='440', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772696698458, creator=13701087609, updateTime=1772696766437, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343105318875204, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343105318875205, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=396, endPage=403, ext={EN=ArticleExt(id=1236342822060749617, articleId=1236342821821674287, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Comparative analysis of domestic and foreign regulatory science literatures based on VOSviewer, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The article was to carry out visualized analysis of Chinese and English literatures of regulatory science, and compare the current research status and hot spots around the world. Using "regulatory science" as the search term, Chinese literature was searched in CNKI, Wanfang and VIP from January 1, 2016 to December 26, 2021. English literature was searched in the Web of Science core collection and PubMed from January 1, 2001 to December 26, 2021. After excluding duplicate or irrelevant literature, the VOSviewer 1.6.17 was used for social network analysis and time series, including countries, organizations, authors and keywords. A total of 264 Chinese and 3 307 English literatures were included in the analysis. The research hotspots of Chinese literature were drugs, medical devices and discipline construction. While the research hotspots of English literature were biomarkers, nano medicine and other specific technologies. China's regulatory science has preliminarily established the framework and system of drug regulatory scientific research by carrying out the first batch of key projects and collaboration with universities. With the further deepening of research in the future, China will be completely in line with the world's level in this area.

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本文对监管科学相关的中、英文文献进行可视化分析，对比国内外研究现状及热点。以“监管科学”为检索词，在中国知网（CNKI）、万方和维普数据库中检索中文文献，检索时间为2016年1月1日—2021年12月26日。以“regulatory science”为检索词，在Web of Science核心数据集和PubMed中检索英文文献，时间选择2001年1月1日—2021年12月26日。排除重复或不相关文献，应用可视化工具VOSviewer 1.6.17对纳入的文献进行社会网络分析并绘制基于时序的知识图谱，角度包括国家、机构、作者和关键词。共有264篇中文文献和3 307篇英文文献被纳入分析。中文文献研究热点为药品、医疗器械、学科建设等，英文文献研究热点为生物标志物、纳米医疗等具体技术。我国监管科学已通过开展首批重点项目、依托高校建立研究基地等契机，初步搭建了药品监管科学研究的框架和体系。随着研究的继续深入，将彻底与世界前沿接轨。

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赵航，女，主要从事药事管理研究。E-mail: zhaohang187430@163.com。

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赵航，女，主要从事药事管理研究。E-mail: zhaohang187430@163.com。

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