| 谢晶鑫,刘明理,王昆,傅瑶,曹丽梅,肖新月.国家药品标准物质保障供应综合数据平台建设[J].中国药事,2019,33(1):16-20 |
| 国家药品标准物质保障供应综合数据平台建设 |
| Establishment of Comprehensive Data Platform to Guarantee the Supply of National Drug Reference Standards |
| 投稿时间：2018-08-02 |
| DOI：10.16153/j.1002-7777.2019.01.003 |
| 中文关键词: 药品 标准物质 研制生产过程 信息化管理 数据平台 |
| 英文关键词: drugs reference standards process of development and production informatization management data platform |
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| 中文摘要: |
| 目的：进一步提高国家药品标准物质供应保障的能力和水平，更好支撑药品监管需求和服务行业发展。方法：将信息化管理和分析方法与现有的标准物质管理技术要求相结合，研究建立数字化、可视化的数据共享系统。结果：建成的国家药品标准物质保障供应综合数据平台，可显示各品种的研制生产阶段和效率。结论：该平台试运行一年来已成为指导研制、生产和管理的有力抓手，为对接国际标准ISO 17034奠定了重要基础。 |
| 英文摘要: |
| Objective:To further improve the capability and level of the national drug reference standards supply in order to better meet the drug regulatory requirements and ensure the development of the industry. Methods:Informatization management and data analytic methods were combined with current technical requirements for reference standards' management to establish a digital and visual data-sharing system. Results:The established comprehensive data platform to guarantee the supply of national drug reference standards can display the stages of development and production and efficiency of all kinds. Conclusion:The platform has been a powerful measure to guide the development, production and management in the first year of trial operation, laying an important foundation for the connection with ISO 17034. |
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