| 李娜,杜颖,隋思涟,谭德讲,施瑞红.能力验证和标准物质提供者专用统计软件的设计与应用[J].中国药事,2022,36(12):1383-1396 |
| 能力验证和标准物质提供者专用统计软件的设计与应用 |
| Design and Application of Proprietary Statistical Software for Proficiency Testing Providers and Reference Material Providers |
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| DOI：10.16153/j.1002-7777.2022.12.008 |
| 中文关键词: 能力验证 标准物质 稳健统计 均匀性 稳定性 Z值 赋值 指定值 |
| 英文关键词: profi ciency testing (PT) reference material (RM) robust statistics homogeneity stability Z-score assignment assigned value |
| 基金项目:中国食品药品检定研究院质量安全和能力建设项目 |
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| 中文摘要: |
| 目的： 为解决能力验证提供者和标准物质提供者对能力验证和标准物质统计评估及计算的困难，研发一款定制化的能力验证评估和标准物质赋值统计软件——PTP/RMP。方法：按照ISO13528和 ISO Guide35中能力验证评估和标准物质赋值所提供的统计方法，利用MATLAB平台进行界面设计和统计程序构建PTP/RMP软件。结果：(1)PTP/RMP软件全面系统地提供了能力验证和标准物质定值中所需的统计内容，包括检测样品的均匀性、稳定性、定值和利用所测样品进行的实验室能力评定等统计内容；(2)充分考虑使用人员的非统计专业特点，将复杂的计算原理和公式置于后台运行，将界面设置的简明清晰，方便快捷；(3)将PTP/RMP软件统计结果，分别与法规中的统计结果和专业统计软件的分析结果对比，验证了本软件统计分析结果的准确性和可靠性。结论：PTP/RMP软件不仅为从业人员提供了一款满足国内外法规对能力验证评价和标准物质赋值的专业统计软件，而且还为监管审查人员对相关内容的统计分析提供了一款科学评估和监管的新工具。 |
| 英文摘要: |
| Objective: To set up a customized statistical software of profi ciency testing evaluation and reference material assignment—PTP/RMP, in order to solve the problems in the statistical evaluation and calculation of profi ciency testing and standard substance for profi ciency testing providers (PTP) and reference material providers (RMP). Methods: The PTP/RMP is set up based on the statistical methods provided by ISO13528 and ISO Guide35 for profi ciency testing and reference material assignment respectively and on the MATLAB platform for interface design and statistical program construction. Results: (1) PTP/RMP software comprehensively and systematically provides statistical content required in profi ciency testing and reference material determination, including analyzing the uniformity, stability, determination of samples and the laboratory capability evaluation using the tested samples. (2) PTP/RMP software runs complex calculation principles and formulas in the background, makes the interface settings concise and intuitive, convenient and fast and gives full consideration to the non-statistical professional characteristics of users; (3) The accuracy and reliability of the PTP/RMP software was verified by comparing the statistical results of the PTP/RMP software with the statistical results in the regulations and the results from the professional statistical software. Conclusion: PTP/RMP software not only provides a professional statistical software that meets the requirements of domestic and foreign regulations on proficiency testing and reference material assignment, but also provides a new scientific evaluation and supervision tool for the statistical analysis of relevant content for regulatory examiners. |
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