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| 药物分析领域相关测量不确定度指导原则简介 |
| Introduction to Guidelines of Measurement Uncertainty in the Field of Drug Analysis |
| 投稿时间：2024-07-22 修订日期：2024-09-24 |
| DOI： |
| 中文关键词: 测量不确定度 指导原则 ISO 自下而上法 自上而下法 发展历史 药物分析 |
| 英文关键词: measurement uncertainty guideline ISO Bottom-up approach Top-down approach development pharmaceutical analysis |
| 基金项目:中国食品药品检定研究院化学药品检定所重点实验室学科建设课题（No.2024HYZX20） |
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| 中文摘要: |
| 目的：梳理和归纳药物分析领域可以参考和借鉴的国内外相关测量不确定度指导原则，为国内测量不确定度评定在药物分析领域的推广和应用提供依据。 方法：主要通过文献检索、阅读以及指导原则比对，归纳总结测量不确定度发展的历史、主要评价方法以及不同指导原则的适用范围。 结果：国际指导原则根据评定测量不确定度方法的不同，大致分为两类：自下而上（Bottom-up）法和自上而下（Top-down）法。国内多个指导原则依据相应的国际指导原则制定，本文也梳理了现行国际和国内指导原则的对应关系。此外本文还介绍了各国和地区药品监管机构制定的一系列测量不确定度评定文件。 结论：无论是测量不确定度评定相关的指导原则还是实验室质量管理文件，亦或各个国家和地区药典中相应的介绍，都是大量实践的总结和归纳，仔细阅读相关内容，可以帮助药物分析工作者更好地理解和应用测量不确定度评定，推动其在药物分析领域的不断发展。 |
| 英文摘要: |
| Objective: To provide a basis for the promotion and application of measurement uncertainty evaluation in domestic pharmaceutical analysis, this review sorts and summarizes the measurement uncertainty guidelines on pharmaceutical analysis that can be referenced from international to national. Methods: Summarize the history of measurement uncertainty, the main evaluation methods and the scope of application of various guidelines mainly through searching, reviewing and comparing guidelines. Results: International measurement uncertainty guidelines can be roughly divided into two categories based on the different methods used to evaluate measurement uncertainty: Bottom-up approach and Top-down approach. Multiple national guidelines are formulated based on the corresponding international guidelines issued earlier, and this review also outlines the relationship between current international and national guidelines. In addition, this review introduces a series of documents on measurement uncertainty evaluation published by drug regulatory agencies in various countries and regions. Conclusion: Whether it is the guidelines related to measurement uncertainty evaluation or laboratory quality management documents, even the relevant introductions in various national and regional pharmacopoeias, they are all a summary of a large number of practices. Carefully reading the relevant content can help pharmaceutical analysts better understand and apply the measurement uncertainty evaluation, and promote its continuous development in pharmaceutical analysis. |
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