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From method validation to result assessment: Established facts and pending questions
Trends in Analytical Chemistry ( IF 13.1 ) Pub Date : 2018-04-30 , DOI: 10.1016/j.trac.2018.04.013
Serge Rudaz , Max Feinberg

This paper aims to present a critical discussion of existing strategies to emphasize possible pitfalls and expected trends that arise from method validation to result assessment. It critically presents some aspects of the three main historical steps, namely terminology, method validation and quality of results. In addition to the formal link between method validation and measurement uncertainty that was recently demonstrated, the abundance of propositions also leads to some problems of consistency. Particular interest is given to the use of tolerance intervals as an appropriate tool to make decisions in method validation, control charts and determination of measurement uncertainty, considering various possibilities regarding adjustments of coverage percentage that can present difficulty for most analytical scientists.



中文翻译:

从方法验证到结果评估:既定事实和未决问题

本文旨在对现有策略进行批判性讨论,以强调从方法验证到结果评估可能出现的陷阱和预期趋势。它批判性地介绍了三个主要历史步骤的某些方面,即术语,方法验证和结果质量。除了最近证明的方法验证和测量不确定度之间的正式联系外,大量的主张还导致了一些一致性问题。考虑到有关调整覆盖率的各种可能性,这对大多数分析科学家来说都是困难的,因此特别关注使用公差区间作为在方法验证,控制图和测量不确定度的确定中做出决定的适当工具。

更新日期:2018-07-12
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