Models to estimate overall analytical measurements uncertainty: Assumptions, comparisons and applications

被引:25
作者
Rozet, E. [1 ]
Rudaz, S. [2 ]
Marini, R. D.
Ziemons, E.
Boulanger, B. [3 ]
Hubert, Ph.
机构
[1] Univ Liege, CHU, Dept Pharm, Analyt Chem Lab,CIRM, B-4000 Liege, Belgium
[2] Univ Geneva, Sch Pharm, Lab Pharmaceut Analyt Chem, CH-1211 Geneva 4, Switzerland
[3] Arlenda SA, B-4000 Liege, Belgium
关键词
Measurement uncertainty; Tolerance interval; Results quality; Method validation; Compliance assessment; RESTRICTED ACCESS MATERIAL; LIQUID-CHROMATOGRAPHIC DETERMINATION; QUANTITATIVE ANALYTICAL PROCEDURES; SPECTROSCOPY METHOD DEVELOPMENT; ANALYTICAL METHOD VALIDATION; MASS-SPECTROMETRY METHOD; TOTAL ERROR; HUMAN PLASMA; PHARMACEUTICAL PELLETS; TOLERANCE INTERVALS;
D O I
10.1016/j.aca.2011.06.055
中图分类号
O65 [分析化学];
学科分类号
070302 [分析化学];
摘要
Evaluation of analytical results reliability is of core importance as crucial decisions are taken with them. From the various methodologies to evaluate the fitness of purpose of analytical methods, overall measurement uncertainty estimation is more and more applied. Overall measurement uncertainty allows to combine simultaneously the remaining systematic influences to the random sources of uncertainty and allows assessing the reliability of results generated by analytical methods. However there are various interpretations on how to estimate overall measurement uncertainty, and thus various models for estimating it. Each model together with its assumptions has great impacts on the risks to abusively declare that analytical methods are suitable for their intended purpose. This review paper aims at (i) summarizing the various models used to estimate overall measurement uncertainty, (ii) provide their pros and cons, (iii) review the main areas of application and (iv) as a conclusion provide some recommendations when evaluating overall measurement uncertainty. (C) 2011 Elsevier B.V. All rights reserved.
引用
收藏
页码:160 / 171
页数:12
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