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Qualitative threshold method validation and uncertainty evaluation: a theoretical framework and application to a 40 analytes LC-MS/MS method.
Drug Testing and Analysis ( IF 2.9 ) Pub Date : 2020-07-06 , DOI: 10.1002/dta.2867
Félix Camirand Lemyre 1, 2, 3 , Brigitte Desharnais 4, 5 , Julie Laquerre 4 , Marc-André Morel 6 , Cynthia Côté 4 , Pascal Mireault 4 , Cameron D Skinner 5
Affiliation  

Qualitative methods hold an important place in drug testing, filling central needs in screening and analyses, among others, linked to per se legislation. Nevertheless, the bioanalytical method validation guidelines do not discuss this type of method or describe method validation procedures ill‐adapted to qualitative methods. The output of qualitative methods are typically categorical, binary results, such as presence/absence or above cut‐off/below cut‐off. As the goal of any method validation is to demonstrate fitness for use under production conditions, qualitative validation guidelines should evaluate performance based on discrete, binary results instead of the continuous measurements obtained from the instrument (e.g. area).

中文翻译:

定性阈值方法验证和不确定性评估:40 种分析物 LC-MS/MS 方法的理论框架和应用。

定性方法在药物测试中占有重要地位,满足筛选和分析等与本身立法相关的核心需求。然而,生物分析方法验证指南并未讨论此类方法或描述不适用于定性方法的方法验证程序。定性方法的输出通常是分类的二元结果,例如存在/不存在或高于临界值/低于临界值。由于任何方法验证的目标都是证明在生产条件下使用的适用性,因此定性验证指南应根据离散的二元结果而不是从仪器(例如面积)获得的连续测量结果来评估性能。
更新日期:2020-07-06
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