欧洲生物分析论坛关于要求提供使用背景说明以成功开发和验证生物标志物检测方法的建议。

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-08-05 DOI:10.1080/17576180.2024.2376436

Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman

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引用次数: 0

摘要

欧洲生物分析论坛与主要的行业利益相关者一起，一直在推动围绕生物标志物检测使用背景的讨论，以确保根据检测目的对这些检测进行适当的验证。在了解为什么要在化验策略中实施 "使用情境 "的深入研究还表明，生物标记物数据的关键利益相关者或请求者有责任为所有生物标记物化验请求提供 "使用情境 "声明。来自各行各业的专家一再寻求一种跨行业的推荐格式，以提供使用背景声明。在本手稿中，欧洲生物分析论坛为此提出了一种格式。

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A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.

The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.