一份关于成功开发和验证生物标志物检测方法需要使用情况说明的欧洲生物分析论坛建议。
A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.
机构信息
Merck KGaA, Research & Development, Drug Metabolism & Pharmacokinetics New Biological Entities, 64293Darmstadt, Germany.
Boehringer Ingelheim Pharma GmbH & Co. KG, Translational Medicine & Clinical Pharmacology, 88400Biberach an der Riss, Germany.
出版信息
Bioanalysis. 2024;16(16):835-842. doi: 10.1080/17576180.2024.2376436. Epub 2024 Aug 5.
Abstract
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.
摘要
欧洲生物分析论坛与主要行业利益相关者一起，积极推动围绕基于应用场景的生物标志物检测方法的实施展开讨论，以确保根据其用途对这些检测方法进行适当的验证。深入了解为什么在检测方法策略中实施基于应用场景的原因还表明，关键利益相关者或生物标志物数据请求者负责为所有生物标志物检测请求提供基于应用场景的声明。来自整个行业的专家们一直在反复寻求一种跨行业推荐的格式，以便提供基于应用场景的声明。在本文中，欧洲生物分析论坛为此提出了一种格式。
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