Recommendations on biomarker assay validation (BAV) in tissues by GCC.

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-04-01 Epub Date: 2025-04-18 DOI:10.1080/17576180.2025.2471243

Moucun Yuan, Aihua Liu, Bin Xu, Kurt Sales, Shane Karnik, Troy Voelker, Danielle Salha, Jennifer Zimmer, Mark O'Dell, Shashank Gorityala, Amanda Hays, Todd Lester, Gregory Reynolds, Magdalena Tary-Lehmann, Mathilde Yu, Martin Roberge, Katherine Malone, Vimal Patel, Iain Love, Jenny Lin, Manisha Diaz, Tao Xu, Wei Garofolo, Jessica McGregor, Amanda Leskovar, Robert Kernstock, Mario Pellerin, Michael Brown, Adriane Spytko, Stephen Lowes, David Ambrose, Dawn Dufield, Cheikh Kane, Rathna Veeramachaneni, Marsha Luna, Dominic Warrino, Varun Dwivedi, Allan Xu, Elizabeth Hyer, Tracy Iles, Ritankar Majumdar, Daniel Sikkema, Eric Thomas, Annika Carlsson, Naveen Dakappagari, Nathan Riccitelli, Chantal Di Marco, Mohammed Bouhajib, Adriana Iordachescu, Mitesh Sanghvi, Hollie Barton, Amy Lavelle, Elizabeth Dompkowski, Stephen Rundlett, Katie Matys, Tim Sangster, Annelies Turksma, Weihua Gu, Jia Liu, Brian Hoffpauir, Agostinho Rocha, John Pirro, Jerome Bergeron, Kyla O'Brien, Xinping Fang, Kelly Dong, Jim Yamashita

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引用次数: 0

Abstract

Biomarker analysis enables a deep understanding of physiological and biological processes and offers insights into pathological disease states and conditions. When measured in tissues, the spatial distribution of biomarkers may be evaluated. To meet regulatory and sponsor requirements, guidance on the approach to validation and the parameters to be evaluated is essential. The main goals of this GCC white paper are to disseminate the survey results discussed during the 16^th& 17^thGCC Closed Forums (2023 & 2024) and to provide recommendations from the GCC members on technical and regulatory considerations for the bioanalysis of biomarkers in tissues.

查看原文本刊更多论文

GCC对组织中生物标志物测定验证（BAV）的建议。

生物标志物分析使人们能够深入了解生理和生物过程，并提供对病理疾病状态和条件的见解。当在组织中测量时，可以评估生物标志物的空间分布。为了满足法规和发起人的要求，关于验证方法和要评估的参数的指导是必不可少的。本GCC白皮书的主要目标是传播第16届和第17届GCC非公开论坛（2023年和2024年）期间讨论的调查结果，并提供GCC成员对组织中生物标志物生物分析的技术和监管考虑的建议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.