第17届GCC闭门论坛：综合生物分析，以患者为中心的采样，新兴技术，数据完整性，样品校准，ELISpot数据差异，交叉验证协调，ADA检测的超灵敏平台，远程监管评估，PCR脱落检测和生物标志物组织检测。

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-08-18 DOI:10.1080/17576180.2025.2529119

Jennifer Zimmer, Mark O'dell, Derrick Johnson, Amanda Hays, Shashank Gorityala, Magdalena Tary-Lehmann, Katherine Malone, Manisha Diaz, Tao Xu, Varun Dwivedi, Dawn Dufield, Tracy Iles, Daniel Sikkema, Ritankar Majumdar, Nathan Riccitelli, Moucun Yuan, Steve Lowes, Aihua Liu, Katie Matys, Annelies Turksma, John Pirro, Jerome Bergeron, Shane Karnik, Troy Voelker, Danielle Salha, Gregory Reynolds, Corbyn Lamy, Mathilde Yu, Wei Garofolo, Sankeetha Nadarajah, Amanda Leskovar, Mario Pellerin, Rathna Veeramachaneni, Cheikh Kane, Allan Xu, Elizabeth Hyer, Annika Carlsson, Mitesh Sanghvi, Elizabeth Dompkowski, Stephen Rundlett, Joseph Bower, Adriane Spytko, Jia Liu, Weihua Gu, Agostinho Rocha, Kyla O'Brien, Xinping Fang

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引用次数: 0

摘要

第17届海湾合作委员会非公开论坛于2024年5月10日在美国德克萨斯州圣安东尼奥举行。来自国际生物分析合同研究组织的代表出席了会议，以便讨论与生物分析有关的科学和监管问题。会议讨论的主题包括综合生物分析、以患者为中心的采样、新兴技术、数据完整性、样品协调努力、ELISpot数据差异、交叉验证协调、免疫原性检测的超灵敏平台、远程监管评估、qPCR/dPCR脱落检测和生物标志物检测。本文包含了对这些主题的讨论得出的结论和共识。

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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17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays.

The 17th GCC Closed Forum was held in San Antonio, TX, USA, on 10^th May 2024. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The topics discussed at the meeting included integrative bioanalysis, patient-centric sampling, emerging technologies, data integrity, sample reconciliation efforts, discrepancies of ELISpot data, cross-validation harmonization, ultrasensitive platforms for immunogenicity assays, remote regulatory assessments, shedding assays by qPCR/dPCR, and biomarker assays. Conclusions and consensus from discussions of these topics are included in this article.

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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.