第 16 届海湾合作委员会闭门论坛：ICH M10 实施；NGS、qPCR/dPCR、流式细胞仪验证；组织生物标志物；IS 响应；免疫原性协调；生物分析行业现状。

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-06-02 Epub Date: 2024-06-12 DOI:10.1080/17576180.2024.2342691

Jennifer Zimmer, Amanda Hays, Todd Lester, Manisha Diaz, Eric Thomas, Mark O'Dell, Elizabeth Hyer, Shabnam Tangri, Naveen Dakappagari, Moucun Yuan, Amy Lavelle, Shane Karnik, Aihua Liu, Bin Xu, Kurt Sales, Shashank Gorityala, Gregory Reynolds, Tim Sangster, Dean Franckaert, Iain Love, Vimal Patel, Martin Roberge, Jenny Lin, Erik Jerks, Tao Xu, Wei Garofolo, Sankeetha Nadarajah, Robert Kernstock, Dawn Dufield, David Ambrose, Dominic Warrino, Marsha Luna, Chantal Di Marco, Ariana Tudoroniu, Adriana Iordachescu, Mitesh Sanghvi, Hollie Barton, Michael Brown, Brian Hoffpauir, Agostinho Rocha, Kelly Dong, Jim Yamashita

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引用次数: 0

摘要

第 16 届海湾合作委员会封闭论坛于 2023 年 6 月 23 日在美国佛罗里达州奥兰多市举行。来自国际生物分析合同研究组织的代表出席了会议，讨论生物分析特有的科学和监管问题。会议讨论的问题包括IS 响应、流式细胞术、生物分析行业的变化、NGS 检测、组织的生物标记检测、dPCR 验证、免疫原性协调和 ICH M10 的实施。本文收录了这些议题的讨论结论和共识。

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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16^th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.

The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. 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.