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

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research 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

Abstract

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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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。

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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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.