• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.

作者信息

Timmerman Philip, Scheel Fjording Marianne, Allinson John, Arfvidsson Cecilia, Barroso Begoña, Diczfalusy Ulf, Freeman Adrian, Hickford Elizabeth, Kandousi Hamza, Katugampola Sidath, Kunz Ulrich, Nelson Robert, Smeraglia John

机构信息

Janssen Research & Development, Turnhoutseweg, 30 B-2340 Beerse, Belgium.

Novo Nordisk, Måløv, Denmark.

出版信息

Bioanalysis. 2017 May;9(9):675-681. doi: 10.4155/bio-2017-0045. Epub 2017 May 18.

DOI:10.4155/bio-2017-0045
PMID:28520459
Abstract

European Bioanalysis Forum Focus Workshop, Lisbon, Portugal, 9-10 June 2016 At the recent European Bioanalysis Forum's Focus Workshop 'Bringing Assay Validation and Analysis of Biomarkers into Practice', the discussion on best practice for biomarker assay validation continued. Both the presentations and the adjacent panel discussions yielded valuable food for thought for the broader bioanalytical community. The present conference report summarizes the essence from these discussions and from the proposals or conclusions made by all delegates on how to increase the necessary connectivity of the stakeholders involved in the bioanalysis of biomarkers.

摘要

相似文献

1
Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.
Bioanalysis. 2017 May;9(9):675-681. doi: 10.4155/bio-2017-0045. Epub 2017 May 18.
2
Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.欧洲生物分析论坛的反馈：免疫原性当前分析重点研讨会——最佳实践与监管障碍
Bioanalysis. 2018 Feb;10(4):197-204. doi: 10.4155/bio-2017-4971. Epub 2018 Jan 18.
3
Conference Report: Analytical challenges in the qualification and validation of pharmacodynamic biomarkers.会议报告：药效学生物标志物的鉴定与验证中的分析挑战
Bioanalysis. 2011 May;3(9):945-8. doi: 10.4155/bio.11.90.
4
Scientific or regulated validation: a tiered approach? Meeting report from a joint EBF/DVDMDG workshop.科学验证或规范验证：一种分层方法？欧洲生物制药论坛/药物研发与医学发展小组联合研讨会会议报告
Bioanalysis. 2015;7(14):1703-10. doi: 10.4155/bio.15.115.
5
AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers.美国药学科学家协会（AAPS）与美国食品药品监督管理局（US FDA）关于生物标志物生物分析方法验证的水晶城第六届研讨会
Bioanalysis. 2016 Feb;8(3):163-7. doi: 10.4155/bio.15.251. Epub 2016 Jan 22.
6
Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice.更新欧洲生物分析论坛关于生物标志物检测的建议；将使用情境付诸实践。
Bioanalysis. 2020 Oct;12(20):1427-1437. doi: 10.4155/bio-2020-0243. Epub 2020 Oct 7.
7
Conference report: emerging technology for bioanalysis in the next decade.
Bioanalysis. 2012 Nov;4(21):2557-61. doi: 10.4155/bio.12.227.
8
Biomarker assay validation: are we having the right discussions?生物标志物检测验证：我们的讨论是否恰当？
Bioanalysis. 2016 Nov;8(22):2299-2303. doi: 10.4155/bio-2016-0142. Epub 2016 Jul 15.
9
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.第八届海湾合作委员会：就美国食品药品监督管理局2013年生物分析方法验证指南草案向其提供的综合反馈。
Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287.
10
Conference report: 12th Annual University of Wisconsin Land O'Lakes Bioanalytical Conference.
Bioanalysis. 2011 Oct;3(19):2171-5. doi: 10.4155/bio.11.236.