• 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

4th US FDA-Drug Information Association pharmacogenomics workshop, held 10-12 December, 2007.

作者信息

Frueh Felix W, Salerno Ronald A, Lesko Lawrence J, Hockett Richard D

机构信息

Medco Health Solutions Inc., 14401 Falling Leaf Drive, Gaithersburg, MD 20878, USA.

出版信息

Pharmacogenomics. 2009 Jan;10(1):111-5. doi: 10.2217/14622416.10.1.111.

DOI:10.2217/14622416.10.1.111
PMID:19102720
Abstract

The 4th US FDA/Industry workshop, in a series on Pharmacogenomics, was on 'Biomarkers and Pharmacogenomics in Drug Development and Regulatory Decision Making' and was held on December 10-12, 2007 in Bethesda, MD, USA, with clear objectives to continue the dialogue that began in 2002 for enabling the use of biomarkers and pharmacogenomics in drug development and regulatory decision-making. This brief commentary will highlight the major topics and outcomes discussed at this meeting that was jointly sponsored by the FDA, The Pharmacogenomics Working Group (PWG), The Pharmaceutical Research and Manufacturers of America (PhRMA), The Biotechnology Industry Organization (BIO) and The Drug Information Association (DIA).

摘要

相似文献

1
4th US FDA-Drug Information Association pharmacogenomics workshop, held 10-12 December, 2007.
Pharmacogenomics. 2009 Jan;10(1):111-5. doi: 10.2217/14622416.10.1.111.
2
Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop.药物-诊断联合开发策略:第四届美国食品药品监督管理局/药物信息协会/制药研究与制造商协会/药物基因组学工作组/生物技术产业组织药物基因组学研讨会上美国食品药品监督管理局与行业的对话
Pharmacogenomics. 2009 Jan;10(1):127-36. doi: 10.2217/14622416.10.1.127.
3
Developing the evidence base for applying pharmacogenomics: proceeds from DIA Workshop IV--Breakout Session 1.
Pharmacogenomics. 2009 Jan;10(1):117-25. doi: 10.2217/14622416.10.1.117.
4
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.药物研发与监管决策中的药物遗传学和药物基因组学:美国食品药品监督管理局-药品安全与风险评估工作组-美国制药研究与制造商协会-药物安全联盟首次研讨会报告
J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244.
5
The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop.药物诊断联合开发概念文件:第三届美国食品药品监督管理局-药物信息协会-制药商工作组-美国制药研究与制造商协会-生物技术产业组织药物基因组学研讨会评论
Pharmacogenomics J. 2006 Nov-Dec;6(6):375-80. doi: 10.1038/sj.tpj.6500392. Epub 2006 May 2.
6
Enabling pharmacogenomic clinical trials through sampling.通过采样实现药物基因组学临床试验。
Pharmacogenomics. 2010 Dec;11(12):1649-54. doi: 10.2217/pgs.10.139.
7
Development and regulatory strategies for drug and diagnostic co-development.药物和诊断试剂联合开发的研发和监管策略。
Pharmacogenomics. 2010 Dec;11(12):1669-75. doi: 10.2217/pgs.10.141.
8
Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.
Pharmacogenomics J. 2006 Mar-Apr;6(2):78-81. doi: 10.1038/sj.tpj.6500345.
9
Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs.从药品标签及标签变化中学习:如何将药物基因组学纳入药物研发项目。
Pharmacogenomics. 2010 Dec;11(12):1637-47. doi: 10.2217/pgs.10.138.
10
Generating and weighing evidence in drug development and regulatory decision making: 5th US FDA-DIA workshop on pharmacogenomics.药物研发和监管决策中的证据生成与权衡:第五次美国 FDA-DIA 药物基因组学研讨会
Pharmacogenomics. 2010 Dec;11(12):1629-35. doi: 10.2217/pgs.10.142.

引用本文的文献

1
Clinical implementation of genetic testing in medicine: a US regulatory science perspective.医学中基因检测的临床应用:美国监管科学视角
Br J Clin Pharmacol. 2014 Apr;77(4):606-11. doi: 10.1111/bcp.12299.
2
Pharmacogenetics and personal genomes.药物遗传学与个人基因组
Per Med. 2009 Nov 1;6(6):643-652. doi: 10.2217/pme.09.55.