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。

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

作者信息

Bower Joseph, Fast Douglas, Garofolo Fabio, Gouty Dominique, Hayes Roger, Lowes Steve, Nicholson Robert, LeLacheur Richard, Bravo Jennifer, Shoup Ronald, Dumont Isabelle, Carbone Mary, Zimmer Jennifer, Ortuno Jordi, Caturla Maria Cruz, Datin Jim, Lansing Tim, Fatmi Saadya, Struwe Petra, Sheldon Curtis, Islam Rafiqul, Yu Mathilde, Hulse Jim, Kamerud John, Lin John, Doughty John, Kurylak Kai, Tang Daniel, Buonarati Mike, Blanchette Alexandre, Levesque Ann, Gagnon-Carignan Sofi, Lin Jenny, Ray Gene, Liu Yanseng, Khan Masood, Xu Allan, El-Sulayman Gibran, DiMarco Chantal, Bouhajib Mohammed, Tacey Dick, Jenkins Rand, der Strate Barry van, Briscoe Chad, Karnik Shane, Rhyne Paul, Garofolo Wei, Schultz Gary, Roberts Andrew, Redrup Mike, DuBey Ira, Conliffe Phyllis, Pekol Teri, Hantash Jamil, Cojocaru Laura, Allen Mike, Reuschel Scott, Watson Andrea, Farrell Colin, Groeber Elizabeth, Malone Michele, Nowatzke William, Fang Xinping

机构信息

Covance Laboratories, Chantilly, VA, USA.

出版信息

Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287.

DOI:10.4155/bio.14.287

PMID:25496252

Abstract

The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.

摘要

第八届海湾合作委员会生物分析闭门论坛于2013年12月5日在美国马里兰州巴尔的摩举行，紧接在2013年美国药学科学家协会研讨会（水晶城第五场）：定量生物分析方法验证与实施——2013年修订的美国食品药品监督管理局指南之后。本次海湾合作委员会会议旨在讨论2013年9月发布的美国食品药品监督管理局生物分析方法验证指南修订草案的内容，并汇总海湾合作委员会成员的反馈意见。来自七个国家的63名高级别参会者代表了46家生物分析合同研究组织公司/机构出席了会议。此次活动为合同研究组织生物分析专家提供了一个独特的机会，以分享他们对美国食品药品监督管理局指南草案的意见和关切，并形成统一意见反馈给美国食品药品监督管理局。