DeSilva Binodh, Garofolo Fabio, Rocci Mario, Martinez Suzanne, Dumont Isabelle, Landry France, Dicaire Catherine, Szekely-Klepser Gabriella, Weiner Russell, Arnold Mark, Bansal Surendra, Bateman Kevin, Bauer Ronald, Booth Brian, Davis Scott, Dudal Sherri, Gouty Dominique, Grundy John, Haidar Sam, Hayes Roger, Jemal Mohammed, Kaur Surinder, Kelley Marian, Knutsson Magnus, Le Blaye Olivier, Lee Jean, Lowes Steve, Ma Mark, Mitsuoka Toshinari, Neto João Tavares, Nicholson Robert, Ormsby Eric, Sailstad Jeffrey, Stevenson Lauren, Tang Daniel, Welink Jan, Viswanathan C T, Wang Laixin, Woolf Eric, Yang Eric
Bristol-Myers Squibb, Princeton, NJ, USA.
Bioanalysis. 2012 Sep;4(18):2213-26. doi: 10.4155/bio.12.205.
Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.
来自制药公司、合同研究组织（CRO）以及多个监管机构的400多名专业人士参加了第六届生物分析近期问题研讨会（WRIB）。与前几届会议一样，本次活动采用了务实、聚焦、高度互动且信息丰富的研讨会形式，旨在实现高质量、更好的法规合规性以及卓越的科学性。小分子和大分子生物分析中的众多“热门”话题得以分享和讨论，在代表生物分析领域的小组成员和与会者之间达成了共识并提出了建议。今年研讨会的主要成果是不同监管机构的多项生物分析指南显著趋同。这代表着生物分析活动全球协调方面向前迈出了切实的一步。这份2012年的白皮书是一份实用的参考文件，它就生物分析这个不断发展的领域中的若干主题和问题提供了关键信息和解决方案。
