Garofolo Fabio, Rocci Mario L, Dumont Isabelle, Martinez Suzanne, Lowes Steve, Woolf Eric, van Amsterdam Peter, Bansal Surendra, Barra Ariadna Cristina Gomes, Bauer Ronald, Booth Brian P, Carrasco-Triguero Montserrat, DeSilva Binodh, Dunn John, Gallicano Keith, Gouty Dominique, Ho Stacy, Hucker Richard, Jemal Mohammed, Katori Noriko, Le Blaye Olivier, Lee Jean, Li Wenkui, Michael Steve, Nehls Corey, Nicholson Robert, Ormsby Eric, Tang Daniel, Viswanathan C T, Weiner Russell, Young Graeme
Algorithme Pharma Inc., Laval (Montreal) Quebec, H7V 4B3, Canada.
Bioanalysis. 2011 Sep;3(18):2081-96. doi: 10.4155/bio.11.192.
The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.
第五届生物分析近期问题研讨会（WRIB）由校准与验证小组组织，是一场为期两天的沉浸式研讨会，面向制药公司、合同研究组织（CRO）和监管机构，旨在讨论、审查、分享观点、提供潜在解决方案，并就小分子和大分子生物分析近期问题达成一致方法。高质量、更好的法规遵从性和科学卓越性是本次研讨会的基础。与这一重要活动的往届会议一样，在包括代表全球生物分析界的行业领袖和监管专家在内的小组成员和与会者之间，就生物分析中的许多“热点”话题提出了建议并达成了共识。这份2011年白皮书基于本次研讨会的结论，旨在为这些话题提供实用的参考指南。
