2012 White Paper on Recent Issues in Bioanalysis And Alignment of Multiple Guidelines

• DOI: 10.4155/bio.12.205
• Publication Date: 2012-10-09T16:59:16Z
• Authors: Binodh DeSilva; Fabio Garofolo; Mario Rocci; Suzanne Martinez; Isabelle Dumont; France Landry; Catherine Dicaire; Gabriella Szekely...; Russell Weiner; Mark Arnold; Surendra Bansal; Kevin Bateman; Ronald Bauer; Brian Booth; Scott Davis; Sherri Dudal; Dominique Gouty; John Grundy; Sam Haidar; Roger Hayes; Mohammed Jemal; Surinder Kaur; Marian Kelley; Magnus Knutsson; Olivier Le Blaye; Jean Lee; Steve Lowes; Mark Ma; Toshinari Mitsuoka; João Tavares Neto; Robert Nicholson; Eric Ormsby; Jeffrey Sailstad; Lauren Stevenson; Daniel Tang; Jan Welink; CT Viswanathan; Laixin Wang; Eric Woolf; Eric Yang
• Keywords: 03 medical and health sciences; 0302 clinical medicine

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 evolvi...