title: 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
abstract: The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 1 covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (hybrid LBA/LCMS and regulatory agencies' inputs) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will also be published in volume 7 of Bioanalysis, issues 23 and 24, respectively.
authors.affiliation: Dutch MEB, Utrecht, The Netherlands.
authors.forename: Jan
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authors.lastname: Welink
authors.affiliation: Pfizer, Pearl River, NY, USA.
authors.forename: Eric
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authors.lastname: Fluhler
authors.affiliation: Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada.
authors.forename: Nicola
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authors.lastname: Hughes
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Mark
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authors.lastname: Arnold
authors.affiliation: Angelini Pharma, Piazzale della Stazione, snc, 0040 S. Palomba Pomezia (RM), Italy.
authors.forename: Fabio
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authors.lastname: Garofolo
authors.affiliation: Health Canada, Ottawa, ON, Canada.
authors.forename: Mark
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authors.affiliation: Apotex, Toronto, ON, Canada.
authors.forename: Laura
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authors.lastname: Coppola
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authors.forename: Raj
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authors.lastname: Dhodda
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Evans
authors.affiliation: Bristol-Myers Squibb, Tully, NY, USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Gleason
authors.affiliation: US FDA, Silver Spring, MD, USA.
authors.forename: Sam
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authors.lastname: Haidar
authors.affiliation: MPI Research, Mattawan, MI, USA.
authors.forename: Roger
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authors.lastname: Hayes
authors.affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland.
authors.forename: Katja
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authors.lastname: Heinig
authors.affiliation: Japan MHLW-NIHS, Tokyo, Japan.
authors.forename: Noriko
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authors.lastname: Katori
authors.affiliation: France ANSM, Saint-Denis, France.
authors.forename: Olivier Le
authors.initials: OL
authors.lastname: Blaye
authors.affiliation: Novartis, East Hanover, NJ, USA.
authors.forename: Wenkui
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authors.lastname: Li
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Guowen
authors.initials: G
authors.lastname: Liu
authors.affiliation: Brazil Anvisa, Brasilia, Brazil.
authors.forename: Gustavo Mendes
authors.initials: GM
authors.lastname: Lima Santos
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authors.forename: Min
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authors.affiliation: PPD, Richmond, VA, USA.
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authors.lastname: Nicholson
authors.affiliation: CFABS, Montreal, QC, Canada.
authors.forename: Natasha
authors.initials: N
authors.lastname: Savoie
authors.affiliation: US FDA, Silver Spring, MD, USA.
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authors.lastname: Skelly
authors.affiliation: Xenon Pharmaceuticals Inc., Burnaby, BC, Canada.
authors.forename: Luis
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authors.lastname: Sojo
authors.affiliation: Health Canada, Ottawa, ON, Canada.
authors.forename: Nilufer
authors.initials: N
authors.lastname: Tampal
authors.affiliation: PRA Health Sciences, Assen, The Netherlands.
authors.forename: Nico van
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authors.lastname: de Merbel
authors.affiliation: Janssen Research & Development, Beerse, Belgium.
authors.forename: Tom
authors.initials: T
authors.lastname: Verhaeghe
authors.affiliation: UK MHRA, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Vinter
authors.affiliation: Eli Lilly & Company, Indianapolis, IN, USA.
authors.forename: Enaksha
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authors.lastname: Wickremsinhe
authors.affiliation: UK MHRA, London, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Whale
authors.affiliation: AstraZeneca, Cambridge, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Wilson
authors.affiliation: Germany BfArM, Bonn, Germany.
authors.forename: Bärbel
authors.initials: B
authors.lastname: Witte
authors.affiliation: Merck Research Labs, West Point, PA, USA.
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authors.lastname: Woolf
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D002853:Chromatography, Liquid / Q000592:standards*; D006801:Humans; D013058:Mass Spectrometry / Q000592:standards*; D054852:Small Molecule Libraries / Q000032:analysis*
chemical_list: D015415:Biomarkers; D054852:Small Molecule Libraries