首页> Bioanalysis> 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

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第一作者： An,Song

第一单位： Genentech, South San Francisco, CA, USA.

作者： An,Song ^[1] ; Anita,Lee ^[2] ; Fabio,Garofolo ^[3] ; Surinder,Kaur ^[1] ; Jeff,Duggan ^[4] ; Christopher,Evans ^[5] ; Joe,Palandra ^[6] ; Lorella Di,Donato ^[7] ; Keyang,Xu ^[1] ; Ronald,Bauer ^[8] ; Mark,Bustard ^[9] ; Linzhi,Chen ^[4] ; Laurent,Cocea ^[9] ; Stephanie,Croft ^[10] ; Fabrizio,Galliccia ^[11] ; Sam,Haidar ^[12] ; Nicola,Hughes ^[13] ; Akiko,Ishii-Watabe ^[14] ; Rafiqul,Islam ^[15] ; Barry,Jones ^[16] ; John,Kadavil ^[12] ; Carsten,Krantz ^[17] ; Gustavo Mendes,Lima Santos ^[18] ; Timothy,Olah ^[19] ; João,Pedras-Vasconcelos ^[12] ; Ludovicus,Staelens ^[20] ; Yoshiro,Saito ^[14] ; Natasha,Savoie ^[21] ; Kara,Scheibner ^[12] ; Susan,Spitz ^[22] ; Nilufer,Tampal ^[12] ; Eric,Thomas ^[23] ; Stephen,Vinter ^[24] ; Jason,Wakelin-Smith ^[24] ; Jan,Welink ^[25] ; Jianing,Zeng ^[19] ; Shaolian,Zhou ^[26]

作者单位： Genentech, South San Francisco, CA, USA. ^[1] Merck & Co., Inc., Rahway, NJ, USA. ^[2] Angelini Pharma, Pomezia, RM, Italy. ^[3] Boehringer-Ingelheim, Ridgefield, CT, USA. ^[4] GlaxoSmithKline, King of Prussia, PA, USA. ^[5] Pfizer, Andover, MA, USA. ^[6] Caprion Biosciences, Montreal, QC, Canada. ^[7] Austria AGES, Wien, Austria. ^[8] Health Canada, Ottawa, ON, Canada. ^[9] WHO, Geneva, Switzerland. ^[10] Italy AIFA, Rome, Italy. ^[11] US FDA, Silver Spring, MD, USA. ^[12] Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada. ^[13] Japan MHLW-NIHS, Tokyo, Japan. ^[14] Celerion, Lincoln, NE, USA. ^[15] Q2 Solutions, Ithaca, NY, USA. ^[16] Novartis, Basel, Switzerland. ^[17] Brazil ANVISA, Brasilia, Brazil. ^[18] Bristol-Myers Squibb, Princeton, NJ, USA. ^[19] UCB Biopharma, Braine L'Alleud, Belgium. ^[20] CFABS, Montreal, QC, Canada. ^[21] Formerly MedImmune, Gaithersburg, MD, USA; currently Incyte Corporation, Wilmington, DE, USA. ^[22] Covance, Indianapolis, IN, USA. ^[23] UK MHRA, London, UK. ^[24] Dutch MEB, Utrecht, The Netherlands. ^[25] Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland. ^[26]