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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Richards, Susan; Amaravadi, Lakshmi; Pillutla, Renuka; Birnboeck, Herbert; Torri, Albert; Cowan, Kyra J; Papadimitriou, Apollon; Garofolo, Fabio; Satterwhite, Christina; Piccoli, Steven; Wu, Bonnie; Krinos-Fiorotti, Corinna; Allinson, John; Berisha, Flora; Cocea, Laurent; Croft, Stephanie; Fraser, Stephanie; Galliccia, Fabrizio; Gorovits, Boris; Gupta, Swati; Gupta, Vinita; Haidar, Sam; Hottenstein, Charles; Ishii-Watabe, Akiko; Jani, Darshana; Kadavil, John; Kamerud, John; Kramer, Daniel; Litwin, Virginia; Lima Santos, Gustavo Mendes; Nelson, Robert; Ni, Yan; Pedras-Vasconcelos, João; Qiu, Yongchang; Rhyne, Paul; Safavi, Afshin; Saito, Yoshiro; Savoie, Natasha; Scheibner, Kara; Schick, Eginhard; Siguenza, Patricia Y; Smeraglia, John; Staack, Roland F; Subramanyam, Meena; Sumner, Giane; Thway, Theingi; Uhlinger, David; Ullmann, Martin; Vitaliti, Alessandra; Welink, Jan.
Affiliation
  • Richards S; Sanofi, Framingham, MA, USA.
  • Amaravadi L; Sanofi, Framingham, MA, USA.
  • Pillutla R; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Birnboeck H; Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland.
  • Torri A; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Cowan KJ; Genentech, South San Francisco, CA, USA.
  • Papadimitriou A; Roche Pharma Research and Early Development, Roche Innovation Center, Munich, Germany.
  • Garofolo F; Angelini Pharma, Pomezia, RM, Italy.
  • Satterwhite C; Charles River, Reno, NV, USA.
  • Piccoli S; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Wu B; Janssen R&D, Spring House, PA, USA.
  • Krinos-Fiorotti C; Bioagilytix Labs, Durham, NC, USA.
  • Allinson J; LGC, Cambridge, UK.
  • Berisha F; Daiichi Sankyo, Edison, NJ, USA.
  • Cocea L; Health Canada, Ottawa, ON, Canada.
  • Croft S; WHO, Geneva, Switzerland.
  • Fraser S; Pfizer, Groton, CT, USA.
  • Galliccia F; Italy AIFA, Rome, Italy.
  • Gorovits B; Pfizer, Andover, MA, USA.
  • Gupta S; Allergan, Irvine, CA, USA.
  • Gupta V; Genentech, South San Francisco, CA, USA.
  • Haidar S; US FDA, Silver Spring, MD, USA.
  • Hottenstein C; GlaxoSmithKline, Paoli, PA, USA.
  • Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan.
  • Jani D; Pfizer, Andover, MA, USA.
  • Kadavil J; US FDA, Silver Spring, MD, USA.
  • Kamerud J; Eurofins Bioanalytical Services, St Charles, MO, USA.
  • Kramer D; Sanofi, Frankfurt am Main, Germany.
  • Litwin V; Covance, Indianapolis, IN, USA.
  • Lima Santos GM; Brazil Anvisa, Brasilia, Brazil.
  • Nelson R; Novimmune, Geneva, Switzerland.
  • Ni Y; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA.
  • Qiu Y; Shire, Lexington, MA, USA.
  • Rhyne P; Q2 Solutions, Marietta, GA, USA.
  • Safavi A; Bioagilytix Labs, Durham, NC, USA.
  • Saito Y; Japan MHLW-NIHS, Tokyo, Japan.
  • Savoie N; CFABS, Laval, QC, Canada.
  • Scheibner K; US FDA, Silver Spring, MD, USA.
  • Schick E; Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland.
  • Siguenza PY; Genentech, South San Francisco, CA, USA.
  • Smeraglia J; UCB Biopharma, Braine L'Alleud, Belgium.
  • Staack RF; Roche Pharma Research and Early Development, Roche Innovation Center, Munich, Germany.
  • Subramanyam M; Biogen, Cambridge, MA, USA.
  • Sumner G; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Thway T; Amgen, Thousand Oaks, CA, USA.
  • Uhlinger D; Janssen R&D, Spring House, PA, USA.
  • Ullmann M; EMD Serono, Aubonne, Switzerland.
  • Vitaliti A; Novartis Pharma, Basel, Switzerland.
  • Welink J; Dutch MEB, Utrecht, The Netherlands.
Bioanalysis ; 8(23): 2475-2496, 2016 Dec.
Article in En | MEDLINE | ID: mdl-27855512
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Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers / Ligands Type of study: Guideline Limits: Humans Language: En Journal: Bioanalysis Year: 2016 Document type: Article Affiliation country:
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Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers / Ligands Type of study: Guideline Limits: Humans Language: En Journal: Bioanalysis Year: 2016 Document type: Article Affiliation country: