2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: immunogenicity, biomarkers and PK assays)
作者:
Gupta, Shalini [1]
;
Richards, Susan [2]
;
Amaravadi, Lakshmi [3]
;
Piccoli, Steven [4]
;
Desilva, Binodh [5]
;
Pillutla, Renuka [6]
;
Stevenson, Lauren [7]
;
Mehta, Devangi [8]
;
Carrasco-Triguero, Montserrat [9]
;
Neely, Robert [10]
;
Partridge, Michael [11]
;
Staack, Roland F. [12]
;
Zhao, Xuemei [13]
;
Gorovits, Boris [14]
;
Kolaitis, Gerry [15]
;
Sumner, Giane [16]
;
Stubenrauch, Kay-Gunnar [17]
;
Zou, Linglong [18]
;
Amur, Shashi [19]
;
Beaver, Chris [20]
;
Berger, Isabella [21]
;
Berisha, Flora [22]
;
Birnboeck, Herbert [23]
;
Bower, Joe [24]
;
Cho, Seongeun (Julia) [25]
;
Cludts, Isabelle [26]
;
Cocea, Laurent [27]
;
Di Donato, Lorella [28]
;
Fischer, Saloumeh [29]
;
Fraser, Stephanie [30]
;
Garofolo, Fabio [31]
;
Haidar, Sam [32]
;
Haulenbeek, Jonathan [33]
;
Hottenstein, Charles [34]
;
Hu, Jenny [35]
;
Ishii-Watabe, Akiko [36]
;
Islam, Rafiq [37]
;
Jani, Darshana [38]
;
Kadavil, John [39]
;
Kamerud, John [40]
;
Kramer, Daniel [41]
;
Kurki, Pekka [42]
;
MacMannis, Stephen [43]
;
McNally, Jim ;
Mullan, Ashley ;
Papadimitriou, Apollon ;
Pedras-Vasconcelos, Joao ;
Ray, Soma ;
Safavi, Afshin ;
Saito, Yoshiro ;
Savoie, Natasha ;
Fjording, Marianne Scheel ;
Scheibner, Kara ;
Smeraglia, John ;
Song, An ;
Stouffer, Bruce ;
Tampal, Nilufer ;
van der Strate, Barry ;
Verch, Thorsten ;
Welink, Jan ;
Xu, Yuanxin ;
Yang, Tong-yuan ;
Yengi, Lilian ;
Zeng, Jianing ;
Zhang, Yan ;
Zhang, Yanhua ;
Zoog, Stephen
作者单位:
UCB Biopharma, Braine Lalleud, Belgium
[1]
PPD, Richmond, VA USA
[2]
Covance, Chantilly, VA USA
[3]
Pfizer, Groton, CT USA
[4]
Pfizer, Andover, MA USA
[5]
US FDA, Silver Spring, MD USA
[6]
Bristol Myers Squibb, Princeton, NJ USA
[7]
Bluebirdbio, Cambridge, MA USA
[8]
Novo Nordisk, Malov, Denmark
[9]
PRA Hlth Sci, Assen, Netherlands
[10]
Capr Biosci, Montreal, PQ, Canada
[11]
MedImmune, Mt Airy, MD USA
[12]
GlaxoSmithKline, King Of Prussia, PA USA
[13]
Celerion, Lincoln, NE USA
[14]
Teva Pharmaceut, W Chester, PA USA
[15]
Japan MHLW NIHS, Tokyo, Japan
[16]
Eurofins Bioanalyt Serv, St Charles, MO USA
[17]
Finland Fimea, Helsinki, Finland
[18]
Roche Innovat Ctr, Roche Pharma Res & Early Dev, Munich, Germany
[19]
Roche Innovat Ctr, Roche Pharma Res & Early Dev, Basel, Switzerland
[20]
Merck, Rahway, NJ USA
[21]
EMD Serono, Billerica, MA USA
[22]
UK MHRA NIBSC, London, England
[23]
Health Canada, Ottawa, ON, Canada
[24]
Neoteric, Princeton, NJ USA
[25]
Dutch MEB, Utrecht, Netherlands
[26]
Bioagilytix Labs, Durham, NC USA
[27]
Vertex Pharmaceut, Boston, MA USA
[28]
Merck, West Point, PA USA
[29]
Alnylam Pharmaceut, Cambridge, MA USA
[30]
Austria AGES, Vienna, Austria
[31]
Sanofi, Framingham, MA USA
[32]
CFABS, Laval, PQ, Canada
[33]
Amgen Inc, Thousand Oaks, CA USA
[34]
InVentiv Hlth, Montreal, PQ, Canada
[35]
Angelini Pharma, Pomezia, Italy
[36]
Genentech Inc, San Francisco, CA USA
[37]
Biogen, Cambridge, MA USA
[38]
Regeneron Pharmaceut, Tarrytown, NY USA
[39]
BioMarin Pharmaceut, San Rafael, CA USA
[40]
Daiichi Sankyo, Edison, NJ USA
[41]
Janssen R&D, Spring House, PA USA
[42]
Sanofi, Frankfurt, Germany
[43]
发布时间
2018-06-26
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Bioanalysis
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