2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3-LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
作者:
Stevenson, Lauren [1]
;
Richards, Susan [2]
;
Pillutla, Renuka [3]
;
Torri, Albert [4]
;
Kamerud, John [5]
;
Mehta, Devangi [6]
;
Keller, Stephen [7]
;
Purushothama, Shobha [8]
;
Gorovits, Boris [9]
;
Litwin, Virginia [10]
;
Stebbins, Christopher [11]
;
Marini, Joseph [12]
;
Beaver, Chris [13]
;
Sperinde, Gizette [14]
;
Siguenza, Patricia [15]
;
Staack, Roland F. [16]
;
Qiu, Yongchang [17]
;
Amaravadi, Lakshmi [18]
;
Amur, Shashi [19]
;
Fleener, Catherine Aversa [20]
;
Baltrukonis, Daniel [21]
;
Catlett, Ian [22]
;
Cherry, Elana [23]
;
Chung, Shan [24]
;
Cludts, Isabelle [25]
;
Di Donato, Lorella [26]
;
Fischer, Saloumeh [27]
;
Fraser, Stephanie [28]
;
Garofolo, Fabio [29]
;
Green, Cherie [30]
;
Gunn, George [31]
;
Haidar, Sam [32]
;
Haulenbeek, Jonathan [33]
;
Henderson, Neil [34]
;
Hopper, Shirley [35]
;
Ishii-Watabe, Akiko [36]
;
Islam, Rafiq [37]
;
Janelsins, Brian [38]
;
Jawa, Vibha [39]
;
Kakkanaiah, Vellalore [40]
;
Kamondi, Szilard [41]
;
Kolaitis, Gerry [42]
;
Kubiak, Robert J. ;
Kumar, Seema ;
Kurki, Pekka ;
Liang, Meina ;
Liu, Patrick ;
Maxfield, Kimberly ;
Myler, Heather ;
Palackal, Nisha ;
Palmer, Rachel ;
Pedras-Vasconcelos, Joao ;
Piccoli, Steven ;
Rhyne, Paul ;
Saito, Yoshiro ;
Savoie, Natasha ;
Schick, Eginhard ;
Schweighardt, Becky ;
Shih, Judy ;
Song, An ;
Sriraman, Priya ;
Staelens, Ludovicus ;
Sumner, Giane ;
Sun, Yongliang ;
Ullmann, Martin ;
Verthelyi, Daniela ;
Wadhwa, Meenu ;
Wang, Yow-Ming ;
Xu, Yuanxin ;
Yan, Haoheng ;
Yang, Tong-yuan ;
Zeng, Rong
作者单位:
PPD, Richmond, VA USA
[1]
UCB Biopharma, Braine Lalleud, Belgium
[2]
Pfizer, Groton, CT USA
[3]
Pfizer, Andover, MA USA
[4]
Merck & Co Inc, Kenilworth, NJ USA
[5]
US FDA, Silver Spring, MD USA
[6]
Bristol Myers Squibb, Princeton, NJ USA
[7]
Capr Biosci, Montreal, PQ, Canada
[8]
EMD Serono Merck KGaA, Billerica, MA USA
[9]
MedImmune, Gaithersburg, MD USA
[10]
GlaxoSmithKline, King Of Prussia, PA USA
[11]
Celerion, Lincoln, NE USA
[12]
Teva Pharmaceut, W Chester, PA USA
[13]
Tesaro, Waltham, MA USA
[14]
MedImmune, San Francisco, CA USA
[15]
Finland Fimea, Helsinki, Finland
[16]
Roche Innovat Ctr, Roche Pharma Res & Early Dev, Munich, Germany
[17]
Pfizer, San Diego, CA USA
[18]
AbbVie, Redwood City, CA USA
[19]
BioMarin, Novato, CA USA
[20]
Angelini Pharma, Pomezia, RM, Italy
[21]
UK MHRA NIBSC, London, England
[22]
Neoteric, Princeton, NJ USA
[23]
AstraZeneca, Molndal, Sweden
[24]
Fresenius Kabi, Aubonne, Switzerland
[25]
Hlth Canada, Ottawa, ON, Canada
[26]
Alnylam Pharmaceut, Cambridge, MA USA
[27]
Syneos Hlth, Princeton, NJ USA
[28]
Japan MHLW NIHS, Kawasaki, Kanagawa, Japan
[29]
Roche Innovat Ctr Basel, Roche Pharma Res & Early Dev, Basel, Switzerland
[30]
Celgene, Summit, NJ USA
[31]
Sanofi, Framingham, MA USA
[32]
CFABS, Laval, PQ, Canada
[33]
Amgen Inc, Thousand Oaks, CA USA
[34]
UK MHRA, London, England
[35]
Genentech Inc, San Francisco, CA USA
[36]
Biogen, Cambridge, MA USA
[37]
Shire, Lexington, MA USA
[38]
Amador Biosci, Pleasanton, CA USA
[39]
BDS Immunoassay Serv, Tampa, FL USA
[40]
Regeneron Pharmaceut, Tarrytown, NY USA
[41]
Janssen R&D, Spring House, PA USA
[42]
发布时间
2019-04-16
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Bioanalysis
Bioanalysis
1973-2001页
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