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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)

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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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