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Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.
Cowan KJ, Golob M, Goodman J, Laurén A, Andersen L, Decker P, Dejager L, Fjording MS, Groenen P, Jasnowski R, Justies N, Kimberg M, Kunz U, Lawrence J, Richter M, Sordé L, Trigt RV, Vermet L, Vitaliti A, Wright M, Timmerman P. Cowan KJ, et al. Bioanalysis. 2022 Jul;14(13):911-917. doi: 10.4155/bio-2022-0143. Epub 2022 Jul 29. Bioanalysis. 2022. PMID: 35904153
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.
Timmerman P, Barfield M, Portabella EB, Calogero S, Cowan K, Faber J, Ferrari L, Golob M, Goodman J, Goodwin L, Gnoth MJ, Hughes R, Ivanova T, Jordan G, Laurén A, Maux D, McDougall S, Milushewa P, Nelson R, Pynaert G, Sklodowski K, Sleigh R, Struwe P, Verhaeghe T, Wheller R, White S, Zeiser K. Timmerman P, et al. Bioanalysis. 2024 Mar;16(5):259-270. doi: 10.4155/bio-2024-0013. Epub 2024 Feb 5. Bioanalysis. 2024. PMID: 38315622
Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum.
Goodman J, Cowan KJ, Golob M, Nelson R, Baltrukonis D, Bloem K, Butsel BV, Champion L, Cook J, Dang M, Galeva D, Guerrieri D, Jordan G, Krantz C, Lai CH, Roch T, Soares de Sonza AL, Stevenson L, Tosar LP, Venema F, Widmaier H, Timmerman P. Goodman J, et al. Among authors: cowan kj. Bioanalysis. 2024;16(17-18):905-913. doi: 10.1080/17576180.2024.2376949. Epub 2024 Aug 9. Bioanalysis. 2024. PMID: 39119660
Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: cowan kj. AAPS J. 2024 Jul 12;26(4):80. doi: 10.1208/s12248-024-00955-1. AAPS J. 2024. PMID: 38992280
51 results