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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 S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Richards S, et al. Among authors: nelson r. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512 Free article.
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. Among authors: nelson r. Bioanalysis. 2024 Mar;16(5):259-270. doi: 10.4155/bio-2024-0013. Epub 2024 Feb 5. Bioanalysis. 2024. PMID: 38315622 Free article.
Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
Goodman J, Cowen S, Devanarayan V, Egging D, Emrich T, Golob M, Kramer D, McNally J, Munday J, Nelson R, Pedras-Vasconcelos JA, Piironen T, Sickert D, Skibeli V, Fjording MS, Timmerman P. Goodman J, et al. Among authors: nelson r. Bioanalysis. 2018 Feb;10(4):197-204. doi: 10.4155/bio-2017-4971. Epub 2018 Jan 18. Bioanalysis. 2018. PMID: 29345496 Free article.
Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the 2021 European Bioanalysis Forum Focus Workshops.
Timmerman P, Barfield M, Cowan K, Golob M, Goodman J, Kunz U, Laurén A, Love I, Nelson R, Staack RF, Stanta J, van de Merbel N, Wilson A. Timmerman P, et al. Among authors: nelson r. Bioanalysis. 2021 Oct;13(19):1459-1465. doi: 10.4155/bio-2021-0200. Epub 2021 Oct 4. Bioanalysis. 2021. PMID: 34605275 Free article.
Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline.
Timmerman P, Barfield M, Cowan K, Ferrari L, Golob M, Goodman J, Kall M, Laurén A, Love I, McDougall S, Nelson R, Pynaert G, Staack RF, Verhaeghe T, White S. Timmerman P, et al. Among authors: nelson r. Bioanalysis. 2022 Nov;14(22):1407-1411. doi: 10.4155/bio-2022-0229. Epub 2023 Jan 27. Bioanalysis. 2022. PMID: 36705021 Free article.
5,642 results