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Biomarker Assay Validation by Mass Spectrometry.
Fernández-Metzler C, Ackermann B, Garofolo F, Arnold ME, DeSilva B, Gu H, Laterza O, Mao Y, Rose M, Vazvaei-Smith F, Steenwyk R. Fernández-Metzler C, et al. Among authors: arnold me. AAPS J. 2022 May 9;24(3):66. doi: 10.1208/s12248-022-00707-z. AAPS J. 2022. PMID: 35534647
11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Islam R, Briscoe C, Bower J, Cape S, Arnold M, Hayes R, Warren M, Karnik S, Stouffer B, Xiao YQ, van der Strate B, Sikkema D, Fang X, Tudoroniu A, Tayyem R, Brant A, Spriggs F, Barry C, Khan M, Keyhani A, Zimmer J, Caturla MC, Couerbe P, Khadang A, Bourdage J, Datin J, Zemo J, Hughes N, Fatmi S, Sheldon C, Fountain S, Satterwhite C, Colletti K, Vija J, Yu M, Stamatopoulos J, Lin J, Wilfahrt J, Dinan A, Ohorodnik S, Hulse J, Patel V, Garofolo W, Savoie N, Brown M, Papac D, Buonarati M, Hristopoulos G, Beaver C, Boudreau N, Williard C, Liu Y, Ray G, Warrino D, Xu A, Green R, Hayward-Sewell J, Marcelletti J, Sanchez C, Kennedy M, Charles JS, Bouhajib M, Nehls C, Tabler E, Tu J, Joyce P, Iordachescu A, DuBey I, Lindsay J, Yamashita J, Wells E. Islam R, et al. Bioanalysis. 2018 Apr 1;10(7):433-444. doi: 10.4155/bio-2018-0014. Epub 2018 Apr 27. Bioanalysis. 2018. PMID: 29701066 Free article.
Quantitative bioanalysis of antibody-conjugated payload in monkey plasma using a hybrid immuno-capture LC-MS/MS approach: Assay development, validation, and a case study.
Liu A, Kozhich A, Passmore D, Gu H, Wong R, Zambito F, Rangan VS, Myler H, Aubry AF, Arnold ME, Wang J. Liu A, et al. Among authors: arnold me. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 1;1002:54-62. doi: 10.1016/j.jchromb.2015.08.007. Epub 2015 Aug 12. J Chromatogr B Analyt Technol Biomed Life Sci. 2015. PMID: 26310897
Liquid chromatography and tandem mass spectrometry for the quantitative determination of ixabepilone (BMS-247550, Ixempra) in human plasma: method validation, overcoming curve splitting issues and eliminating chromatographic interferences from degradants.
Xu XS, Zeng J, Mylott W, Arnold M, Waltrip J, Iacono L, Mariannino T, Stouffer B. Xu XS, et al. J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Feb 15;878(5-6):525-37. doi: 10.1016/j.jchromb.2009.12.014. Epub 2009 Dec 16. J Chromatogr B Analyt Technol Biomed Life Sci. 2010. PMID: 20083444
A validated HPLC-MS/MS assay for quantifying unstable pharmacologically active metabolites of clopidogrel in human plasma: application to a clinical pharmacokinetic study.
Furlong MT, Savant I, Yuan M, Scott L, Mylott W, Mariannino T, Kadiyala P, Roongta V, Arnold ME. Furlong MT, et al. Among authors: arnold me. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 May 1;926:36-41. doi: 10.1016/j.jchromb.2013.02.031. Epub 2013 Mar 1. J Chromatogr B Analyt Technol Biomed Life Sci. 2013. PMID: 23542721
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Fluhler E, Hayes R, Garofolo F, Dumont I, Blaye OL, Arnold M, Bansal S, Verhaeghe T, Wilson A, Stevenson L, Myler H, Bauer R, Bergeron A, Bustard M, Cai XY, Carbone M, Cojocaru L, Desai-Krieger D, Duggan J, Haidar S, Ho S, Ingelse B, Katori N, Lévesque A, Lowes S, Ma M, Mettke K, Michon J, Musuku A, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Spooner N, Stouffer B, Vazvaei F, Wakelin-Smith J, Wang J, Welink J, Whale E, Woolf E, Xue L, Yang TY. Fluhler E, et al. Bioanalysis. 2014;6(22):3039-49. doi: 10.4155/bio.14.265. Bioanalysis. 2014. PMID: 25496256 Free article.
Antibody-drug conjugate bioanalysis using LB-LC-MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding assays.
Wang J, Gu H, Liu A, Kozhich A, Rangan V, Myler H, Luo L, Wong R, Sun H, Wang B, Vezina HE, Deshpande S, Zhang Y, Yang Z, Olah TV, Aubry AF, Arnold ME, Pillutla R, DeSilva B. Wang J, et al. Among authors: arnold me. Bioanalysis. 2016 Jul;8(13):1383-401. doi: 10.4155/bio-2016-0017. Epub 2016 Jun 9. Bioanalysis. 2016. PMID: 27277879
166 results