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Page 1
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. Szapacs M, et al. Among authors: goykhman d. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Welink J, Xu Y, Yang E, Wilson A, Henderson N, Luo L, Fraser S, Kavita U, Musuku A, James C, Fraier D, Zhang Y, Goykhman D, Summerfield S, Woolf E, Verhaeghe T, Hughes N, Behling A, Brown K, Bulychev A, Buonarati M, Cherry E, Cho SJ, Cludts I, Dillen L, Dodge R, Edmison A, Garofolo F, Green R, Haidar S, Hottenstein C, Ishii-Watabe A, Jang HG, Ji A, Jones B, Kassim S, Ma M, Lima Santos GM, Norris DA, Owen T, Piccoli S, Ramanathan R, Röhl I, Rosenbaum AI, Saito Y, Sangster T, Savoie N, Stebbins C, Sydor J, de Merbel NV, Verthelyi D, Vinter S, Whale E. Welink J, et al. Among authors: goykhman d. Bioanalysis. 2018 Nov 1;10(22):1781-1801. doi: 10.4155/bio-2018-0268. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488725
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).
Yang E, Welink J, Cape S, Woolf E, Sydor J, James C, Goykhman D, Arnold M, Addock N, Bauer R, Buonarati M, Ciccimaro E, Dodda R, Evans C, Garofolo F, Hughes N, Islam R, Nehls C, Wilson A, Briscoe C, Bustard M, Coppola L, Croft S, Drexler D, Ferrari L, Fraier D, Jenkins R, Kadavil J, King L, Li W, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Sun R, Tampal N, Vinter S, Wakelin-Smith J, Yue Q. Yang E, et al. Among authors: goykhman d. Bioanalysis. 2016 Nov;8(22):2363-2378. doi: 10.4155/bio-2016-4992. Epub 2016 Oct 7. Bioanalysis. 2016. PMID: 27712081
Quantitation of anacetrapib, stable-isotope labeled-anacetrapib (microdose), and four metabolites in human plasma using liquid chromatography tandem mass spectrometry.
Chavez-Eng CM, Lutz RW, Li H, Goykhman D, Bateman KP, Woolf E. Chavez-Eng CM, et al. Among authors: goykhman d. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Feb 1;1011:204-14. doi: 10.1016/j.jchromb.2015.12.053. Epub 2015 Dec 29. J Chromatogr B Analyt Technol Biomed Life Sci. 2016. PMID: 26773885
Insulin glargine and its two active metabolites: A sensitive (16pM) and robust simultaneous hybrid assay coupling immunoaffinity purification with LC-MS/MS to support biosimilar clinical studies.
Xu Y, Sun L, Anderson M, Bélanger P, Trinh V, Lavallée P, Kantesaria B, Marcoux MJ, Breidinger S, Bateman KP, Goykhman D, Woolf EJ. Xu Y, et al. Among authors: goykhman d. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Sep 15;1063:50-59. doi: 10.1016/j.jchromb.2017.08.018. Epub 2017 Aug 19. J Chromatogr B Analyt Technol Biomed Life Sci. 2017. PMID: 28846865
Cardiovascular monkey telemetry: sensitivity to detect QT interval prolongation.
Chaves AA, Keller WJ, O'Sullivan S, Williams MA, Fitzgerald LE, McPherson HE, Goykhman D, Ward PD, Hoe CM, Mixson L, Briscoe RJ. Chaves AA, et al. Among authors: goykhman d. J Pharmacol Toxicol Methods. 2006 Sep-Oct;54(2):150-8. doi: 10.1016/j.vascn.2006.03.004. Epub 2006 Mar 27. J Pharmacol Toxicol Methods. 2006. PMID: 16679034