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Interlaboratory evaluation of LC-MS-based biomarker assays.
Saito K, Goda R, Arai K, Asahina K, Kawabata M, Uchiyama H, Andou T, Shimizu H, Takahara K, Kakehi M, Yamauchi S, Nitta SI, Suga T, Fujita H, Ishikawa R, Saito Y. Saito K, et al. Among authors: saito y. Bioanalysis. 2024 Mar;16(6):389-402. doi: 10.4155/bio-2023-0173. Epub 2024 Feb 9. Bioanalysis. 2024. PMID: 38334082 Review.
Consideration for the validation of clinical laboratory methods in nonclinical fields.
Minomo H, Inoue Y, Iwachido T, Oota H, Otabe K, Kubono K, Kondo S, Sasaki D, Suzuki Y, Nakamura Y, Naraoka H, Higashiyama M, Fujisawa N, Honda K, Matsumoto T, Yasui H, Saito Y, Toyota N. Minomo H, et al. Among authors: saito y. Bioanalysis. 2022 Nov;14(21):1337-1348. doi: 10.4155/bio-2022-0178. Epub 2023 Jan 19. Bioanalysis. 2022. PMID: 36655693 Free article.
Multi-laboratory evaluation of immunoaffinity LC-MS-based glucagon-like peptide-1 assay.
Ishikawa R, Saito K, Tachiki H, Goda R, Arai K, Shimizu H, Andou T, Takahara K, Uchiyama H, Nitta SI, Kakehi M, Hayashi K, Katagiri N, Kojima K, Fujita H, Tsuchinaga K, Saito Y. Ishikawa R, et al. Among authors: saito k, saito y. Bioanalysis. 2023 Feb;15(4):207-218. doi: 10.4155/bio-2022-0240. Epub 2023 Mar 24. Bioanalysis. 2023. PMID: 36961372
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: saito y. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500 Free article.
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: saito y. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363 Free article.
9,427 results