A Multilaboratory Validation Study of Lc/Ms Biomarker Assays for Three Lysophosphatidylcholines

References

• FDA-NIH Biomarker Working Group . BEST (Biomarkers, EndpointS, and other Tools) resource (2016). http://www.ncbi.nlm.nih.gov/books/NBK338448/
   Google Scholar
• Zineh I , HuangSM. Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine. Biomark. Med.5(6), 705–713 (2011).
   PubMed Web of Science ®Google Scholar
• Yee LM , LivelyTG, McShaneLM. Biomarkers in early-phase trials: fundamental issues. Bioanalysis10(12), 933–944 (2018).
   PubMed Web of Science ®Google Scholar
• Colburn WA . Selecting and validating biologic markers for drug development. J. Clin. Pharmacol.37(5), 355–362 (1997).
   PubMed Web of Science ®Google Scholar
• US FDA . Guidance of industry: bioanalytical method validation (2018). http://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
   Google Scholar
• European Medicines Agency . Guideline on bioanalytical method validation (2011). http://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
   Google Scholar
• Japan Ministry of Health, Labor and Welfare . Guideline on bioanalytical method validation in pharmaceutical development (2013). http://www.pmda.go.jp/files/000206209.pdf
   Google Scholar
• Japan Ministry of Health, Labor and Welfare . Guideline on bioanalytical method (ligand binding assay) validation in pharmaceutical development (2014). http://www.pmda.go.jp/files/000206208.pdf
   Google Scholar
• Biomarker Assay Collaborative Evidentiary Considerations Writing Group, Critical Path Institute . Points to consider document: scientific and regulatory considerations for the analytical validation of assays used in the qualification of biomarkers in biological matrices (2019). https://c-path.org/wp-content/uploads/2019/06/evidconsid-whitepaper-analyticalsectionv20190613.pdf
   Google Scholar
• Chau CH , RixeO, McleodH, FiggWD. Validation of analytic methods for biomarkers used in drug development. Clin. Cancer Res.14(19), 5967–5976 (2008).
   PubMed Web of Science ®Google Scholar
• Lowes S , AckermannBL. AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers. Bioanalysis8(3), 163–167 (2016).
   PubMed Web of Science ®Google Scholar
• Hougton R , GoutyD, AllinsonJet al. Recommendations on biomarker bioanalytical method validation by GCC. Bioanalysis4(20), 2439–2446 (2012).
   PubMed Web of Science ®Google Scholar
• Lee JW , DevanarayanV, BarrettYCet al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res.23(2), 312–328 (2006).
   PubMed Web of Science ®Google Scholar
• Sillen H , MitchellR, SleighRet al. Determination of avibactam and ceftazidime in human plasma samples by LC–MS. Bioanalysis7(12), 1423–1434 (2015).
   PubMed Web of Science ®Google Scholar
• Mano Y . Method validation studies and an inter-laboratory cross validation study of lenvatinib assay in human plasma using LC–MS/MS. Pract. Lab. Med.12, e00103 (2018).
   PubMedGoogle Scholar
• Pham HT , ArnhardK, AsadYJet al. Inter-laboratory robustness of next-generation bile acid study in mice and humans: international ring trial involving 12 laboratories. J. Appl. Lab. Med.1(2), 129–142 (2016).
   PubMedGoogle Scholar
• Wang-Sattler R , YuZ, HerderCet al. Novel biomarkers for pre-diabetes identified by metabolomics. Mol. Syst. Biol.8, 615 (2012).
   PubMed Web of Science ®Google Scholar
• Barber MN , RisisS, YangCet al. Plasma lysophosphatidylcholine levels are reduced in obesity and Type 2 diabetes. PLoS ONE7(7), e41456 (2012).
   PubMed Web of Science ®Google Scholar
• Patterson A , MaurhoferO, BeyogluDet al. Aberrant lipid metabolism in hepatocellular carcinoma revealed by plasma metabolomics and lipid profiling. Cancer Res.71(21), 6590–6600 (2011).
   PubMed Web of Science ®Google Scholar
• Chen S , YinP, ZhaoXet al. Serum lipid profiling of patients with chronic hepatitis B, cirrhosis and hepatocellular carcinoma by ultra fast LC/IT–TOF MS. Electrophoresis34(19), 2848–2856 (2013).
   PubMed Web of Science ®Google Scholar
• Zhao Z , XiaoY, ElsonPet al. Plasma lysophosphatidylcholine levels: potential biomarkers for colorectal cancer. J. Clin. Oncol.25(19), 2696–2701 (2007).
   PubMed Web of Science ®Google Scholar
• Saito K , MaekawaK, IshikawaMet al. Glucosylceramide and lysophosphatidylcholines as potential blood biomarkers for drug-induced hepatic phospholipidosis. Toxicol. Sci.141(2), 377–386 (2014).
   PubMed Web of Science ®Google Scholar
• Bowden JA , HeckertA, UlmerCZet al. Harmonizing lipidomics: NIST interlaboratory comparison exercise for lipidomics using SRM 1950-metabolites in frozen human plasma. J. Lipid Res.58(12), 2275–2288 (2017).
   PubMed Web of Science ®Google Scholar
• Suárez-García S , ArolaL, Pascual-SerranoAet al. Development and validation of a UHPLC–ESI–MS/MS method for the simultaneous quantification of mammal lysophosphatidylcholines and lysophosphatidylethanolamines in serum. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.1055–1056, 86–97 (2017).
   PubMed Web of Science ®Google Scholar
• Yu S , PengM, RonisM, BadgerT, FangN. Analysis of polar lipids in the serum from rats fed shiitake by liquid chromatography-mass spectrometry/mass spectrometry. J. Agric. Food Chem.58(24), 12650–12656 (2010).
   PubMed Web of Science ®Google Scholar
• Jones BR , SchultzGA, EcksteinJA, AckermannBL. Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules. Bioanalysis4(19), 2343–2356 (2012).
   PubMed Web of Science ®Google Scholar
• Le A , NgA, KwanT, Cusmano-OzogK, CowanTM. A rapid, sensitive method for quantitative analysis of underivatized amino acids by liquid chromatography-tandem mass spectrometry (LC–MS/MS). J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.944, 166–174 (2014).
   PubMed Web of Science ®Google Scholar
• Yoshida H , KondoK, YamamotoHet al. Validation of an analytical method for human plasma free amino acids by high-performance liquid chromatography ionization mass spectrometry using automated precolumn derivatization. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.998–999, 88–96 (2015).
   PubMed Web of Science ®Google Scholar
• Han J , LiuY, WangRet al. Metabolic profiling of bile acids in human and mouse blood by LC–MS/MS in combination with phospholipid-depletion solid-phase extraction. Anal. Chem.87(2), 1127–1136 (2015).
   PubMed Web of Science ®Google Scholar
• Squellerio I , PorroB, SongiaPet al. Liquid chromatography-tandem mass spectrometry for simultaneous measurement of thromboxane B2 and 12(S)-hydroxyeicosatetraenoic acid in serum. J. Pharm. Biomed. Anal.96, 256–262 (2014).
   PubMed Web of Science ®Google Scholar
• Jian W , EdomRW, XueXet al. Quantitation of leukotriene B4 in human sputum as a biomarker using UPLC–MS/MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.932, 59–65 (2013).
   PubMed Web of Science ®Google Scholar
• Kortz L , DorowJ, BeckerS, ThieryJ, CeglarekU. Fast liquid chromatography-quadrupole linear ion trap- mass spectrometry analysis of polyunsaturated fatty acids and eicosanoids in human plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.927, 209–213 (2013).
   PubMed Web of Science ®Google Scholar
• Jenkins RG . Accuracy: a potential quandary in regulated bioanalysis of ‘endogenous’ analytes. Bioanalysis8(23), 2393–2397 (2016).
   PubMed Web of Science ®Google Scholar
• Yin F , LingY, MartinJet al. Quantitation of uridine and L-dihydroorotic acid in human plasma by LC–MS/MS using a surrogate matrix approach. J. Pharm. Biomed. Anal.192, 113669 (2021).
   PubMed Web of Science ®Google Scholar