Ultra-sensitive bioanalysis of the therapeutic peptide exenatide for accurate pharmacokinetic analyses at effective plasma concentrations utilizing UPLC-MS/MS

Garber, 2018, Consensus statement by the American association of clinical endocrinologists and American college of endocrinology on the comprehensive type 2 diabetes management algorithm - 2018 executive summary, Endocr. Pract., 24, 91, 10.4158/CS-2017-0153 Knop, 2017, Exenatide: pharmacokinetics, clinical use, and future directions, Expert Opin. Pharmacother., 18, 555, 10.1080/14656566.2017.1282463 Eng, 1992, Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. Further evidence for an exendin receptor on dispersed acini from Guinea pig pancreas, J. Biol. Chem., 267, 7402, 10.1016/S0021-9258(18)42531-8 Edwards, 2001, Exendin-4 reduces fasting and postprandial glucose and decreases energy intake in healthy volunteers, Am. J. Physiol. Endocrinol. Metab., 281, E155, 10.1152/ajpendo.2001.281.1.E155 Fineman, 2003, Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metformin and/or sulfonylurea treatment in patients with type 2 diabetes, Diabetes Care, 26, 2370, 10.2337/diacare.26.8.2370 Nielsen, 2004, Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes, Regul. Pept., 117, 77, 10.1016/j.regpep.2003.10.028 2018 2018 Andrés-Ramos, 2015, Exenatide-induced eosinophil-rich granulomatous panniculitis: a novel case showing injected microspheres, Am. J. Dermatopathol., 37, 801, 10.1097/DAD.0000000000000243 Boysen, 2014, Eosinophil-rich granulomatous panniculitis caused by exenatide injection, J. Cutan. Pathol., 41, 63, 10.1111/cup.12246 Jones, 2015, Injection-site nodules associated with the use of exenatide extended-release reported to the US Food and Drug administration adverse event reporting system, Diabetes Spectr., 28, 283, 10.2337/diaspect.28.4.283 Riswold, 2018, Persistent injection site nodules from exenatide: successful treatment with intralesional triamcinolone, JAAD Case Rep., 4, 830, 10.1016/j.jdcr.2018.06.009 Shan, 2014, Exenatide-induced eosinophilic sclerosing lipogranuloma at the injection site, Am. J. Dermatopathol., 36, 510, 10.1097/DAD.0000000000000036 Vidal, 2018, Exenatide-induced panniculitis: utility of the acid-fast stain to identify injected microspheres, Am. J. Dermatopathol., 40, 867, 10.1097/DAD.0000000000000952 Fineman, 2011, Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing, Clin. Pharmacokinet., 50, 65, 10.2165/11585880-000000000-00000 Cui, 2013, Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus, J. Diabetes, 5, 127, 10.1111/1753-0407.12020 Kolterman, 2005, Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus, Am. J. Health Syst. Pharm., 62, 173, 10.1093/ajhp/62.2.173 Kothare, 2008, Pharmacokinetics, pharmacodynamics, tolerability, and safety of exenatide in Japanese patients with type 2 diabetes mellitus, J. Clin. Pharmacol., 48, 1389, 10.1177/0091270008323750 Malloy, 2009, Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study, Clin. Therapeut., 31, 806, 10.1016/j.clinthera.2009.04.005 2019 Granhall, 2019, Safety and pharmacokinetics of single and multiple ascending doses of the novel oral human GLP-1 analogue, oral semaglutide, in healthy subjects and subjects with type 2 diabetes, Clin. Pharmacokinet., 58, 781, 10.1007/s40262-018-0728-4 Zhang, 2013, Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry, J. Pharm. Anal., 3, 235, 10.1016/j.jpha.2012.12.007 Morin, 2013, Large-molecule quantification: sensitivity and selectivity head-to-head comparison of triple quadrupole with Q-TOF, Bioanalysis, 5, 1181, 10.4155/bio.13.87 Kehler, 2010, Application of DBS for quantitative assessment of the peptide Exendin-4; comparison of plasma and DBS method by UHPLC–MS/MS, Bioanalysis, 2, 1461, 10.4155/bio.10.108 2018 2009 Matuszewski, 2003, Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC− MS/MS, Anal. Chem., 75, 3019, 10.1021/ac020361s Sauter, 2019, An ultrasensitive UPLC–MS/MS assay for the quantification of the therapeutic peptide liraglutide in plasma to assess the oral and nasal bioavailability in beagle dogs, Bioanalysis, 11, 887, 10.4155/bio-2018-0322 Chen, 2013, Interspecies modeling and prediction of human exenatide pharmacokinetics, Pharm. Res. (N. Y.), 30, 751, 10.1007/s11095-012-0917-z