Tukey RH, Strassburg CP. Human UDP-glucuronosyltransferases: metabolism, expression, and disease. Annu Rev Pharmacol Toxicol. 2000;40:581–616.
Article CAS PubMed Google Scholar
US Food and Drug Administration: Guidance for industry: safety testing of drug metabolites (2020). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-testing-drug-metabolites. Accessed 21 Sep 2022.
Frances B, Gout R, Campistron G, Panconi E, Cros J. Morphine-6-glucuronide is more mu-selective and potent in analgesic tests than morphine. Prog Clin Biol Res. 1990;328:477–80.
van Heek M, Farley C, Compton DS, Hoos L, Alton KB, Sybertz EJ, Davis HR Jr. Comparison of the activity and disposition of the novel cholesterol absorption inhibitor, SCH58235, and its glucuronide, SCH60663. Br J Pharmacol. 2000;129(8):1748–54.
Article PubMed PubMed Central Google Scholar
Faed EM. Properties of acyl glucuronides: implications for studies of the pharmacokinetics and metabolism of acidic drugs. Drug Metab Rev. 1984;15(5-6):1213–49.
Article CAS PubMed Google Scholar
Skonberg C, Olsen J, Madsen KG, Hansen SH, Grillo MP. Metabolic activation of carboxylic acids. Expert Opin Drug Metab Toxicol. 2008;4:425–38.
Article CAS PubMed Google Scholar
Bailey M, Dickinson RG. Acyl glucuronide reactivity in perspective: biological consequences. Chem Biol Interact. 2003;145(2):117–37.
Article CAS PubMed Google Scholar
Zhang Z. Bioanalysis of unstable analytes in generic drug review. Regulated Bioanalysis Workshop: Requirements and Expectations, June 30, 2020, Small Business and Industry Assistance. < https://sbiaevents.com/bioanalysis2020/> (2020). Accessed 21 Sep 2022.
Shipkova M, Armstrong VW, Oellerich M, Wieland E. Acyl glucuronide drug metabolites: toxicological and analytical implications. Ther Drug Monit. 2003;25:1–16.
Article CAS PubMed Google Scholar
Illing HP, Wilson ID. pH dependent formation of beta-glucuronidase resistant conjugates from the biosynthetic ester glucuronide of isoxepac. Biochem Pharmacol. 1981;30(24):3381–4.
Article CAS PubMed Google Scholar
Patel SR. Bioanalytical challenges and strategies for accurately measuring acyl glucuronide metabolites in biological fluids. Biomed Chromatogr. 2020;34(1):e4640.
Article CAS PubMed Google Scholar
Silvestro L, Gheorghe M, Iordachescu A, Ciuca V, Tudoroniu A, Savu SR, Tarcomnicu I. Development and validation of an HPLC–MS/MS method to quantify clopidogrel acyl glucuronide, clopidogrel acid metabolite, and clopidogrel in plasma samples avoiding analyte back-conversion. Anal Bioanal Chem. 2011;401(3):1023–34.
Article CAS PubMed Google Scholar
Sparidans RW, Lagas JS, Schinkel AH, Schellens JHM, Beijnen JH. Liquid chromatography–tandem mass spectrometric assay for diclofenac and three primary metabolites in mouse plasma. J Chromatogr B. 2008;872(1):77–82.
Mullangi R, Bhamidipati RK, Srinivas NR. Bioanalytical aspects in characterization and quantification of glucuronide conjugates in various biological matrices. Curr Pharm Anal. 2005;1(3):251–64.
Schwartz MS, Desai RB, Bi S, Miller AR, Matuszewski BK. Determination of a prostaglandin D2 antagonist and its acyl glucuronide metabolite in human plasma by high performance liquid chromatography with tandem mass spectrometric detection – a lack of MS/MS selectivity between a glucuronide conjugate and a Phase I metabolite. J Chromatogr B. 2006;837(1):116–24.
Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res. 2007;24(10):1962–73.
Article CAS PubMed Google Scholar
Subramaniam S, Stier E, Davit BM. Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications. Bioanalysis. 2014;6(24):3349–54.
Article CAS PubMed Google Scholar
Zhou J, Li F, Duggan JX. LC-MS bioanalysis of acyl glucuronides. In Handbook of LC-MS bioanalysis: best practices, Experimental Protocols, and Regulations, First Edition (eds. Li W, Zhang J, and Tse FLS) 447–460 (John Wiley & Sons, Inc., Philadelphia, 2013).
Montpetitm H, Ranger M, Colin P, Furtado M, Garofolo F. Discovery of a novel trimebutine metabolite and its impact on N-desmethyltrimebutine quantification by LC–MS/MS. Bioanalysis. 2015;7(8):1007–15.
Camilleri P, Buch A, Soldo B, Hutt AJ. The influence of physicochemical properties on the reactivity and stability of acyl glucuronides. Xenobiotica. 2018;48(9):958–72.
Article CAS PubMed Google Scholar
FDA label for PRADAXA® (dabigatran etexilate) capsule, revised 6/2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s041lbl.pdf. Accessed 21 Sep 2022.
FDA draft guidance on dabigatran etexilate mesylate capsule, recommended Jun 2012; revised Sep 2015, Jul 2017. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabigatran%20etexilate%20mesylate_oral%20capsule_NDA%20022512_RV05-17.pdf. Accessed 21 Sep 2022.
Zhong S, Jones R, Lu W, Schadt S, Ottaviani G. A new rapid in vitro assay for assessing reactivity of acyl glucuronides. Drug Metab Dispos. 2015;43(11):1711–7.
Article CAS PubMed Google Scholar
Shipkova M, Armstrong VW, Schneider T, Niedmann PD, Schütz E, Wieland E, Oellerich M. Stability of mycophenolic acid and mycophenolic acid glucuronide in human plasma. Clin Chem. 1999;45(1):127–9.
Article CAS PubMed Google Scholar
US Food and Drug Administration: M10 bioanalytical method validation (2018) https://www.fda.gov/media/128343/download. Accessed 21 Sep 2022.
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