Pediatric Microdose Study of [14C]Paracetamol to Study Drug Metabolism Using Accelerated Mass Spectrometry: Proof of Concept

Clinical Pharmacokinetics

Volumn 53, Issue 11, 2014, Pages 1045-1051

  Mooij, Miriam G ^a   van Duijn, Esther ^b   Knibbe, Catherijne A J ^c   Windhorst, Albert D ^d   Hendrikse, N Harry ^d   Vaes, Wouter H J ^b   Spaans, Edwin ^a   Fabriek, Babs O ^b   Sandman, Hugo ^b   Grossouw, Dimitri ^b   Hanff, Lidwien M ^e   Janssen, Paul J J M ^e   Koch, Birgit C P ^e   Tibboel, Dick ^a   de Wildt, Saskia N ^a  

^a SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^b TNO   (Netherlands)

^c LEIDEN UNIVERSITY   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CARBON 14; DRUG METABOLITE; PARACETAMOL; ANALGESIC AGENT; CARBON;

ACCELERATOR MASS SPECTROMETRY; ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG METABOLISM; FEMALE; HUMAN; INDWELLING CATHETER; INFANT; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; NEWBORN; OPEN STUDY; PHARMACOKINETICS; PILOT STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; CHEMISTRY; DRUG ADMINISTRATION; FEASIBILITY STUDY; INTRAVENOUS DRUG ADMINISTRATION; NETHERLANDS; ORAL DRUG ADMINISTRATION; PROCEDURES; TANDEM MASS SPECTROMETRY;

ACETAMINOPHEN; ADMINISTRATION, INTRAVENOUS; ADMINISTRATION, ORAL; ANALGESICS, NON-NARCOTIC; CARBON RADIOISOTOPES; CHILD; CHILD, PRESCHOOL; CHROMATOGRAPHY, LIQUID; DRUG ADMINISTRATION SCHEDULE; FEASIBILITY STUDIES; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; NETHERLANDS; PILOT PROJECTS; TANDEM MASS SPECTROMETRY;

EID: 84920986722     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-014-0176-8     Document Type: Article

References (32)

1. Schirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LT. Lack of appropriate formulations of medicines for children in the community. Acta Paediatr. 2003;92(12):1486–9.
2. t Jong GW, van der Linden PD, Bakker EM, van der Lely N, Eland IA, Stricker BH. Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol. 2002;58(4):293–7.
3. Hoppu K. Reflection: medicines for children–science alone is not enough. Eur J Clin Pharmacol. 2013;69(Suppl 1):59–63.
4. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157–67.
5. Krekels EH, Danhof M, Tibboel D, Knibbe CA. Ontogeny of hepatic glucuronidation; methods and results. Curr Drug Metab. 2012;13(6):728–43.
6. De Cock RF, Piana C, Krekels EH, Danhof M, Allegaert K, Knibbe CA. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67(Suppl 1):5–16.
7. Barrett JS, Della Casa Alberighi O, Laer S, Meibohm B. Physiologically based pharmacokinetic (PBPK) modeling in children. Clin Pharmacol Ther. 2012;92(1):40–9.
8. Knibbe CA, Danhof M. Individualized dosing regimens in children based on population PKPD modelling: are we ready for it? Int J Pharm. 2011;415(1–2):9–14.
9. Knibbe CA, Krekels EH, Danhof M. Advances in paediatric pharmacokinetics. Expert Opin Drug Metab Toxicol. 2011;7(1):1–8.
10. Food and Drug Administration US Department of Health and Human Services. Guidance for Industry Investigators and Reviewers. Exploratory IND Studies. January 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf. Accessed 25 Aug 2014.
11. European Medicines Agency. ICH topic M3 (R2). Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. London: European Medicines Agency; Jul 2008.
12. Lappin G, Kuhnz W, Jochemsen R, Kneer J, Chaudhary A, Oosterhuis B, et al. Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs. Clin Pharmacol Ther. 2006;80(3):203–15.
13. Salehpour M, Possnert G, Bryhni H. Subattomole sensitivity in biological accelerator mass spectrometry. Anal Chem. 2008;80(10):3515–21.
14. Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, et al. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial. JAMA. 2013;309(2):149–54.
15. Pathak CM, Kaur B, Khanduja KL. 14C-urea breath test is safe for pediatric patients. Nucl Med Commun. 2010;31(9):830–5.
16. Vuong LT, Blood AB, Vogel JS, Anderson ME, Goldstein B. Applications of accelerator MS in pediatric drug evaluation. Bioanalysis. 2012;4(15):1871–82.
17. Lappin G, Shishikura Y, Jochemsen R, Weaver RJ, Gesson C, Brian Houston J, et al. Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers. Eur J Pharm Sci. 2011;43(3):141–50.
18. Tozuka Z, Kusuhara H, Nozawa K, Hamabe Y, Ikushima I, Ikeda T, et al. Microdose study of 14C-acetaminophen with accelerator mass spectrometry to examine pharmacokinetics of parent drug and metabolites in healthy subjects. Clin Pharmacol Ther. 2010;88(6):824–30.
19. Allegaert K, Tibboel D. Comments on “shift from biliary to urinary elimination of acetaminophen-glucuronide in acetaminophen-pretreated rats”. J Pharmacol Exp Ther. 2006;316(2):966–7.
20. van der Marel CD, Anderson BJ, van Lingen RA, Holford NH, Pluim MA, Jansman FG, et al. Paracetamol and metabolite pharmacokinetics in infants. Eur J Clin Pharmacol. 2003;59(3):243–51.
21. Zhou XJ, Garner RC, Nicholson S, Kissling CJ, Mayers D. Microdose pharmacokinetics of IDX899 and IDX989, candidate HIV-1 non-nucleoside reverse transcriptase inhibitors, following oral and intravenous administration in healthy male subjects. J Clin Pharmacol. 2009;49(12):1408–16.
22. van Duijn E, Sandman H, Grossouw D, Mocking JA, Coulier L, Vaes WH. Automated combustion accelerator mass spectrometry for the analysis of biomedical samples in the low attomole range. Anal Chem. 2014;86(15):7635–41.
23. Klein MV, Vaes WHJ, Fabriek B, Sandman H, Mous DJW, Gottdang A. The 1 MV multi-element AMS system for biomedical applications at the Netherlands Organization for Applied Scientific Research (TNO). Nucl Instr Meth Phys Res B. 2013;294:14–7.
24. Higton D, Young G, Timmerman P, Abbott R, Knutsson M, Svensson LD. European Bioanalysis Forum recommendation: scientific validation of quantification by accelerator mass spectrometry. Bioanalysis. 2012;4(22):2669–79.
25. Hopkins CS, Underhill S, Booker PD. Pharmacokinetics of paracetamol after cardiac surgery. Arch Dis Child. 1990;65(9):971–6.
26. Anderson BJ, van Lingen RA, Hansen TG, Lin YC, Holford NH. Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis. Anesthesiology. 2002;96(6):1336–45.
27. Walson PD, Halvorsen M, Edge J, Casavant MJ, Kelley MT. Pharmacokinetic comparison of acetaminophen elixir versus suppositories in vaccinated infants (aged 3 to 36 months): a single-dose, open-label, randomized, parallel-group design. Clin Ther. 2013;35(2):135–40.
28. Mooij MG, de Koning BA, Huijsman ML, de Wildt SN. Ontogeny of oral drug absorption processes in children. Expert Opin Drug Metab Toxicol. 2012;8(10):1293–303.
29. Ratnapalan S, Bona N, Chandra K, Koren G. Physicians’ perceptions of teratogenic risk associated with radiography and CT during early pregnancy. AJR Am J Roentgenol. 2004;182(5):1107–9.
30. de Wildt SN, Taguchi N, Koren G. Unintended pregnancy during radiotherapy for cancer. Nat Clin Pract Oncol. 2009;6(3):175–8.
31. Maeda K, Ikeda Y, Fujita T, Yoshida K, Azuma Y, Haruyama Y, et al. Identification of the rate-determining process in the hepatic clearance of atorvastatin in a clinical cassette microdosing study. Clin Pharmacol Ther. 2011;90(4):575–81.
32. Gorski JC, Jones DR, Haehner-Daniels BD, Hamman MA, O’Mara EM Jr, Hall SD. The contribution of intestinal and hepatic CYP3A to the interaction between midazolam and clarithromycin. Clin Pharmacol Ther. 1998;64(2):133–43.