References
- Saurina J, Sentellas S. Strategies for metabolite profiling based on liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Feb 15;1044-1045:103–111.
- Food and Drug Administration. Safety testing of drug metabolites. 2016 Nov.
- Fura A, Shu YZ, Zhu M, et al. Discovering drugs through biological transformation: role of pharmacologically active metabolites in drug discovery. J Med Chem. 2004 Aug 26;47(18):4339–4351.
- Fernie AR, Trethewey RN, Krotzky AJ, et al. Metabolite profiling: from diagnostics to systems biology. Nat Rev Mol Cell Biol. 2004 Sep;5(9):763–769.
- International Commission on Radiological Protection. Ann ICRP. 1992;22(3).
- Yamane N, Igarashi A, Kusama M, et al. Cost-effectiveness analysis of microdose clinical trials in drug development. Drug Metab Pharmacokinet. 2013;28(3):187–195.
- Lappin G. Microdosing: current and the future. Bioanalysis. 2010 Mar;2(3):509–517.
- Rowland M. Microdosing: a critical assessment of human data. J Pharm Sci. 2012 Nov;101(11):4067–4074.
- Lappin G, Garner RC. The utility of microdosing over the past 5 years. Expert Opin Drug Metab Toxicol. 2008 Dec;4(12):1499–1506.
- Penner N, Xu L, Prakash C. Radiolabeled absorption, distribution, metabolism, and excretion studies in drug development: why, when, and how? Chem Res Toxicol. 2012 Mar 19;25(3):513–531.
- Food and Drug Administration. ICH M3(R2): guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. 2010.
- Johnson CH, Ivanisevic J, Siuzdak G. Metabolomics: beyond biomarkers and towards mechanisms. Nat Rev Mol Cell Biol. 2016 Jul;17(7):451–459.
- Kosmides AK, Kamisoglu K, Calvano SE, et al. Metabolomic fingerprinting: challenges and opportunities. Crit Rev Biomed Eng. 2013;41(3):205–221.
- Everett JR. From metabonomics to pharmacometabonomics: the role of metabolic profiling in personalized medicine. Front Pharmacol. 2016;7:297.
- Klepacki J, Klawitter J, Klawitter J, et al. A high-performance liquid chromatography-tandem mass spectrometry-based targeted metabolomics kidney dysfunction marker panel in human urine. Clin Chim Acta. 2015 Jun;15(446):43–53.
- Turner MA, Mooij MG, Vaes WH, et al. Pediatric microdose and microtracer studies using 14C in Europe. Clin Pharmacol Ther. 2015 Sep;98(3):234–237.
- Fanos V, Barberini L, Antonucci R, et al. Pharma-metabolomics in neonatology: is it a dream or a fact? Curr Pharm Des. 2012;18(21):2996–3006.
- Roffel AF, van Marle SP, van Lier JJ, et al. An evaluation of human ADME and mass balance studies using regular or low doses of radiocarbon. J Labelled Comp Radiopharm. 2016 Dec;59(14):619–626.
- Lappin G, Shishikura Y, Jochemsen R, 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 Jun 14;43(3):141–150.