Abstract

BioanalysisVol. 3, No. 24 CommentaryThe use of accelerator MS in support of MISTAngus NeddermanAngus NeddermanDepartment of Pharmacokinetics, Dynamics & Metabolism, Pfizer Worldwide Research & Development, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK; Unilabs York Bioanalytical Solutions, Discovery Park, Ramsgate Road, Sandwich, CT13 9NJ, UK. Search for more papers by this authorEmail the corresponding author at angus.nedderman@yorkbio.comPublished Online:20 Dec 2011https://doi.org/10.4155/bio.11.269AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: accelerator MSmetabolitesmetabolites in safety testingMISTsafetyReferences1 Baillie TA, Cayen MN, Fouda H et al. Drug metabolites in safety testing. Toxicol. App. Pharmacol.182,188–196 (2002).Crossref, Medline, CAS, Google Scholar2 Smith DA, Obach RS. Seeing through the MIST: abundance versus percentage. Commentary on metabolites in safety testing. Drug Metab. Dispos.33,1409–1417 (2005).Crossref, Medline, CAS, Google Scholar3 Smith DA, Obach RS. Metabolites and safety: what are the concerns and how should we address them? Chem. Res. Toxicol.19,1570–1579 (2006).Crossref, Medline, CAS, Google Scholar4 Humphreys WG, Unger SE. Safety assessment of drug metabolites: characterization of chemically stable metabolites. Chem. Res. Toxicol.19,1564–1569 (2006).Crossref, Medline, CAS, Google Scholar5 Walker D, Brady J, Dalvie D et al. A holistic strategy for characterizing the safety of metabolites through drug discovery and development. Chem. Res. Toxicol.22,1653–1662 (2009).Crossref, Medline, CAS, Google Scholar6 Zhu M, Zhang D, Zhang H, Shyu WC. Integrated strategies for assessment of metabolite exposure in humans during drug development: analytical challenges and clinical development considerations. Biopharm. Drug Dispos.30,163–184 (2009).Crossref, Medline, CAS, Google Scholar7 Nedderman ANR, Dear GJ, North S, Obach RS, Higton D. From definition to implementation: a cross-industry perspective of past, current and future MIST strategies. Xenobiotica41,605–622 (2011).Crossref, Medline, CAS, Google Scholar8 Bennett CL, Beukens RP, Clover MR et al. Radiocarbon dating using electrostatic accelerators: negative ions provide the key. Science198,508–510 (1977).Crossref, Medline, CAS, Google Scholar9 Litherland AE. Ultrasensitive mass spectrometry with accelerators. Ann. Rev. Nuc. Part. Sci.30,437–473 (1980).Crossref, CAS, Google Scholar10 Kaye B, Garner RC, Mauthe RJ, Freeman SPHT, Turteltaub KW. A preliminary evaluation of accelerator mass spectrometry in the biomedical field. J. Pharm. Biomed. Anal.16,541–543 (1997).Crossref, Medline, CAS, Google Scholar11 Young G, Ellis W, Ayrton J, Hussey E, Adamkiewicz B. Accelerator mass spectrometry (AMS): recent experience of its use in a clinical study and the potential future of the technique. Xenobiotica31,619–632 (2001).Crossref, Medline, CAS, Google Scholar12 Garner RC, Goris I, Laenen AAE et al. Evaluation of accelerator mass spectrometry in a human mass balance and pharmacokinetic study – experience with 14C-labelled (R)-6-[Amino(4-chlorophenyl)(1-methyl-1H-imidazol-5-yl)methyl]-4-(3-chlorophenyl)-1-methyl-2(1H)-quinolinone (R115777), a farnesyl transferase inhibitor. Drug Metab. Disp.30,823–830 (2002).Crossref, Medline, CAS, Google Scholar13 Comezoglu SN, Ly VT, Zhang D et al. Biotransformation profiling of [14C]ixabepilone in human plasma, urine and feces samples using accelerator mass spectrometry (AMS). Drug Metab. Pharmacokinet.24,511–522 (2009).Crossref, Medline, CAS, Google Scholar14 Prakash C, Shaffer CL, Nedderman A. Analytical strategies for identifying drug metabolites. Mass Spectrom. Rev.26,340–369 (2007).Crossref, Medline, CAS, Google Scholar15 Lappin G, Seymour M, Young G, Higton D, Hill HM. An AMS method to determine analyte recovery from pharmacokinetic studies with concomitant extravascular and intravenous administration. Bioanalysis3(4),407–410 (2011).Link, CAS, Google Scholar16 Young GC, Ellis WJ. AMS in drug development at GSK. Nuc. Inst. Methods Phys. Res. B259,752–757 (2007).Crossref, CAS, Google Scholar17 Lappin G, Seymour M. Addressing metabolite safety during first-in-man studies using 14C-labeled drug and accelerator mass spectrometry. Bioanalysis2(7),1315–1324 (2010).Link, CAS, Google Scholar101 US FDA guidance for industry. Safety testing of drug metabolites (2008). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079266.pdfGoogle Scholar102 ICH topic M3 (R2) (2009): non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002720.pdfGoogle ScholarFiguresReferencesRelatedDetailsCited By“MIST” AND OTHER METABOLITE GUIDELINES IN THE CONTEXT OF INDUSTRIAL DRUG METABOLISM11 July 2016METABOLITE TECHNOLOGY11 July 2016Application of a tiered approach to the validation of accelerator MS assaysDavid Higton & Mark Seymour12 March 2014 | Bioanalysis, Vol. 6, No. 5The early estimation of circulating drug metabolites in humans10 June 2012 | Expert Opinion on Drug Metabolism & Toxicology, Vol. 8, No. 8Conference Report: The 19th International Reid Bioanalytical ForumHoward Hill20 December 2011 | Bioanalysis, Vol. 3, No. 24 Vol. 3, No. 24 Follow us on social media for the latest updates Metrics Downloaded 223 times History Published online 20 December 2011 Published in print December 2011 Information© Future Science LtdKeywordsaccelerator MSmetabolitesmetabolites in safety testingMISTsafetyFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

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