BioanalysisVol. 7, No. 5 CommentaryRadiolabeled metabolite and disposition studies in support of safety assessmentAshley Beattie, Stephen Madden, Chris Lowrie & David MacPhersonAshley BeattieAuthor for correspondence: E-mail Address: ashley.beattie@crl.comDepartment of Environmental Sciences, Charles River, Edinburgh, EH33 2NE, UKSearch for more papers by this author, Stephen MaddenDepartment of Metabolism & Pharmacokinetics, Preclinical Services, Charles River, Edinburgh, EH33 2NE, UKSearch for more papers by this author, Chris LowrieDepartment of Environmental Sciences, Charles River, Edinburgh, EH33 2NE, UKSearch for more papers by this author & David MacPhersonDepartment of Chemistry, Charles River, Edinburgh, EH33 2NE, UKSearch for more papers by this authorPublished Online:31 Mar 2015https://doi.org/10.4155/bio.15.18AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: distributionexposuremass spectrometrymetabolismradiochromatographysafety assessmentReferences1 ICH M3 (R2) – Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. (2008) www.ema.europa.eu/docs Google Scholar2 Pellegatti M. The debate on animal ADME studies in drug development: an update. Expert Opin. Drug Metabol. Toxicol. 11(1), 1615–1620 (2014).Crossref, Google Scholar3 Obach RS, Nedderman AN, Smith DA. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary? Xenobiotica 42, 46–46 (2012).Crossref, Medline, CAS, Google Scholar4 White RE, Evans DC, Hop CE et al. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: a commentary on why they are still necessary. Xenobiotica 43, 219–425 (2013).Crossref, Medline, CAS, Google Scholar5 Nedderman AN, Dear GJ, North S et al. From definition to implementation: a cross-industry perspective of past, current and future MIST strategies. Xenobiotica 41(8), 605–622 (2011).Crossref, Medline, CAS, Google Scholar6 OECD. Test No. 503: Metabolism in Livestock (Section 5). In: OECD Guidelines for the Testing of Chemicals. OECD Publishing, Paris, France (2007). www.oecd-ilibrary.orgGoogle Scholar7 EPA. Residue chemistry test guidelines, OPPTS 860. In: 1340 Residue Analytical Method, EPA Publishing, Washington, DC, USA (1996). www.epa.govGoogle Scholar8 VICH GL46 Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues. (2012) www.fda.gov Google Scholar9 Regulations (EC) No 1107/2009 of the European Parliament and of the Council (2009). http://eur-lex.europa.eu/LexUriServGoogle ScholarFiguresReferencesRelatedDetailsCited ByDeuterium- und tritiummarkierte Verbindungen: Anwendungen in den modernen Biowissenschaften4 January 2018 | Angewandte Chemie, Vol. 130, No. 7Deuterium- and Tritium-Labelled Compounds: Applications in the Life Sciences4 January 2018 | Angewandte Chemie International Edition, Vol. 57, No. 7Themed Issue on Radioisotopic BioanalysisMark Seymour31 March 2015 | Bioanalysis, Vol. 7, No. 5 Vol. 7, No. 5 Follow us on social media for the latest updates Metrics Downloaded 149 times History Published online 31 March 2015 Published in print March 2015 Information© Future Science LtdKeywordsdistributionexposuremass spectrometrymetabolismradiochromatographysafety assessmentFinancial & competing interests disclosureThe authors have 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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