000119897 001__ 119897 000119897 005__ 20240228134959.0 000119897 0247_ $$2doi$$a10.1016/j.fct.2013.10.030 000119897 0247_ $$2pmid$$apmid:24176677 000119897 0247_ $$2ISSN$$a0278-6915 000119897 0247_ $$2ISSN$$a1873-6351 000119897 037__ $$aDKFZ-2017-00488 000119897 041__ $$aeng 000119897 082__ $$a630 000119897 1001_ $$0P:(DE-He78)621efe295db6fdfa7f9f95011a5ea943$$aEdler, Lutz$$b0$$eFirst author$$udkfz 000119897 245__ $$aSelection of appropriate tumour data sets for Benchmark Dose Modelling (BMD) and derivation of a Margin of Exposure (MoE) for substances that are genotoxic and carcinogenic: considerations of biological relevance of tumour type, data quality and uncertainty assessment. 000119897 260__ $$aNew York, NY [u.a.]$$bElsevier$$c2014 000119897 3367_ $$2DRIVER$$aarticle 000119897 3367_ $$2DataCite$$aOutput Types/Journal article 000119897 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1490265436_30632 000119897 3367_ $$2BibTeX$$aARTICLE 000119897 3367_ $$2ORCID$$aJOURNAL_ARTICLE 000119897 3367_ $$00$$2EndNote$$aJournal Article 000119897 520__ $$aThis article addresses a number of concepts related to the selection and modelling of carcinogenicity data for the calculation of a Margin of Exposure. It follows up on the recommendations put forward by the International Life Sciences Institute - European branch in 2010 on the application of the Margin of Exposure (MoE) approach to substances in food that are genotoxic and carcinogenic. The aims are to provide practical guidance on the relevance of animal tumour data for human carcinogenic hazard assessment, appropriate selection of tumour data for Benchmark Dose Modelling, and approaches for dealing with the uncertainty associated with the selection of data for modelling and, consequently, the derived Point of Departure (PoD) used to calculate the MoE. Although the concepts outlined in this article are interrelated, the background expertise needed to address each topic varies. For instance, the expertise needed to make a judgement on biological relevance of a specific tumour type is clearly different to that needed to determine the statistical uncertainty around the data used for modelling a benchmark dose. As such, each topic is dealt with separately to allow those with specialised knowledge to target key areas of guidance and provide a more in-depth discussion on each subject for those new to the concept of the Margin of Exposure approach. 000119897 536__ $$0G:(DE-HGF)POF3-313$$a313 - Cancer risk factors and prevention (POF3-313)$$cPOF3-313$$fPOF III$$x0 000119897 588__ $$aDataset connected to CrossRef, PubMed, 000119897 650_7 $$2NLM Chemicals$$aCarcinogens 000119897 650_7 $$2NLM Chemicals$$aHazardous Substances 000119897 7001_ $$aHart, Andy$$b1 000119897 7001_ $$aGreaves, Peter$$b2 000119897 7001_ $$aCarthew, Philip$$b3 000119897 7001_ $$aCoulet, Myriam$$b4 000119897 7001_ $$aBoobis, Alan$$b5 000119897 7001_ $$aWilliams, Gary M$$b6 000119897 7001_ $$aSmith, Benjamin$$b7 000119897 773__ $$0PERI:(DE-600)1483645-2$$a10.1016/j.fct.2013.10.030$$gVol. 70, p. 264 - 289$$p264 - 289$$tFood and chemical toxicology$$v70$$x0278-6915$$y2014 000119897 909CO $$ooai:inrepo02.dkfz.de:119897$$pVDB 000119897 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)621efe295db6fdfa7f9f95011a5ea943$$aDeutsches Krebsforschungszentrum$$b0$$kDKFZ 000119897 9131_ $$0G:(DE-HGF)POF3-313$$1G:(DE-HGF)POF3-310$$2G:(DE-HGF)POF3-300$$3G:(DE-HGF)POF3$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vCancer risk factors and prevention$$x0 000119897 9141_ $$y2014 000119897 915__ $$0StatID:(DE-HGF)0420$$2StatID$$aNationallizenz 000119897 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bFOOD CHEM TOXICOL : 2015 000119897 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS 000119897 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline 000119897 915__ $$0StatID:(DE-HGF)0310$$2StatID$$aDBCoverage$$bNCBI Molecular Biology Database 000119897 915__ $$0StatID:(DE-HGF)0600$$2StatID$$aDBCoverage$$bEbsco Academic Search 000119897 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bASC 000119897 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bThomson Reuters Master Journal List 000119897 915__ $$0StatID:(DE-HGF)0110$$2StatID$$aWoS$$bScience Citation Index 000119897 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection 000119897 915__ $$0StatID:(DE-HGF)0111$$2StatID$$aWoS$$bScience Citation Index Expanded 000119897 915__ $$0StatID:(DE-HGF)1060$$2StatID$$aDBCoverage$$bCurrent Contents - Agriculture, Biology and Environmental Sciences 000119897 915__ $$0StatID:(DE-HGF)1030$$2StatID$$aDBCoverage$$bCurrent Contents - Life Sciences 000119897 915__ $$0StatID:(DE-HGF)1050$$2StatID$$aDBCoverage$$bBIOSIS Previews 000119897 915__ $$0StatID:(DE-HGF)9900$$2StatID$$aIF < 5 000119897 9201_ $$0I:(DE-He78)C060-20160331$$kC060$$lBiostatistik$$x0 000119897 980__ $$ajournal 000119897 980__ $$aVDB 000119897 980__ $$aI:(DE-He78)C060-20160331 000119897 980__ $$aUNRESTRICTED