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@ARTICLE{Edler:119897,
      author       = {L. Edler$^*$ and A. Hart and P. Greaves and P. Carthew and
                      M. Coulet and A. Boobis and G. M. Williams and B. Smith},
      title        = {{S}election of appropriate tumour data sets for {B}enchmark
                      {D}ose {M}odelling ({BMD}) and derivation of a {M}argin of
                      {E}xposure ({M}o{E}) for substances that are genotoxic and
                      carcinogenic: considerations of biological relevance of
                      tumour type, data quality and uncertainty assessment.},
      journal      = {Food and chemical toxicology},
      volume       = {70},
      issn         = {0278-6915},
      address      = {New York, NY [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2017-00488},
      pages        = {264 - 289},
      year         = {2014},
      abstract     = {This 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.},
      keywords     = {Carcinogens (NLM Chemicals) / Hazardous Substances (NLM
                      Chemicals)},
      cin          = {C060},
      ddc          = {630},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:24176677},
      doi          = {10.1016/j.fct.2013.10.030},
      url          = {https://inrepo02.dkfz.de/record/119897},
}