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  • Krebs, AliceUniv Konstanz, Dept inaugurated Doerenkamp Zbinden Fdn, Vitro Toxicol & Biomedicine, Univ Str 10, D-78464 Constance, Germany;Univ Konstanz, Konstanz Res Sch Chem Biol KoRS CB, Constance, Germany,University of Konstanz, Germany (författare)

Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data

  • Artikel/kapitelEngelska2019

Förlag, utgivningsår, omfång ...

  • 2019
  • ALTEX Edition,2019
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-407274
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-407274URI
  • https://doi.org/10.14573/altex.1909271DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:142900138URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:ri:diva-40888URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:vet swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Correction in: ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION, Volume: 37, Issue:1, Pages:164-164DOI:10.14573/altex.1909271e
  • Erratum to Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data.
  • Only few cell-based test methods are described by Organisation for Economic Co-operation and Development (OECD) test guidelines or other regulatory references (e.g., the European Pharmacopoeia). The majority of toxicity tests still falls into the category of non-guideline methods. Data from these tests may nevertheless be used to support regulatory decisions or to guide strategies to assess compounds (e.g., drugs, agrochemicals) during research and development if they fulfill basic requirements concerning their relevance, reproducibility and predictivity. Only a method description of sufficient clarity and detail allows interpretation and use of the data. To guide regulators faced with increasing amounts of data from non-guideline studies, the OECD formulated Guidance Document 211 (GD211) on method documentation for the purpose of safety assessment. As GD211 is targeted mainly at regulators, it leaves scientists less familiar with regulation uncertain as to what level of detail is required and how individual questions should be answered. Moreover, little attention was given to the description of the test system (i.e., cell culture) and the steps leading to it being established in the guidance. To address these issues, an annotated toxicity test method template (ToxTemp) was developed (i) to fulfill all requirements of GD211, (ii) to guide the user concerning the types of answers and detail of information required, (iii) to include acceptance criteria for test elements, and (iv) to define the cells sufficiently and transparently. The fully annotated ToxTemp is provided here, together with reference to a database containing exemplary descriptions of more than 20 cell-based tests.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Waldmann, TanjaUniv Konstanz, Dept inaugurated Doerenkamp Zbinden Fdn, Vitro Toxicol & Biomedicine, Univ Str 10, D-78464 Constance, Germany (författare)
  • Wilks, Martin F.Univ Basel, Swiss Ctr Appl Human Toxicol, Basel, Switzerland,University of Basel, Switzerland (författare)
  • van Vugt-Lussenburg, Barbara M. A.BioDetect Syst BV, Amsterdam, Netherlands,BioDetection Systems BV, The Netherlands (författare)
  • van der Burg, BartBioDetect Syst BV, Amsterdam, Netherlands (författare)
  • Terron, AndreaEuropean Food Safety Author, Parma, Italy,European Food Safety Authority, Italy (författare)
  • Steger-Hartmann, ThomasBayer AG, Invest Toxicol Drug Discovery Pharmaceut, Wuppertal, Germany (författare)
  • Ruegg, JoelleKarolinska Institutet,Uppsala universitet,Miljötoxikologi,Uppsala University, Sweden(Swepub:uu)joeru493 (författare)
  • Rovida, CostanzaUniv Konstanz, CAAT Europe, Constance, Germany,University of Konstanz, Germany (författare)
  • Pedersen, EmmaRISE,Kemi och material(Swepub:ri)emma.pedersen@ri.se (författare)
  • Pallocca, GiorgiaUniv Konstanz, CAAT Europe, Constance, Germany (författare)
  • Luijten, MirjamNatl Inst Publ Hlth & Environm RIVM, Ctr Hlth Protect, Bilthoven, Netherlands,RIVM National Institute for Public Health and the Environment, The Netherlands (författare)
  • Leite, Sofia B.European Commiss, Joint Res Ctr JRC, Ispra, Italy,JCR European Commission Joint Research Centre, Italy (författare)
  • Kustermann, StefanPharmaceut Sci Roche Innovat Ctr, F Hoffmann Roche, Pharma Res & Early Dev, Basel, Switzerland;Philip Morris Int R&D, Neuchatel, Switzerland,Roche Innovation Center, Switzerland (författare)
  • Kamp, HennickePhilip Morris Int R&D, Neuchatel, Switzerland,BASF SE, Germany (författare)
  • Hoeng, JuliaPhilip Morris Int R&D, Neuchatel, Switzerland (författare)
  • Hewitt, PhilipMerck KGaA, Non Clin Safety, Darmstadt, Germany (författare)
  • Herzler, MatthiasGerman Fed Inst Risk Assessment, Dept Chem Safety, Berlin, Germany,German Federal Institute for Risk Assessment, Germany (författare)
  • Hengstler, Jan G.Tech Univ Dortmund, Leibniz Res Ctr Working Environm & Human Factors, Dortmund, Germany,Technical University of Dortmund, Germany (författare)
  • Heinonen, TuulaTampere Univ, Fac Med & Life Sci, FICAM, Tampere, Finland,Tampere University, Finland (författare)
  • Hartung, ThomasJohns Hopkins Univ, Ctr Alternat Anim Testing CAAT, Baltimore, MD USA,Johns Hopkins University, USA (författare)
  • Hardy, BarryEdelweiss Connect GmbH, Technol Pk Basel, Basel, Switzerland (författare)
  • Gantner, FlorianBoehringer Ingelheim Pharma GmbH Co KG, Translat Med Clin Pharmacol, Biberach, Germany (författare)
  • Fritsche, EllenIUF Leibniz Res Inst Environm Med, Dusseldorf, Germany,IUF Leibniz Research Institute for Environmental Medicine, Germany (författare)
  • Fant, KristinaRISE,Kemi, biomaterial och textil (författare)
  • Ezendam, JanineCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands (författare)
  • Exner, ThomasEdelweiss Connect GmbH, Technology Park Basel, Basel, Switzerland (författare)
  • Dunkern, TorstenGrunenthal GmbH, Aachen, Germany (författare)
  • Dietrich, Daniel R.Univ Konstanz, Human & Environm Toxicol, Constance, Germany (författare)
  • Coecke, SandraEuropean Commission, Joint Research Centre (JRC), Ispra, Italy (författare)
  • Busquet, FrancoisUniv Konstanz, CAAT Europe, Constance, Germany;ALTERTOX SPRL, Ixelles, Brussels, Belgium,Bruxelles, Belgium (författare)
  • Braeuning, AlbertGerman Fed Inst Risk Assessment, Dept Food Safety, Berlin, Germany,German Federal Institute for Risk Assessment, Germany (författare)
  • Bondarenko, OlesjaNICPB, Lab Environm Toxicol, Tallinn, Estonia,National Institute of Chemical Physics and Biophysics, Estonia (författare)
  • Bennekou, Susanne H.Tech Univ Denmark, Natl Food Inst, Lyngby, Denmark,DTU Technical University of Denmark, Denmark (författare)
  • Beilmann, MarioBoehringer Ingelheim Pharma GmbH Co KG, Nonclin Drug Safety, Biberach, Germany (författare)
  • Leist, MarcelUniv Konstanz, Dept inaugurated Doerenkamp Zbinden Fdn, Vitro Toxicol & Biomedicine, Univ Str 10, D-78464 Constance, Germany;Univ Konstanz, Konstanz Res Sch Chem Biol KoRS CB, Constance, Germany;Univ Konstanz, CAAT Europe, Constance, Germany,University of Konstanz, Germany (författare)
  • Univ Konstanz, Dept inaugurated Doerenkamp Zbinden Fdn, Vitro Toxicol & Biomedicine, Univ Str 10, D-78464 Constance, Germany;Univ Konstanz, Konstanz Res Sch Chem Biol KoRS CB, Constance, GermanyUniversity of Konstanz, Germany (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Altex: ALTEX Edition36:4, s. 682-6991868-596X1868-8551

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