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The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods.
Krebs, Alice; van Vugt-Lussenburg, Barbara M A; Waldmann, Tanja; Albrecht, Wiebke; Boei, Jan; Ter Braak, Bas; Brajnik, Maja; Braunbeck, Thomas; Brecklinghaus, Tim; Busquet, Francois; Dinnyes, Andras; Dokler, Joh; Dolde, Xenia; Exner, Thomas E; Fisher, Ciarán; Fluri, David; Forsby, Anna; Hengstler, Jan G; Holzer, Anna-Katharina; Janstova, Zofia; Jennings, Paul; Kisitu, Jaffar; Kobolak, Julianna; Kumar, Manoj; Limonciel, Alice; Lundqvist, Jessica; Mihalik, Balázs; Moritz, Wolfgang; Pallocca, Giorgia; Ulloa, Andrea Paola Cediel; Pastor, Manuel; Rovida, Costanza; Sarkans, Ugis; Schimming, Johannes P; Schmidt, Bela Z; Stöber, Regina; Strassfeld, Tobias; van de Water, Bob; Wilmes, Anja; van der Burg, Bart; Verfaillie, Catherine M; von Hellfeld, Rebecca; Vrieling, Harry; Vrijenhoek, Nanette G; Leist, Marcel.
Afiliación
  • Krebs A; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
  • van Vugt-Lussenburg BMA; Konstanz Research School Chemical Biology, University of Konstanz, 78457, Konstanz, Germany.
  • Waldmann T; BioDetection Systems BV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
  • Albrecht W; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
  • Boei J; trenzyme GmbH, Byk-Gulden-Str. 2, 78467, Konstanz, Germany.
  • Ter Braak B; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
  • Brajnik M; Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
  • Braunbeck T; Division of Drug Discovery and Safety, Leiden Academic Center for Drug Research, Leiden University, Einsteinweg 55, 2333 CC, Leiden, The Netherlands.
  • Brecklinghaus T; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
  • Busquet F; Aquatic Ecology and Toxicology Group, Center for Organismal Studies, University of Heidelberg, Im Neuenheimer Feld 504, 69120, Heidelberg, Germany.
  • Dinnyes A; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
  • Dokler J; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
  • Dolde X; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllo, 2100, Hungary.
  • Exner TE; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
  • Fisher C; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
  • Fluri D; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
  • Forsby A; Simcyp Division, Certara UK Limited, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.
  • Hengstler JG; InSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
  • Holzer AK; Unit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
  • Janstova Z; Department of Biochemistry and Biophysics, Stockholm University, 10691, Stockholm, Sweden.
  • Jennings P; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
  • Kisitu J; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
  • Kobolak J; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllo, 2100, Hungary.
  • Kumar M; Division of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
  • Limonciel A; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
  • Lundqvist J; Konstanz Research School Chemical Biology, University of Konstanz, 78457, Konstanz, Germany.
  • Mihalik B; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllo, 2100, Hungary.
  • Moritz W; Department of Development and Regeneration, Stem Cell Biology and Embryology, Stem Cell Institute Leuven, KU Leuven, O&N IV Herestraat 49, 3000, Leuven, Belgium.
  • Pallocca G; Division of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
  • Ulloa APC; Unit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
  • Pastor M; Department of Biochemistry and Biophysics, Stockholm University, 10691, Stockholm, Sweden.
  • Rovida C; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllo, 2100, Hungary.
  • Sarkans U; InSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
  • Schimming JP; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
  • Schmidt BZ; Unit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
  • Stöber R; Department of Experimental and Health Sciences, Research Programme on Biomedical Informatics (GRIB), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Pompeu Fabra, 08003, Barcelona, Spain.
  • Strassfeld T; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
  • van de Water B; European Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Cambridge, UK.
  • Wilmes A; Leiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
  • van der Burg B; Switch Laboratory, Department of Cellular and Molecular Medicine, VIB-KU Leuven Center for Brain and Disease Research, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
  • Verfaillie CM; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
  • von Hellfeld R; InSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
  • Vrieling H; Leiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
  • Vrijenhoek NG; Division of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
  • Leist M; BioDetection Systems BV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Arch Toxicol ; 94(7): 2435-2461, 2020 07.
Article en En | MEDLINE | ID: mdl-32632539
Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usable for integrated hazard assessment, strategic project decisions and/or for regulatory purposes. The EU-ToxRisk project developed a strategy to provide regulatorily valid data, and exemplified this using a panel of > 20 assays (with > 50 individual endpoints), each exposed to 19 well-known test compounds (e.g. rotenone, colchicine, mercury, paracetamol, rifampicine, paraquat, taxol). Examples of strategy implementation are provided for all aspects required to ensure data validity: (i) documentation of test methods in a publicly accessible database; (ii) deposition of standard operating procedures (SOP) at the European Union DB-ALM repository; (iii) test readiness scoring accoding to defined criteria; (iv) disclosure of the pipeline for data processing; (v) link of uncertainty measures and metadata to the data; (vi) definition of test chemicals, their handling and their behavior in test media; (vii) specification of the test purpose and overall evaluation plans. Moreover, data generation was exemplified by providing results from 25 reporter assays. A complete evaluation of the entire test battery will be described elsewhere. A major learning from the retrospective analysis of this large testing project was the need for thorough definitions of the above strategy aspects, ideally in form of a study pre-registration, to allow adequate interpretation of the data and to ensure overall scientific/toxicological validity.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Toxicología / Procesamiento Automatizado de Datos / Pruebas de Toxicidad / Regulación Gubernamental / Documentación Tipo de estudio: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Animals / Humans País/Región como asunto: Europa Idioma: En Revista: Arch Toxicol Año: 2020 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Toxicología / Procesamiento Automatizado de Datos / Pruebas de Toxicidad / Regulación Gubernamental / Documentación Tipo de estudio: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Animals / Humans País/Región como asunto: Europa Idioma: En Revista: Arch Toxicol Año: 2020 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania