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Template for the De...
Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data
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- Krebs, Alice (author)
- 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, Germany,University of Konstanz, Germany
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- Waldmann, Tanja (author)
- Univ Konstanz, Dept inaugurated Doerenkamp Zbinden Fdn, Vitro Toxicol & Biomedicine, Univ Str 10, D-78464 Constance, Germany
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- Wilks, Martin F. (author)
- Univ Basel, Swiss Ctr Appl Human Toxicol, Basel, Switzerland,University of Basel, Switzerland
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- van Vugt-Lussenburg, Barbara M. A. (author)
- BioDetect Syst BV, Amsterdam, Netherlands,BioDetection Systems BV, The Netherlands
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- van der Burg, Bart (author)
- BioDetect Syst BV, Amsterdam, Netherlands
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- Terron, Andrea (author)
- European Food Safety Author, Parma, Italy,European Food Safety Authority, Italy
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- Steger-Hartmann, Thomas (author)
- Bayer AG, Invest Toxicol Drug Discovery Pharmaceut, Wuppertal, Germany
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- Ruegg, Joelle (author)
- Karolinska Institutet,Uppsala universitet,Miljötoxikologi,Uppsala University, Sweden
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- Rovida, Costanza (author)
- Univ Konstanz, CAAT Europe, Constance, Germany,University of Konstanz, Germany
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- Pedersen, Emma (author)
- RISE,Kemi och material
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- Pallocca, Giorgia (author)
- Univ Konstanz, CAAT Europe, Constance, Germany
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- Luijten, Mirjam (author)
- Natl Inst Publ Hlth & Environm RIVM, Ctr Hlth Protect, Bilthoven, Netherlands,RIVM National Institute for Public Health and the Environment, The Netherlands
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- Leite, Sofia B. (author)
- European Commiss, Joint Res Ctr JRC, Ispra, Italy,JCR European Commission Joint Research Centre, Italy
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- Kustermann, Stefan (author)
- Pharmaceut Sci Roche Innovat Ctr, F Hoffmann Roche, Pharma Res & Early Dev, Basel, Switzerland;Philip Morris Int R&D, Neuchatel, Switzerland,Roche Innovation Center, Switzerland
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- Kamp, Hennicke (author)
- Philip Morris Int R&D, Neuchatel, Switzerland,BASF SE, Germany
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- Hoeng, Julia (author)
- Philip Morris Int R&D, Neuchatel, Switzerland
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- Hewitt, Philip (author)
- Merck KGaA, Non Clin Safety, Darmstadt, Germany
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- Herzler, Matthias (author)
- German Fed Inst Risk Assessment, Dept Chem Safety, Berlin, Germany,German Federal Institute for Risk Assessment, Germany
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- Hengstler, Jan G. (author)
- Tech Univ Dortmund, Leibniz Res Ctr Working Environm & Human Factors, Dortmund, Germany,Technical University of Dortmund, Germany
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- Heinonen, Tuula (author)
- Tampere Univ, Fac Med & Life Sci, FICAM, Tampere, Finland,Tampere University, Finland
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- Hartung, Thomas (author)
- Johns Hopkins Univ, Ctr Alternat Anim Testing CAAT, Baltimore, MD USA,Johns Hopkins University, USA
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- Hardy, Barry (author)
- Edelweiss Connect GmbH, Technol Pk Basel, Basel, Switzerland
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- Gantner, Florian (author)
- Boehringer Ingelheim Pharma GmbH Co KG, Translat Med Clin Pharmacol, Biberach, Germany
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- Fritsche, Ellen (author)
- IUF Leibniz Res Inst Environm Med, Dusseldorf, Germany,IUF Leibniz Research Institute for Environmental Medicine, Germany
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- Fant, Kristina (author)
- RISE,Kemi, biomaterial och textil
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- Ezendam, Janine (author)
- Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands
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- Exner, Thomas (author)
- Edelweiss Connect GmbH, Technology Park Basel, Basel, Switzerland
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- Dunkern, Torsten (author)
- Grunenthal GmbH, Aachen, Germany
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- Dietrich, Daniel R. (author)
- Univ Konstanz, Human & Environm Toxicol, Constance, Germany
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- Coecke, Sandra (author)
- European Commission, Joint Research Centre (JRC), Ispra, Italy
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- Busquet, Francois (author)
- Univ Konstanz, CAAT Europe, Constance, Germany;ALTERTOX SPRL, Ixelles, Brussels, Belgium,Bruxelles, Belgium
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- Braeuning, Albert (author)
- German Fed Inst Risk Assessment, Dept Food Safety, Berlin, Germany,German Federal Institute for Risk Assessment, Germany
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- Bondarenko, Olesja (author)
- NICPB, Lab Environm Toxicol, Tallinn, Estonia,National Institute of Chemical Physics and Biophysics, Estonia
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- Bennekou, Susanne H. (author)
- Tech Univ Denmark, Natl Food Inst, Lyngby, Denmark,DTU Technical University of Denmark, Denmark
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- Beilmann, Mario (author)
- Boehringer Ingelheim Pharma GmbH Co KG, Nonclin Drug Safety, Biberach, Germany
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- Leist, Marcel (author)
- 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, Germany;Univ Konstanz, CAAT Europe, Constance, Germany,University of Konstanz, Germany
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(creator_code:org_t)
- 2019
- 2019
- English.
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In: Altex. - : ALTEX Edition. - 1868-596X .- 1868-8551. ; 36:4, s. 682-699
- Related links:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://www.altex.or...
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https://ri.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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https://urn.kb.se/re...
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Abstract
Subject headings
Close
- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
Publication and Content Type
- vet (subject category)
- art (subject category)
Find in a library
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Altex
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To the university's database
- By the author/editor
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Krebs, Alice
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Waldmann, Tanja
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Wilks, Martin F.
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van Vugt-Lussenb ...
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van der Burg, Ba ...
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Terron, Andrea
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show more...
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Steger-Hartmann, ...
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Ruegg, Joelle
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Rovida, Costanza
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Pedersen, Emma
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Pallocca, Giorgi ...
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Luijten, Mirjam
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Leite, Sofia B.
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Kustermann, Stef ...
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Kamp, Hennicke
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Hoeng, Julia
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Hewitt, Philip
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Herzler, Matthia ...
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Hengstler, Jan G ...
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Heinonen, Tuula
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Hartung, Thomas
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Hardy, Barry
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Gantner, Florian
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Fritsche, Ellen
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Fant, Kristina
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Ezendam, Janine
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Exner, Thomas
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Dunkern, Torsten
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Dietrich, Daniel ...
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Coecke, Sandra
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Busquet, Francoi ...
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Braeuning, Alber ...
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Bondarenko, Oles ...
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Bennekou, Susann ...
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Beilmann, Mario
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Leist, Marcel
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmacology and ...
- Articles in the publication
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Altex
- By the university
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Uppsala University
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Karolinska Institutet
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RISE