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

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

Krebs, Alice (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, Germany,University of Konstanz, Germany

Waldmann, Tanja (författare): Univ Konstanz, Dept inaugurated Doerenkamp Zbinden Fdn, Vitro Toxicol & Biomedicine, Univ Str 10, D-78464 Constance, Germany

Wilks, Martin F. (författare): Univ Basel, Swiss Ctr Appl Human Toxicol, Basel, Switzerland,University of Basel, Switzerland

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van Vugt-Lussenburg, Barbara M. A. (författare): BioDetect Syst BV, Amsterdam, Netherlands,BioDetection Systems BV, The Netherlands

van der Burg, Bart (författare): BioDetect Syst BV, Amsterdam, Netherlands

Terron, Andrea (författare): European Food Safety Author, Parma, Italy,European Food Safety Authority, Italy

Steger-Hartmann, Thomas (författare): Bayer AG, Invest Toxicol Drug Discovery Pharmaceut, Wuppertal, Germany

Ruegg, Joelle (författare): Karolinska Institutet,Uppsala universitet,Miljötoxikologi,Uppsala University, Sweden

Rovida, Costanza (författare): Univ Konstanz, CAAT Europe, Constance, Germany,University of Konstanz, Germany

Pedersen, Emma (författare): RISE,Kemi och material

Pallocca, Giorgia (författare): Univ Konstanz, CAAT Europe, Constance, Germany

Luijten, Mirjam (författare): Natl Inst Publ Hlth & Environm RIVM, Ctr Hlth Protect, Bilthoven, Netherlands,RIVM National Institute for Public Health and the Environment, The Netherlands

Leite, Sofia B. (författare): European Commiss, Joint Res Ctr JRC, Ispra, Italy,JCR European Commission Joint Research Centre, Italy

Kustermann, Stefan (författare): 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

Kamp, Hennicke (författare): Philip Morris Int R&D, Neuchatel, Switzerland,BASF SE, Germany

Hoeng, Julia (författare): Philip Morris Int R&D, Neuchatel, Switzerland

Hewitt, Philip (författare): Merck KGaA, Non Clin Safety, Darmstadt, Germany

Herzler, Matthias (författare): German Fed Inst Risk Assessment, Dept Chem Safety, Berlin, Germany,German Federal Institute for Risk Assessment, Germany

Hengstler, Jan G. (författare): Tech Univ Dortmund, Leibniz Res Ctr Working Environm & Human Factors, Dortmund, Germany,Technical University of Dortmund, Germany

Heinonen, Tuula (författare): Tampere Univ, Fac Med & Life Sci, FICAM, Tampere, Finland,Tampere University, Finland

Hartung, Thomas (författare): Johns Hopkins Univ, Ctr Alternat Anim Testing CAAT, Baltimore, MD USA,Johns Hopkins University, USA

Hardy, Barry (författare): Edelweiss Connect GmbH, Technol Pk Basel, Basel, Switzerland

Gantner, Florian (författare): Boehringer Ingelheim Pharma GmbH Co KG, Translat Med Clin Pharmacol, Biberach, Germany

Fritsche, Ellen (författare): IUF Leibniz Res Inst Environm Med, Dusseldorf, Germany,IUF Leibniz Research Institute for Environmental Medicine, Germany

Fant, Kristina (författare): RISE,Kemi, biomaterial och textil

Ezendam, Janine (författare): Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands

Exner, Thomas (författare): Edelweiss Connect GmbH, Technology Park Basel, Basel, Switzerland

Dunkern, Torsten (författare): Grunenthal GmbH, Aachen, Germany

Dietrich, Daniel R. (författare): Univ Konstanz, Human & Environm Toxicol, Constance, Germany

Coecke, Sandra (författare): European Commission, Joint Research Centre (JRC), Ispra, Italy

Busquet, Francois (författare): Univ Konstanz, CAAT Europe, Constance, Germany;ALTERTOX SPRL, Ixelles, Brussels, Belgium,Bruxelles, Belgium

Braeuning, Albert (författare): German Fed Inst Risk Assessment, Dept Food Safety, Berlin, Germany,German Federal Institute for Risk Assessment, Germany

Bondarenko, Olesja (författare): NICPB, Lab Environm Toxicol, Tallinn, Estonia,National Institute of Chemical Physics and Biophysics, Estonia

Bennekou, Susanne H. (författare): Tech Univ Denmark, Natl Food Inst, Lyngby, Denmark,DTU Technical University of Denmark, Denmark

Beilmann, Mario (författare): Boehringer Ingelheim Pharma GmbH Co KG, Nonclin Drug Safety, Biberach, Germany

Leist, Marcel (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, Germany;Univ Konstanz, CAAT Europe, Constance, Germany,University of Konstanz, Germany

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(creator_code:org_t)

2019
2019
Engelska.
Ingår i: Altex. - : ALTEX Edition. - 1868-596X .- 1868-8551. ; 36:4, s. 682-699

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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)

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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.

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Medicinska och f ...; och Farmakologi och ...

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

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