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Key Challenges and Opportunities Associated with the Use of In Vitro Models to Detect Human DILI: Integrated Risk Assessment and Mitigation Plans.

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Title: Key Challenges and Opportunities Associated with the Use of In Vitro Models to Detect Human DILI: Integrated Risk Assessment and Mitigation Plans.
Authors: Atienzar FA; UCB BioPharma SPRL, Chemin du Foriest, R9 Building, 1420 Braine-l'Alleud, Belgium., Blomme EA; AbbVie, 1 North Waukegan Road, North Chicago, IL 60064, USA., Chen M; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration (FDA), Jefferson, AR 72079, USA., Hewitt P; Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany., Kenna JG; Drug Safety Consultant, Macclesfield, Cheshire SK11, UK., Labbe G; Sanofi, Bâtiment C. Bernard, 13 Quai Jules Guesdes, Zone B, BP14, 94403 Vitry-sur-Seine Cedex, France., Moulin F; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA., Pognan F; Novartis Pharma AG, Klybeckstrasse 141, 4057 Basel, Switzerland., Roth AB; Hoffmann La-Roche Inc., 4000 Basel, Switzerland., Suter-Dick L; School of Life Sciences, University of Applied Sciences Northwestern Switzerland, Gründenstrasse 40, 4132 Muttenz, Switzerland., Ukairo O; Ipsen Biosciences Inc., 650 E Kendall Street, Cambridge, MA 02142, USA., Weaver RJ; Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France., Will Y; Pfizer R&D, Drug Safety Research and Development, Eastern Point Road, Groton, CT 06340, USA., Dambach DM; Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
Source: BioMed research international [Biomed Res Int] 2016; Vol. 2016, pp. 9737920. Date of Electronic Publication: 2016 Sep 05.
Publication Type: Review; Journal Article
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 101600173 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2314-6141 (Electronic) NLM ISO Abbreviation: Biomed Res Int
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Atienzar+FA%22">Atienzar FA</searchLink>; UCB BioPharma SPRL, Chemin du Foriest, R9 Building, 1420 Braine-l'Alleud, Belgium.<br /><searchLink fieldCode="AU" term="%22Blomme+EA%22">Blomme EA</searchLink>; AbbVie, 1 North Waukegan Road, North Chicago, IL 60064, USA.<br /><searchLink fieldCode="AU" term="%22Chen+M%22">Chen M</searchLink>; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration (FDA), Jefferson, AR 72079, USA.<br /><searchLink fieldCode="AU" term="%22Hewitt+P%22">Hewitt P</searchLink>; Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Kenna+JG%22">Kenna JG</searchLink>; Drug Safety Consultant, Macclesfield, Cheshire SK11, UK.<br /><searchLink fieldCode="AU" term="%22Labbe+G%22">Labbe G</searchLink>; Sanofi, Bâtiment C. Bernard, 13 Quai Jules Guesdes, Zone B, BP14, 94403 Vitry-sur-Seine Cedex, France.<br /><searchLink fieldCode="AU" term="%22Moulin+F%22">Moulin F</searchLink>; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA.<br /><searchLink fieldCode="AU" term="%22Pognan+F%22">Pognan F</searchLink>; Novartis Pharma AG, Klybeckstrasse 141, 4057 Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Roth+AB%22">Roth AB</searchLink>; Hoffmann La-Roche Inc., 4000 Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Suter-Dick+L%22">Suter-Dick L</searchLink>; School of Life Sciences, University of Applied Sciences Northwestern Switzerland, Gründenstrasse 40, 4132 Muttenz, Switzerland.<br /><searchLink fieldCode="AU" term="%22Ukairo+O%22">Ukairo O</searchLink>; Ipsen Biosciences Inc., 650 E Kendall Street, Cambridge, MA 02142, USA.<br /><searchLink fieldCode="AU" term="%22Weaver+RJ%22">Weaver RJ</searchLink>; Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France.<br /><searchLink fieldCode="AU" term="%22Will+Y%22">Will Y</searchLink>; Pfizer R&D, Drug Safety Research and Development, Eastern Point Road, Groton, CT 06340, USA.<br /><searchLink fieldCode="AU" term="%22Dambach+DM%22">Dambach DM</searchLink>; Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
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