General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy.
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| Title: | General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy. |
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| Authors: | Li Z; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Mirams GR; Centre for Mathematical Medicine & Biology, School of Mathematical Sciences, University of Nottingham, Nottingham, UK., Yoshinaga T; Global Cardiovascular Assessment, Eisai Co., Ltd., Tokyo, Japan., Ridder BJ; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Han X; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Chen JE; Division of Biometrics VI, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Stockbridge NL; Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wisialowski TA; Global Safety Pharmacology, Pfizer, Inc., Groton, Connecticut, USA., Damiano B; Global Safety Pharmacology/Nonclinical Safety, Janssen Research & Development, Raritan, New Jersey, USA., Severi S; Department of Electrical, Electronic, and Information Engineering, University of Bologna, Cesena, Italy., Morissette P; Department of Safety Assessment and Laboratory Animal Resources, Merck & Co., Kenilworth, New Jersey, USA., Kowey PR; Main Line Health and Sidney Kimmel Medical College, Philadelphia, Pennsylvania, USA., Holbrook M; Certara, Ltd., Sheffield, UK., Smith G; Clyde Biosciences Ltd, Glasgow, UK.; Institute of Cardiovascular and Medical Sciences, Glasgow University, Glasgow, UK., Rasmusson RL; Department of Physiology and Biophysics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA., Liu M; Division of Cardiology, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA., Song Z; Division of Cardiology, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA., Qu Z; Division of Cardiology, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA., Leishman DJ; Department of Toxicology and Pathology, Eli Lilly and Company, Indianapolis, Indiana, USA., Steidl-Nichols J; Covance Inc., Madison, Wisconsin, USA., Rodriguez B; Department of Computer Science, University of Oxford, Oxford, UK., Bueno-Orovio A; Department of Pharmacology, University of California Davis, Davis, California, USA., Zhou X; Victor Chang Cardiac Research Institute, Darlinghurst, New South Wales, Australia., Passini E; Department of Computer Science, University of Oxford, Oxford, UK., Edwards AG; Department of Pharmacology, University of California Davis, Davis, California, USA., Morotti S; Department of Pharmacology, University of California Davis, Davis, California, USA., Ni H; Department of Pharmacology, University of California Davis, Davis, California, USA., Grandi E; Department of Pharmacology, University of California Davis, Davis, California, USA., Clancy CE; Department of Pharmacology, University of California Davis, Davis, California, USA., Vandenberg J; Victor Chang Cardiac Research Institute, Darlinghurst, New South Wales, Australia.; St Vincent's Clinical School, UNSW Sydney, Darlinghurst, New South Wales, Australia., Hill A; Victor Chang Cardiac Research Institute, Darlinghurst, New South Wales, Australia.; St Vincent's Clinical School, UNSW Sydney, Darlinghurst, New South Wales, Australia., Nakamura M; Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan., Singer T; Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Polonchuk L; Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Greiter-Wilke A; Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Wang K; Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Nave S; Roche Product Development, Safety Science/Licensing & Early Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Fullerton A; Department of Safety Assessment, Genentech, Inc., South San Francisco, California, USA., Sobie EA; Icahn School of Medicine at Mount Sinai, New York, New York, USA., Paci M; BioMediTech, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland., Musuamba Tshinanu F; Federal Agency for Medicines and Health Products, Brussels, Belgium.; European Medicines Agency, Amsterdam, The Netherlands., Strauss DG; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. |
| Source: | Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2020 Jan; Vol. 107 (1), pp. 102-111. Date of Electronic Publication: 2019 Nov 10. |
| Publication Type: | Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S. |
| Journal Info: | Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1532-6535 |
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| DOI: | 10.1002/cpt.1647 |
