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Cardiac safety research consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward

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第一作者: Darpo,B.
作者: Darpo,B. [1] ; Garnett,C. [2] ; Benson,C.T. [3] ; Keirns,J. [4] ; Leishman,D. [5] ; Malik,M. [6] ; Mehrotra,N. [7] ; Prasad,K. [8] ; Riley,S. [9] ; Rodriguez,I. [10] ; Sager,P. [11] ; Sarapa,N. [12] ; Wallis,R. [13]
作者单位: St Paul's Cardiac Electrophysiology, University of London, Imperial College, London, United Kingdom [1] Lilly Corporate Center, Eli Lilly and Co, Indianapolis, IN, United States [2] Karolinska Institutet, Department of Clinical Sciences, Danderyd's Hospital, Stockholm, Sweden [3] Global PK/PD and Pharmacometrics, Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, IN [4] Medicines and Healthcare Products Regulatory Agency, DoH, London, United Kingdom [5] Division of Pharmacometrics, Center for Drug Evaluation and Research, United States Food and Drug [6] Safety Pharmacology Consultant, Sandwich, United Kingdom [7] Certara, St Louis, MO, United States [8] Clinical Pharmacology, Global Innovative Pharma Business, Pfizer Inc., Groton, CT, United States [9] Pharma Development Safety Risk Management, Roche TCRC, Inc., New York, NY, United States [10] Global Clinical Pharmacology and Exploratory Development, Astellas Pharma Global, Development, Inc [11] Stanford School of Medicine, Palo Alto, CA, United States [12] Clinical Sciences, Bayer Healthcare, Inc., Whippany, NJ, United States [13]
发布时间 2018-07-27
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