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A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm.
Ridder, Bradley J; Leishman, Derek J; Bridgland-Taylor, Matthew; Samieegohar, Mohammadreza; Han, Xiaomei; Wu, Wendy W; Randolph, Aaron; Tran, Phu; Sheng, Jiansong; Danker, Timm; Lindqvist, Anders; Konrad, Daniel; Hebeisen, Simon; Polonchuk, Liudmila; Gissinger, Evgenia; Renganathan, Muthukrishnan; Koci, Bryan; Wei, Haiyang; Fan, Jingsong; Levesque, Paul; Kwagh, Jae; Imredy, John; Zhai, Jin; Rogers, Marc; Humphries, Edward; Kirby, Robert; Stoelzle-Feix, Sonja; Brinkwirth, Nina; Rotordam, Maria Giustina; Becker, Nadine; Friis, Søren; Rapedius, Markus; Goetze, Tom A; Strassmaier, Tim; Okeyo, George; Kramer, James; Kuryshev, Yuri; Wu, Caiyun; Himmel, Herbert; Mirams, Gary R; Strauss, David G; Bardenet, Rémi; Li, Zhihua.
Afiliación
  • Ridder BJ; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Leishman DJ; Department of Toxicology and Pathology, Eli Lilly and Company, Indianapolis, IN, USA.
  • Bridgland-Taylor M; Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, United Kingdom.
  • Samieegohar M; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Han X; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Wu WW; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Randolph A; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Tran P; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Sheng J; CiPA LAB, 900 Clopper Rd, Suite 130, Gaithersburg, MD 20878, USA.
  • Danker T; NMI-TT GmbH, Markwiesenstr. 55, 72770 Reutlingen, Germany.
  • Lindqvist A; Sophion Bioscience A/S, Baltorpvej 154, 2750 Ballerup, Denmark.
  • Konrad D; B'SYS GmbH, The Ion Channel Company, Benkenstrasse 254, CH-4108, Witterswil, Switzerland.
  • Hebeisen S; B'SYS GmbH, The Ion Channel Company, Benkenstrasse 254, CH-4108, Witterswil, Switzerland.
  • Polonchuk L; F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd Bldg. 73/R. 103b Grenzacherstrasse, 124, CH-4070 Basel, Switzerland.
  • Gissinger E; F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd Bldg. 73/R. 103b Grenzacherstrasse, 124, CH-4070 Basel, Switzerland.
  • Renganathan M; Eurofins Scientific, Eurofins Discovery, 6 Research Park Drive, St. Charles, MO 63304, USA.
  • Koci B; Eurofins Scientific, Eurofins Discovery, 6 Research Park Drive, St. Charles, MO 63304, USA.
  • Wei H; Eurofins Scientific, Eurofins Discovery, 6 Research Park Drive, St. Charles, MO 63304, USA.
  • Fan J; Bristol-Myers Squibb Company, Discovery Toxicology, Bristol-Myers Squibb, 3551 Lawrenceville, Princeton Rd, Lawrence Township, NJ 08648, USA.
  • Levesque P; Bristol-Myers Squibb Company, Discovery Toxicology, Bristol-Myers Squibb, 3551 Lawrenceville, Princeton Rd, Lawrence Township, NJ 08648, USA.
  • Kwagh J; Bristol-Myers Squibb Company, Discovery Toxicology, Bristol-Myers Squibb, 3551 Lawrenceville, Princeton Rd, Lawrence Township, NJ 08648, USA.
  • Imredy J; Merck & Co., Inc, Kenilworth, NJ, USA.
  • Zhai J; Merck & Co., Inc, Kenilworth, NJ, USA.
  • Rogers M; Metrion Biosciences Limited, Riverside 3, Suite 1, Granta Park, Great Abington, Cambridge CB21, 6AD, United Kingdom.
  • Humphries E; Metrion Biosciences Limited, Riverside 3, Suite 1, Granta Park, Great Abington, Cambridge CB21, 6AD, United Kingdom.
  • Kirby R; Metrion Biosciences Limited, Riverside 3, Suite 1, Granta Park, Great Abington, Cambridge CB21, 6AD, United Kingdom.
  • Stoelzle-Feix S; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Brinkwirth N; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Rotordam MG; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Becker N; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Friis S; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Rapedius M; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Goetze TA; Nanion Technologies Munich, Ganghoferstrasse 70A, 80339 Munich, Germany.
  • Strassmaier T; Nanion Technologies, USA, 1 Naylon Place, Suite C, Livingston, NJ 07039, USA.
  • Okeyo G; Nanion Technologies, USA, 1 Naylon Place, Suite C, Livingston, NJ 07039, USA.
  • Kramer J; Charles River Laboratories, 14656 Neo Parkway, Cleveland, OH 44128, USA.
  • Kuryshev Y; Charles River Laboratories, 14656 Neo Parkway, Cleveland, OH 44128, USA.
  • Wu C; Charles River Laboratories, 14656 Neo Parkway, Cleveland, OH 44128, USA.
  • Himmel H; Bayer AG, RD-TS-TOX-SP-SPL1, Aprather Weg 18a, 42096 Wuppertal, Germany.
  • Mirams GR; Centre for Mathematical Medicine & Biology, School of Mathematical Sciences, University of Nottingham, Nottingham, United Kingdom.
  • Strauss DG; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
  • Bardenet R; Université de Lille, CNRS, Centrale Lille, UMR 9189 - CRIStAL, Villeneuve d'Ascq, France.
  • Li Z; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA. Electronic address: Zhihua.li@fda.hhs.gov.
Toxicol Appl Pharmacol ; 394: 114961, 2020 05 01.
Article en En | MEDLINE | ID: mdl-32209365
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Torsades de Pointes / Medición de Riesgo / Canal de Potasio ERG1 Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Toxicol Appl Pharmacol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Torsades de Pointes / Medición de Riesgo / Canal de Potasio ERG1 Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Toxicol Appl Pharmacol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos