Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations.

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Title: Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations.
Authors: Gintant G; Department of Integrative Pharmacology, Integrated Sciences and Technology, AbbVie, North Chicago, IL, 60064, USA. Electronic address: gary.gintant@abbvie.com., Kaushik EP; Takeda Pharmaceutical Co, Cambridge, MA, 02139, USA. Electronic address: emily.kaushik@takeda.com., Feaster T; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: tromondae.feaster@fda.hhs.gov., Stoelzle-Feix S; Nanion Technologies, Munich, Germany. Electronic address: sonja.stoelzle-feix@nanion.de., Kanda Y; Division of Pharmacology, National Institute of Health Sciences, Kanagawa, Japan. Electronic address: kanda@nihs.go.jp., Osada T; LSI Medience Corporation, Tokyo, Japan. Electronic address: osada.tomoharu@mg.medience.co.jp., Smith G; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK; Clyde Biosciences Ltd., Scotland, UK. Electronic address: godfrey.smith@glasgow.ac.uk., Czysz K; Fujifilm Cellular Dynamics, Inc., Madison, WI, 53711, USA. Electronic address: katherine.czysz@fujifilm.com., Kettenhofen R; Fraunhofer-Institute for Biomed Engineering IBMT, Sulzbach, Germany. Electronic address: ralf.kettenhofen@ibmt.fraunhofer.de., Lu HR; Nonclinical Safety, Johnson & Johnson R&D, Beerse, Belgium. Electronic address: hlu@its.jnj.com., Cai B; Takeda California, Inc., San Diego, CA, 92121, USA. Electronic address: beibei.cai@gmail.com., Shi H; Bristol-Myers Squibb, New York, NY, 10016, USA. Electronic address: hong.shi@bms.com., Herron TJ; Frankel Cardiovascular Regeneration Core Laboratory, University of Michigan, Ann Arbor, MI, 48109, USA. Electronic address: toddherr@umich.edu., Dang Q; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: qianyu.dang@fda.hhs.gov., Burton F; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK; Clyde Biosciences Ltd., Scotland, UK. Electronic address: francis.burton@glasgow.ac.uk., Pang L; Division of Systems Biology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA. Electronic address: li.pang@fda.hhs.gov., Traebert M; Novartis Inst Biomed Res, Switzerland. Electronic address: martin.traebert@novartis.com., Abassi Y; Agilent Technologies, San Diego, CA, 92121, USA. Electronic address: yama.abassi@agilent.com., Pierson JB; Health and Environmental Sciences Institute, Washington, DC, 20005, USA. Electronic address: jpierson@hesiglobal.org., Blinova K; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: ksenia.blinova@fda.hhs.gov.
Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Nov; Vol. 117, pp. 104756. Date of Electronic Publication: 2020 Aug 19.
Publication Type: Journal Article; Review
Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE
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  Data: Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations.
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  Data: <searchLink fieldCode="AU" term="%22Gintant+G%22">Gintant G</searchLink>; Department of Integrative Pharmacology, Integrated Sciences and Technology, AbbVie, North Chicago, IL, 60064, USA. Electronic address: gary.gintant@abbvie.com.<br /><searchLink fieldCode="AU" term="%22Kaushik+EP%22">Kaushik EP</searchLink>; Takeda Pharmaceutical Co, Cambridge, MA, 02139, USA. Electronic address: emily.kaushik@takeda.com.<br /><searchLink fieldCode="AU" term="%22Feaster+T%22">Feaster T</searchLink>; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: tromondae.feaster@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Stoelzle-Feix+S%22">Stoelzle-Feix S</searchLink>; Nanion Technologies, Munich, Germany. Electronic address: sonja.stoelzle-feix@nanion.de.<br /><searchLink fieldCode="AU" term="%22Kanda+Y%22">Kanda Y</searchLink>; Division of Pharmacology, National Institute of Health Sciences, Kanagawa, Japan. Electronic address: kanda@nihs.go.jp.<br /><searchLink fieldCode="AU" term="%22Osada+T%22">Osada T</searchLink>; LSI Medience Corporation, Tokyo, Japan. Electronic address: osada.tomoharu@mg.medience.co.jp.<br /><searchLink fieldCode="AU" term="%22Smith+G%22">Smith G</searchLink>; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK; Clyde Biosciences Ltd., Scotland, UK. Electronic address: godfrey.smith@glasgow.ac.uk.<br /><searchLink fieldCode="AU" term="%22Czysz+K%22">Czysz K</searchLink>; Fujifilm Cellular Dynamics, Inc., Madison, WI, 53711, USA. Electronic address: katherine.czysz@fujifilm.com.<br /><searchLink fieldCode="AU" term="%22Kettenhofen+R%22">Kettenhofen R</searchLink>; Fraunhofer-Institute for Biomed Engineering IBMT, Sulzbach, Germany. Electronic address: ralf.kettenhofen@ibmt.fraunhofer.de.<br /><searchLink fieldCode="AU" term="%22Lu+HR%22">Lu HR</searchLink>; Nonclinical Safety, Johnson & Johnson R&D, Beerse, Belgium. Electronic address: hlu@its.jnj.com.<br /><searchLink fieldCode="AU" term="%22Cai+B%22">Cai B</searchLink>; Takeda California, Inc., San Diego, CA, 92121, USA. Electronic address: beibei.cai@gmail.com.<br /><searchLink fieldCode="AU" term="%22Shi+H%22">Shi H</searchLink>; Bristol-Myers Squibb, New York, NY, 10016, USA. Electronic address: hong.shi@bms.com.<br /><searchLink fieldCode="AU" term="%22Herron+TJ%22">Herron TJ</searchLink>; Frankel Cardiovascular Regeneration Core Laboratory, University of Michigan, Ann Arbor, MI, 48109, USA. Electronic address: toddherr@umich.edu.<br /><searchLink fieldCode="AU" term="%22Dang+Q%22">Dang Q</searchLink>; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: qianyu.dang@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Burton+F%22">Burton F</searchLink>; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK; Clyde Biosciences Ltd., Scotland, UK. Electronic address: francis.burton@glasgow.ac.uk.<br /><searchLink fieldCode="AU" term="%22Pang+L%22">Pang L</searchLink>; Division of Systems Biology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA. Electronic address: li.pang@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Traebert+M%22">Traebert M</searchLink>; Novartis Inst Biomed Res, Switzerland. Electronic address: martin.traebert@novartis.com.<br /><searchLink fieldCode="AU" term="%22Abassi+Y%22">Abassi Y</searchLink>; Agilent Technologies, San Diego, CA, 92121, USA. Electronic address: yama.abassi@agilent.com.<br /><searchLink fieldCode="AU" term="%22Pierson+JB%22">Pierson JB</searchLink>; Health and Environmental Sciences Institute, Washington, DC, 20005, USA. Electronic address: jpierson@hesiglobal.org.<br /><searchLink fieldCode="AU" term="%22Blinova+K%22">Blinova K</searchLink>; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: ksenia.blinova@fda.hhs.gov.
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  Data: <searchLink fieldCode="JN" term="%228214983%22">Regulatory toxicology and pharmacology : RTP</searchLink> [Regul Toxicol Pharmacol] 2020 Nov; Vol. 117, pp. 104756. <i>Date of Electronic Publication: </i>2020 Aug 19.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8214983 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1096-0295 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2202732300%22">02732300 </searchLink><i>NLM ISO Abbreviation: </i>Regul Toxicol Pharmacol <i>Subsets: </i>MEDLINE
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