CiPA: Ongoing testing, future qualification procedures, and pending issues
作者： Icilio Cavero , Henry Holzgrefe
DOI: 10.1016/J.VASCN.2015.06.004
关键词:
摘要: Abstract Introduction The comprehensive in vitro proarrhythmia assay (CiPA) is a nonclinical, mechanism-based paradigm for assessing drug proarrhythmic liability. Topics covered first CiPA determines effects on cloned human cardiac ion channels. second investigates whether the latter study-generated metrics engender markers computationally reconstructed ventricular action potential. third evaluates conclusions from, and searches possibly missed by silico analysis, stem cell-derived cardiomyocytes (hSC-CMs). ad hoc Expert-Working Groups have proposed patch clamp protocols seven channels, modified O'Hara-Rudy model detailed procedures field (MEA) potential (VSD) measurements hSC-CMs, 29 reference drugs testing validation. Discussion adoption as development tool identifying electrophysiological mechanisms conferring liability to candidate complex, multi-functional task requiring significant time, reflection, efforts be fully achieved.
elsevier.com
sci-hub.se 参考文章(46)
Norman Stockbridge, Joel Morganroth, Rashmi R. Shah, Christine Garnett, Dealing with Global Safety Issues Drug Safety. ,vol. 36, pp. 167- 182 ,(2013) , 10.1007/S40264-013-0016-Z
Pras Pathmanathan, Richard A. Gray, Verification of computational models of cardiac electro-physiology International Journal for Numerical Methods in Biomedical Engineering. ,vol. 30, pp. 525- 544 ,(2014) , 10.1002/CNM.2615
Henry Holzgrefe, Icilio Cavero, Comprehensive in vitro Proarrhythmia Assay, a novel in vitro/in silico paradigm to detect ventricular proarrhythmic liability: a visionary 21st century initiative. Expert Opinion on Drug Safety. ,vol. 13, pp. 745- 758 ,(2014) , 10.1517/14740338.2014.915311
Charles Antzelevitch, Vladislav Nesterenko, John C. Shryock, Sridharan Rajamani, Yejia Song, Luiz Belardinelli, The Role of Late I Na in Development of Cardiac Arrhythmias Voltage Gated Sodium Channels. ,vol. 221, pp. 137- 168 ,(2014) , 10.1007/978-3-642-41588-3_7
Ping Liang, Feng Lan, Andrew S. Lee, Tingyu Gong, Veronica Sanchez-Freire, Yongming Wang, Sebastian Diecke, Karim Sallam, Joshua W. Knowles, Paul J. Wang, Patricia K. Nguyen, Donald M. Bers, Robert C. Robbins, Joseph C. Wu, Drug Screening Using a Library of Human Induced Pluripotent Stem Cell–Derived Cardiomyocytes Reveals Disease-Specific Patterns of Cardiotoxicity Circulation. ,vol. 127, pp. 1677- 1691 ,(2013) , 10.1161/CIRCULATIONAHA.113.001883
Kylie A. Beattie, Chris Luscombe, Geoff Williams, Jordi Munoz-Muriedas, David J. Gavaghan, Yi Cui, Gary R. Mirams, Evaluation of an in silico cardiac safety assay: using ion channel screening data to predict QT interval changes in the rabbit ventricular wedge. Journal of Pharmacological and Toxicological Methods. ,vol. 68, pp. 88- 96 ,(2013) , 10.1016/J.VASCN.2013.04.004
Qinghai Tian, Martin Oberhofer, Sandra Ruppenthal, Anke Scholz, Volker Buschmann, Hidekazu Tsutsui, Atsushi Miyawaki, André Zeug, Peter Lipp, Lars Kaestner, Optical Action Potential Screening on Adult Ventricular Myocytes as an Alternative QT-screen Cellular Physiology and Biochemistry. ,vol. 27, pp. 281- 290 ,(2011) , 10.1159/000327954
Junzhi Ji, Jiesheng Kang, David Rampe, L-type Ca2+ channel responses to bay k 8644 in stem cell-derived cardiomyocytes are unusually dependent on holding potential and charge carrier. Assay and Drug Development Technologies. ,vol. 12, pp. 352- 360 ,(2014) , 10.1089/ADT.2014.596
David T.M. Du, Nicola Hellen, Christopher Kane, Cesare M.N. Terracciano, Action Potential Morphology of Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Does Not Predict Cardiac Chamber Specificity and Is Dependent on Cell Density Biophysical Journal. ,vol. 108, pp. 1- 4 ,(2015) , 10.1016/J.BPJ.2014.11.008
Yongming Wang, Ping Liang, Feng Lan, Haodi Wu, Leszek Lisowski, Mingxia Gu, Shijun Hu, Mark A. Kay, Fyodor D. Urnov, Rami Shinnawi, Joseph D. Gold, Lior Gepstein, Joseph C. Wu, Genome Editing of Isogenic Human Induced Pluripotent Stem Cells Recapitulates Long QT Phenotype for Drug Testing Journal of the American College of Cardiology. ,vol. 64, pp. 451- 459 ,(2014) , 10.1016/J.JACC.2014.04.057