과제정보
This study was supported by a grant (21181MFDS276) from the Ministry of Food and Drug Safety, Republic of Korea from 2021-2022.
참고문헌
- Kannankeril PJ, Roden DM. Drug-induced long QT and torsade de pointes: recent advances. Curr Opin Cardiol. 2007;22:39-43. https://doi.org/10.1097/HCO.0b013e32801129eb
- Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004;3:711-715. https://doi.org/10.1038/nrd1470
- Food and Drug Administration, HHS. International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice. Fed Regist. 2005;70:61134-61135.
- Food and Drug Administration, HHS. International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice. Fed Regist. 2005;70:61133-61134.
- Guo L, Coyle L, Abrams RM, Kemper R, Chiao ET, Kolaja KL. Refining the human iPSC-cardiomyocyte arrhythmic risk assessment model. Toxicol Sci. 2013;136:581-594. https://doi.org/10.1093/toxsci/kft205
- Cavero I, Holzgrefe H. Comprehensive in vitro Proarrhythmia Assay, a novel in vitro/in silico paradigm to detect ventricular proarrhythmic liability: a visionary 21st century initiative. Expert Opin Drug Saf. 2014;13:745-758.
- Sager PT, Gintant G, Turner JR, Pettit S, Stockbridge N. Rechanneling the cardiac proarrhythmia safety paradigm: a meeting report from the Cardiac Safety Research Consortium. Am Heart J. 2014;167:292-300. https://doi.org/10.1016/j.ahj.2013.11.004
- Magyar J, Iost N, Kortvely A, Banyasz T, Virag L, Szigligeti P, Varro A, Opincariu M, Szecsi J, Papp JG, Nanasi PP. Effects of endothelin-1 on calcium and potassium currents in undiseased human ventricular myocytes. Pflugers Arch. 2000;441:144-149. https://doi.org/10.1007/s004240000400
- Ando H, Yoshinaga T, Yamamoto W, Asakura K, Uda T, Taniguchi T, Ojima A, Shinkyo R, Kikuchi K, Osada T, Hayashi S, Kasai C, Miyamoto N, Tashibu H, Yamazaki D, Sugiyama A, Kanda Y, Sawada K, Sekino Y. A new paradigm for drug-induced torsadogenic risk assessment using human iPS cell-derived cardiomyocytes. J Pharmacol Toxicol Methods. 2017;84:111-127. https://doi.org/10.1016/j.vascn.2016.12.003
- Cavero I, Crumb W. ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis. Expert Opin Drug Saf. 2005;4:509-530. https://doi.org/10.1517/14740338.4.3.509
- Giorgi MA, Bolanos R, Gonzalez CD, Di Girolamo G. QT interval prolongation: preclinical and clinical testing arrhythmogenesis in drugs and regulatory implications. Curr Drug Saf. 2010;5:54-57. https://doi.org/10.2174/157488610789869148
- Lu HR, Marien R, Saels A, De Clerck F. Species plays an important role in drug-induced prolongation of action potential duration and early afterdepolarizations in isolated Purkinje fibers. J Cardiovasc Electrophysiol. 2001;12:93-102. https://doi.org/10.1046/j.1540-8167.2001.00093.x
- Bussek A, Wettwer E, Christ T, Lohmann H, Camelliti P, Ravens U. Tissue slices from adult mammalian hearts as a model for pharmacological drug testing. Cell Physiol Biochem. 2009;24:527-536. https://doi.org/10.1159/000257528
- Thomas D, Wu K, Kathofer S, Katus HA, Schoels W, Kiehn J, Karle CA. The antipsychotic drug chlorpromazine inhibits HERG potassium channels. Br J Pharmacol. 2003;139:567-574. https://doi.org/10.1038/sj.bjp.0705283
- Gualdani R, Tadini-Buoninsegni F, Roselli M, Defrenza I, Contino M, Colabufo NA, Lentini G. Inhibition of hERG potassium channel by the antiarrhythmic agent mexiletine and its metabolite mhydroxymexiletine. Pharmacol Res Perspect. 2015;3:e00160.
- Crumb WJ Jr, Vicente J, Johannesen L, Strauss DG. An evaluation of 30 clinical drugs against the comprehensive in vitro proarrhythmia assay (CiPA) proposed ion channel panel. J Pharmacol Toxicol Methods. 2016;81:251-262. https://doi.org/10.1016/j.vascn.2016.03.009
- Katchman AN, Koerner J, Tosaka T, Woosley RL, Ebert SN. Comparative evaluation of HERG currents and QT intervals following challenge with suspected torsadogenic and nontorsadogenic drugs. J Pharmacol Exp Ther. 2006;316:1098-1106. https://doi.org/10.1124/jpet.105.093393
- Gintant GA, Su Z, Martin RL, Cox BF. Utility of hERG assays as surrogate markers of delayed cardiac repolarization and QT safety. Toxicol Pathol. 2006;34:81-90. https://doi.org/10.1080/01926230500431376
- Belardinelli L, Liu G, Smith-Maxwell C, Wang WQ, El-Bizri N, Hirakawa R, Karpinski S, Li CH, Hu L, Li XJ, Crumb W, Wu L, Koltun D, Zablocki J, Yao L, Dhalla AK, Rajamani S, Shryock JC. A novel, potent, and selective inhibitor of cardiac late sodium current suppresses experimental arrhythmias. J Pharmacol Exp Ther. 2013;344:23-32. https://doi.org/10.1124/jpet.112.198887
- Johannesen L, Vicente J, Mason JW, Sanabria C, Waite-Labott K, Hong M, Guo P, Lin J, Sorensen JS, Galeotti L, Florian J, Ugander M, Stockbridge N, Strauss DG. Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, quinidine, ranolazine, and verapamil. Clin Pharmacol Ther. 2014;96:549-558. https://doi.org/10.1038/clpt.2014.155
- Fermini B, Hancox JC, Abi-Gerges N, Bridgland-Taylor M, Chaudhary KW, Colatsky T, Correll K, Crumb W, Damiano B, Erdemli G, Gintant G, Imredy J, Koerner J, Kramer J, Levesque P, Li Z, Lindqvist A, Obejero-Paz CA, Rampe D, Sawada K, et al. A new perspective in the field of cardiac safety testing through the comprehensive in vitro Proarrhythmia Assay paradigm. J Biomol Screen. 2016;21:1-11. https://doi.org/10.1177/1087057115594589