ICH (2005) ICH E14: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. CPMP/ICH/2/04 http://www.emea.eu.int/pdfs/human/ich/000204en.pdf:Accessed 23 November 2023
ICH (2005) ICH S7B: The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. CPMP/ICHhttp://www.emea.eu.int/pdfs/human/ich/042302en.pdf:Accessed 23 November 2023
ICH (2000) ICH Topic S7A: Safety Pharmacology Studies for Human Pharmaceuticals. CPMP/ICH/539/00 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-7-safety-pharmacology-studies-human-pharmaceuticals-step-5_en.pdf:Accessed 23 November 2023
ICH (2022) ICH E14/S7B Q&As. Clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - Questions and answers. https://database.ich.org/sites/default/files/E14-S7B_QAs_Step4_2022_0221.pdf Accessed 4 January 2025
Bouvy JC, Koopmanschap MA, Shah RR, Schellekens H (2012) The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies. Clin Pharmacol Ther 91(2):281–288. https://doi.org/10.1038/clpt.2011.224
Article CAS PubMed Google Scholar
Strauss DG, Wu WW, Li Z, Koerner J, Garnett C (2021) Translational models and tools to reduce clinical trials and improve regulatory decision making for QTc and proarrhythmia risk (ICH E14/S7B Updates). Clin Pharmacol Ther 109(2):319–333. https://doi.org/10.1002/cpt.2137
Article PubMed PubMed Central Google Scholar
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC (2020) An FDA/CDER perspective on nonclinical testing strategies: classical toxicology approaches and new approach methodologies (NAMs). Regul Toxicol Pharmacol 114:104662. https://doi.org/10.1016/j.yrtph.2020.104662
Article CAS PubMed Google Scholar
Dessertenne F (1966) [Ventricular tachycardia with 2 variable opposing foci]. Arch Mal Coeur Vaiss 59(2):263–272
Viskin S, Chorin E, Viskin D, Hochstadt A, Schwartz AL, Rosso R (2021) Polymorphic ventricular tachycardia: terminology, mechanism, diagnosis, and emergency therapy. Circulation 144(10):823–839. https://doi.org/10.1161/CIRCULATIONAHA.121.055783
Article CAS PubMed Google Scholar
Valentin JP, Hoffmann P, Ortemann-Renon C, Koerner J, Pierson J, Gintant G, Willard J, Garnett C, Skinner M, Vargas HM, Wisialowski T, Pugsley MK (2022) The challenges of predicting Drug-Induced QTc prolongation in humans. Toxicol Sci 187(1):3–24. https://doi.org/10.1093/toxsci/kfac013
Article CAS PubMed PubMed Central Google Scholar
CPMP (1997) Points to Consider: The Assessment of the Potential for QT Interval Prolongation by Non-Cardiovascular Medicinal Products. European Agency for the Evaluation of Medicinal Products. Accessed 14 January 2025
Bialecki RA, Gallacher DJ, Valentin J-P (2024) Drug-Induced QT Prolongation. In: McQueen C (ed) Reference Module in Biomedical Sciences. Elsevier. https://doi.org/10.1016/B978-0-323-95488-4.00070-X
Pollard CE, Abi Gerges N, Bridgland-Taylor MH, Easter A, Hammond TG, Valentin JP (2010) An introduction to QT interval prolongation and non-clinical approaches to assessing and reducing risk. Br J Pharmacol 159(1):12–21. https://doi.org/10.1111/j.1476-5381.2009.00207.x
Article CAS PubMed PubMed Central Google Scholar
PharmaPendium (2024) Last update December 18, 2024 Edn. Elsevier, Amsterdam, Netherlands
Puisieux FL, Adamantidis MM, Dumotier BM, Dupuis BA (1996) Cisapride-induced prolongation of cardiac action potential and early afterdepolarizations in rabbit purkinje fibres. Br J Pharmacol 117(7):1377–1379. https://doi.org/10.1111/j.1476-5381.1996.tb15295.x
Article CAS PubMed PubMed Central Google Scholar
Champeroux P, Viaud K, El Amrani AI, Fowler JS, Martel E, Le Guennec JY, Richard S (2005) Prediction of the risk of torsade de pointes using the model of isolated canine purkinje fibres. Br J Pharmacol 144(3):376–385. https://doi.org/10.1038/sj.bjp.0706070
Article CAS PubMed PubMed Central Google Scholar
Lawrence CL, Pollard CE, Hammond TG, Valentin JP (2005) Nonclinical proarrhythmia models: predicting Torsades de pointes. J Pharmacol Toxicol Methods 52(1):46–59. https://doi.org/10.1016/j.vascn.2005.04.011
Article CAS PubMed Google Scholar
Lawrence CL, Pollard CE, Hammond TG, Valentin JP (2008) In vitro models of proarrhythmia. Br J Pharmacol 154(7):1516–1522. https://doi.org/10.1038/bjp.2008.195
Article CAS PubMed PubMed Central Google Scholar
Beattie KA, Luscombe C, Williams G, Munoz-Muriedas J, Gavaghan DJ, Cui Y, Mirams GR (2013) Evaluation of an in Silico cardiac safety assay: using ion channel screening data to predict QT interval changes in the rabbit ventricular wedge. J Pharmacol Toxicol Methods 68(1):88–96. https://doi.org/10.1016/j.vascn.2013.04.004
Article CAS PubMed PubMed Central Google Scholar
Mirams GR, Cui Y, Sher A, Fink M, Cooper J, Heath BM, McMahon NC, Gavaghan DJ, Noble D (2011) Simulation of multiple ion channel block provides improved early prediction of compounds’ clinical Torsadogenic risk. Cardiovasc Res 91(1):53–61. https://doi.org/10.1093/cvr/cvr044
Article CAS PubMed PubMed Central Google Scholar
Valentin JP, Hoffmann P, De Clerck F, Hammond TG, Hondeghem L (2004) Review of the predictive value of the Langendorff heart model (Screenit system) in assessing the proarrhythmic potential of drugs. J Pharmacol Toxicol Methods 49(3):171–181. https://doi.org/10.1016/j.vascn.2004.03.008
Article CAS PubMed Google Scholar
Eckardt L, Haverkamp W, Mertens H, Johna R, Clague JR, Borggrefe M, Breithardt G (1998) Drug-related Torsades de pointes in the isolated rabbit heart: comparison of clofilium, d,l-sotalol, and erythromycin. J Cardiovasc Pharmacol 32(3):425–434. https://doi.org/10.1097/00005344-199809000-00013
Article CAS PubMed Google Scholar
Stockbridge N, Throckmorton DC (2004) Regulatory advice on evaluation of the proarrhythmic potential of drugs. J Electrocardiol 37 Suppl:40–41. https://doi.org/10.1016/j.jelectrocard.2004.08.007
Cavero I, Holzgrefe H (2015) CiPA: ongoing testing, future qualification procedures, and pending issues. J Pharmacol Toxicol Methods 76:27–37. https://doi.org/10.1016/j.vascn.2015.06.004
Article CAS PubMed Google Scholar
Gintant G, Sager PT, Stockbridge N (2016) Evolution of strategies to improve preclinical cardiac safety testing. Nat Rev Drug Discov 15(7):457–471. https://doi.org/10.1038/nrd.2015.34
Article CAS PubMed Google Scholar
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 (2014) Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, Quinidine, Ranolazine, and verapamil. Clin Pharmacol Ther 96(5):549–558. https://doi.org/10.1038/clpt.2014.155
Article CAS PubMed Google Scholar
Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, Yamanaka S (2007) Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 131(5):861–872. https://doi.org/10.1016/j.cell.2007.11.019
Article CAS PubMed Google Scholar
Schmid C, Abi-Gerges N, Leitner MG, Zellner D, Rast G (2021) Ion channel expression and electrophysiology of singular human (Primary and induced pluripotent stem Cell-Derived). Cardiomyocytes Cells 10(12). https://doi.org/10.3390/cells10123370
Pognan F, Beilmann M, Boonen HCM, Czich A, Dear G, Hewitt P, Mow T, Oinonen T, Roth A, Steger-Hartmann T, Valentin JP, Van Goethem F, Weaver RJ, Newham P (2023) The evolving role of investigative toxicology in the pharmaceutical industry. Nat Rev Drug Discov 22(4):317–335. https://doi.org/10.1038/s41573-022-00633-x
Article CAS PubMed PubMed Central Google Scholar
Kanda Y, Yamazaki D, Kurokawa J, Inutsuka T, Sekino Y (2016) Points to consider for a validation study of iPS cell-derived cardiomyocytes using a multi-electrode array system. J Pharmacol Toxicol Methods 81:196–200. https://doi.org/10.1016/j.vascn.2016.06.007
Article CAS PubMed Google Scholar
Kanda Y, Yamazaki D, Osada T, Yoshinaga T, Sawada K (2018) Development of Torsadogenic risk assessment using human induced pluripotent stem cell-derived cardiomyocytes: Japan iPS cardiac safety assessment (JiCSA) update. J Pharmacol Sci 138(4):233–239. https://doi.org/10.1016/j.jphs.2018.10.010
Article CAS PubMed Google Scholar
Vargas HM, Rolf MG, Wisialowski TA, Achanzar W, Bahinski A, Bass A, Benson CT, Chaudhary KW, Couvreur N, Dota C, Engwall MJ, Michael Foley C, Gallacher D, Greiter-Wilke A, Guillon JM, Guth B, Himmel HM, Hegele-Hartung C, Ito M, Jenkinson S, Chiba K, Lagrutta A, Levesque P, Martel E, Okai Y, Peri R, Pointon A, Qu Y, Teisman A, Traebert M, Yoshinaga T, Gintant GA, Leishman DJ, Valentin JP (2021) Time for a fully integrated Nonclinical-Clinical risk assessment to streamline QT prolongation liability determinations: A pharma industry perspective. Clin Pharmacol Ther 109(2):310–318.
Comments (0)