The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index.
A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm
Open accessAbstract
For the past decade, cardiac safety screening to evaluate the propensity of drugs to produce QT interval prolongation and Torsades de Pointes (TdP) arrhythmia has been conducted according to ICH S7B and ICH E14 guidelines. Central to the existing approach are hERG channel assays and in vivo QT measurements. Although effective, the present paradigm carries a risk of unnecessary compound attrition and high cost, especially when considering costly thorough QT (TQT) studies conducted later in drug development. The C: omprehensive I: n Vitro P: roarrhythmia A: ssay (CiPA) initiative is a public-private collaboration with the aim of updating the existing cardiac safety testing paradigm to better evaluate arrhythmia risk and remove the need for TQT studies. It is hoped that CiPA will produce a standardized ion channel assay approach, incorporating defined tests against major cardiac ion channels, the results of which then inform evaluation of proarrhythmic actions in silico, using human ventricular action potential reconstructions. Results are then to be confirmed using human (stem cell-derived) cardiomyocytes. This perspective article reviews the rationale, progress of, and challenges for the CiPA initiative, if this new paradigm is to replace existing practice and, in time, lead to improved and widely accepted cardiac safety testing guidelines.
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MiRP1 Forms IKr Potassium Channels with HERG and Is Associated with Cardiac Arrhythmia
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Engineering Adolescence: Maturation of Human Pluripotent Stem Cell–Derived Cardiomyocytes
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Self-citationThe impact of drug-induced QT interval prolongation on drug discovery and development
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Self-citationA common polymorphism associated with antibiotic-induced cardiac arrhythmia
Sesti, F., Abbott, G. W., Wei, J., Murray, K. T., Saksena, S., Schwartz, P. J., Priori, S. G., Roden, D. M., George, A. L., & Goldstein, S. A. N. (2000) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.180223197 · Cited by 479
A minK–HERG complex regulates the cardiac potassium current IKr
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Cited by
Human Engineered Heart Tissue: Analysis of Contractile Force
Mannhardt, I., Breckwoldt, K., Letuffe-Brenière, D., Schaaf, S., Schulz, H., Neuber, C., Benzin, A., Werner, T., Eder, A., Schulze, T., et al. (2016) · Stem Cell Reports · doi:10.1016/j.stemcr.2016.04.011 · Cited by 398
Blinova, K., Dang, Q., Millard, D., Smith, G., Pierson, J., Guo, L., Brock, M., Lu, H. R., Kraushaar, U., Zeng, H., et al. (2018) · Cell Reports · doi:10.1016/j.celrep.2018.08.079 · Cited by 373
Self-citationNguyen, N., Nguyen, W., Nguyenton, B., Ratchada, P., Page, G., Miller, P. E., Ghetti, A., & Abi-Gerges, N. (2017) · Frontiers in Physiology · doi:10.3389/fphys.2017.01073 · Cited by 75
Self-citationKeung, W., Chan, P. K. W., Backeris, P. C., Lee, E. K., Wong, N., Wong, A. O. T., Wong, G. K. Y., Chan, C. W. Y., Fermini, B., Costa, K. D., et al. (2019) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1385 · Cited by 54
Self-citationBlazeski, A., Lowenthal, J., Zhu, R., Ewoldt, J., Boheler, K. R., & Tung, L. (2019) · Stem Cell Reports · doi:10.1016/j.stemcr.2019.04.002 · Cited by 40
Metadata
- Authors
- Fermini, B., Hancox, J. C., Abi-Gerges, N., Bridgland-Taylor, M., Chaudhary, K. W., 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, C. A., Rampe, D., Sawada, K., Strauss, D. G., & Vandenberg, J. I.
- Venue
- SLAS Discovery
- Publisher
- Elsevier BV
- Published
- 2016-01
- Volume
- 21
- Issue
- 1
- Pages
- 1-11
- ISSN
- 2472-5552 (ISSN-L)
- OpenAlex
- W878990122
- Cited by
- 302
- References
- 45
- FWCI
- 26.10
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Fermini, B., Hancox, J. C., Abi-Gerges, N., Bridgland-Taylor, M., Chaudhary, K. W., 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, C. A., Rampe, D., . . . Vandenberg, J. I. (2016). A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm. SLAS Discovery. https://doi.org/10.1177/1087057115594589
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
