ArticleClinical pharmacology and therapeutics2020
General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy.
Article in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers.
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Who cites it
50 citing papers in PubMed.
- Improving In Silico Cardiac Safety Prediction by Consensus Averaging of Transmural Ventricular Cell Models.Annals of biomedical engineering · 2026Article
- Genetic drivers of congenital cardiac fibrosis.Communications biology · 2026Review
- Drug Proarrhythmic Evaluation in a High Throughput Cardiac New Approach Methodology.bioRxiv : the preprint server for biology · 2026Article
- Reimagining human-centric drug development with new approach methodologies.Science (New York, N.Y.) · 2026Review
- Models of the human heart for biomedical research: Opportunities and challenges.Physiological reports · 2026Review
- 25 years of applying the 3Rs principles in safety pharmacology: success stories and future perspectives.Frontiers in physiology · 2026Review
- Toward Standardized Methodologies for Drug-Induced Proarrhythmia Classification: An In Silico Proof of Concept.Computational and structural biotechnology journal · 2026Article
- QT interval prolongation: clinical assessment, risk factors and quantitative pharmacological considerations.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Development and Clinical Validation of a Cross-Sex Translator of ECG Drug Responses.JACC. Clinical electrophysiology · 2025Article
- Comparison of in silico predictions of action potential duration in response to inhibition of IKr and ICaL with new human ex vivo recordings.PLoS computational biology · 2025Article
- Digital twin for sex-specific identification of class III antiarrhythmic drugs based on in vitro measurements, computer models, and machine learning tools.PLoS computational biology · 2025Article
- Precision cardiac electrophysiology: toward digital twins and beyond.Journal of precision medicine (Amsterdam, Netherlands) · 2025Article
- Generation and applications of cardiac spheroids.npj biomedical innovations · 2025Review
- A comprehensive review of 20 years of progress in nonclinical QT evaluation and proarrhythmic assessment.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Challenges and opportunities in uncertainty quantification for healthcare and biological systems.Philosophical transactions. Series A, Mathematical, physical, and engineering sciences · 2025Review
- The UK's Early Access to Medicines Scheme 10 years on: an evaluation using publicly available data.JRSM open · 2025Article
- Article
- Quantitative systems toxicology modeling in pharmaceutical research and development: An industry-wide survey and selected case study examples.CPT: pharmacometrics & systems pharmacology · 2024Review
- An overview of drug-induced sodium channel blockade and changes in cardiac conduction: Implications for drug safety.Clinical and translational science · 2024Review
- Integrative human atrial modelling unravels interactive protein kinase A and Ca2+/calmodulin-dependent protein kinase II signalling as key determinants of atrial arrhythmogenesis.Cardiovascular research · 2023Article
Corrections and comments
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Authors and funding
42 authors.
Funding
Abstract
This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration-sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model-based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia assessment. This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.