ArticleClinical pharmacology and therapeutics2019
Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative.
Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05716854 (Clinical ECG Study to Evaluate Electrophysiological Effects of Potential QT Prolonging Drugs With Novel ECG Biomarkers With Exposure-Response Analysis), which is not on this map. Cited by 90 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical ECG Study to Evaluate Electrophysiological Effects of Potential QT Prolonging Drugs With Novel ECG Biomarkers With Exposure-Response Analysis
Who cites it
90 citing papers in PubMed.
- Improving In Silico Cardiac Safety Prediction by Consensus Averaging of Transmural Ventricular Cell Models.Annals of biomedical engineering · 2026Article
- Induced pluripotent stem cells from discovery to translation.Nature medicine · 2026Review
- Does Changing the Context of Use Change the Value Proposition of CiPA?Clinical pharmacology and therapeutics · 2026Article
- Can in silico models predict drug-induced cardiac risk in vulnerable populations?Toxicology reports · 2026Article
- Drug Proarrhythmic Evaluation in a High Throughput Cardiac New Approach Methodology.bioRxiv : the preprint server for biology · 2026Article
- Stacking Ensemble Machine Learning for Cardiac Safety Assessment Using hiPSC-CM MEA Data.Annals of biomedical engineering · 2026Article
- Proarrhythmic Risk Assessment of Sildenafil under High-Dose Misuse Conditions Using the Comprehensive In Vitro Proarrhythmia Assay (CiPA).Biomolecules & therapeutics · 2026Article
- A machine learning platform for genotype-specific cardiotoxicity risk prediction using patient-derived iPSC-CMs.Journal of advanced research · 2026Article
- 25 years of applying the 3Rs principles in safety pharmacology: success stories and future perspectives.Frontiers in physiology · 2026Review
- A multiscale computational model of cardiac electrophysiology for drug-induced pro-arrhythmic risk stratification.Biomedical engineering letters · 2026Article
- Toward Standardized Methodologies for Drug-Induced Proarrhythmia Classification: An In Silico Proof of Concept.Computational and structural biotechnology journal · 2026Article
- PersonalizedFrontiers in physiology · 2026Article
- Advanced cardiotoxicity profiling using field potential imaging with UHD-CMOS-MEA in human iPSC-derived cardiomyocytes.Toxicological sciences : an official journal of the Society of Toxicology · 2025Article
- Validation of new AI-based classification method for in silico cardiac safety assessment of drugs following the CiPA framework.Archives of toxicology · 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
- Computational modelling for improved translation of cardiac inotropic and lusitropic drug effects from rats to humans.Journal of pharmacological and toxicological methods · 2025Article
- Optimizing experimental designs for model selection of ion channel drug-binding mechanisms.Philosophical transactions. Series A, Mathematical, physical, and engineering sciences · 2025Article
- Article
- Fast and accurate prediction of drug induced proarrhythmic risk with sex specific cardiac emulators.NPJ digital medicine · 2024Article
- Cardiotoxicity evaluation of two-drug fixed-dose combination therapy under CiPA: a computational study.Translational and clinical pharmacology · 2024Article
30 more citing papers are in PubMed but not listed here.
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Authors and funding
15 authors.
Funding
Abstract
The International Council on Harmonization (ICH) S7B and E14 regulatory guidelines are sensitive but not specific for predicting which drugs are pro-arrhythmic. In response, the Comprehensive In Vitro Proarrhythmia Assay (CiPA) was proposed that integrates multi-ion channel pharmacology data in vitro into a human cardiomyocyte model in silico for proarrhythmia risk assessment. Previously, we reported the model optimization and proarrhythmia metric selection based on CiPA training drugs. In this study, we report the application of the prespecified model and metric to independent CiPA validation drugs. Over two validation datasets, the CiPA model performance meets all pre-specified measures for ranking and classifying validation drugs, and outperforms alternatives, despite some in vitro data differences between the two datasets due to different experimental conditions and quality control procedures. This suggests that the current CiPA model/metric may be fit for regulatory use, and standardization of experimental protocols and quality control criteria could increase the model prediction accuracy even further.
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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.