Calibration of ionic and cellular cardiac electrophysiology models
Cardiac electrophysiology models are among the most mature and well‐studied
mathematical models of biological systems. This maturity is bringing new challenges as …
mathematical models of biological systems. This maturity is bringing new challenges as …
Mechanistic model‐informed proarrhythmic risk assessment of drugs: review of the “CiPA” initiative and design of a prospective clinical validation study
The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and
validating a mechanistic‐based assessment of the proarrhythmic risk of drugs. CiPA …
validating a mechanistic‐based assessment of the proarrhythmic risk of drugs. CiPA …
[HTML][HTML] An evaluation framework for new approach methodologies (NAMs) for human health safety assessment
ST Parish, M Aschner, W Casey, M Corvaro… - Regulatory Toxicology …, 2020 - Elsevier
The need to develop new tools and increase capacity to test pharmaceuticals and other
chemicals for potential adverse impacts on human health and the environment is an active …
chemicals for potential adverse impacts on human health and the environment is an active …
Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative
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 …
sensitive but not specific for predicting which drugs are pro‐arrhythmic. In response, the …
Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment
S Dutta, KC Chang, KA Beattie, J Sheng… - Frontiers in …, 2017 - frontiersin.org
Drug-induced Torsade-de-Pointes (TdP) has been responsible for the withdrawal of many
drugs from the market and is therefore of major concern to global regulatory agencies and …
drugs from the market and is therefore of major concern to global regulatory agencies and …
Improving the in silico assessment of proarrhythmia risk by combining hERG (human ether-à-go-go-related gene) channel–drug binding kinetics and multichannel …
Background—The current proarrhythmia safety testing paradigm, although highly efficient in
preventing new torsadogenic drugs from entering the market, has important limitations that …
preventing new torsadogenic drugs from entering the market, has important limitations that …
Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment
KC Chang, S Dutta, GR Mirams, KA Beattie… - Frontiers in …, 2017 - frontiersin.org
The Comprehensive in vitro Proarrhythmia Assay (CiPA) is a global initiative intended to
improve drug proarrhythmia risk assessment using a new paradigm of mechanistic assays …
improve drug proarrhythmia risk assessment using a new paradigm of mechanistic assays …
General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy
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 …
regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research …
When Does the IC50 Accurately Assess the Blocking Potency of a Drug?
J Gomis-Tena, BM Brown, J Cano… - Journal of chemical …, 2020 - ACS Publications
Preclinical assessment of drug-induced proarrhythmicity is typically evaluated by the
potency of the drug to block the potassium human ether-à-go-go-related gene (hERG) …
potency of the drug to block the potassium human ether-à-go-go-related gene (hERG) …
Natural products modulating the hERG channel: heartaches and hope
Covering: 1996–December 2016 The human Ether-à-go-go Related Gene (hERG) channel
is a voltage-gated potassium channel playing an essential role in the normal electrical …
is a voltage-gated potassium channel playing an essential role in the normal electrical …