The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative is a novel proposal to screen a new drug’s potential to cause Torsade de Pointes (TdP), a potentially fatal abnormal heart rhythm, before the drug is on the market. Using a computer model of the heart, CiPA will analyze the effects of the new drug on the molecular level to predict its potential to cause TdP. To validate this proposal, we will test 28 drugs with different levels of risks for causing TdP. This project will integrate computer modeling and clinical assessments from post-market databases to investigate whether there are differences in TdP risk between men and women. If such sex-differences are found, then this information will be used to improve and implement sex-specific models of the human heart cell for regulatory assessment of TdP risk for new drugs.
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