Drug Safety Suite
DRUG INDUCED CARDIAC TOXICITY
Data generated by in vitro tests are used as input for in silico testing and risk assessment, to screen as early as possible drug candidates on potential cardiotoxicity liabilities, and to predict their effects on the cardiac action potential at the cellular level.
In silico testing helps to also identify the drug compound safety window, through virtual screening of multiple concentrations, guiding in vitro and in vivo testing and resulting in a drastic reduction of risks and investments.
Regulatory bodies are recommending an enhanced assessment of drug-induced proarrhytmic risks and Torsade de Pointes in drug candidates early screening.
The ICHS7B and ICH E14 gui-delines will be soon replaced by one that will regulate both preclinical and clinical studies. The comprehensive In Vitro proarrhythmya Assay (CiPA) initiative has the goal of increasing cardiac safety and it recommends testing on 7 ionic channels instead of one and the use of Modelling and Simulation. This can lead to a huge increase of R&D costs and time in a traditional industrial setting.