MATHEMATICS, SIMULATION AND MODELLING
7 February 2014
Certara, a provider of software and scientific consulting, has announced the launch of its Phoenix QT+ cardiac safety assessment tool. The product provides data processing, statistical, and modelling capabilities to determine whether a drug candidate prolongs cardiac repolarisation.
It is important to know whether a drug candidate causes disruption of the electrical potential in the left ventricular cardiac cells and QT prolongation because they can lead to potentially-fatal arrhythmias.
For that reason, systemic new drug candidates are required to undergo a Thorough QT (TQT) study under the ICH E14 Guidelines (ICH, 2005). The TQT study is a clinical pharmacology study designed to demonstrate that a drug does not prolong the QT/QTc interval in healthy volunteers.
Phoenix QT+ performs a quick but comprehensive analysis of electrocardiogram (ECG) interval data collected in TQT studies and sub-studies in other clinical trials to determine whether that is the case. It also supports concentration-QTc modeling of pooled data collected in early phase 1 studies. Results are displayed automatically in worksheets and graphics.
Phoenix QT+ is Certara’s second cardiac safety tool; it introduced the Cardiac Safety Simulator (CSS), an in-silico model of human ventricular heart cells, in mid-2013. When Certara’s CSS is integrated with its Simcyp Population-based Simulator, it permits the in-vitro to in-vivo extrapolation of pharmacokinetic and pharmacodynamic data to predict the likelihood that a drug candidate will exhibit cardiac toxicity.