The new CIPA paradigm will be driven by a suite of mechanistically based in vitro assays coupled to in silico reconstructions of cellular cardiac electrophysiologic activity, with verification of completeness through comparison of predicted and observed responses in human-derived cardiac myocytes. To the extent that the ongoing validation program is successful, we envision petitioning for corresponding changes to regulatory requirements for proarrhythmia assessment and these might include eliminating or waiving the need for the TQT.
