Unfortunately not. The quality of data collected in Phase I must be sufficient to establish a robust C-QTc model. The pharmacokinetic and 12-lead Holter ECG data should be collected in the same format and of the same quality as applied in a TQT study. Furthermore, the observed concentration range should adequately cover the high clinical exposure, ideally reaching approximately two-fold the highest clinically relevant steady-state exposure. When sufficient exposure multiples cannot be achieved, an integrated nonclinical risk assessment may be used to supplement the clinical C–QTc analysis.