CONCETRATION-QT ANALYSIS
How can I eliminate the need for a thorough QT study?
I can perform a concentration-QT (C-QT) analysis to establish your drug’s QT prolongation risk. If the analysis is negative, you can apply for a waiver of the TQT study because the FDA recognizes it is not needed. A TQT study is likely to cost you several million dollars. Do not you think it is worth trying to avoid it?