If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?

@article{Shah2008IfAD,
  title={If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?},
  author={Rashmi R Shah},
  journal={Pharmacology & therapeutics},
  year={2008},
  volume={119 2},
  pages={
          215-21
        }
}
New drugs are now routinely investigated for their QT-liability in nonclinical studies as well as in a formal Thorough QT Study in man. Data from these studies in man have provided better evidence of the benefits of defining concentration-QT effect relationship of a drug. Therefore, sponsors also frequently monitor electrocardiograms in early phase I clinical pharmacology studies. Although very rare, it is not inconceivable that a drug deemed safe in nonclinical studies may be found to have QT… CONTINUE READING
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