Statistical issues including design and sample size calculation in thorough QT/QTc studies.

@article{Zhang2008StatisticalII,
  title={Statistical issues including design and sample size calculation in thorough QT/QTc studies.},
  author={Joanne Juan Zhang and Stella G Machado},
  journal={Journal of biopharmaceutical statistics},
  year={2008},
  volume={18 3},
  pages={451-67}
}
After several drugs were removed from the market in recent years because of death due to ventricular tachycardia resulting from drug-induced QT prolongation (Khongphatthanayothin et al., 1998; Lasser et al., 2002; Pratt et al., 1994; Wysowski et al., 2001), the ICH Regulatory agencies requested all sponsors of new drugs to conduct a clinical study, named a Thorough QT/QTc (TQT) study, to assess any possible QT prolongation due to the study drug. The final version of the ICH E14 guidance (ICH… CONTINUE READING