Prediction and modeling of effects on the QTc interval for clinical safety margin assessment, based on single-ascending-dose study data with AZD3839.

@article{Sparve2014PredictionAM,
  title={Prediction and modeling of effects on the QTc interval for clinical safety margin assessment, based on single-ascending-dose study data with AZD3839.},
  author={Erik Sparve and Angelica Linnea Quartino and Maria L{\"u}ttgen and Karin Tunblad and Anna Teiling G{\aa}rdlund and Johanna F{\"a}lting and Robert Alexander and Jens K{\aa}gstr{\"o}m and Linnea Sj{\"o}din and Alexander Bulgak and Ahmad Al-Saffar and Matthew H. Bridgland-Taylor and Chris E Pollard and Michael D B Swedberg and Torbj{\"o}rn Vik and Bj{\"o}rn Paulsson},
  journal={The Journal of pharmacology and experimental therapeutics},
  year={2014},
  volume={350 2},
  pages={469-78}
}
Corrected QT interval (QTc) prolongation in humans is usually predictable based on results from preclinical findings. This study confirms the signal from preclinical cardiac repolarization models (human ether-a-go-go-related gene, guinea pig monophasic action potential, and dog telemetry) on the clinical effects on the QTc interval. A thorough QT/QTc study is generally required for bioavailable pharmaceutical compounds to determine whether or not a drug shows a QTc effect above a threshold of… CONTINUE READING
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