The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

@article{Darpo2014TheIP,
  title={The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".},
  author={Borje Darpo and Nenad Sarapa and Christine Garnett and Charles J Benson and Corina D Dota and Georg Ferber and Venkateswar Jarugula and Lars Johannesen and James J. Keirns and Kevin Krudys and Catherine Ortemann-Renon and Steve Riley and Danise Rogers-Subramaniam and Norman L. Stockbridge},
  journal={Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc},
  year={2014},
  volume={19 1},
  pages={70-81}
}
A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac Safety Research Consortium has been formed to design a clinical study in healthy subjects demonstrating that the thorough QT (TQT) study can be replaced by robust ECG monitoring and exposure-response (ER) analysis of data generated from First-in-Man single ascending dose (SAD) studies. Six marketed drugs with well-characterized QTc effects were identified in discussions with FDA; five… CONTINUE READING

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Guideline E14

  • ICH Harmonized Tripartit
  • The Clinical Evaluation of QT/QTc Interval…
  • 2013

Population pharmacokinetic-pharmacodynamics modelling of the QTc prolongation of moxifloxacin and levofloxacin in healthy volunteers: Selection of the positive control in mandatory QT/QTc studies

  • K Brendel, L Canini, M. Chenel
  • Poster presented at 9th PAGE meeting,
  • 2010

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