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Articles

Assay sensitivity in “Hybrid thorough QT/QTc (TQT)” study

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Pages 378-384 | Received 27 Oct 2017, Accepted 02 Oct 2018, Published online: 22 Oct 2018

References

  • Darpo, B., Garnett, C., Benson, C., Keirns, J., Leishman, D., Malik, M., Mehrotra, N., Prasingle, K., Riley, S., Rodriguez, I., Sager, P., Sarapa, N., Wallis, R. (2014). The IQ-CSRC prospective clinical phase 1 study: Can early QT assessment using exposure response analysis replace the thorough QT study. Annals of Noninvasive Electrocardiology : the Official Journal of the International Society for Holter and Noninvasive Electrocardiology, Inc 19(1): 70–81.
  • Darpo, B., Benson, C., Dota, C., Ferber, G., Garnett, C., Green, C., Jarugula, V., Johannesen, L., Keirns, J., Krudys, K., Liu, J., Ortemann-Renon, C., Riley, S., Sarapa, N., Smith, B., Stoltz, R., Zhou, M., Stockbridge, N. (2015). Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clinical Pharmacology and Therapeutics 97(4): 326–335.
  • Garnett, C., Needleman, K., Liu, J., Brundage, R., Wang, Y. (2016). Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies. Clinical Pharmacology & Therapeutics 100(2): 170–178.
  • ICH E14 Guideline (2005) The Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-an-tiarrhythmic drugs. http://www.ich.org/#64257;leadmin/Public_Web_Site/ICH_Products/Guidelines/Ef#64257;cacy/E14/E14_Guideline.pdf
  • ICH E14 Guideline (2015) The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-an-tiarrhythmic drugs. Questions & Answers (R3). http://www.ich.org/#64257;leadmin/Public_Web_Site/ICH_Products/Guidelines/Ef#64257;cacy/E14/E14_Q_AsvR3_Step4.pdf
  • Yan, L., Zhang, J., Ng, M., Dang, Q. (2010). Statistical Characteristics of Moxifloxacin-Induced QTc Effect. Journal of Biopharmaceutical Statistics 20(3): 497–507.
  • Zhang, J. (2008). Testing for Positive Control Activity in a Thorough QTc Study. Journal of Biopharmaceutical Statistics 18(3): 517–528.

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