Concentration–QTc analysis for single arm studies

Author:

Orihashi YasushiORCID,Ohwada Shoichi,Kumagai Yuji

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Reference21 articles.

1. ICH E14 Expert Working Group (2005) The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs E14. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

2. ICH E14 Implementation Working Group (2015) The Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers (R3). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf

3. Rock EP, Finkle J, Fingert HJ, et al (2009) Assessing proarrhythmic potential of drugs when optimal studies are infeasible. Am. Heart J.

4. Fradley MG, Moslehi J (2015) QT Prolongation and oncology drug development. Card Electrophysiol Clin 341–355

5. Garnett C, Bonate PL, Dang Q et al (2018) Scientific white paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn 45:383–397. https://doi.org/10.1007/s10928-017-9558-5

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