1. 1 ICH Harmonised Tripartite Guideline. The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals S7B. Recommended for adoption at step 4 of the ICH process on 12 May 2005 by the ICH Steering Committee. ICH; (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S7B/Step4/S7B_Guideline. pdf)
2. 2 ICH Harmonised Tripartite Guideline. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14. Recommended for adoption at step 4 of the ICH process on 12 May 2005 by the ICH Steering Committee. ICH; (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf)
3. 3 Darpo B. The thorough QT study four years after the implementation of the ICH E14 guidance. Br J Pharmacol. 2010;159:49–57.
4. 4 E14 Implementation Working Group ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers (R1). 2012. (http://www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Efficacy/E14/E14_Q_As_R1_step4.pdf)
5. 5 Sugiyama A, Hashimoto H, Nakamura Y, Fujita T, Kumagai Y. QT/QTc study conducted in Japanese adult healthy subjects: a novel xanthine oxidase inhibitor topiroxostat was not associated with QT prolongation. J Clin Pharmacol. In press.