Arrhythmias Seen in Baseline 24-Hour Holter ECG Recordings in Healthy Normal Volunteers During Phase 1 Clinical Trials

Author:

Hingorani Pooja1,Karnad Dilip R.1,Rohekar Prashant1,Kerkar Vaibhav1,Lokhandwala Yash Y.1,Kothari Snehal1

Affiliation:

1. Quintiles Cardiac Safety Services; Mumbai India

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference21 articles.

1. Cardiac safety investigations 10 years after ICH guidance E14: evolving industry and regulatory viewpoints on evaluation of proarrhythmic risk during new drug development;Kothari;J Clin Stud.,2015

2. Reducing QT liability and proarrhythmic risk in drug discovery and development;Valentin;Br J Pharmacol,2010

3. ICH Harmonized Tripartite Guideline The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs E14 2005 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

4. Automated QT interval measurements in 12-lead digital Holter ECGs: a comparison of ECGs sampled at 180 Hz and 1000 Hz;Panicker;Comput Cardiol,2010

5. Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development;Salvi;Br J Pharmacol,2010

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