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- Title
Replacing the thorough QT study: reflections of a baby in the bath water.
- Authors
Kleiman, Robert B.; Shah, Rashmi R.; Morganroth, Joel
- Abstract
The authors discuss the "Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs" E14 guidance published by the International Conference on Harmonization (ICH) for the evaluation of potential pro-arrhythmic risk of drugs during clinical development. Topics include the U.S. Food and Drug Administration (FDA), the Thorough Electrocardiography (ECG) Trial (TET), and the drug development programmes.
- Subjects
DRUG development; MYOCARDIAL depressants; INTERNATIONAL Conference on Harmonisation; ELECTROCARDIOGRAPHY; CLINICAL trials; UNITED States. Food &; Drug Administration; GOVERNMENT policy
- Publication
British Journal of Clinical Pharmacology, 2014, Vol 78, Issue 2, p195
- ISSN
0306-5251
- Publication type
Article
- DOI
10.1111/bcp.12296