Model averaging for robust assessment of QT prolongation by concentration-response analysis
Author:
Affiliation:
1. Uppsala University; Uppsala Sweden
2. Novartis Pharma AG; Basel Switzerland
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Reference27 articles.
1. International Conference on Harmonisation E14: guidance on clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs 2005
2. Comparison of QTc data analysis methods recommended by the ICH E14 guidance and exposure-response analysis: case study of a thorough QT study of asenapine;Chapel;Clin Pharmacol Ther,2010
3. Performance characteristics for some typical QT study designs under the ICH E-14 guidance;Hutmacher;J Clin Pharmacol,2008
4. The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies;Bouvy;Clin Pharmacol Ther,2012
5. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review;Garnett;J Clin Pharmacol,2008
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