Model averaging for robust assessment of QT prolongation by concentration-response analysis

Author:

Dosne A.G.1ORCID,Bergstrand M.1,Karlsson M.O.1,Renard D.2,Heimann G.2

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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