Identifying the translational gap in the evaluation of drug-induced QTcinterval prolongation

Author:

Chain Anne S.Y.1,Dubois Vincent F.S.1,Danhof Meindert1,Sturkenboom Miriam C.J.M.23,Della Pasqua Oscar14,

Affiliation:

1. Leiden/Amsterdam Center for Drug Research; Division of Pharmacology; Leiden University; Leiden the Netherlands

2. Department of Medical Informatics; Erasmus Medical Center; Rotterdam the Netherlands

3. Department of Epidemiology; Erasmus Medical Center; Rotterdam the Netherlands

4. Clinical Pharmacology and Discovery Medicine; GlaxoSmithKline; Uxbridge UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference41 articles.

1. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline;Darpo;J Clin Pharmacol,2006

2. ICH Harmonised tripartite guideline. E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic;ICH Expert Working Group;Drugs,2005

3. Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research;Danhof;Trends Pharmacol Sci,2008

4. ICH Expert Working Group ICH Harmonised tripartite guideline 2000

5. ICH Expert Working Group ICH Harmonised tripartite guideline 2005

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