Draft ICH guideline S7B: Guideline on safety pharmacology studies for assessing the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals

Nonclinical assessment of potential of QT interval prolongation caused by non-antiarrhythmic drugs has been an issue for drug development because QT interval prolongation increases the risk of ventricular tachyarrhythmia, including torsade de pointes when combined with other risk factors. However, t...

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Veröffentlicht in:	Folia Pharmacologica Japonica 2003, Vol.121(6), pp.377-383
1. Verfasser:	HASHIMOTO, Munehiro
Format:	Artikel
Sprache:	jpn
Schlagworte:	Drug-Related Side Effects and Adverse Reactions Electrodiagnosis guideline Humans Long QT Syndrome - chemically induced Long QT Syndrome - diagnosis Long QT Syndrome - prevention & control Practice Guidelines as Topic QT interval prolongation Risk Assessment - standards Safety safety pharmacology Tachycardia, Ventricular - chemically induced Torsades de Pointes - chemically induced ventricular repolarization ventricular tachyarrhythmia
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