Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a …
WS Redfern, L Carlsson, AS Davis… - Cardiovascular …, 2003 - academic.oup.com
Objective: To attempt to determine the relative value of preclinical cardiac electrophysiology
data (in vitro and in vivo) for predicting risk of torsade de pointes (TdP) in clinical use …
data (in vitro and in vivo) for predicting risk of torsade de pointes (TdP) in clinical use …
Nonclinical proarrhythmia models: predicting Torsades de Pointes
CL Lawrence, CE Pollard, TG Hammond… - … of pharmacological and …, 2005 - Elsevier
Prolongation of the QT interval and the cardiac action potential have been linked to a
potentially fatal but rare tachyarrhythmia known as Torsades de Pointes (TdP). Nonclinical …
potentially fatal but rare tachyarrhythmia known as Torsades de Pointes (TdP). Nonclinical …
Evaluation of drug-induced QT interval prolongation: implications for drug approval and labelling
M Malik, AJ Camm - Drug safety, 2001 - Springer
Assessment of proarrhythmic toxicity of newly developed drugs attracts significant attention
from drug developers and regulatory agencies. Although no guidelines exist for such …
from drug developers and regulatory agencies. Although no guidelines exist for such …
Safety of non-antiarrhythmic drugs that prolong the QT interval or induce torsade de pointes: an overview
The long and growing list of non-antiarrhythmic drugs associated with prolongation of the QT
interval of the electrocardiogram has generated concern not only for regulatory interventions …
interval of the electrocardiogram has generated concern not only for regulatory interventions …
Predicting drug‐induced changes in QT interval and arrhythmias: QT‐shortening drugs point to gaps in the ICHS7B Guidelines
HR Lu, E Vlaminckx, AN Hermans… - British journal of …, 2008 - Wiley Online Library
Background and purpose: The regulatory guidelines (ICHS7B) recommending inhibition of
the delayed rectifier K+ current (IKr), carried by human ether‐a‐go‐go‐related gene (hERG) …
the delayed rectifier K+ current (IKr), carried by human ether‐a‐go‐go‐related gene (hERG) …
Drugs that prolong QT interval as an unwanted effect: assessing their likelihood of inducing hazardous cardiac dysrhythmias
I Cavero, M Mestre, JM Guillon… - Expert opinion on …, 2000 - Taylor & Francis
Medicinal products that, as an unwanted effect, prolong the QT interval of the
electrocardiogram (ECG) can trigger episodes of polymorphic ventricular dysrhythmias …
electrocardiogram (ECG) can trigger episodes of polymorphic ventricular dysrhythmias …
ILSI-HESI cardiovascular safety subcommittee initiative: evaluation of three non-clinical models of QT prolongation
LA Hanson, AS Bass, G Gintant, S Mittelstadt… - … of Pharmacological and …, 2006 - Elsevier
INTRODUCTION: Drugs that delay cardiac repolarization pose potential safety risks to
patients and cause serious regulatory concern because of the link between QT interval …
patients and cause serious regulatory concern because of the link between QT interval …
Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical …
B Darpo, T Nebout, PT Sager - The Journal of Clinical …, 2006 - Wiley Online Library
Proarrhythmias due to drug‐induced QT prolongation are the second most common cause
for drug withdrawal and have caused increasing concern. Two new International …
for drug withdrawal and have caused increasing concern. Two new International …
Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development
V Salvi, DR Karnad, GK Panicker… - British journal of …, 2010 - Wiley Online Library
Following reports of death from cardiac arrhythmias with drugs like terfenadine and
cisapride, the International Conference for Harmonization formulated a guidance (E14) …
cisapride, the International Conference for Harmonization formulated a guidance (E14) …
Combined pharmacological block of IKr and IKs increases short‐term QT interval variability and provokes torsades de pointes
Background and purpose: Assessing the proarrhythmic potential of compounds during drug
development is essential. However, reliable prediction of drug‐induced torsades de pointes …
development is essential. However, reliable prediction of drug‐induced torsades de pointes …
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