Design and analysis considerations for thorough QT studies employing conventional (10 s, 12-lead) ECG recordings

Expert Review of Clinical Pharmacology

Volumn 1, Issue 6, 2008, Pages 815-839

  Beasley Jr , Charles M ^a   Dmitrienko, Alex ^a   Mitchell, Malcolm I ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Cardiac safety; Drug development; ICH E14; International Conference on Harmonization; QT; QT study; QTc; Thorough QT study; Torsade de Pointes; Ventricular repolarization

Indexed keywords

ALFUZOSIN; BRIVARACETAM; CAPRAVIRINE; CIPROFLOXACIN; DARIFENACIN; DULOXETINE; ETIRACETAM; ETRAVIRINE; IBUTILIDE; LAMOTRIGINE; LEVOCETIRIZINE; LEVOFLOXACIN; MARAVIROC; MOXIFLOXACIN; PLACEBO; POTASSIUM CHANNEL BLOCKING AGENT; RALTEGRAVIR; RITONAVIR; RIVAROXABAN; ROTIGOTINE; SILDENAFIL; TADALAFIL; TOLTERODINE; VARDENAFIL;

DRUG DOSE TITRATION; DRUG RESEARCH; DRUG SAFETY; ELECTROCARDIOGRAM; HEART RATE VARIABILITY; HEART REPOLARIZATION; HEART VENTRICLE TACHYCARDIA; HUMAN; MAXIMUM PLASMA CONCENTRATION; QT INTERVAL; QT PROLONGATION; REVIEW; RISK ASSESSMENT; RR INTERVAL;

EID: 70049099675     PISSN: 17512433     EISSN: None     Source Type: Journal    
DOI: 10.1586/17512433.1.6.815     Document Type: Review

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