Model-based evaluation of drug-induced QTc prolongation for compounds in early development

British Journal of Clinical Pharmacology

Volumn 79, Issue 1, 2015, Pages 148-161

  Dubois, Vincent F S ^a   Yu, Huixin ^a   Danhof, Meindert ^a   Della Pasqua, Oscar ^a,b,c  

^a LEIDEN UNIVERSITY   (Netherlands)

^b GLAXOSMITHKLINE   (United Kingdom)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Bayesian modelling; cardiovascular safety; drug development; pharmacokinetic pharmacodynamic modelling; QT interval prolongation; translational pharmacology

Indexed keywords

DRUG; NCE 01; NCE 02; NCE 03; PLACEBO; UNCLASSIFIED DRUG; NEW DRUG;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; BEAGLE; CASE REPORT; CIRCADIAN RHYTHM; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG SCREENING; ELIMINATION HALF-LIFE; HUMAN; MALE; MIDDLE AGED; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); VOLUME OF DISTRIBUTION; ANIMAL; BIOLOGICAL MODEL; CHEMICALLY INDUCED; CLINICAL TRIAL; DOG; DOUBLE BLIND PROCEDURE; DRUG DEVELOPMENT; DRUG EFFECTS; ELECTROCARDIOGRAPHY; FEMALE; LONG QT SYNDROME; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TRANSLATIONAL RESEARCH; YOUNG ADULT;

ADULT; ANIMALS; DOGS; DOUBLE-BLIND METHOD; DRUG DISCOVERY; DRUGS, INVESTIGATIONAL; ELECTROCARDIOGRAPHY; FEMALE; HUMANS; LONG QT SYNDROME; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; TRANSLATIONAL MEDICAL RESEARCH; YOUNG ADULT;

EID: 85000200645     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12482     Document Type: Article

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