Not-in-trial simulation I: Bridging cardiovascular risk from clinical trials to real-life conditions

British Journal of Clinical Pharmacology

Volumn 76, Issue 6, 2013, Pages 964-972

  Chain, Anne S Y ^a,b   Dieleman, Jeanne P ^b   Van Noord, Charlotte ^b   Hofman, Albert ^b   Stricker, Bruno H Ch ^b   Danhof, Meindert ^a   Sturkenboom, Miriam C J M ^b   Della Pasqua, Oscar ^a,c  

^a LEIDEN UNIVERSITY   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c GLAXOSMITHKLINE   (United Kingdom)

Author keywords

model based drug development; observational cohorts; pharmacokinetic pharmacodynamic modelling; QTc interval prolongation; Risk management; sotalol

Indexed keywords

SOTALOL;

ARTICLE; CARDIOVASCULAR RISK; COMORBIDITY; COMPARATIVE STUDY; DIABETES MELLITUS; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG EXPOSURE; ELECTROCARDIOGRAPHY; FOLLOW UP; HEART FAILURE; HEART INFARCTION; HUMAN; HYPERTENSION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; QT PROLONGATION; RISK ASSESSMENT; TREATMENT RESPONSE;

MODEL-BASED DRUG DEVELOPMENT, RISK MANAGEMENT; OBSERVATIONAL COHORTS; PHARMACOKINETIC-PHARMACODYNAMIC MODELLING; QTC INTERVAL PROLONGATION; SOTALOL;

ADOLESCENT; ADRENERGIC BETA-ANTAGONISTS; ADULT; COHORT STUDIES; COMPUTER SIMULATION; ELECTROCARDIOGRAPHY; FEMALE; HEALTHY VOLUNTEERS; HUMANS; LONG QT SYNDROME; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PROSPECTIVE STUDIES; QUESTIONNAIRES; RISK ASSESSMENT; SOTALOL; STATISTICS, NONPARAMETRIC; YOUNG ADULT;

EID: 84888067533     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12151     Document Type: Article

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