Not‐in‐trial simulation I: Bridging cardiovascular risk from clinical trials to real‐life conditions - Chain, Anne S. Y.; Dieleman, Jeanne P.; Noord, Charlotte; Hofman, Albert; Stricker, Bruno H. Ch; Danhof, Meindert; Sturkenboom, Miriam C. J. M.; Della Pasqua, Oscar (British journal of clinical pharmacology, 2013)
Keywords: Adolescent; Adrenergic beta-Antagonists - adverse effects; Adrenergic beta-Antagonists - pharmacokinetics; Adrenergic beta-Antagonists - pharmacology; Adrenergic beta-Antagonists - therapeutic use; Adult; Cohort Studies; Computer Simulation; Electrocardiography; Female; Healthy Volunteers; Humans; Long QT Syndrome - chemically induced; Long QT Syndrome - metabolism; Male; Methods in Clinical Pharmacology; Middle Aged; Models, Biological; model‐based drug development, risk management; observational cohorts; pharmacokinetic–pharmacodynamic modelling; Prospective Studies; QTc interval prolongation; Risk Assessment; sotalol; Sotalol - adverse effects; Sotalol - pharmacokinetics; Sotalol - pharmacology; Sotalol - therapeutic use; Statistics, Nonparametric; Surveys and Questionnaires; Young Adult; QTc interval prolongation; observational cohorts; model-based drug development, risk management; sotalol; pharmacokinetic-pharmacodynamic modelling