title: Stability of the Effect of a Standardized Meal on QTc.
abstract: BACKGROUND
  The assessment of QTc changes after the intake of a standardized meal has been proposed as an alternative approach to prove assay sensitivity when the proarrhythimic potential of a drug is to be excluded in either TQT or intensive Phase I QT studies.
  
  
  METHODS
  In this article, an analysis of the food effect at baseline across periods in two different studies is presented to support the robustness of the method.
  
  
  RESULTS
  The results show that the time-effect attributed to food is stable over different study periods demonstrating consistency of the physiological response triggered by food.
  
  
  CONCLUSIONS
  Stability and reproducibility of the effect is comparable with moxifloxacin.
authors.affiliation: Richmond Pharmacology Ltd., St George's University of London, London, United Kingdom.
authors.forename: Jörg
authors.initials: J
authors.lastname: Täubel
authors.affiliation: Richmond Pharmacology Ltd., St George's University of London, London, United Kingdom.
authors.forename: Sara
authors.initials: S
authors.lastname: Fernandes
authors.affiliation: Statistik Georg Ferber GmbH, Riehen, Switzerland.
authors.forename: Georg
authors.initials: G
authors.lastname: Ferber
mesh_terms: D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000494:pharmacology*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004435:Eating / Q000502:physiology*; D004562:Electrocardiography / Q000187:drug effects*; D064368:Healthy Volunteers; D006329:Heart Conduction System / Q000187:drug effects*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D009025:Morpholines / Q000494:pharmacology*; D019518:Postprandial Period / Q000502:physiology; D011720:Pyrazoles / Q000494:pharmacology*; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000494:pharmacology
chemical_list: C576663:4-(2-((5-methyl-1-(2-naphthalenyl)-1H-pyrazol-3-yl)oxy)ethyl)morpholine; D014150:Antipsychotic Agents; D009025:Morpholines; D011720:Pyrazoles; D013469:Sulpiride; D000077582:Amisulpride
keywords: QTc; assay sensitivity; food effect; interval