Open AccessStability of the Effect of a Standardized Meal on QTc
Author(s) -
Täubel Jörg,
Fernandes Sara,
Ferber Georg
Publication year - 2017
Publication title -
annals of noninvasive electrocardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.494
H-Index - 48
eISSN - 1542-474X
pISSN - 1082-720X
DOI - 10.1111/anec.12371
Subject(s) - medicine , meal , moxifloxacin , reproducibility , qt interval , stable angina , consistency (knowledge bases) , robustness (evolution) , statistics , antibiotics , biochemistry , chemistry , coronary artery disease , mathematics , geometry , gene , microbiology and biotechnology , biology
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.