Evaluation of Design Factors in Thorough QT Study for Drug Safety

Determine key design factors to improve the information-to-cost ratio and to reduce uncertainty in thorough QT studies. Explore novel approaches to analysis of QT studies. NISS evaluated 12 candidate models for the QT correction based on statistical properties of the models and on data from testing at Eli Lilly. Three possible definitions (univariate measures) of treatment difference were… more