How to successfully generate an alternative approach to a thorough QT Study? Scientists from Galapagos, Servier and Pharmetheus have in collaboration published a tutorial describing a path to create a feasible alternative to a thorough QT (TQT) study. These considerations are based on insights from an application to FDA for an ADAMTS-5 inhibitor (GLPG1972), where the sponsor successfully argued for waiving a TQT study based on a model-based C-QTc analysis using the pre-specified linear mixed-effect approach published by FDA.
Feel free to reach out to Pharmetheus if you need help with assessing if and how your drug development program can benefit from a similar approach.
