Thorough QT Studies
Cardio Analytics has tirelessly strived over the last decade and succeeded in achieving a world wide reputation of excellence for QT measurement and analysis and is highly respected in the global market place.
What is a Thorough QT Study?
In recent years the ICH and FDA guidelines have recommended additional cardiac safety testing when QT prolongation is found in the development of a drug. The importance of a Thorough QT study is to detect and evaluate the QT interval prolongation in healthy volunteers using a double-blind, randomised, placebo and active controlled study. Cardio Analytics work strictly to ICH E14 guidance document ‘Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs’ which has been approved in both the United States and Europe as to how a thorough QT study should be conducted.
Cardio Analytics Thorough QT Process is a highly in depth procedure.