Assessing a Drug's Proarrhythmic Liability:An Overview of Computer Simulation Modeling,Nonclinical Assays, and the Thorough QT/QTc Study

摘要

We would like to acknowledge the excellent article published in this journal in 2005 by Dr Colette Strnadova (1), which focused on QT prolongation in clinical trials and captured the state of the science at that time extremely well. Cardiac safety is a fast-moving field, and it is hoped that, 6 years later, this article will provide readers with a comprehensive overview of the current landscape.There is considerable current interest in drug safety among multiple stakeholders in the United States, including Congress, individual congressional committees, the Food and Drug Administration (FDA), the Supreme Court, the Institute of Medicine (IOM), pharmaceutical and biopharmaceutical companies, patient advocacy groups, the media, and, not least, prescribing physicians and their patients (2). The same level of interest in drug safety is present in many other countries.