| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5520943 | Drug Discovery Today | 2017 | 6 Pages |
â¢Thorough TQT study is required for all drugs under development.â¢TQT study methodology is described.â¢The role of a TQT trial as a tool for proarrhythmic risk prediction is discussed.â¢The concordance of the TQT study results with the published TdP cases was assessed.
Since 2005, when the International Conference on Harmonisation (ICH) E14 guideline was adopted, no drug has been withdrawn because of QTc prolongation or torsade de pointes arrhythmia. There are, however, costs associated with this success. In addition to the time and money invested, thorough QT (TQT) studies have limited the efficiency of the drug development pipeline. In this paper, we discuss the relevance of TQT trials as a tool for proarrhythmic risk prediction as a part of the debate regarding their usefulness.
