|
|||||
|
|
Practice and challenges of thorough QT studies |
|
| Authors: | Norman Stockbridge Joanne Zhang Christine Garnett Marek Malik |
| Affiliation: | 1. Division of Cardiovascular and Renal Products, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA;2. Division of Biometrics VI, Office of Biostatistics, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA;3. Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA;4. St. Paul''s Cardiac Electrophysiology and St. George''s, University of London, London, England |
| Abstract: | The drug-induced Torsade de Pointes (TdP) tachycardia is a known regulatory problem which led to the concept of the so-called thorough QT (TQT) studies now required for practically every new pharmaceutical compound. This review summarizes the concept of the TQT studies, their statistical evaluation, and related pharmacodynamic /pharmacokinetic modeling. The review also lists suggestions of how to make TQT studies more efficient and how to improve the interpretation of clinical data obtained during drug development to identify drugs prone to TdP induction more effectively. |
| Keywords: | QT interval Torsade de pointes tachycardia Drug safety |
| 本文献已被 ScienceDirect 等数据库收录！ | |