title: Practice and challenges of thorough QT studies.
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.
authors.affiliation: Division of Cardiovascular and Renal Products, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.forename: Joanne
authors.initials: J
authors.lastname: Zhang
authors.forename: Christine
authors.initials: C
authors.lastname: Garnett
authors.forename: Marek
authors.initials: M
authors.lastname: Malik
mesh_terms: D000465:Algorithms; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects*; D003936:Diagnosis, Computer-Assisted / Q000379:methods*; D004562:Electrocardiography / Q000187:drug effects*; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016171:Torsades de Pointes / Q000139:chemically induced* / Q000175:diagnosis*
chemical_list: D000889:Anti-Arrhythmia Agents