Detection of Clinically Significant QTc Prolongation in Phase I Studies in Healthy Participants: Comparison of 2 Semiautomated QT Measurement Methods.

The article presents a study which compares the corrected Q-T interval (QTc) prolongation by a quinolone antibiotic detected by the 2 semiautomated QT measurement methods in phase I study in healthy participants. The prolongation of drug-induced QTc is a critical issue for the outcome of the regulatory review of new drug applications. It notes that the assessment of QTc in phase I can facilitate early decisions on the viability of drug development and optimal timing of thorough QTc study.