Evaluation of drug-induced QT interval prolongation in animal and human studies: a literature review of concordance.

ABSTRACT: Evaluating whether a new medication prolongs QT intervals is a critical safety activity that is conducted in a sensitive animal model during non-clinical drug development. The importance of QT liability detection has been reinforced by non-clinical [International Conference on Harmonization (ICH) S7B] and clinical (ICH E14) regulatory guidance from the International Conference on Harmonization. A key challenge for the cardiovascular safety community is to understand how the finding from a non-clinical in vivo QT assay in animals predicts the outcomes of a clinical QT evaluation in humans. The Health and Environmental Sciences Institute Pro-Arrhythmia Working Group performed a literature search (1960-2011) to identify both human and non-rodent animal studies that assessed QT signal concorda

SUBMITTER: Vargas HM 

PROVIDER: S-EPMC4543608 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature