Cardiac safety repolarization assays

Among these initiatives, the project of the HESI Cardiovascular Safety Subcommittee represented an analysis of the largest database among the different consortia, a survey of 150 molecules studied in the clinic for QT prolongation (Koemer et al. 2013). This initiative is comparing the concordance between preclinical cardiac repolarization assays and the results from the TQT study data were collected from INDs and NDAs submitted to the FDA between the periods of March 2006 and July 2012. Due to the proprietary namre of these datasets, the FDA populated the spreadsheets with the data and carried out a quality control and statistical analysis based on a methodology that was devised by the subcommittee in advance of the collection of data. The summary results of this analysis of 150 compounds has been presented at conferences and is due for publication in 2015 (Koemer et al. 2013). 

One example of a cell-based assay that has been successfully incorporated into the safety assessment pathway is the assessment of drug-induced proarrhythmia risk based on block of the cardiac repolarization current IKr and the clinical assessment of the electrocardiographic QT interval, as discussed in the ICH S7B and ICH E14 harmonized... 

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