Topic of Timely Interest—Decision Criteria for Negative QT Assessment Using Exposure Response Analysis of Data From Early-Phase Clinical Studies

Abstract

Get full access to this article

View all access options for this article.

References

Garnett

Beasley

Bhattaram

. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008;48:13–18.

Darpo

Benson

Dota

. Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clin Pharmacol Ther. 2015; 97:326–335.

Darpo

Garnett

. Early QT assessment—how can our confidence in the data be improved? Br J Clin Pharmacol. 2013;76:642–648.

Westerberg

Chiesa

Andersen

. Safety, pharmacokinetics, pharmacogenomics and QT concentration-effect modelling of the SirT1 inhibitor selisistat in healthy volunteers. Br J Clin Pharmacol. 2015;79:477–491.

Zhang

Chen

Tsong

Stockbridge

. Lessons learned from hundreds of thorough QT studies. Therapeutic Innovation & Regulatory Science. 2015;49:392–397.