Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro-arrhythmia Assay initiative studies.

Xavier Ligneau Rashmi R ShahIsabelle Berrebi-BertrandGary R MiramsPhilippe RobertLaurent LandaisPierre Maison-BlancheJean-François FaivreJeanne-Marie LecomteJean-Charles Schwartz

Published in: British journal of pharmacology (2017)

Our findings support the CiPA initiative but suggest that sponsors should consider investigating drug effects on EADs and the use of pro-arrhythmia models when the results from CiPA studies are ambiguous.

Keyphrases

quality improvement
case control
anti inflammatory
high throughput
catheter ablation
single cell