| Literature DB >> 23567075 |
Jennifer B Pierson1, Brian R Berridge, Marjory B Brooks, Kevin Dreher, John Koerner, A Eric Schultze, R Dustan Sarazan, Jean-Pierre Valentin, Hugo M Vargas, Syril D Pettit.
Abstract
INTRODUCTION: The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues are a major cause of attrition and withdrawal due to adverse drug reactions (ADRs) in pharmaceutical drug development.Keywords: ADRs; Animal models; CDER; CV; Cardiac biomarkers; Cardiac repolarization; Cardiac safety; Center for Drug Evaluation and Research; ECG; EMA; EWG; European Medicines Agency; Expert Working Group; FDA; HESI; Health and Environmental Sciences Institute; ICH; IKr; ILSI; ILSI/HESI; IND; Integrated risk assessment; International Conference on Harmonization; International Life Sciences Institute; JPMA; Japanese Pharmaceutical Manufacturer Association; NDA; PRODACT; PSTC; Predictive Safety Testing Consortium; QTc; SC-CM; Stem cells; TQT; TdP; US FDA; United States Food and Drug Administration; adverse drug reactions; cTn; cardiac troponin; cardiovascular; corrected QT interval; delayed rectifier potassium current; electrocardiogram; hERG; human ether-á-go-go related gene; investigational new drug; new drug application; project for database construction; stem-cell derived cardiac myocytes; thorough QT study; torsades de pointes
Mesh:
Year: 2013 PMID: 23567075 DOI: 10.1016/j.vascn.2013.03.008
Source DB: PubMed Journal: J Pharmacol Toxicol Methods ISSN: 1056-8719 Impact factor: 1.950