A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee

作者：Pierson Jennifer B^*; Berridge Brian R; Brooks Marjory B; Dreher Kevin; Koerner John; Schultze A Eric; Sarazan R Dustan; Valentin Jean Pierre; Vargas Hugo M; Pettit Syril D

来源：Journal of Pharmacological and Toxicological Methods, 2013, 68(1): 7-12.

DOI：10.1016/j.vascn.2013.03.008

• Animal models
• Cardiac repolarization
• Cardiac safety
• Cardiac biomarkers
• FDA
• ILSI/HESI
• Integrated risk assessment
• Stem cells

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. Methods: The evolution of the HESI Technical Committee on Cardiac Safety from 2000-2013 is presented as an example of an effective international consortium of academic, government, and industry scientists working to improve cardiac safety. Results and Discussion: The HESI Technical Committee Working Groups facilitated the development of a variety of platforms for resource sharing and communication among experts that led to innovative strategies for improved drug safety. The positive impacts arising from these Working Groups are described in this article.

• 出版日期2013-8