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
Health and Environmental Sciences Institute, 1156 15th Street, Northwest, Suite 200, Washington, DC 20005, USA.
J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):7-12. doi: 10.1016/j.vascn.2013.03.008. Epub 2013 Apr 6.
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.
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.
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.
心血管副作用评估是所有新药和化学品研发中的关键要素。在药物研发过程中,心脏安全问题是因药物不良反应(ADR)导致药物淘汰和撤市的主要原因。
以2000年至2013年心脏安全方面的卫生经济与结果研究学会(HESI)技术委员会的发展历程为例,展示一个由学术、政府和行业科学家组成的有效国际联盟如何致力于改善心脏安全。
HESI技术委员会工作组推动了各种资源共享平台和专家间交流平台的发展,从而催生了改善药物安全的创新策略。本文阐述了这些工作组所产生的积极影响。