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DOI10.1016/j.vascn.2013.03.008
A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee
Pierson, Jennifer B.1; Berridge, Brian R.2; Brooks, Marjory B.3; Dreher, Kevin4; Koerner, John5; Schultze, A. Eric6; Sarazan, R. Dustan7; Valentin, Jean-Pierre8; Vargas, Hugo M.9; Pettit, Syril D.1
发表日期2013-07-01
ISSN1056-8719
卷号68期号:1页码:7-12
英文摘要

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. (C) 2013 Elsevier Inc. All rights reserved.


英文关键词Animal models;Cardiac repolarization;Cardiac safety;Cardiac biomarkers;FDA;ILSI/HESI;Integrated risk assessment;Stem cells
语种英语
WOS记录号WOS:000321442300176
来源期刊JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61564
作者单位1.Hlth & Environm Sci Inst, Washington, DC 20005 USA;
2.GlaxoSmithKline Res & Dev Ltd, Res Triangle Pk, NC 27709 USA;
3.Cornell Univ, Comparat Coagulat Sect, Dept Populat Med & Diagnost Sci, Ithaca, NY 14850 USA;
4.US EPA, Environm Publ Hlth Div, Off Res & Dev, Res Triangle Pk, NC 27711 USA;
5.US FDA, Div Cardiovasc & Renal Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA;
6.Lilly Res Labs, Dept Pathol, Indianapolis, IN 46285 USA;
7.DSI, St Paul, MN USA;
8.AstraZeneca, Global Safety Assessment, Macclesfield SK10 4TG, Cheshire, England;
9.Amgen Inc, Toxicol Sci, Thousand Oaks, CA 91320 USA
推荐引用方式
GB/T 7714
Pierson, Jennifer B.,Berridge, Brian R.,Brooks, Marjory B.,et al. A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee[J]. 美国环保署,2013,68(1):7-12.
APA Pierson, Jennifer B..,Berridge, Brian R..,Brooks, Marjory B..,Dreher, Kevin.,Koerner, John.,...&Pettit, Syril D..(2013).A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee.JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS,68(1),7-12.
MLA Pierson, Jennifer B.,et al."A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee".JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS 68.1(2013):7-12.
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