www.med8th.com | 2006年6月1日
美国商业新闻2006年5月16日加利福尼亚州SAN RAMON消息——
Elsevier MDL(纽约证券交易所:RUK)(纽约证券交易所:ENL)(伦敦证券交易所:REL)非常高兴地发布重要的药品安全信息来源PharmaPendium(TM) ( www.pharmapendium.com ),从而使得研究人员能够前所未有的访问拥有包括可搜索的美国药品食品管理局批准信息包在内的同类最佳的药品安全内容集合。
Elsevier MDL首席执行官Lars Barfod说道:“药品安全是制药行业、政府监管机构以及公共卫生机构所面临的紧急问题。我们的客户告诉我们PharmaPendium能够满足有效访问药品安全数据的明确需求,能够帮助使得药品研究实现重大变革。”
几位临床研究人员在他们日常工作中使用药品安全资料时得到了灵感,从而提出了建立资料来源的方案。更多的想法则来自于美国食品药物管理局(FDA)与MDL Information Systems之间的协作研发协议(CRADA)。美国食品药物管理局药品评估与研究中心制药科学办公室的Edwin Matthews博士与Joseph Contrera博士均为美国食品药物管理局的CRADA调查员。“我们相信这一方案对于科学界以及我们自己的药品副作用与毒性活动的研究非常有用。这项资料来源同时也是推动实现美国食品药物管理局的关键路径计划(Critical Path Initiative) ( http://www.fda.gov/oc/initiatives/criticalpath/ )以及支持药品安全与药品研发计划的重要工具。”
PharmaPendium是唯一一种以搜索美国食品药物管理局的批准信息包为特色的产品。研究人员与信息专家不再需要订购相关的信息包,从而花费几周或者几个月时间来从长长的文档中寻找适当的信息。PharmaPendium能够提供临床前、临床中与上市后的药品安全信息的纵向视图,从而使得研究人员能够确定类似的候选复方药品已经观察到的动物疗效能否适用于人类。除此之外,上述资料来源还提供了四种途径来访问药品安全信息:按药品(类别)、副作用/毒性、目标与化学结构分类进行访问。
PharmaPendium能够为药理学家、药品安全专家、药品安全小组成员与药品科学信息专家提供帮助。用户还可以在几秒种之内搜索像是“副作用事故报告系统(Adverse Event Reporting System,AERS)”、Meyler的药品副作用与Mosby的Drug Consult(TM)药品专题等资料,从而能够为临床前与临床研究人员节省数以小时计的时间。除此之外,PharmaPendium还内置了来自于《监管活动医疗词典(MedDRA(R))》中的精选词汇,从而能够加强副作用效果搜索与浏览的智能化水平。作为知识数据库的领导企业,Elsevier MDL致力于为药品研究人员提供前所未有的访问基础药品安全信息的渠道。
关于Elsevier MDL
Elsevier MDL提供信息学、数据库、工作流解决方案,通过提高科学家的决策速度和质量,来加快成功完成生命科学研发的速度。全球商业、学术和政府领域的生命科学研究人员都依靠Elsevier MDL为他们提供创新可靠的发现信息学软件解决方案及服务。Elsevier旗下的400家化学与生命科学杂志及相关产品为这些解决方案和服务提供了更为丰富的诠释。了解更多信息,请访问网站 www.mdl.com 。Elsevier是一家科学、技术与医疗信息产品与服务的世界级出版商。了解更多信息,请访问网站 www.elsevier.com 。
Elsevier是世界领先的出版商和信息供应商Reed Elsevier Group Plc的一部分。Reed Elsevier的股票代码是REN(阿姆斯特丹欧洲交易所)、REL(伦敦股票交易所)、RUK和ENL(纽约证券交易所)。
编者注:
了解关于PharmaPendium的更多信息,请联系Elsevier MDL客户经理,访问网站 www.mdl.com 或者 www.pharmapendium.com ,或者发送信息至pharmapendium@elsevier.com。Edwin Matthews博士(Edwin.Matthews@fda.hhs.gov)和Joseph Contrera博士(Joseph.contrera@fda.hhs.gov)均为美国药品食品管理局的CRADA调查员。
MDL和PharmaPendium是属于MDL Information Systems, Inc.(‘Elsevier MDL’)在美国所有的注册商标。MedDRA是属于位于美国的国际药品制造商联合会(International Federation of Pharmaceutical Manufacturers Associations)所有的注册商标。MedDRA使用需要得到单独授权。其他名称或者产品可能是属于各自所有权人所有的商标或者注册商标。保留所有权利。
联系方式:Elsevier MDL Phil McHale博士,925-543-7800 p.mchale@mdl.com
(BW)(CA-ELSEVIER-MDL)(RUK)(ENL)(REL.L) Elsevier MDL Unveils PharmaPendium(TM) -- A New Drug Safety Product
SAN RAMON, Calif.--(BUSINESS WIRE)--May 16, 2006--
Elsevier MDL (NYSE:RUK)(NYSE:ENL)(LSE:REL) is pleased to announce the release of PharmaPendium(TM) (www.pharmapendium.com), an essential drug safety resource that provides researchers with unprecedented access to an online collection of best-in-class drug safety content, including searchable FDA approval packages.
"Drug safety is a pressing issue for the pharmaceutical industry, governmental regulators and our public health," said Lars Barfod, CEO of Elsevier MDL. "Our customers tell us that PharmaPendium meets a clear need for efficient access to drug safety data and can help make an important difference in drug research."
The concept for this resource was developed with input from various preclinical researchers utilizing drug safety in their daily work. Extensive input was also provided by the FDA under a Cooperative Research and Development Agreement (CRADA) between the FDA and MDL Information Systems. Dr. Edwin Matthews and Dr. Joseph Contrera, FDA's Center for Drug Evaluation and Research, Office of Pharmaceutical Science, are the FDA Investigators on the CRADA. "We believe this concept will be very useful to the scientific community and to our own research on the adverse effects and toxicological activities of pharmaceuticals. This resource could also be an important tool to facilitate the goals of the FDA's Critical Path Initiative (http://www.fda.gov/oc/initiatives/criticalpath/), and to support drug safety and drug development programs."
PharmaPendium is the only product featuring searchable access to FDA Approval Packages. Researchers and information specialists no longer have to order relevant packages and spend weeks or months sifting through long documents looking for pertinent information. PharmaPendium provides a longitudinal view of preclinical, clinical and post-market safety data, which allows researchers to determine what observed effects in animals translate to humans for similar candidate compound drugs. In addition, the resource provides four pathways into drug safety information: by drug (class), by adverse effect/toxicity, by target and by chemical structure.
PharmaPendium will help toxicologists, safety pharmacologists, drug safety team members and information specialists in the pharmaceutical sciences. Other key resources such as the Adverse Event Reporting System (AERS), Meyler's Side Effects of Drugs and Drug monographs from Mosby's Drug Consult(TM) can be searched in seconds, saving hours for preclinical and clinical researchers. In addition, selected terminology from the Medical Dictionary for Regulatory Activities (MedDRA(R)) has been built into PharmaPendium to enhance intelligent searching and browsing of side effect content. As a knowledge database leader, Elsevier MDL is committed to providing pharmaceutical researchers with unprecedented access to essential drug safety information.
About Elsevier MDL
Elsevier MDL provides informatics, database and workflow solutions that accelerate successful life sciences R&D by improving the speed and quality of scientists' decision making. Researchers around the world depend on Elsevier MDL for innovative and reliable discovery informatics software solutions and services augmented by 400 Elsevier chemistry and life sciences journals and related products. For more information, visit www.mdl.com. Elsevier is a world-leading publisher of scientific, technical and medical information products and services. For more information visit www.elsevier.com.
Elsevier is part of Reed Elsevier Group plc, a world-leading publisher and information provider. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
Notes to Editors:
To learn more about PharmaPendium, contact your Elsevier MDL Account Manager, visit www.mdl.com or www.pharmapendium.com or send a message to pharmapendium@elsevier.com. Dr. Edwin Matthews (edwin.matthews@fda.hhs.gov) and Dr. Joseph Contrera (joseph.contrera@fda.hhs.gov) are the FDA Investigators on the CRADA.
MDL and PharmaPendium are registered trademarks of MDL Information Systems, Inc. ('Elsevier MDL') in the United States. MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers Associations in the United States. Separate license to MedDRA required. Other names or products may be the trademarks or registered trademarks of their respective owners. All rights reserved.
CONTACT: Elsevier MDL Dr. Phil McHale, 925-543-7800 p.mchale@mdl.com
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