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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Critical Path Institute ： ウィキペディア英語版 Critical Path Institute Critical Path Institute (C-Path) is an independent, non-profit organization committed to transformational improvement of the drug development process. C-Path has established first-of-its-kind, global consortia that currently include over 1,000 scientists from government regulatory and research agencies, academia, patient advocacy organizations, and forty one major biopharmaceutical companies.〔Woosley, R. L. ("The FDA’s Critical Path Initiative." ) ''PharmacoVigilance Review'' 1.3 (August 2007): 16-18〕〔U.S. Food and Drug Administration. (''The Critical Path Initiative: Transforming the Way FDA-Regulated Products are Developed, Evaluated, Manufactured, and Used'' ) April 2009〕〔(FDA: Paving the Pathway for Innovation )〕 ==Background== New drug development can cost nearly $1 billion and take, on average, 15 years to get from laboratory testing to regulatory approval;〔("Drug Development Timeline" ).〕 only five- to 15-percent of new medicines that enter human testing reach the market.〔〔Coons, S. J. ("The FDA's Critical Path Initiative: a Brief Introduction." ) ''Clinical Therapeutics'' 31.11(2009): 2572-2573〕 In 2010, only 21 new drugs were approved for marketing.〔http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm243824.jpg〕 To address the declining productivity of the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) launched the Critical Path Initiative (CPI) in 2004, its national strategy for forming collaborations to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. C-Path was created with support and funding from the FDA, (Science Foundation Arizona ), and the Tucson community. C-Path's creation was designed to fill an essential role as a neutral third party that enables scientists from the regulated industry and international regulatory agencies to work together to establish a faster, safer, and more efficient path through the drug development process.〔 Since its launch in 2005, six C-Path consortia—made up of participants from industry, academia, regulatory agencies, and patient advocacy groups—have focused on identifying the best methods for testing drug safety and efficacy, and have shared their data and knowledge about major diseases (clinical trial data, quantitative disease progression models, and biomarkers). 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Critical Path Institute」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.