Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development

Author:

Reinisch Walter,Gottlieb Klaus,Colombel Jean-Frederic,Danese Silvio,Panaccione Remo,Panes Julian,Peyrin-Biroulet Laurent,Rubin David,Sands Bruce E.,Schreiber Stefan,Vermeire Severine,Mulberg Andrew,Sandborn Bill

Publisher

Elsevier BV

Subject

Gastroenterology,Hepatology

Reference19 articles.

1. Ulcerative colitis: clinical trial endpoints guidance for industry. Draft guidance. Report no. 15028dft.doc 07/27/16 UCM515143,2016

2. European Medicines Agency. Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis. CHMP/EWP/18463/2006 Rev.1. Available from: https://www.ema.europa.eu/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf. Accessed June 28, 2018.

3. Development of an index to define overall disease severity in IBD;Siegel;Gut,2018

4. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis;Dignass;J Crohn's Colitis,2012

5. A critical assessment of composite and coprimary endpoints: a complex problem;Buzney;J Am Acad Dermatol,2008

Cited by 23 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3