The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream

Author:

Reaney MatthewORCID,Bush Elizabeth,New Mary,Paty Jean,de Climens Aude Roborel,Skovlund Soren E.,Nelsen Linda,Flood Emuella,Gater Adam

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference40 articles.

1. Medical Device Innovation Consortium (MDIC). Patient Centered Benefit-Risk (PCBR) framework overview: a framework for incorporating information on patient preferences regarding benefit and risk into regulatory assessments of new medical technology. https://www.fda.gov/downloads/scienceresearch/specialtopics/regulatoryscience/ucm486253.pdf. Published 2015. Accessed June 26, 2018.

2. CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. Report of CIOMS Working Group IV. https://cioms.ch/wp-content/uploads/2017/01/benefit-risk.pdf. Published 1998. Accessed June 26, 2018.

3. Food and Drug Administration (FDA). Factors to consider regarding benefit-risk in medical device product availability, compliance, and enforcement decisions. Guidance for Industry and Food and Drug Administration Staff. US Department of Health and Human Services, Food and Drug Administration Center for Devices and Radiological Health (CDRH). https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm506679.pdf. Published 2016. Accessed June 26, 2018.

4. European Medicines Agency (EMA). Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. Committee for Medicinal Products for Human Use (CHMP); EMEA/CHMP/15404/2007. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf. Published 2008. Accessed June 26, 2018.

5. European Medicines Agency (EMA). Information on benefit-risk of medicines: patients’, consumers’ and healthcare professionals’ expectations. Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Group (HCP WG); EMEA/40926/2009. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500018433.pdf. Published 2009. Accessed June 26, 2018.

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