Author:
Colopy Michael W.,Damaraju C. V.,He Weili,Jiang Qi,Levitan Bennett S.,Ruan Shiling,Yuan Zhong
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference31 articles.
1. Council for International Organizations of Medial Science. Report of CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. Geneva, Switzerland: 1998.
2. Levitan BS, Andrews A, Gilsenan A, et al. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011;89:217–224. doi:10.1038/clpt.2010.280.
3. Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value Health. 2010;13:657–666.
4. Guidance for industry and food and drug administration staff. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications. Silver Spring, MD: FDA CDRH; 2012.
5. Providing postmarket periodic safety reports in the ICH E2C (R2) format (periodic benefit-risk evaluation report). Silver Spring, MD: FDA; April 2013.
Cited by
11 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