1. Pignatti F, Ashby D, Brass EP, et al. Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions. Clin Pharmacol Ther. 2015;98:522–533.
2. Mussen F, Salek S, Walker SR. Benefit-Risk Appraisal of Medicines: A Systematic Approach to Decision Making. Surrey, UK: Wiley; 2009.
3. Center for Innovation in Regulatory Science. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. http://www.cirsci.org/sites/default/files/June_2008.pdf. Accessed September 12, 2016.
4. Centre for Innovation in Regulatory Science. Refining the benefit-risk framework for the assessment of medicines: valuing and weighting benefit and risk parameters. http://cirsci.org/sites/default/files/CIRS_June2010_Workshop_Report.pdf. Accessed September 12, 2016.
5. Leong J, McAuslane N, Walker S, Salek S. Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives. Pharmacoepidemiol Drug Saf. 2013;22:1004–1012.