1. International Conference on Harmonisation. The common technical document for the registration of pharmaceutics for human use. Efficacy–M4E (R1). Clinical Overview and Clinical Summary of Module 2; Module 5: Clinical Study Reports. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf. Published September 12, 2002. Accessed May 6, 2016.
2. Wolka A, Warner M, Bullok K, Wang J, Radawski C, Noel R. Incorporation of a benefit-risk assessment framework into the Clinical Overview of marketing authorization applications. Therapeutic Innovation & Regulatory Science. 2016;50:130–134.
3. Mt-Isa S, Wang N, Hallgreen CE, et al. Review of methodologies for benefit and risk assessment of medication. http://www.imi-protect.eu/documents/ShahruletalReviewofmethodologiesforbenefitandriskassessmentofmedicationMay2013.pdf. Version 4 published February 14, 2012. Revised April 10, 2013. Accessed May 6, 2016.
4. Coplan PM, Noel RA, Levitan BS, et al. Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines. Clin Pharmacol Ther. 2011;89:312–315.
5. Levitan BS, Andrews EB, Gilsenan A, et al. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011;89:217–224.