Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications

Author:

Wolka Anne,Warner Margaret,Bullok Kristin,Wang JuAn,Radawski Christine,Noel Rebecca

Publisher

Springer Science and Business Media LLC

Subject

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

Reference11 articles.

1. 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. Published 2013. Accessed April 16, 2015.

2. International Conference on Harmonisation. The common technical document for the registration of pharmaceuticals 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 2002. Accessed April 16, 2015.

3. 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.

4. 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.

5. Noel R, Hermann R, Levitan B, et al. Application of the Benefit-Risk Action Team (BRAT) framework in pharmaceutical R&D: results from a pilot program. Drug Inform J. 2012;46:736–743.

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