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Qualitative methods of benefit / risk assessment

Abstract

In this article authors describe some existing methods of benefit / risk assessment.

About the Authors

A. P. Pereverzev
Scientific Centre for Expert Evaluation of Medicinal Products Russian Federation
Russian Federation


A. N. Mironov
Scientific Centre for Expert Evaluation of Medicinal Products Russian Federation
Russian Federation


N. D. Bunyatyan
Scientific Centre for Expert Evaluation of Medicinal Products Russian Federation
Russian Federation


V. K. Lepakhin
Scientific Centre for Expert Evaluation of Medicinal Products Russian Federation
Russian Federation


B. K. Romanov
Scientific Centre for Expert Evaluation of Medicinal Products Russian Federation
Russian Federation


References

1. Belton, V. & Stewart, T. J. Multi ple Criteria Decision An alysis: An Integrated Approach (Kluwer, Boston, MA, 2001).

2. Benefit-risk methodology project: Work package 2 report EMA/549682/2010.

3. Bennett Levitan, Fili p Mussen. Evaluating benefit-risk during and beyond drug development: an industry view. Regulatory Rapporteur – Vol 9, No 6, June 2012.

4. Bennett Levitan, Intern ation al Society for Pharmacoeconomics and Outcomes Research 16th Annual Meeting, May 24, 2011.

5. BS Levitan et al. ‘Application of the BRAT Framework to Case Studies: Observations and Insights’, Clin Pharmacol Ther, 89, 217-224, 2011.

6. CHMP working group on benefit – risk assessment methods, 2008.

7. DIR 2001/83/EC Art 1(28a); DIR 2001/83/EC Art 1(28).

8. Dodgson, J.S., Spackman, M., Pearman, A., & Philli ps, L.D. Multi-Criteria An alysis: A Manual (Department for Communities and Local Government, London, 2009).

9. Edwards R, Wiholm BE, Martinez C. Concepts in risk-benefit assessment. A simple merit an alysis of a medicine? Drug Saf. 1996 Jul;15(1):1-7.

10. Keeney, R.L. & Raiffa, H. Decisions with Multi ple Objectives: Preferences and Value Tradeoffs (Cambridge University Press, NY, 1993).

11. Leviatan, B. A concise display of multi ple end points for benefit-risk assessment. Clin. Pharmacol. Ther. (2010); e-pub ahead of print 24 November 2010.

12. PM Coplan, RA Noel, BS Levitan, J Ferguson and F Mussen, Development of a Framework for Enhancing the Transparency, Reproducibility and Communication of the Benefit–Risk Balance of Medicines. Clin Pharmacol Ther, 89, 312-315, 2011.


Review

For citations:


Pereverzev A.P., Mironov A.N., Bunyatyan N.D., Lepakhin V.K., Romanov B.K. Qualitative methods of benefit / risk assessment. Safety and Risk of Pharmacotherapy. 2014;(2):22-27. (In Russ.)

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ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)