Editor's Commentary: Letters to the Editor,a New Publishing Partner,and Benefit-Risk Estimation

Turner JR . Editor's commentary: A vision for the journal's continued growth. Drug Inf J. 2011;45:113–117.

Turner JR . Editor's commentary: Regulatory science and the science of safety. Drug Inf J. 2011 45:221–227.

Garattini S . Evaluation of benefit-risk. Pharmacoeconomics. 2010;28:981–986.

Johnson KP . Risks vs benefits of glatiramer acetate: A changing perspective as new therapies emerge for multiple sclerosis. Ther Clin Risk Manag. 2010;6:153–172.

Oster G Weycker D Edelsberg J Benefits and risks of live attenuated influenza vaccine in young children. Am J Manag Care. 2010;16(9): e235–244.

Coplan PM Noel RA Levitan BS Ferguson J Mussen F . 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.

Cuppone F Bria E Vaccaro V Magnitude of risks and benefits of the addition of bevacizumab to chemotherapy for advanced breast cancer patients: Meta-regression analysis of randomized trials. J Exp Clin Cancer Res. 2011;30:54.

Schulman S Majeed A . A benefit-risk assessment of dabigatran in the prevention of venous thromboembolism in orthopaedic surgery. Drug Saf. 2011;34:449–463.

Turner JR . New Drug Development: An Introduction to Clinical Trials, 2nd ed. New York: Springer; 2010.

Durham TA Turner JR . Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press; 2008.

Turner JR Satin LZ Callahan TS Litwin JS . The science of cardiac safety. Appl Clin Trials. 2010;19 (11, suppl):4–8, 14.

Institute of Medicine of the National Academies. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academies Press; 2007. (Report released September 2006, published in book form in 2007.).

Strom BL . Sample size considerations for pharmacoepidemiology studies. In Strom BL (ed.), Pharmacoepidemiology, 4th ed. Chichester, UK: Wiley; 2005.

Caveney E Turner JR . Regulatory landscapes for future antidiabetic drug development (part I): FDA guidance on assessment of cardiovascular risks. J Clin Stud. 2010;(January):34–36.

Caveney E Caveney BJ Somaratne R Turner JR Gourgiotis L . Pharmaceutical interventions for obesity: A public health perspective. Diabetes Obesity Metabol. 2011;13:490–497.

Food and Drug Administration. The Sentinel Initiative: national strategy for monitoring medical product safety. Washington, DC: Food and Drug Administration; May 2008.

Califf RM . How should we determine benefit:risk and how much risk is acceptable? Presentation at the DIA conference “Cardiovascular Safety in Drug Development: State-of-the-art Assessments,” Washington DC, April 14–15, 2011.

O'Neill RT . A perspective on characterizing benefits and risks derived from clinical trials: Can we do more? Drug Inf J. 2008;42:235–245.

Guo JJ Pandey S Doyle J 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.

Ouellet D . Benefit-risk assessment: The use of clinical utility index. Expert Opin Drug Saf. 2010;9:289–300.

Freedman AN Yu B Gail MH Benefit/risk assessment for breast cancer chemoprevention with raloxifene or tamoxifen for women age 50 years or older. J Clin Oncol. 2011;(May 2) [Epub ahead of print].

Tervonen T van Valkenhoef G Buskens E Hillege HL Postmus D . A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis. Stat Med. 2011;30:1419–1428.

Van Houtven G Johnson FR Kilambi V Hauber AB . Eliciting benefit-risk preferences and probability-weighted utility using choice-format conjoint analysis. Med Decis Making. 2011;31:469–480.

Walker S Liberti L McAuslane N . Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters. Clin Pharmacol Ther. 2011;89: 179–182.

Yuan Z Levitan B Berlin JA . Benefit-risk assessment: To quantify or not to quantify, that is the question. Pharmacoepidemiol Drug Saf. 2011;(April 27) [Epub ahead of print].