Journal Articles

Brizmohun N. Standardising Benefit:Risk Assessment Heads DIA EuroMeeting News. Regulatory Affairs J. 2010; 21:221-224. 

Liberti L, McAuslane N, Walker SR. Expediting Patients' Access to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval Process. Clin Pharmacol Ther. 2010;87:27-31. http://www.ncbi.nlm.nih.gov/pubmed/20019699  

Liberti L, Pichler, F, Walker SR. Preparing for Regulatory Review and

Liberti L, McAuslane N, Walker SRW. Progress on the development of a benefit/risk framework for evaluating medicines. Regulatory Focus. 2010: March. Copyright 2010 by the Regulatory Affairs Professional Society (RAPS). Reprinted from the March 2010 Issue of Regulatory Focus with the permission of RAPS.  PDF 

McAuslane N, Cone M, Collins J, Walker S. Emerging Markets and Emerging Agencies: A comparative study of how key regulatory agencies in Asia, Latin America, the Middle East and Africa are developing regulatory processes and review models for new medicinal products. Drug Info J. 2009;43:349-359. 

Walker S, McAuslane N, Liberti L, Salek S. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. Clin Pharmacol Ther. 2009; 85:241-246.  http://www.ncbi.nlm.nih.gov/pubmed/19223879

Mussen F, Salek S, Walker S, Phillips L. A quantitative approach to benefit-risk assessment of medicines - part 2: the practical application of a new model. Pharmacoepidemiol Drug Saf. 2007;16 Suppl 1:S16-41. http://www.ncbi.nlm.nih.gov/pubmed/17546574

Mussen F, Salek S, Walker S. A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis. Pharmacoepidemiol Drug Saf. 2007;16 Suppl 1:S2-S15. http://www.ncbi.nlm.nih.gov/pubmed/17546573

Hirako M, McAuslane N, Salek S, Anderson C, Walker S. A Comparison of the Drug Review Process at Five International Regulatory Agencies. Drug Info J.2007; 41: 291–308, 2007.