Benefit-Risk Assessment in Pharmaceutical Research and Development
Edited by Andreas Sashegyi, James Felli, Rebecca Noel
To Be Published November 26th 2013 by Chapman and Hall/CRC – 224 pages
This work presents an overview of benefit-risk assessment approaches for pharmaceutical research and development. It covers various decision-making points along the R&D spectrum that would benefit from benefit risk analysis, including during lead development and optimization, early and late planning of clinical development, and regulatory review. The book also looks at health outcomes and comparative effectiveness analysis. In addition, the authors address current and future barriers to using risk-benefit modeling, including greater regulatory acceptance.