Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D, from early clinical development to late-stage development to regulatory review to post-launch assessment. Suitable for those in b
Inhaltsverzeichnis
Early Clinical Development: Pharmaceutical Benefit-Risk Assessment in Early Development. Full Clinical Development: Key Questions, Issues, and Challenges in Benefit-Risk Assessment in Full Clinical Development. The Clinical Aspects of Benefit and Risk. Quantifying Patient Preferences to Inform Benefit-Risk Evaluations. Benefit-Risk Modeling of Medicinal Products: Methods and Applications. Benefit-Risk Communication: Learning from Our Past and Creating Our Future. Regulatory Review and Policy: Policy Considerations and Strategic Issues Regarding Benefit-Risk. Systematic Approaches to Benefit-Risk Assessment. Post-Launch Assessment: Considerations and Strategies for Benefit-Risk Assessment in the Real World Setting. Benefit-Risk Assessment and the Payer Perspective. Epilogue. Glossary. Index.
