Benefit-Risk Assessment in Pharmaceutical Research and Development

ISBN: 9781439867945 出版年：2013 页码：216 CRC Press

Early Clinical Development Pharmaceutical Benefit-Risk Assessment in Early Development Bennett Levitan and James Cross Full Clinical Development Key Questions, Issues, and Challenges in Benefit-Risk Assessment in Full Clinical Development John Ferguson and Marilyn Metcalf The Clinical Aspects of Benefit and Risk Marilyn Metcalf Quantifying Patient Preferences to Inform Benefit-Risk Evaluations F. Reed Johnson, A. Brett Hauber, and Jing Zhang Benefit-Risk Modeling of Medicinal Products: Methods and Applications Lawrence D. Phillips Benefit-Risk Communication: Learning from Our Past and Creating Our Future Marilyn Metcalf Regulatory Review and Policy Policy Considerations and Strategic Issues Regarding Benefit-Risk Timothy Franson and Philip Bonforte Systematic Approaches to Benefit-Risk Assessment Rebecca Noel Post-Launch Assessment Considerations and Strategies for Benefit-Risk Assessment in the Real-World Setting Alicia Gilsenan and Elizabeth Andrews Benefit-Risk Assessment and the Payer Perspective Joseph Johnston, Ralph Swindle, James Felli, and Don Buesching Epilogue Glossary Index