Summary and Info
Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment.The book first presents interpretations. Read more... Front Cover; Contents; Editors; Contributors; Prologue; Chapter 1: Pharmaceutical Benefit-Risk Assessment in Early Development; Chapter 2: Key Questions, Issues, and Challenges in Benefit-Risk Assessment in Full Clinical Development; Chapter 3: The Clinical Aspects of Benefit and Risk; Chapter 4: Quantifying Patient Preferences to Inform Benefit-Risk Evaluations; Chapter 5: Benefit-Risk Modeling of Medicinal Products: Methods and Applications; Chapter 6: Benefit-Risk Communication: Learning from Our Past and Creating Our Future Chapter 7: Policy Considerations and Strategic Issues Regarding Benefit-RiskChapter 8: Systematic Approaches to Benefit-Risk Assessment; Chapter 9: Considerations and Strategies for Benefit-Risk Assessment in the Real-World Setting; Chapter 10: Benefit-Risk Assessment and the Payer Perspective; Epilogue; Glossary; Back Cover
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