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Full Description
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 of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule's journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule's entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety.
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. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.
Contents
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.
