Benefit-Risk Assessment in Pharmaceutical Research and Development Hardback
Edited by Andreas Sashegyi, James Felli, Rebecca Noel
Part of the Chapman & Hall/CRC Biostatistics Series series
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.
- Format: Hardback
- Pages: 220 pages, A 7 fig, 4-page color insert will appear of Figs. 5.10-5.16. follows page 96; 16 Tables,
- Publisher: Taylor & Francis Ltd
- Publication Date: 27/11/2013
- Category: Management & management techniques
- ISBN: 9781439867945