{"product_id":"benefit-risk-assessment-in-pharmaceutical-research-and-development-paperback-softback","title":"Benefit-Risk Assessment in Pharmaceutical Research and Development - Paperback \/ softback","description":"\u003cp\u003eMany 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, \u003cstrong\u003eBenefit-Risk Assessment in Pharmaceutical Research and Development\u003c\/strong\u003e provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R\u0026amp;D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThe 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.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eBringing 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\u0026amp;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\u0026amp;D processes.\u003c\/p\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Default Title","offer_id":45600742146286,"sku":"9780367576240","price":77.59,"currency_code":"AUD","in_stock":true}],"url":"https:\/\/bookland.com.au\/products\/benefit-risk-assessment-in-pharmaceutical-research-and-development-paperback-softback","provider":"Book Land AU","version":"1.0","type":"link"}