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portada Benefit-Risk Assessment in Pharmaceutical Research and Development
Type
Physical Book
Publisher
Author
Language
English
Pages
220
Format
Hardcover
Dimensions
23.1x15.7x1.8 cm
Weight
0.43 kg.
ISBN13
9781439867945
Edition No.
1
Categories

Benefit-Risk Assessment in Pharmaceutical Research and Development

Sashegyi, Andreas ; Felli, James ; Noel, Rebecca (Author) · CRC Press · Hardcover

Benefit-Risk Assessment in Pharmaceutical Research and Development - Sashegyi, Andreas ; Felli, James ; Noel, Rebecca

New Book Imported to Austria
Delivery: 29 Oct - 02 Nov Shipping: 14 to 15 business days.
172,82 €
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172,82 €

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Synopsis "Benefit-Risk Assessment in Pharmaceutical Research and Development"

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.

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