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Chapman & Hall/CRC Biostatistics - Benefit-Risk Assessment In Pharmaceutical Research And Development (Cód: 9265449)

Sashegyi,Andreas; Felli,James; Noel,Rebecca

Crc Press

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Chapman & Hall/CRC Biostatistics - Benefit-Risk Assessment In Pharmaceutical Research And Development

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Descrição

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.'

Características

Produto sob encomenda Sim
Marca Crc Press
Cód. Barras 9781439867945
Altura 23.11 cm
I.S.B.N. 9781439867945
Profundidade 1.78 cm
Referência 9781439867945
Acabamento Capa dura
Ano da edição 2013
País de Origem Estados Unidos
Número de Páginas 220
Peso 0.43 Kg
Largura 15.75 cm
AutorSashegyi,Andreas; Felli,James; Noel,Rebecca