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" Benefit-risk assessment in pharmaceutical research and development "
edited by Andreas Sashegyi, Eli Lilly and Company Indianapolis, Indiana, USA, James Felli, Eli Lilly and Company Indianapolis, Indiana, USA, Rebecca Noel, Eli Lilly and Company Indianapolis, Indiana, USA.
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BL
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| Record Number
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724502
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| Doc. No
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b544221
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| Main Entry
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edited by Andreas Sashegyi, Eli Lilly and Company Indianapolis, Indiana, USA, James Felli, Eli Lilly and Company Indianapolis, Indiana, USA, Rebecca Noel, Eli Lilly and Company Indianapolis, Indiana, USA.
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| Title & Author
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Benefit-risk assessment in pharmaceutical research and development\ edited by Andreas Sashegyi, Eli Lilly and Company Indianapolis, Indiana, USA, James Felli, Eli Lilly and Company Indianapolis, Indiana, USA, Rebecca Noel, Eli Lilly and Company Indianapolis, Indiana, USA.
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| Publication Statement
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Boca Raton: CRC Press, [2014] ©2014
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| Series Statement
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Chapman & Hall/CRC biostatistics series.
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| Page. NO
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: text file, PDF
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| ISBN
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1439867941
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: 143986795X
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: 9781439867945
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: 9781439867952
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| Contents
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Section 1. Early clinical development --;section 2. Full clinical development --;section 3. Regulatory review and policy --;section 4. Post-launch assessment.
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| Abstract
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This book is about benefit and risk. More precisely, this book is about the definition, assessment, balance and communication of favorable and unfavorable consequences of treatments in pharmaceutical research and development. This book is not a definitive treatise on benefit and risk in pharmaceutical research and development. It is not a prescriptive guide for characterizing the benefits and risks of a molecule under development. Nor is it a collection of best practices and recommendations for a successful benefit and risk assessment. It is a gateway. It is a gateway that opens into a long corridor that chronicles the concepts, assessment methods, interpretations and implications of benefits and risks as a molecule journeys from concept to customer. Along the corridor are four doors that open into four galleries. Depending upon our experiences and state of mind, these doors may appear dark and foreboding, etched with esoteric runes and rubbed with mystic herbs ... or curious and unusual entryways we've walked by for years yet never thought to enter ... or enticing and accessible points of access to newly revealed vistas abundant with challenge and promise. Each door in the corridor will bear one of four brass plates: Early Clinical Development, Full Clinical Development, Regulatory Review and Policy, Post Launch Assessment. In the Early Clinical Development gallery, we will encounter interpretations of benefit and risk in the context of a molecule moving from discovery through its preclinical evaluation and its initial testing in man. The Full Clinical Development door opens into a gallery that considers benefit and risk during a molecule's journey from its entry into man until it is submitted to regulators for approval--
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| Subject
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Drugs -- Testing.
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Health risk assessment.
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Pharmacoepidemiology.
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| LC Classification
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RM301.27E358 9999
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| Added Entry
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Andreas Sashegyi
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James Felli
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Rebecca Noel
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