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Record Nr. |
UNINA9910828713903321 |
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Titolo |
Accelerating the development of biomarkers for drug safety : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
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Pubbl/distr/stampa |
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Washington, D.C., : National Academies Press, c2009 |
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ISBN |
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0-309-14231-8 |
1-282-27265-9 |
9786612272653 |
0-309-13125-1 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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1 online resource (99 p.) |
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Altri autori (Persone) |
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GiffinRobert B |
OlsonSteve <1956-> |
RobinsonSally |
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Disciplina |
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Soggetti |
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Biochemical markers |
Drugs - Safety measures |
Drugs - Testing |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Bibliographic Level Mode of Issuance: Monograph |
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Nota di bibliografia |
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Includes bibliographical references (p. 55-57). |
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Nota di contenuto |
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Overview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations. |
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Sommario/riassunto |
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"Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held 'Assessing and Accelerating Development of Biomarkers for Drug Safety,' a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development."--Publisher's website. |
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