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150223 r ||| eng |
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|a 9780309158893
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|a 0309158893
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|a RM301.25
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|a Lebovitz, Yeonwoo
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|a Building a national framework for the establishment of regulatory science for drug development
|h Elektronische Ressource
|b workshop summary
|c Yeonwoo Lebovitz, Rebecca A. English and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
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|a Regulatory science for drug development
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|a Forum on Drug Discovery, Development, and Translation
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|a Washington, D.C.
|b National Academies Press
|c c2011, 2011
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| 300 |
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|a xvi, 78 p.
|b col. ill.
|c 23 cm
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|a Introduction -- Defining regulatory sciences -- The urgent need for regulatory science -- Barriers to enhanced regulatory science -- Potential models for building a regulatory science infrastructure -- Challenges in engaging the public policy community -- Envisioning successsful regulatory science at FDA -- Considering next steps
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|a Includes bibliographical references
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|a Drug Evaluation
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|a United States
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|a Clinical Trials as Topic
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|a Drug Discovery
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|a Drug Approval
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|a English, Rebecca A.
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|a Claiborne, Anne B.
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|a Institute of Medicine (U.S.)
|b Forum on Drug Discovery, Development, and Translation
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|a eng
|2 ISO 639-2
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|b NCBI
|a National Center for Biotechnology Information
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|u https://www.ncbi.nlm.nih.gov/books/NBK54404
|3 Volltext
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|u http://www.nap.edu/catalog.php?record_id=12968
|3 Volltext
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|a 610
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|a "The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it."--Publisher's description
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