Building a national framework for the establishment of regulatory science for drug development : workshop summary /

"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 ex...

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Bibliographic Details
Corporate Author: Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Other Authors: Lebovitz, Yeonwoo, English, Rebecca A., Claiborne, Anne B.
Format: Electronic eBook
Language:English
Published: Washington, D.C. : National Academies Press, ©2011.
Subjects:
Online Access: Full text (Emmanuel users only)

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245 0 0 |a Building a national framework for the establishment of regulatory science for drug development :  |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. 
246 3 0 |a Regulatory science for drug development 
246 3 0 |a Forum on Drug Discovery, Development, and Translation 
260 |a Washington, D.C. :  |b National Academies Press,  |c ©2011. 
300 |a 1 online resource (xvi, 78 pages) :  |b color illustrations 
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505 0 0 |t Introduction --  |t Defining regulatory sciences --  |t The urgent need for regulatory science --  |t Barriers to enhanced regulatory science --  |t Potential models for building a regulatory science infrastructure --  |t Challenges in engaging the public policy community --  |t Envisioning successsful regulatory science at FDA --  |t Considering next steps. 
520 |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 
546 |a English. 
588 0 |a Print version record. 
610 1 0 |a United States.  |b Food and Drug Administration. 
650 0 |a Drug development  |z United States  |v Congresses. 
650 1 2 |a Drug Discovery 
650 2 2 |a Clinical Trials as Topic 
650 2 2 |a Drug Approval 
650 2 2 |a Drug Evaluation 
651 2 |a United States 
655 2 |a Congress 
655 7 |a Conference papers and proceedings.  |2 lcgft 
700 1 |a Lebovitz, Yeonwoo. 
700 1 |a English, Rebecca A. 
700 1 |a Claiborne, Anne B. 
710 2 |a Institute of Medicine (U.S.).  |b Forum on Drug Discovery, Development, and Translation. 
758 |i has work:  |a Building a national framework for the establishment of regulatory science for drug development (Text)  |1 https://id.oclc.org/worldcat/entity/E39PCFFHCDqPmgFpdM7y8RXDFX  |4 https://id.oclc.org/worldcat/ontology/hasWork 
776 0 8 |i Print version:  |t Building a national framework for the establishment of regulatory science for drug development.  |d Washington, D.C. : National Academies Press, ©2011  |z 9780309158893  |w (OCoLC)681488332 
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