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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Main Author: Lebovitz, Yeonwoo
Corporate Author: Institute of Medicine (U.S.) Forum on Drug Discovery, Development, and Translation
Other Authors: English, Rebecca A., Claiborne, Anne B.
Format: eBook
Language:English
Published: Washington, D.C. National Academies Press c2011, 2011
Subjects:
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
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100 1 |a Lebovitz, Yeonwoo 
245 0 0 |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 
246 3 1 |a Regulatory science for drug development 
246 3 1 |a Forum on Drug Discovery, Development, and Translation 
260 |a Washington, D.C.  |b National Academies Press  |c c2011, 2011 
300 |a xvi, 78 p.  |b col. ill.  |c 23 cm 
505 0 |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 
505 0 |a Includes bibliographical references 
653 |a Drug Evaluation 
653 |a United States 
653 |a Clinical Trials as Topic 
653 |a Drug Discovery 
653 |a Drug Approval 
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 
041 0 7 |a eng  |2 ISO 639-2 
989 |b NCBI  |a National Center for Biotechnology Information 
856 |u https://www.ncbi.nlm.nih.gov/books/NBK54404  |3 Volltext 
856 |u http://www.nap.edu/catalog.php?record_id=12968  |3 Volltext 
082 0 |a 610 
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