Building a national framework for the establishment of regulatory science for drug development: workshop summary
Gespeichert in:
Format: | Elektronisch E-Book |
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Sprache: | English |
Veröffentlicht: |
Washington, D.C.
National Academies Press
c2011
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Schlagworte: | |
Online-Zugang: | FAW01 FAW02 Volltext |
Beschreibung: | "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 Includes bibliographical references (p. 53-55) 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 |
Beschreibung: | 1 Online-Ressource (xvi, 78 p.) |
ISBN: | 0309158893 0309158907 9780309158893 9780309158909 |
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245 | 1 | 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 | 1 | 3 | |a Regulatory science for drug development |
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264 | 1 | |a Washington, D.C. |b National Academies Press |c c2011 | |
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500 | |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 | ||
500 | |a Includes bibliographical references (p. 53-55) | ||
500 | |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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610 | 1 | 4 | |a United States / Food and Drug Administration |
610 | 2 | 4 | |a United States |b Food and Drug Administration |
650 | 7 | |a POLITICAL SCIENCE / Government / State & Provincial |2 bisacsh | |
650 | 7 | |a Drug development |2 fast | |
650 | 4 | |a Drug Discovery / Congresses / United States | |
650 | 4 | |a Clinical Trials as Topic / Congresses / United States | |
650 | 4 | |a Drug Approval / Congresses / United States | |
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650 | 4 | |a Drug development |z United States |v Congresses | |
651 | 4 | |a USA | |
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isbn | 0309158893 0309158907 9780309158893 9780309158909 |
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spelling | Building a national framework for the establishment of regulatory science for drug development workshop summary 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 Regulatory science for drug development Forum on Drug Discovery, Development, and Translation Washington, D.C. National Academies Press c2011 1 Online-Ressource (xvi, 78 p.) txt rdacontent c rdamedia cr rdacarrier "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 Includes bibliographical references (p. 53-55) 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 United States / Food and Drug Administration fast United States / Food and Drug Administration United States Food and Drug Administration POLITICAL SCIENCE / Government / State & Provincial bisacsh Drug development fast Drug Discovery / Congresses / United States Clinical Trials as Topic / Congresses / United States Drug Approval / Congresses / United States Drug Evaluation / Congresses / United States Drug development United States Congresses USA (DE-588)1071861417 Konferenzschrift gnd-content Lebovitz, Yeonwoo Sonstige oth English, Rebecca A. Sonstige oth Claiborne, Anne B. Sonstige oth Institute of Medicine (U.S.) Forum on Drug Discovery, Development, and Translation Sonstige oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=359520 Aggregator Volltext |
spellingShingle | Building a national framework for the establishment of regulatory science for drug development workshop summary United States / Food and Drug Administration fast United States / Food and Drug Administration United States Food and Drug Administration POLITICAL SCIENCE / Government / State & Provincial bisacsh Drug development fast Drug Discovery / Congresses / United States Clinical Trials as Topic / Congresses / United States Drug Approval / Congresses / United States Drug Evaluation / Congresses / United States Drug development United States Congresses |
subject_GND | (DE-588)1071861417 |
title | Building a national framework for the establishment of regulatory science for drug development workshop summary |
title_alt | Regulatory science for drug development Forum on Drug Discovery, Development, and Translation |
title_auth | Building a national framework for the establishment of regulatory science for drug development workshop summary |
title_exact_search | Building a national framework for the establishment of regulatory science for drug development workshop summary |
title_full | Building a national framework for the establishment of regulatory science for drug development workshop summary 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 |
title_fullStr | Building a national framework for the establishment of regulatory science for drug development workshop summary 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 |
title_full_unstemmed | Building a national framework for the establishment of regulatory science for drug development workshop summary 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 |
title_short | Building a national framework for the establishment of regulatory science for drug development |
title_sort | building a national framework for the establishment of regulatory science for drug development workshop summary |
title_sub | workshop summary |
topic | United States / Food and Drug Administration fast United States / Food and Drug Administration United States Food and Drug Administration POLITICAL SCIENCE / Government / State & Provincial bisacsh Drug development fast Drug Discovery / Congresses / United States Clinical Trials as Topic / Congresses / United States Drug Approval / Congresses / United States Drug Evaluation / Congresses / United States Drug development United States Congresses |
topic_facet | United States / Food and Drug Administration United States Food and Drug Administration POLITICAL SCIENCE / Government / State & Provincial Drug development Drug Discovery / Congresses / United States Clinical Trials as Topic / Congresses / United States Drug Approval / Congresses / United States Drug Evaluation / Congresses / United States Drug development United States Congresses USA Konferenzschrift |
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