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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor Corporativo: | |
| Otros Autores: | , , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. :
National Academies Press,
©2011.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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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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| 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 | ||
| 504 | |a Includes bibliographical references (pages 53-55). | ||
| 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. |
| 588 | 0 | |a Print version record. | |
| 546 | |a English. | ||
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| 610 | 1 | 0 | |a United States. |b Food and Drug Administration. |
| 610 | 1 | 7 | |a United States. |b Food and Drug Administration |2 fast |
| 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 | |
| 650 | 6 | |a Médicaments |x Développement |z États-Unis |v Congrès. | |
| 650 | 7 | |a POLITICAL SCIENCE |x Government |x State & Provincial. |2 bisacsh | |
| 650 | 7 | |a Drug development |2 fast | |
| 651 | 7 | |a United States |2 fast |1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq | |
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| 655 | 7 | |a Actes de congrès. |2 rvmgf | |
| 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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