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Record Nr. |
UNINA9910828319503321 |
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Titolo |
Building a national framework for the establishment of regulatory science for drug development : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs |
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Pubbl/distr/stampa |
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Washington, D.C., : National Academies Press, 2011 |
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ISBN |
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0-309-20959-5 |
1-283-01910-8 |
9786613019103 |
0-309-15890-7 |
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Edizione |
[First edition.] |
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Descrizione fisica |
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1 online resource (95 pages) |
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Altri autori (Persone) |
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LebovitzYeonwoo |
EnglishRebecca A |
ClaiborneAnne B |
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Disciplina |
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Soggetti |
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Pharmaceutical policy - United States |
Drug development - Government policy - United States |
Pharmaceutical industry - Government policy - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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"Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy." |
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Nota di bibliografia |
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Includes bibliographical references. |
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Nota di contenuto |
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""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""Preface""; ""1 Introduction""; ""2 Defining Regulatory Science""; ""3 The Urgent Need for Regulatory Science""; ""4 Barriers to Enhanced Regulatory Science""; ""5 Potential Models for Building a Regulatory Science Infrastructure""; ""6 Challenges in Engaging the Public Policy Community""; ""7 Envisioning Successful Regulatory Science at FDA""; ""8 Considering Next Steps""; ""References""; ""Appendix A: Agenda""; ""Appendix B: Participant Biographies"" |
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Sommario/riassunto |
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"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 |
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