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Record Nr. |
UNINA9910819115603321 |
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Titolo |
Challenges for the FDA : the future of drug safety : workshop summary / / Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs |
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Pubbl/distr/stampa |
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Washington, DC, : National Academies Press, c2007 |
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ISBN |
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0-309-17944-0 |
1-281-09355-6 |
9786611093556 |
0-309-10987-6 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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Altri autori (Persone) |
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PrayLeslie A |
RobinsonSally |
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Soggetti |
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Drugs - United States - Testing |
Drugs - United States - Safety measures |
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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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Bibliographic Level Mode of Issuance: Monograph |
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Nota di bibliografia |
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Includes bibliographical references (p. 78-79). |
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Nota di contenuto |
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FrontMatter -- Reviewers -- Preface -- Contents -- Tables, Figures, and Boxes -- Summary -- 1 Introduction -- 2 Addressing the FDA's Resource Challenges -- 3 Strengthening the Scientific Base of the Agency -- 4 Integrating Pre- and Postmarket Review -- 5 Enhancing Postmarket Safety Monitoring -- 6 Conducting Confirmatory Drug Safety and Efficacy Studies -- 7 Enhancing the Value of Clinical Trial Registration -- 8 Enhancing Postmarket Regulation and Enforcement -- 9 Looking to the Future -- References -- Appendixes -- Appendix A Workshop Agenda -- Appendix B Speaker Biographies. |
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