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Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary [Minkštas viršelis]

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  • Formatas: Paperback / softback, 94 pages, aukštis x plotis: 229x152 mm, Illustrations
  • Išleidimo metai: 15-Mar-2011
  • Leidėjas: National Academies Press
  • ISBN-10: 0309158893
  • ISBN-13: 9780309158893
Kitos knygos pagal šią temą:
Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop SummaryDidesnis paveikslėlis
  • Formatas: Paperback / softback, 94 pages, aukštis x plotis: 229x152 mm, Illustrations
  • Išleidimo metai: 15-Mar-2011
  • Leidėjas: National Academies Press
  • ISBN-10: 0309158893
  • ISBN-13: 9780309158893
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9780309158893.html
Raktažodžiai:
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.
Acronyms xiii
Preface xv
1 Introduction 1(4)
Workshop Purpose and Objectives,
2(1)
Organization of This Report,
3(2)
2 Defining Regulatory Science 5(8)
3 The Urgent Need For Regulatory Science 13(10)
Challenges Faced by FDA,
13(2)
The Need for Regulatory Science in Predicting or Addressing Rare Adverse Reactions,
15(2)
The Need for Regulatory Science in Genomics,
17(2)
The Need for Regulatory Science in Statistical Design and Analysis,
19(4)
4 Barriers To Enhanced Regulatory Science 23(8)
Findings of the FDA Science Board,
23(6)
Systemic Barriers,
29(2)
5 Potential Models For Building A Regulatory Science Infrastructure 31(8)
Collaborative Models,
32(3)
The Centers of Excellence Model,
35(4)
6 Challenges In Engaging The Public Policy Community 39(6)
Challenges in Engaging the Public Policy Community,
40(1)
Public Opinion Poll Data on FDA,
40(3)
The Power of Patient Advocacy,
43(2)
7 Envisioning Successful Regulatory Science At FDA 45(4)
Key Areas of Scientific Emphasis,
45(4)
8 Considering Next Steps 49(4)
Immediate Next Steps for FDA,
50(1)
Building a Framework: Themes from the Workshop,
51(2)
References 53(4)
Appendixes
A Agenda
57(4)
B Participant Biographies
61