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Benefit-Risk Assessment Methods in Medical Product Development

- Bridging Qualitative and Quantitative Assessments

Bag om Benefit-Risk Assessment Methods in Medical Product Development

This book provides guidance on selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9780367737085
  • Indbinding:
  • Paperback
  • Sideantal:
  • 296
  • Udgivet:
  • 18. december 2020
  • Størrelse:
  • 178x254x0 mm.
  • Vægt:
  • 539 g.
  • 2-4 uger.
  • 18. december 2024
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This book provides guidance on selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The

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