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Benefit-Risk Assessment Methods in Medical Product Development

- Bridging Qualitative and Quantitative Assessments

About 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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  • Language:
  • English
  • ISBN:
  • 9780367737085
  • Binding:
  • Paperback
  • Pages:
  • 296
  • Published:
  • December 18, 2020
  • Dimensions:
  • 178x254x0 mm.
  • Weight:
  • 539 g.
Delivery: 1-2 weeks
Expected delivery: June 29, 2024

Description of 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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