Benefit-Risk Assessment Methods in Medical Product Development (eBook, PDF)
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  • Format: PDF

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 book delineates approaches for uncertainty quantifications, describes how to elicit patients' views on benefits and risks, and explains how to select the appropriate B-R method for various evaluation settings. It also covers the graphical presentation of a B-R profile.…mehr

Produktbeschreibung
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 book delineates approaches for uncertainty quantifications, describes how to elicit patients' views on benefits and risks, and explains how to select the appropriate B-R method for various evaluation settings. It also covers the graphical presentation of a B-R profile.

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