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Benefit-Risk Assessment Methods in Medical Product Development - Bridging Qualitative and Quantitative Assessments (Hardcover)
Loot Price: R2,876
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Benefit-Risk Assessment Methods in Medical Product Development - Bridging Qualitative and Quantitative Assessments (Hardcover)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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Guides You on the Development and Implementation of B-R Evaluations
Benefit-Risk Assessment Methods in Medical Product Development:
Bridging Qualitative and Quantitative Assessments provides general
guidance and case studies to aid practitioners in 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 first section
of the book discusses the role of B-R assessments in medicine
development and regulation, the need for both a common B-R
framework and patient input into B-R decisions, and future
directions. The second section focuses on legislative and
regulatory policy initiatives as well as decisions made at the U.S.
FDA's Center for Devices and Radiological Health. The third section
examines key elements of B-R evaluations in a product's life cycle,
such as uncertainty evaluation and quantification, quantifying
patient B-R trade-off preferences, ways to identify subgroups with
the best B-R profiles, and data sources used to assist B-R
assessment. The fourth section equips practitioners with tools to
conduct B-R evaluations, including assessment methodologies, a
quantitative joint modeling and joint evaluation framework, and
several visualization tools. The final section presents a rich
collection of case studies. With top specialists sharing their
in-depth knowledge, thought-provoking considerations, and practical
advice, this book offers comprehensive coverage of B-R evaluation
methods, tools, and case studies. It gives practitioners a
much-needed toolkit to develop and conduct their own B-R
evaluations.
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