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Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments by Weili He, Qi Jiang (Hardcover, 2016)

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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.

Product Identifiers

Publisher
Apple Academic Press Inc.
ISBN-13
9781482259360
eBay Product ID (ePID)
223057100

Product Key Features

Subject Area
Chemical Engineering
Author
Weili He, Qi Jiang
Publication Name
Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments
Format
Hardcover
Language
English
Subject
Medicine
Publication Year
2016
Type
Textbook
Number of Pages
296 Pages

Dimensions

Item Height
254mm
Item Width
178mm
Item Weight
816g

Additional Product Features

Series Title
Chapman & Hall/Crc Biostatistics Series
Country/Region of Manufacture
Canada
Editor
Weili He, Qi Jiang

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Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments by Weili He, Qi Jiang (Hardcover, 2016)

About this product

Product Information

Product Identifiers

Product Key Features

Dimensions

Additional Product Features

Best Selling in Textbooks

Diagnostic and Statistical Manual of Mental Disorders DSM-5-TR by American Psychiatric Association (2022, Trade Paperback)

Self Heal by Design : The Role of Micro-organisms for Health by Barbara O'Neill (2018, Trade Paperback)

Leadership : Theory and Practice by Peter G. Northouse (2021, Trade Paperback, Revised edition)

Research Design : Qualitative, Quantitative, and Mixed Methods Approaches by J. David Creswell and John W. Creswell (2022, Trade Paperback)

Designing Data-Intensive Applications : The Big Ideas Behind Reliable, Scalable, and Maintainable Systems by Martin Kleppmann (2017, Trade Paperback)

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Encyclopedia of Counseling : Master Review and Tutorial for the National Counselor Examination, State Counseling Exams, and the Counselor Preparation Comprehensive Examination by Howard Rosenthal (2017, Trade Paperback, Revised edition,New Edition)

Save on Textbooks

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