Benefit-Risk Assessment Methods in Medical Product Development

Bridging Qualitative and Quantitative Assessments

Nonfiction, Health & Well Being, Medical, Reference, Biostatistics, Medical Science, Pharmacology, Science & Nature, Mathematics, Statistics
Cover of the book Benefit-Risk Assessment Methods in Medical Product Development by , CRC Press
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9781315355016
Publisher: CRC Press Publication: December 19, 2017
Imprint: Chapman and Hall/CRC Language: English
Author:
ISBN: 9781315355016
Publisher: CRC Press
Publication: December 19, 2017
Imprint: Chapman and Hall/CRC
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from CRC Press

Cover of the book Circuits, Signals, and Speech and Image Processing by
Cover of the book Wastewater Treatment and Reuse Theory and Design Examples, Volume 2 by
Cover of the book Applications of Fire Engineering by
Cover of the book Valuation: Special Properties & Purposes by
Cover of the book Survival Analysis with Interval-Censored Data by
Cover of the book Introduction to Holomorphic Functions of Several Variables, Volume I by
Cover of the book Nanomedicine for Inflammatory Diseases by
Cover of the book Semiconductor Transport by
Cover of the book Numerical Modeling in Micromechanics via Particle Methods by
Cover of the book More Cooking Innovations by
Cover of the book Recent Advances in Information Technology by
Cover of the book Electric Power Transformer Engineering by
Cover of the book Species by
Cover of the book Real Variables by
Cover of the book Microbial Biofilms by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy