Tracked shipping to South Africa with premium packaging for just R199 

Ship to
South Africa
0

My Account

  • argentina
  • chile
  • colombia
  • españa
  • méxico
  • perú
  • estados unidos
  • internacional

menu

Select your country

Americas

Europe

Rest of the world

portada Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments
Type
Physical Book
Publisher
Author
Language
English
Pages
296
Format
Hardcover
ISBN13
9781482259360
Categories

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments

Jiang, Qi ; He, Weili (Author) · CRC Press · Hardcover

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments - Jiang, Qi ; He, Weili

New Book Imported to South Africa
Delivery: 26 Aug - 04 Sep Shipping: 13 to 14 business days.
R 3,096
R 3,096

Choose the list to add your product or create one New List

Go to My Wishlists
Calculate shipping cost

Synopsis "Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments"

Guides You on the Development and Implementation of B-R EvaluationsBenefit-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.

Customers reviews

More customer reviews
  • 0% (0)
  • 0% (0)
  • 0% (0)
  • 0% (0)
  • 0% (0)

Frequently Asked Questions about the Book

Is the book original?

All books in our catalog are Original.

In what language is the book written?

The book is written in English.

What is the format of this book?

The binding of this edition is Hardcover.

Questions and Answers about the Book

Do you have a question about the book? Login to be able to add your own question.

Opinions about Bookdelivery

More customer reviews