Name: Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (Chapman & Hall (en Inglés)
Price: 83960.00 CLP
Availability: InStock
Author: Jiang, Qi ; He, Weili
ISBN: 9780367737085

portada Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (Chapman & Hall (en Inglés)

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (Chapman & Hall (en Inglés)

Formato

Libro Físico

Ilustrado por

Qi Jiang

Weili He

Editorial

CRC Press

Autor

Jiang, Qi ; He, Weili

Año

2020

Idioma

Inglés

N° páginas

296

Encuadernación

Tapa Blanda

Dimensiones

24.9 x 17.5 x 2.0 cm

Peso

0.52 kg.

ISBN13

9780367737085

N° edición

Categorías

Investigación médica
Epidemiología y estadística médica
Farmacología
Probabilidad y estadística

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (Chapman & Hall (en Inglés)

Qi Jiang (Ilustrado por) · Weili He (Ilustrado por) · CRC Press · Tapa Blanda

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Reseña del libro "Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (Chapman & Hall (en Inglés)"

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.