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

Summary

This book provides guidance on 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

Product details

• Authors: Qi He Jiang
• Assisted by: Weili He (Editor), He Weili (Editor), Qi Jiang (Editor), Jiang Qi (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Paperback / Softback
• Released: 18.12.2020
• EAN: 9780367737085
• ISBN: 978-0-367-73708-5
• No. of pages: 296
• Series: Chapman & Hall/CRC Biostatistics Series
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Pharmacy; Epidemiology & medical statistics, MEDICAL / Pharmacology, MEDICAL / Biostatistics, MEDICAL / Epidemiology, Pharmacology, Epidemiology and Medical statistics