Benefit-risk assessment methods in medical product development: bridging qualitative and quantitative assessments
Éditeur :
Taylor & Francis Ltd
ISBN :
9780367737085
Date de publication :
18 déc. 2020
Dimensions :
25,4 x 17,8 cm
Poids :
580 g
Langue :
Anglais
Pays d'origine :
Grande Bretagne
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