Statistical methods for immunogenicity assessment
Auteur :
Yang, Harry / Zhang, Jianchun / Yu, Binbing / Zhao, Wei
Éditeur :
Taylor & Francis Ltd
ISBN :
9780367737979
Date de publication :
18 déc. 2020
Dimensions :
23,4 x 15,6 cm
Poids :
367 g
Langue :
Anglais
Pays d'origine :
Grande Bretagne
A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. Along with covering regulatory requirements, the authors discuss statisti