Statistical Methods for Immunogenicity Assessment

Summary

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

Product details

• Authors: Harry Yang, Harry (Medimmune Yang, Yang Harry, Binbing Yu, Yu Binbing, Jianchun Zhang, Zhang Jianchun, Wei Zhao, Zhao Wei
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Paperback / Softback
• Released: 18.12.2020
• EAN: 9780367737979
• ISBN: 978-0-367-73797-9
• No. of pages: 259
• Series: Chapman & Hall/CRC Biostatistics Series
• Subjects: Social sciences, law, business > Sociology; Sociology, Medical research, Epidemiology & medical statistics, SOCIAL SCIENCE / Sociology / General, MATHEMATICS / Probability & Statistics / General, MEDICAL / Biostatistics, MEDICAL / Research, MEDICAL / Epidemiology, Probability & statistics, Probability and statistics, Epidemiology and Medical statistics