Statistical Methods for Immunogenicity Assessment

by Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao

Overview

Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra

Product Details

ISBN-13:	9781040211830
Publisher:	CRC Press
Publication date:	07/17/2015
Series:	Chapman & Hall/CRC Biostatistics Series
Sold by:	Barnes & Noble
Format:	eBook
Pages:	259
File size:	3 MB

About the Author

Harry Yang is a senior director, Jianchun Zhang is a principal statistician, Binbing Yu is an associate director, and Wei Zhao is a senior principal statistician at MedImmune, LLC in Gaithersburg, Maryland, USA.

Table of Contents

Introduction. ADA Assay Development and Validation. Determination of ADA Assay Cut Point. Clinical Immunogenicity Assessment. Immunogenicity Risk Control. Computational Tools for Immunogenicity Analysis. Bibliography. Index.

Editorial Reviews

"In summary, this book is a good resource to the professionals and practitioners developing the biological therapies, including statisticians, clinicians, pharmacokineticists, regulatory reviewers, toxicologists, clinical assay developers, and biopharmaceutical engineers."
~Journal of Biopharmaceutical Statistics

"The authors' work brings light into some of the issues surrounding immunogenicity of drugs. It is of great help to both clinical and nonclinical professionals, while some of the concepts can also be applied to situations when an immune response towards a drug (a vaccine) is desirable."
~Paul Tudor Tamas

"In summary, this book is a good resource to the professionals and practitioners developing the biological therapies, including statisticians, clinicians, pharmacokineticists, regulatory reviewers, toxicologists, clinical assay developers, and biopharmaceutical engineers."
~Journal of Biopharmaceutical Statistics

"The authors' work brings light into some of the issues surrounding immunogenicity of drugs. It is of great help to both clinical and nonclinical professionals, while some of the concepts can also be applied to situations when an immune response towards a drug (a vaccine) is desirable."
~Paul Tudor Tamas

From the Publisher