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.

• 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.

"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

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.

• 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.

"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

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.

• 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.

"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