Bookeditors, Robert Dodge, Renuka C. Pillutla.
Contents:
Immunogenicity assay development, validation and implementation / Robert Dodge & Renuka C. Pillutla
Current regulatory guidelines for immunogenicity assays / Xiao-Yan Cai & Constance Cullen
New technology and solutions in immunogenicity detection : case studies / Zhandong Don Zhong
Critical comparison of cell-based assays and immunoassays for neutralizing antibody detection / Renuka C. Pillutla & Robert Dodge
Drug-tolerant immunogenicity testing / Dharmesh D. Desai
Good practices for statistical estimation of cut point / Zhandong Don Zhong & Lei Zhou
Special challenges and considerations for developing assays for the detection of antidrug neutralizing antibodies / Mark A. Kroenke & Shalini Gupta
Tiered approach to anti-drug antibody testing / Robert Dodge & Heather Myler
Critical reagent stability for immunogenicity assays / Arron S.L. Xu & Jessica Weant
Index.