TY - BOOK AU - Pillutla,Renuka C. AU - Dodge,Robert ED - Future Science Ltd., TI - Immunogenicity assay development, validation and implementation T2 - The Future Science Group eBook collection, PY - 2013///] CY - London, England PB - Future Science Ltd KW - Biological assay KW - Immunogenetics KW - Electronic books N1 - Includes bibliographical references and index; 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; Restricted to subscribers or individual electronic text purchasers; Also available in print UR - https://doi.org/10.4155/9781909453791 UR - https://doi-org.eresourcesptsl.ukm.remotexs.co/10.4155/9781909453791 ER -