Immunogenicity assay development, validation and implementation / editors, Robert Dodge, Renuka C. Pillutla.
Series: Future Science Group eBook collectionPublisher: London, England : Future Science Ltd , [2013]Description: 1 PDF (106 pages) : color illustrations, digital fileContent type:- text
- computer
- online resource
- 9781909453784 (ePub)
- 9781909453791 (eISBN)
- Also available in print.
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.
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Also available in print.
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Mode of access: World Wide Web.
Title from PDF title page (Future Science eBooks Web site, viewed November 18, 2013).
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