Immunogenicity assay development, validation and implementation / 
editors, Robert Dodge, Renuka C. Pillutla. 
 - 1 PDF (106 pages) :  color illustrations, digital file. 
 - The Future Science Group eBook collection,  2047-332X .
 - Future Science Group eBook collection, .
<br/><br/>Includes bibliographical references and index. 
<br/><br/>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. 
<br/><br/> Restricted to subscribers or individual electronic text purchasers. 
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<br/><br/><br/>System requirements: Adobe Acrobat Reader. <br/>Mode of access: World Wide Web. 
<br/><br/><label>ISBN: </label>9781909453784 (ePub) 9781909453791 (eISBN) 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Biological assay.<br/>Immunogenetics.
<br/><br/><label>Index Terms--Genre/Form: </label><br/>Electronic books.