Immunogenicity assay development, validation and implementation /
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, .
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.
System requirements: Adobe Acrobat Reader.
Mode of access: World Wide Web.
9781909453784 (ePub) 9781909453791 (eISBN)
Biological assay.
Immunogenetics.
Electronic books.
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.
System requirements: Adobe Acrobat Reader.
Mode of access: World Wide Web.
9781909453784 (ePub) 9781909453791 (eISBN)
Biological assay.
Immunogenetics.
Electronic books.