Detection and quantification of antibodies to biopharmaceuticals : practical and applied considerations

Detection and quantification of antibodies to biopharmaceuticals : practical and applied considerations Tovey, Michael G. Wiley InterScience (Online service) text bibliography Electronic books. Electronic books. nju Hoboken, N.J Wiley �2011 2011 monographic eng 1 online resource (xxiii, 404 pages) Principals of risk assessment and monitoring of antibody responses to biopharmaceuticals / Eugen Koren, Erik Foehr, and Charles A. O'Neill -- Immunogenicity of therapeutic proteins : a regulatory perspective / Susan Kirshner -- Guidance on immunogenicity assessment of biologically-derived therapeutic proteins : an European perspective / Meenu Wadhwa and Robin Thorpe -- Japanese regulatory perspective on immunogenicity / Takao Hayakawa and Akiko Ishii -- Enzyme immunoassays and radioimmune assays for quantification of anti-TNF biopharmaceuticals and anti-drug antibodies / Klaus Bendtzen and Morten Svenson -- Confirmatory immunogenicity assays / Eric Wakshull and Daniel Coleman -- The use of pharmacodynamics as a surrogate marker for the detection of anti-drug neutralizing antibodies / Florian Deisenhammer -- Cell-based assays for the detection of neutralizing antibodies to interferon beta (IFN-?) and tumor necrosis factor-alpha (TNF-?) inhibitors / Anthony Meager -- Detection of neutralizing antibodies (NABs) to Interferon-beta by real time RT-PCR / Francesca Gilli and Antonio Bertolotto -- Competitive ligand binding assays for the detection of neutralizing antibodies / Bonnie Wu, George R. Gunn III, and Gopi Shankar. The use of surface plasmon resonance for the detection and characterization of antibodies / Steven J. Swanson and Daniel Mytych -- Hypersensitivity reactions to biopharmaceuticals : detection and quantification of drug-specific IgE antibodies / J�rgen Dahlstr�m and Lennart Venemalm -- Standardization and validation of immunoassays and biophysical assays for the detection of anti-drug antibodies / Daniel Kramer -- Standardization and validation of cell-based assays for the detection of neutralizing anti-drug antibodies / Deborah Finco-Kent and Amy Grenham -- Standardization of neutralizing antibody unitge by bioassay design : constant antigen and constant antibody methodology / Sidney E. Grossberg, Yoshimi Kawade, and Leslie D. Grossberg -- Cut-points and performance characteristics for anti-drug antibody assays / Viswanath Devanarayan and Michael G. Tovey -- Dilutional linearity for neutralizing antibody assays / David Lansky and Carrie Wager -- Detection of neutralizing antibodies to biopharmaceuticals in the presence of high levels of circulating drug / Arno Kromminga and Michael G. Tovey. [edited] by Michael G. Tovey. Includes bibliographical references. Immunoglobulins Analysis Immunoassay MEDICAL Immunology Immunoassay Immunoglobulins Analysis Antibodies, Neutralizing analysis Antibodies, Neutralizing immunology Biological Factors immunology Immunoassay methods QR186.7 .D48 2011 616.07/98 QW 575 Detection and quantification of antibodies to biopharmaceuticals Hoboken, N.J. : Wiley, �2011 (DLC) 2011002984 9781118075685 1118075684 9781118075661 1118075668 0470566663 9780470566664 10.1002/9781118075685 Wiley InterScience http://onlinelibrary.wiley.com/book/10.1002/9781118075685 http://onlinelibrary.wiley.com/book/10.1002/9781118075685 DG1 110706 20171116135243.0 ocn739120274 eng