05202cam a2200745Ka 4500 ocn739120274 OCoLC 20171116135243.0 m o d cr cn||||||||| 110706s2011 nju ob 000 0 eng 2011002984 9781118075685 1118075684 9781118075661 (e-book) 1118075668 (e-book) 0470566663 (Cloth) 9780470566664 (Cloth) 9780470566664 (cloth) 9781118075678 (ePub) 9786613203854 AU@ 000049163109 AU@ 000053280047 DKDLA 820120-katalog:000571996 DKDLA 830060-katalog:10484657 DKDLA 860900-katalog:10484657 NZ1 15915613 DEBBG BV043393313 (OCoLC)739120274 (OCoLC)747412453 (OCoLC)751680753 (OCoLC)758670738 (OCoLC)961555913 (OCoLC)962625736 (OCoLC)966204491 10.1002/9781118075685 Wiley InterScience http://www3.interscience.wiley.com DG1 eng pn DG1 E7B OCLCQ CDX YDXCP N$T OCLCQ OCLCF OCLCA OCLCQ NLGGC OCLCQ EBLCP OCLCQ DEBBG AZK LOA OCLCO OCLCA MERER OCLCO MAIN QR186.7 .D48 2011 QW 575 MED 044000 bisacsh 616.07/98 23 Detection and quantification of antibodies to biopharmaceuticals : practical and applied considerations / [edited] by Michael G. Tovey. [electronic resource] Hoboken, N.J. : Wiley, ©2011. 1 online resource (xxiii, 404 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier data file rda Bibliography Includes bibliographical references. 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 / Jørgen Dahlstrøm 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. Print version record. Immunoglobulins Analysis. Immunoassay. MEDICAL Immunology. bisacsh Immunoassay. fast (OCoLC)fst00967921 Immunoglobulins Analysis. fast (OCoLC)fst00967962 Antibodies, Neutralizing analysis. Antibodies, Neutralizing immunology. Biological Factors immunology. Immunoassay methods. Electronic books. Electronic books. local Tovey, Michael G. Wiley InterScience (Online service) Print version: Detection and quantification of antibodies to biopharmaceuticals. Hoboken, N.J. : Wiley, ©2011 (DLC) 2011002984 http://onlinelibrary.wiley.com/book/10.1002/9781118075685 Wiley Online Library ddc BK 205173 205173