03780nam a2200373 a 4500 ebr10484657 CaPaEBR m u cr cn||||||||| 110121s2011 njuadf sb 001 0 eng d 2011002984 9780470566664 (cloth) 9781118075685 (oBook) 9781118075661 (ePDF) 9781118075678 (ePub) 9781118075661 (e-book) CaPaEBR CaPaEBR (OCoLC)739120274 QR186.7 .D48 2011eb 616.07/98 22 Detection and quantification of antibodies to biopharmaceuticals [electronic resource] : practical and applied considerations / edited by Michael G. Tovey. Hoboken, N.J. : Wiley, c2011. xxiii, 404 p., [12] p. of plates : ill. (some col.) Includes bibliographical references and index. 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. Electronic reproduction. Palo Alto, Calif. : ebrary, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries. Immunoglobulins Analysis. Immunoassay. Electronic books. local Tovey, Michael G. ebrary, Inc. http://site.ebrary.com/lib/rucke/Doc?id=10484657 An electronic book accessible through the World Wide Web; click to view 120700 120700