03749nam a2200361 a 4500001001200000003000800012006001900020007001500039008004100054010001700095020002600112020002600138020002500164020002500189020002700214040002100241035002100262050002500283082001800308245016300326260003600489300005700525504005100582505124300633505111701876533015202993650003103145650001703176655002903193700002203222710001703244856012603261ebr10484657CaPaEBRm        u        cr cn|||||||||110121s2011    njuadf  sb    001 0 eng d  z  2011002984  z9780470566664 (cloth)  z9781118075685 (oBook)  z9781118075661 (ePDF)  z9781118075678 (ePub)  z9781118075661 (e-book)  aCaPaEBRcCaPaEBR  a(OCoLC)73912027414aQR186.7b.D48 2011eb04a616.07/9822200aDetection and quantification of antibodies to biopharmaceuticalsh[electronic resource] :bpractical and applied considerations /cedited by Michael G. Tovey.  aHoboken, N.J. :bWiley,cc2011.  axxiii, 404 p., [12] p. of plates :bill. (some col.)  aIncludes bibliographical references and index.0 aPrincipals 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 --8 aThe 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.  aElectronic reproduction.bPalo Alto, Calif. :cebrary,d2011.nAvailable via World Wide Web.nAccess may be limited to ebrary affiliated libraries. 0aImmunoglobulinsxAnalysis. 0aImmunoassay. 7aElectronic books.2local1 aTovey, Michael G.2 aebrary, Inc.40uhttp://site.ebrary.com/lib/rucke/Doc?id=10484657zAn electronic book accessible through the World Wide Web; click to view