LEADER 04641nam 2200589 a 450 001 9910806999703321 005 20200520144314.0 010 $a1-283-20385-5 010 $a9786613203854 010 $a1-118-07567-6 010 $a1-118-07568-4 010 $a1-118-07566-8 035 $a(CKB)2550000000041471 035 $a(EBL)697533 035 $a(OCoLC)828303987 035 $a(SSID)ssj0000535802 035 $a(PQKBManifestationID)12200792 035 $a(PQKBTitleCode)TC0000535802 035 $a(PQKBWorkID)10546284 035 $a(PQKB)11038768 035 $a(MiAaPQ)EBC697533 035 $a(PPN)240475747 035 $a(EXLCZ)992550000000041471 100 $a20110121d2011 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aDetection and quantification of antibodies to biopharmaceuticals $epractical and applied considerations /$fedited by Michael G. Tovey 205 $a1st ed. 210 $aHoboken, N.J. $cWiley$dc2011 215 $a1 online resource (442 p.) 300 $aDescription based upon print version of record. 311 $a0-470-56666-3 320 $aIncludes bibliographical references and index. 327 $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 -- 327 $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 / Jrgen Dahlstrm 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. 330 $a The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection an 606 $aImmunoglobulins$xAnalysis 606 $aImmunoassay 615 0$aImmunoglobulins$xAnalysis. 615 0$aImmunoassay. 676 $a616.07/98 701 $aTovey$b Michael G$01698469 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910806999703321 996 $aDetection and quantification of antibodies to biopharmaceuticals$94079969 997 $aUNINA