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008 110706s2011 nju ob 000 0 eng
010 _z 2011002984
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019 _a747412453
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020 _a9781118075685
020 _a1118075684
020 _a9781118075661
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020 _a1118075668
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024 8 _a9786613203854
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035 _a(OCoLC)739120274
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_z(OCoLC)961555913
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037 _a10.1002/9781118075685
_bWiley InterScience
_nhttp://www3.interscience.wiley.com
050 4 _aQR186.7
_b.D48 2011
060 4 _aQW 575
072 7 _aMED
_x044000
_2bisacsh
082 0 4 _a616.07/98
_223
049 _aMAIN
245 0 0 _aDetection and quantification of antibodies to biopharmaceuticals :
_bpractical and applied considerations /
_c[edited] by Michael G. Tovey.
260 _aHoboken, N.J. :
_bWiley,
_c©2011.
300 _a1 online resource (xxiii, 404 pages)
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _adata file
_2rda
380 _aBibliography
504 _aIncludes bibliographical references.
505 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.
505 0 _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 / 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.
588 0 _aPrint version record.
650 0 _aImmunoglobulins
_xAnalysis.
650 0 _aImmunoassay.
650 7 _aMEDICAL
_xImmunology.
_2bisacsh
650 7 _aImmunoassay.
_2fast
_0(OCoLC)fst00967921
650 7 _aImmunoglobulins
_xAnalysis.
_2fast
_0(OCoLC)fst00967962
650 2 _aAntibodies, Neutralizing
_xanalysis.
650 2 _aAntibodies, Neutralizing
_ximmunology.
650 2 _aBiological Factors
_ximmunology.
650 2 _aImmunoassay
_xmethods.
655 4 _aElectronic books.
655 7 _aElectronic books.
_2local
700 1 _aTovey, Michael G.
710 2 _aWiley InterScience (Online service)
776 0 8 _iPrint version:
_tDetection and quantification of antibodies to biopharmaceuticals.
_dHoboken, N.J. : Wiley, ©2011
_w(DLC) 2011002984
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9781118075685
_zWiley Online Library
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