000			03780nam a2200373 a 4500
001			ebr10484657
003			CaPaEBR
006			m u
007			cr cn|||||||||
008			110121s2011 njuadf sb 001 0 eng d
010			_z 2011002984
020			_z9780470566664 (cloth)
020			_z9781118075685 (oBook)
020			_z9781118075661 (ePDF)
020			_z9781118075678 (ePub)
020			_z9781118075661 (e-book)
040			_aCaPaEBR _cCaPaEBR
035			_a(OCoLC)739120274
050	1	4	_aQR186.7 _b.D48 2011eb
082	0	4	_a616.07/98 _222
245	0	0	_aDetection and quantification of antibodies to biopharmaceuticals _h[electronic resource] : _bpractical and applied considerations / _cedited by Michael G. Tovey.
260			_aHoboken, N.J. : _bWiley, _cc2011.
300			_axxiii, 404 p., [12] p. of plates : _bill. (some col.)
504			_aIncludes bibliographical references and index.
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	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.
533			_aElectronic reproduction. _bPalo Alto, Calif. : _cebrary, _d2011. _nAvailable via World Wide Web. _nAccess may be limited to ebrary affiliated libraries.
650		0	_aImmunoglobulins _xAnalysis.
650		0	_aImmunoassay.
655		7	_aElectronic books. _2local
700	1		_aTovey, Michael G.
710	2		_aebrary, Inc.
856	4	0	_uhttp://site.ebrary.com/lib/rucke/Doc?id=10484657 _zAn electronic book accessible through the World Wide Web; click to view
999			_c223811 _d223811