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- 000 03431cam a22003374a 4500
- 008 110121s2011 nju b 000 0 eng
- 020 __ |a 9780470566664 (cloth)
- 040 __ |a DNLM/DLC |c DLC
- 050 00 |a QR186.7 |b .D48 2011
- 082 00 |a 616.07/98 |2 22
- 245 00 |a Detection and quantification of antibodies to biopharmaceuticals : |b practical and applied considerations / |c [edited] by Michael G. Tovey.
- 260 __ |a Hoboken, N.J. : |b Wiley, |c c2011.
- 300 __ |a xxiii, 404 p., [12] p. of plates : |b ill. (some col.) ; |c 24 cm.
- 504 __ |a Includes bibliographical references.
- 505 0_ |a 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 --
- 505 0_ |a 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瞨gen Dahlstr瞞 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.
- 650 _0 |a Immunoglobulins |x Analysis.
- 650 12 |a Antibodies, Neutralizing |x analysis.
- 650 22 |a Antibodies, Neutralizing |x immunology.
- 650 22 |a Biological Products |x immunology.
- 650 22 |a Immunoassay |x methods.
- 700 1_ |a Tovey, Michael G.
- 950 __ |a SCNU |f Q939.91/T736