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题名/责任者:

Detection and quantification of antibodies to biopharmaceuticals : practical and applied considerations / [edited] by Michael G. Tovey.

出版发行项:

Hoboken, N.J. : Wiley, c2011.

ISBN:

9780470566664 (cloth)

载体形态项:

xxiii, 404 p., [12] p. of plates : ill. (some col.) ; 24 cm.

附加个人名称:

Tovey, Michael G.

论题主题:

Immunoglobulins-Analysis.

论题主题:

Immunoassay.

论题主题:

Antibodies, Neutralizing-analysis.

论题主题:

Antibodies, Neutralizing-immunology.

论题主题:

Biological Products-immunology.

论题主题:

Immunoassay-methods.

中图法分类号:

Q939.91

书目附注:

Includes bibliographical references.

内容附注:

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 --

内容附注:

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.

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