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Detection and quantification of anti...

Tovey, Michael G.

Detection and quantification of antibodies to biopharmaceuticals :practical and applied considerations /

纪录类型:	书目-语言数据,印刷品 : Monograph/item
[NT 15000414] null:	616.07/98
[NT 47271] Title/Author:	Detection and quantification of antibodies to biopharmaceuticals : : practical and applied considerations // edited by Michael G. Tovey.
[NT 51406] other author:	Tovey, Michael G.
出版者:	Hoboken, N.J. : : Wiley,, c2011.
面页册数:	xxiii, 404 p., [12] p. of plates : : ill. (some col.) ;; 25 cm.
标题:	Immunoglobulins - Analysis.
标题:	Immunoassay.
标题:	Antibodies, Neutralizing - analysis.
标题:	Antibodies, Neutralizing - immunology.
标题:	Biological Products - immunology.
标题:	Immunoassay - methods.
ISBN:	9780470566664 (hbk.) :
ISBN:	0470566663 (hbk.)
ISBN:	9781118075685 (oBook)
ISBN:	1118075684 (oBook)
ISBN:	9781118075661 (ePDF)
ISBN:	1118075668 (ePDF)
ISBN:	9781118075678 (ePub)
ISBN:	1118075676 (ePub)
[NT 15000227] null:	Includes bibliographical references and index.
[NT 15000228] null:	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 --

Detection and quantification of antibodies to biopharmaceuticals :practical and applied considerations /
Detection and quantification of antibodies to biopharmaceuticals :practical and applied considerations /edited by Michael G. Tovey. - Hoboken, N.J. :Wiley,c2011. - xxiii, 404 p., [12] p. of plates :ill. (some col.) ;25 cm.

Includes bibliographical references and index.

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 --

ISBN: 9780470566664 (hbk.) :NTD 4,116

LCCN: 2011002984Subjects--Topical Terms:

461367
Immunoglobulins
--Analysis.

LC Class. No.: QR186.7 / .D48 2011

Dewey Class. No.: 616.07/98

Detection and quantification of antibodies to biopharmaceuticals :practical and applied considerations /
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020 $a 1118075668 (ePDF)
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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 / 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.
650 0 $a Immunoglobulins $x Analysis. $3 461367
650 0 $a Immunoassay. $3 422558
650 1 2 $a Antibodies, Neutralizing $x analysis. $3 461368
650 2 2 $a Antibodies, Neutralizing $x immunology. $3 461369
650 2 2 $a Biological Products $x immunology. $3 461370
650 2 2 $a Immunoassay $x methods. $3 461371
700 1 $a Tovey, Michael G. $3 461366