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Detection and quantification of antibodies to biopharmaceuticals [[electronic resource] ] : practical and applied considerations / / edited by Michael G. Tovey
| Detection and quantification of antibodies to biopharmaceuticals [[electronic resource] ] : practical and applied considerations / / edited by Michael G. Tovey |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (442 p.) |
| Disciplina |
616.07/98
616.0798 |
| Altri autori (Persone) | ToveyMichael G |
| Soggetto topico |
Immunoglobulins - Analysis
Immunoassay |
| ISBN |
1-283-20385-5
9786613203854 1-118-07567-6 1-118-07568-4 1-118-07566-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 --
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. |
| Record Nr. | UNINA-9910139617103321 |
| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Detection and quantification of antibodies to biopharmaceuticals : practical and applied considerations / / edited by Michael G. Tovey
| Detection and quantification of antibodies to biopharmaceuticals : practical and applied considerations / / edited by Michael G. Tovey |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (442 p.) |
| Disciplina | 616.07/98 |
| Altri autori (Persone) | ToveyMichael G |
| Soggetto topico |
Immunoglobulins - Analysis
Immunoassay |
| ISBN |
1-283-20385-5
9786613203854 1-118-07567-6 1-118-07568-4 1-118-07566-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 --
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 / Jrgen Dahlstrm 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. |
| Record Nr. | UNINA-9910806999703321 |
| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||