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Detection and Quantification of Antibodies to Biopharmaceuticals : Practical and Applied Considerations.
The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Chicester :
Wiley,
2011.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 082 | 0 | 4 | |a 616.07/98 |a 616.0798 |
| 049 | |a UAMI | ||
| 100 | 1 | |a Tovey, Michael G. | |
| 245 | 1 | 0 | |a Detection and Quantification of Antibodies to Biopharmaceuticals : |b Practical and Applied Considerations. |
| 260 | |a Chicester : |b Wiley, |c 2011. | ||
| 300 | |a 1 online resource (442 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 588 | 0 | |a Print version record. | |
| 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 | 8 | |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. | |
| 520 | |a The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection an. | ||
| 504 | |a Includes bibliographical references and index. | ||
| 546 | |a English. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Immunoglobulins |x Analysis. | |
| 650 | 0 | |a Immunoassay. | |
| 650 | 2 | |a Immunoassay | |
| 650 | 6 | |a Immunodosage. | |
| 650 | 7 | |a Immunoassay |2 fast | |
| 650 | 7 | |a Immunoglobulins |x Analysis |2 fast | |
| 758 | |i has work: |a Detection and quantification of antibodies to biopharmaceuticals (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGJmmHHQvrr9KdD64YdKgq |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Tovey, Michael G. |t Detection and Quantification of Antibodies to Biopharmaceuticals : Practical and Applied Considerations. |d Chicester : Wiley, ©2011 |z 9780470566664 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=697533 |z Texto completo |
| 880 | 0 | |6 505-00/(S |a DETECTION AND QUANTIFICATION OF ANTIBODIES TO BIOPHARMACEUTICALS -- CONTENTS -- INTRODUCTION : A PERSPECTIVE -- CONTRIBUTORS -- PART I: RISK-BASED STRATEGIES -- 1: PRINCIPLES OF RISK ASSESSMENT AND MONITORING OF ANTIBODY RESPONSES TO BIOPHARMACEUTICALS -- PART II: REGULATORY REQUIREMENTS -- 2: IMMUNOGENICITY OF THERAPEUTIC PROTEINS: A REGULATORY PERSPECTIVE -- 3: GUIDANCE ON IMMUNOGENICITY ASSESSMENT OF BIOLOGICALLY DERIVED THERAPEUTIC PROTEINS: A EUROPEAN PERSPECTIVE -- 4: JAPANESE REGULATORY PERSPECTIVE ON IMMUNOGENICITY -- PART III: PRINCIPAL TECHNOLOGIES EMPLOYED FOR THE QUANTIFICATION OF ANTI-DRUG ANTIBODIES -- 5: ENZYME IMMUNOASSAYS AND RADIOIMMUNOASSAYS FOR QUANTIFICATION OF ANTI-TNF BIOPHARMACEUTICALS AND ANTI-DRUG ANTIBODIES -- 6: CONFIRMATORY IMMUNOGENICITY ASSAYS -- 7: THE USE OF PHARMACODYNAMICS AS A SURROGATE MARKER FOR THE DETECTION OF ANTI-DRUG NEUTRALIZING ANTIBODIES -- 8: CELL-BASED ASSAYS FOR THE DETECTION OF NEUTRALIZING ANTIBODIES TO INTERFERON BETA (IFN-β) AND TUMOR NECROSIS FACTOR ALPHA (TNF-α) INHIBITORS -- 9: DETECTION OF NEUTRALIZING ANTIBODIES AGAINST INTERFERON BETA BY REAL-TIME RT-PCR -- 10: COMPETITIVE LIGAND-BINDING ASSAYS FOR THE DETECTION OF NEUTRALIZING ANTIBODIES -- 11: THE USE OF SURFACE PLASMON RESONANCE FOR THE DETECTION AND CHARACTERIZATION OF ANTIBODIES -- 12: HYPERSENSITIVITY REACTIONS TO BIOPHARMACEUTICALS: DETECTION AND QUANTIFICATION OF DRUG-SPECIFIC IGE ANTIBODIES -- PART IV: ASSAY STANDARDIZATION AND VALIDATION -- 13: STANDARDIZATION AND VALIDATION OF IMMUNOASSAYS -- 14: STANDARDIZATION AND VALIDATION OF CELL-BASED ASSAYS FOR THE DETECTION OF NEUTRALIZING ANTI-DRUG ANTIBODIES -- 15: STANDARDIZATION OF NEUTRALIZING ANTIBODY UNITAGE BY BIOASSAY DESIGN: CONSTANT ANTIGEN AND CONSTANT ANTIBODY METHODOLOGY -- PART V: STATISTICAL CONSIDERATIONS. | |
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