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Title
Immunogenicity/Hypersensitivity of Biologics
Authors
Keywords
-
Journal
TOXICOLOGIC PATHOLOGY
Volume 42, Issue 1, Pages 293-300
Publisher
SAGE Publications
Online
2013-11-16
DOI
10.1177/0192623313510987
References
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Related references
Note: Only part of the references are listed.- Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products [excerpts]
- (2013) BIOTECHNOLOGY LAW REPORT
- Biomarkers for non-human primate Type-I hypersensitivity: Antigen-specific immunoglobulin E assays
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- (2012) Ami C. Bautista et al. AAPS Journal
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- (2012) Steven J Swanson et al. CURRENT OPINION IN MICROBIOLOGY
- Structural basis for the killing of human beta cells by CD8+ T cells in type 1 diabetes
- (2012) Anna M Bulek et al. NATURE IMMUNOLOGY
- Regulatory Forum Opinion Piece*
- (2012) Michael W. Leach TOXICOLOGIC PATHOLOGY
- Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity
- (2012) Francesca Civoli et al. Bioanalysis
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- (2011) F. Jonsson et al. BLOOD
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- (2011) Friederike Jönsson et al. JOURNAL OF CLINICAL INVESTIGATION
- Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: an immunoassay platform comparison
- (2011) Troy E. Barger et al. NEPHROLOGY DIALYSIS TRANSPLANTATION
- Proposal for a new protein therapeutic immunogenicity titer assay cutpoint
- (2011) Eric Wakshull et al. Bioanalysis
- Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies
- (2010) Kay Stubenrauch et al. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
- Reducing risk, improving outcomes: Bioengineering less immunogenic protein therapeutics
- (2009) Anne S. De Groot et al. CLINICAL IMMUNOLOGY
- Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
- (2009) Rafael Ponce et al. REGULATORY TOXICOLOGY AND PHARMACOLOGY
- Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
- (2008) Gopi Shankar et al. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
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