Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: Regulatory and bioanalytical considerations

Bioanalysis

Volumn 5, Issue 5, 2013, Pages 561-574

  Chamberlain, Paul ^a  

^a NDA Advisory Services Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ANTINUCLEAR ANTIBODY; BIOSIMILAR AGENT; CELL PROTEIN; DOUBLE STRANDED DNA ANTIBODY; DRUG ANTIBODY; ESCHERICHIA COLI PROTEIN; IMMUNOGLOBULIN E; IMMUNOGLOBULIN F(AB')2 FRAGMENT; IMMUNOGLOBULIN G1; IMMUNOGLOBULIN M; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY; NEUTRALIZING ANTIBODY; PLACEBO; RECOMBINANT ERYTHROPOIETIN; TUMOR NECROSIS FACTOR ALPHA ANTIBODY;

ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY SPECIFICITY; ANTIGEN BINDING; BIOASSAY; BIOEQUIVALENCE; CROHN DISEASE; DELAYED HYPERSENSITIVITY; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DETERMINATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG MARKETING; DRUG MONITORING; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERANCE; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; IMMUNOGENICITY; IMMUNOGLOBULIN E MEDIATED HYPERSENSITIVITY; INCIDENCE; INFUSION RELATED REACTION; INJECTION SITE REACTION; RADIOIMMUNOASSAY; REVIEW; RHEUMATOID ARTHRITIS; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SENSITIVITY AND SPECIFICITY; SINGLE DRUG DOSE; SYSTEMIC LUPUS ERYTHEMATOSUS; UNSPECIFIED SIDE EFFECT;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; AUTOIMMUNE DISEASES; BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; HUMANS; RECOMBINANT PROTEINS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84874169316     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.6     Document Type: Review

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