Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins

Journal of Pharmaceutical Sciences

Volumn 101, Issue 10, 2012, Pages 3560-3567

  Rosenberg, Amy S ^a   Verthelyi, Daniela ^a   Cherney, Barry W ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Immunology; Microparticles; Particle size; Physicochemical properties; Protein aggregation

Indexed keywords

ALPHA INTERFERON; BETA GLUCAN; DNA; ENDOTOXIN; FLAGELLIN; HUMAN GROWTH HORMONE; MONOCLONAL ANTIBODY; NANOPARTICLE; PROTEIN;

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CROSS LINKING; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; ENZYME REPLACEMENT; FIELD FLOW FRACTIONATION; FLOW CYTOMETRY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INNATE IMMUNITY; MOISTURE; MOLECULAR WEIGHT; NONHUMAN; OXIDATION; PH; PHYSICAL CHEMISTRY; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REDUCTION; UNSPECIFIED SIDE EFFECT; WART VIRUS;

EID: 84865349352     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23244     Document Type: Note

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