Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development

Bioanalysis

Volumn 5, Issue 5, 2013, Pages 517-520

  Cai, Xiao Yan ^a   Wake, Ashleigh ^b   Gouty, Dominique ^c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Intertek Pharmaceutical   (United Kingdom)

^c Intertek   (United States)

Author keywords

analytical; bioanalytical; biologics; biopharmaceuticals; biosimilars; comparability studies

Indexed keywords

AMINO ACID; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; CARBOHYDRATE; DISULFIDE; DRUG ANTIBODY; GENERIC DRUG; NEUTRALIZING ANTIBODY; RECOMBINANT ERYTHROPOIETIN; THIOL DERIVATIVE;

AMINO TERMINAL SEQUENCE; ANEMIA; BIOASSAY; BIOEQUIVALENCE; BIOTECHNOLOGICAL PRODUCTION; CARBOHYDRATE ANALYSIS; COMPARATIVE STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG ISOLATION; DRUG LEGISLATION; DRUG MARKETING; DRUG POTENCY; DRUG PURIFICATION; DRUG QUALITY; DRUG SAFETY; DRUG STRUCTURE; ELECTROPHORESIS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; LIMIT OF DETECTION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULAR WEIGHT; PEPTIDE MAPPING; PROTEIN PROCESSING; REVIEW; SIDE EFFECT; UNSPECIFIED SIDE EFFECT;

BIOSIMILAR PHARMACEUTICALS; CHEMISTRY TECHNIQUES, ANALYTICAL; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; IMMUNOGENETIC PHENOMENA; THERAPEUTIC EQUIVALENCY;

EID: 84874140621     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.1     Document Type: Review

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