Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products

Journal of Pharmaceutical Sciences

Volumn 105, Issue 2, 2016, Pages 542-550

  Halim, Liem Andhyk ^a   Brinks, Vera ^a   Jiskoot, Wim ^b   Romeijn, Stefan ^b   Haselberg, Rob ^c   Burns, Chris ^d   Wadhwa, Meenu ^d   Schellekens, Huub ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

^c VU UNIVERSITY AMSTERDAM   (Netherlands)

^d NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

biosimilar; immunogenicity; physicochemical properties; protein characterization; recombinant human erythropoietin

Indexed keywords

BIOSIMILAR AGENT; DODECYL SULFATE SODIUM; RECOMBINANT ERYTHROPOIETIN; ERYTHROPOIETIN; RECOMBINANT PROTEIN;

ANIMAL EXPERIMENT; ARTICLE; BIOASSAY; CAPILLARY ZONE ELECTROPHORESIS; DRUG MEGADOSE; DRUG POTENCY; DRUG QUALITY; FEMALE; FIELD FLOW FRACTIONATION; IN VIVO STUDY; LOW DRUG DOSE; MOUSE; NONHUMAN; POLYACRYLAMIDE GEL ELECTROPHORESIS; SIZE EXCLUSION CHROMATOGRAPHY; ANIMAL; BAGG ALBINO MOUSE; CHEMISTRY; HUMAN; MEDICINAL CHEMISTRY; PROCEDURES; STANDARDS; THERAPEUTIC EQUIVALENCE;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; CHEMISTRY, PHARMACEUTICAL; EPOETIN ALFA; ERYTHROPOIETIN; FEMALE; HUMANS; MICE; MICE, INBRED BALB C; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 84964555766     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1016/j.xphs.2015.10.019     Document Type: Article

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