Non-clinical safety studies on biosimilar recombinant human erythropoietin

Basic and Clinical Pharmacology and Toxicology

Volumn 100, Issue 2, 2007, Pages 73-83

  Parnham, Michael J ^a,d   Schindler Horvat, Janice ^b   Kozlović, Marija ^c  

^a PLIVA Research Institute Ltd   (Croatia)

^b SRI INTERNATIONAL   (United States)

^c PLIVA CROATIA LTD   (Croatia)

^d GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CYCLOPHOSPHAMIDE; ERYTHROPOIETIN; ERYTHROPOIETIN ANTIBODY; IODINE 125; NEUTRALIZING ANTIBODY; PLD 106; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

AMINO ACID SEQUENCE; ANEMIA; ANTIBODY TITER; AREA UNDER THE CURVE; BAGG ALBINO MOUSE; BIOASSAY; CAPILLARY ZONE ELECTROPHORESIS; CHRONIC KIDNEY DISEASE; CROSS REACTION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG HALF LIFE; DRUG MARKETING; DRUG POTENCY; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHROCYTE COUNT; GENOTOXICITY; GLYCOSYLATION; HEMATOCRIT; HEMATOLOGICAL PARAMETERS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOAFFINITY CHROMATOGRAPHY; IMMUNOASSAY; IMMUNOGENICITY; ISOELECTRIC FOCUSING; MICROFILTRATION; MICRONUCLEUS TEST; NANOFILTRATION; NONHUMAN; PEPTIDE MAPPING; PRIORITY JOURNAL; PURE RED CELL ANEMIA; REPEATED DRUG DOSE; RETICULOCYTE; RETICULOCYTE COUNT; SHORT SURVEY; TANDEM MASS SPECTROMETRY; TOXICITY TESTING; TOXICOKINETICS; UNITED STATES; URINALYSIS;

ANIMALS; BIOLOGICAL PRODUCTS; CROATIA; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; ERYTHROPOIETIN, RECOMBINANT; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; THERAPEUTIC EQUIVALENCY;

EID: 33846463047     PISSN: 17427835     EISSN: 17427843     Source Type: Journal    
DOI: 10.1111/j.1742-7843.2007.00028.x     Document Type: Short Survey

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