Biomarkers and coagulation tests for assessing the biosimilarity of a generic low-molecular-weight heparin: Results of a study in healthy subjects with enoxaparin

Journal of Clinical Pharmacology

Volumn 48, Issue 10, 2008, Pages 1189-1196

  Kuczka, Karina ^a   Harder, Sebastian ^a   Picard Willems, Bettina ^a   Warnke, André ^b   Donath, Frank ^b   Bianchini, Pietro ^c   Parma, Bruna ^c   Blume, Henning ^b  

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^b SocraTec R and D GmbH   (Germany)

^c Opocrin SpA   (Italy)

Author keywords

Biosimilarity; Enoxaparin; Factor Xa; Tissue factor pathway inhibitor

Indexed keywords

BIOLOGICAL MARKER; BLOOD CLOTTING FACTOR 10A; ENOXAPARIN; GENERIC DRUG; LOW MOLECULAR WEIGHT HEPARIN; TISSUE FACTOR PATHWAY INHIBITOR;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD CLOTTING TEST; BLOOD CLOTTING TIME; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; PROTEIN SECRETION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

ADULT; ANTICOAGULANTS; AREA UNDER CURVE; BLOOD COAGULATION; BLOOD COAGULATION TESTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUGS, GENERIC; ENOXAPARIN; FACTOR XA; FEMALE; HUMANS; LIPOPROTEINS; MALE; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN; THERAPEUTIC EQUIVALENCY;

EID: 51849086920     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270008322911     Document Type: Article

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