Comparative field study: Impact of laboratory assay variability on the assessment of recombinant factor IX Fc fusion protein (rFIXFc) activity

Thrombosis and Haemostasis

Volumn 112, Issue 5, 2014, Pages 932-940

  Sommer, Jurg M ^a   Buyue, Yang ^a   Bardan, Sara ^a   Peters, Robert T ^a   Jiang, Haiyan ^a   Kamphaus, George D ^a   Gray, Elaine ^b   Pierce, Glenn F ^a  

^a BIOGEN   (United States)

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

Author keywords

Activated partial thromboplastin time (aPTT); Blood; Coagulation factor IX; Coagulation tests; Haemophilia B; Standardisation

Indexed keywords

ELLAGIC ACID; HYBRID PROTEIN; KAOLIN; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT FIX FC FUSION PROTEIN; SILICON DIOXIDE; UNCLASSIFIED DRUG; BLOOD CLOTTING FACTOR 9; CHROMOGENIC SUBSTRATE; DYES, REAGENTS, INDICATORS, MARKERS AND BUFFERS; FACTOR IX FC FUSION PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ARTICLE; BLOOD CLOTTING; BLOOD SAMPLING; CHROMOGENIC ASSAY; CLINICAL EVALUATION; EXPERIMENTAL DESIGN; HEMOPHILIA B; HEMOSTASIS; HUMAN; LABORATORY TEST; QUANTITATIVE ASSAY; THROMBOPLASTIN TIME; WORLD HEALTH ORGANIZATION; BLOOD; BLOOD CLOTTING TEST; CALIBRATION; COMPARATIVE STUDY; DRUG MONITORING; GOOD LABORATORY PRACTICE; LABORATORY; REPRODUCIBILITY; SINGLE BLIND PROCEDURE; STANDARD;

BLOOD COAGULATION TESTS; CALIBRATION; CHROMOGENIC COMPOUNDS; DRUG MONITORING; FACTOR IX; HEMOPHILIA B; HUMANS; IMMUNOGLOBULIN FC FRAGMENTS; INDICATORS AND REAGENTS; LABORATORIES; LABORATORY PROFICIENCY TESTING; RECOMBINANT FUSION PROTEINS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SINGLE-BLIND METHOD;

EID: 84908528868     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH13-11-0971     Document Type: Article

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