A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25°C stable formulation

Haemophilia

Volumn 13, Issue 5, 2007, Pages 527-532

  Bysted, B V ^a   Scharling, B ^a   Moller T ^a   Hansen, B L ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

25 C stable formulation; Bioequivalence; Pharmacokinetics; Recombinant activated factor VII; Safety and tolerability

Indexed keywords

PROTEIN ANTIBODY; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ADULT; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BIOEQUIVALENCE; BLOOD CLOTTING PARAMETERS; BLURRED VISION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; DRUG TOLERABILITY; HEMATOMA; HERPES VIRUS INFECTION; HUMAN; HUMAN EXPERIMENT; INJECTION SITE PAIN; MALE; MEAN RESIDENCE TIME; NORMAL HUMAN; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STORAGE TEMPERATURE; TEMPERATURE MEASUREMENT;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; COAGULANTS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FACTOR VII; FEMALE; HEMOPHILIA A; HEMOPHILIA B; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 34548321383     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2007.01516.x     Document Type: Article

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