Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim neupogen®: Single-blind, randomized, crossover trial

BioDrugs

Volumn 23, Issue 1, 2009, Pages 43-51

  Lubenau, Heinz ^a,d   Bias, Peter ^b   Maly, Anne Katrin ^c   Siegler, Karl Ernst ^c   Mehltretter, Kai ^d  

^a BioGeneriX AG   (Germany)

^b TEVA PHARMACEUTICALS   (Israel)

^c CRS Mannheim GmbH   (Germany)

^d UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CD34 ANTIBODY; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG; XM 02;

ALOPECIA; APPETITE; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BONE PAIN; CELL COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG BLOOD LEVEL; DRUG SAFETY; FATIGUE; FEMALE; FEVER; FLOW CYTOMETRY; GASTROINTESTINAL DISEASE; HEADACHE; HEMATOMA; HUMAN; HYPERHIDROSIS; INJECTION SITE BURNING; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; NEUTROPHIL COUNT; PARESTHESIA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE BLIND PROCEDURE; SORE THROAT; STEM CELL; TOOTH PAIN;

ADOLESCENT; ADULT; ANTIGENS, CD34; CELL MOVEMENT; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; FEMALE; FILGRASTIM; GERMANY; HEMATOPOIETIC STEM CELL MOBILIZATION; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; LEUKOCYTE COUNT; MALE; MIDDLE AGED; NEUTROPHILS; SINGLE-BLIND METHOD; STEM CELLS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 64149127559     PISSN: 11738804     EISSN: None     Source Type: Journal    
DOI: 10.2165/00063030-200923010-00005     Document Type: Article

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