Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: Results from a randomized, phase i trial

Annals of Hematology

Volumn 89, Issue 10, 2010, Pages 971-978

  Waller, Cornelius F ^d   Bronchud, Miguel ^a   Mair, Stuart ^b   Challand, Rodeina ^c  

^a HOSPITAL GENERAL DE CATALUNYA   (Spain)

^b CHARLES RIVER LABORATORIES   (United Kingdom)

^c Hospira Ltd   (United Kingdom)

^d NONE

Author keywords

Biosimilar; Filgrastim; G CSF; Neutropenia

Indexed keywords

ALKALINE PHOSPHATASE; BILIRUBIN; GAMMA GLUTAMYLTRANSFERASE; LACTATE DEHYDROGENASE; NIVESTIM; PARACETAMOL; PHOSPHATE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG; URIC ACID;

ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; APPLICATION SITE REACTION; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACKACHE; BASOPHIL; BIOEQUIVALENCE; BLOOD PRESSURE; CAUCASIAN; CD34 SELECTION; CELL COUNT; CLINICAL TRIAL; COMPARATIVE STUDY; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EOSINOPHIL COUNT; EPISTAXIS; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL DISEASE; HUMAN; HUMAN EXPERIMENT; INFECTION; INFESTATION; LACTATE DEHYDROGENASE BLOOD LEVEL; LEUKOCYTE COUNT; LIMB PAIN; MALE; MAXIMUM PLASMA CONCENTRATION; MEDIASTINUM DISEASE; MONOCYTE; MULTIPLE DRUG DOSE; MUSCLE SPASM; MUSCULOSKELETAL CHEST PAIN; MUSCULOSKELETAL DISEASE; NAUSEA; NECK PAIN; NEGRO; NEUROLOGIC DISEASE; NEUTROPHIL COUNT; NORMAL HUMAN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SIDE EFFECT; SUBCUTANEOUS TISSUE; THORAX DISEASE; THROMBOCYTE COUNT; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; URIC ACID BLOOD LEVEL; URINALYSIS; ADOLESCENT; HEMATOLOGIC DISEASE; MIDDLE AGED; NEOPLASM; PHARMACOKINETICS;

ADOLESCENT; ADULT; AREA UNDER CURVE; CROSS-OVER STUDIES; FEMALE; FILGRASTIM; HEMATOLOGIC DISEASES; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 77956671914     PISSN: 09395555     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00277-010-0973-6     Document Type: Article

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