Development of a new G-CSF product based on biosimilarity assessment

Annals of Oncology

Volumn 21, Issue 7, 2009, Pages 1419-1429

  Gascon, P ^a   Fuhr, U ^b,c   Sorgel F ^d,e   Kinzig Schippers, M ^d   Makhson, A ^f   Balser, S ^g   Einmahl, S ^h   Muenzberg, M ^g  

^a UNIVERSITY OF BARCELONA   (Spain)

^b UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^c ITECRA GmbH and Co KG   (Germany)

^d IBMP Institute for Biomedical and Pharmaceutical Research   (Germany)

^e UNIVERSITY OF DUISBURG ESSEN   (Germany)

^f Moscow City Oncology Hospital   (Russian Federation)

^g Sandoz Pharma Ltd   (Switzerland)

^h Triskel Integrated Services   (Switzerland)

Author keywords

Biosimilar; Clinical trial; Filgrastim; Neutropenia; Recombinant human granulocyte colony stimulating factor

Indexed keywords

DOCETAXEL; DOXORUBICIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG; ZARZIO;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BREAST CANCER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LEUKOCYTOSIS; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NEUTROPENIA; NEUTROPHIL COUNT; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DOXORUBICIN; FEMALE; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; MALE; MIDDLE AGED; NEUTROPENIA; RECOMBINANT PROTEINS; SURVIVAL RATE; TAXOIDS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77954262673     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdp574     Document Type: Article

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