Clinical trial design in biosimilar drug development

Investigational New Drugs

Volumn 31, Issue 2, 2013, Pages 479-487

  Dranitsaris, G ^a,b,c   Dorward, K ^a,b   Hatzimichael, E ^a,b   Amir, E ^a,b  

^a UNIVERSITY OF IOANNINA   (Greece)

^b PRINCESS MARGARET HOSPITAL   (Canada)

^c NONE   (Canada)

Author keywords

Biosimilars; Clinical trial; Follow on biologics; Non inferiority; Regulations

Indexed keywords

ADALIMUMAB; ALPHA INTERFERON; ALTEPLASE; ANTIRHEUMATIC AGENT; BALUGRASTIM; BIOSIMILAR AGENT; CT P 13; DOCETAXEL; DOXORUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; INFLIXIMAB; LOW MOLECULAR WEIGHT HEPARIN; PLACEBO; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; RITUXIMAB; STREPTOKINASE; TENECTEPLASE; TISSUE PLASMINOGEN ACTIVATOR; TRASTUZUMAB; UNCLASSIFIED DRUG;

ANKYLOSING SPONDYLITIS; AUTOIMMUNE DISEASE; BREAST METASTASIS; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CROHN DISEASE; DOSE RESPONSE; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG POTENCY; DRUG PURITY; DRUG RESEARCH; DRUG SAFETY; DRUG STABILITY; EUROPE; HEART INFARCTION; HUMAN; MALIGNANT NEOPLASTIC DISEASE; NEUTROPENIA; PATENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; SINGLE DRUG DOSE; STUDY DESIGN; ULCERATIVE COLITIS; UNITED STATES;

EID: 84879555074     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-012-9899-2     Document Type: Review

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