EMEA guidelines on biosimilars and their clinical implications

Kidney and Blood Pressure Research

Volumn 30, Issue SUPPL. 1, 2007, Pages 13-17

  Rossert, Jerome ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABSEAMED; ALPHA INTERFERON; BETA INTERFERON; BINOCRIT; BIOLOGICAL PRODUCT; ERYTHROPOIETIN; FOLLITROPIN; GAMMA INTERFERON; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; HEXAL; HUMAN GROWTH HORMONE; HUMAN INSULIN; INTERLEUKIN 2; RECOMBINANT ERYTHROPOIETIN; STREPTOKINASE; TISSUE PLASMINOGEN ACTIVATOR; UNCLASSIFIED DRUG; VALTROPIN;

ANEMIA; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; CONFERENCE PAPER; DOSE RESPONSE; DRUG CLASSIFICATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; SINGLE DRUG DOSE;

ANIMALS; DRUG EVALUATION, PRECLINICAL; DRUGS, GENERIC; EUROPE; GUIDELINES; HUMANS; RANDOMIZED CONTROLLED TRIALS; THERAPEUTIC EQUIVALENCY;

EID: 34548168792     PISSN: 14204096     EISSN: None     Source Type: Journal    
DOI: 10.1159/000107276     Document Type: Conference Paper

References (18)

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18. Press release. Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21 June, 2007. http://www.emea.europa.eu/pdfs/human/ press/pr/26755607en.pdf.