A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects

British Journal of Clinical Pharmacology

Volumn , Issue , 2016, Pages 64-73

  Lee, Yoon Jung ^a   Shin, Donghoon ^a   Kim, Youngdoe ^a   Kang, Jungwon ^a   Gauliard, Anke ^b   Fuhr, Rainard ^b  

^a Samsung Bioepis Co Ltd   (South Korea)

^b PAREXEL INTERNATIONAL   (United States)

Author keywords

biosimilar; etanercept; immunogenicity; pharmacokinetics; safety; SB4

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; ETANERCEPT; SB 4; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; EUROPEAN UNION; HEADACHE; HERPETIC STOMATITIS; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE REACTION; LIGAMENT RUPTURE; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RHINOPHARYNGITIS; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; UNITED STATES;

EID: 84976601138     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12929     Document Type: Article

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