A Randomized, Phase i Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade®) in Healthy Subjects

BioDrugs

Volumn 29, Issue 6, 2015, Pages 381-388

  Shin, Donghoon ^a   Kim, Youngdoe ^a   Kim, Yoo Seok ^a   Körnicke, Thomas ^b   Fuhr, Rainard ^b  

^a Samsung Bioepis Co Ltd   (South Korea)

^b PAREXEL INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; INFLIXIMAB; SB 2; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BORRELIA INFECTION; COMPARATIVE STUDY; CONCUSSION; CONTROLLED STUDY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INCIDENCE; KIDNEY CYST; MAJOR CLINICAL STUDY; MALE; NORMAL HUMAN; PRIORITY JOURNAL; RHINOPHARYNGITIS; SINGLE DRUG DOSE; CLINICAL TRIAL; CROSSOVER PROCEDURE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE;

ADMINISTRATION, INTRAVENOUS; ADULT; BIOSIMILAR PHARMACEUTICALS; CROSS-OVER STUDIES; FEMALE; HEALTHY VOLUNTEERS; HUMANS; INFLIXIMAB; MALE; MIDDLE AGED; SINGLE-BLIND METHOD;

EID: 84951020928     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-015-0150-5     Document Type: Article

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