Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial

BioDrugs

Volumn 30, Issue 1, 2016, Pages 17-25

  Morita, Jun ^a   Tanaka, Masashi ^a   Nomoto, Masahiro ^a   Matsuki, Shunji ^b   Tsuru, Tomomi ^c   Matsuguma, Kyoko ^b   Shiramoto, Masanari ^b  

^a MEIJI SEIKA KAISHA LTD   (Japan)

^b Sugioka Memorial Hospital   (Japan)

^c PS Clinic   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMYLASE; ASPARTATE AMINOTRANSFERASE; BIOSIMILAR AGENT; BRAIN NATRIURETIC PEPTIDE; C REACTIVE PROTEIN; CREATINE KINASE; PHOSPHOTRANSFERASE; TRASTUZUMAB; ANTINEOPLASTIC AGENT;

ACNE; ADULT; AMYLASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SAFETY; ECHOCARDIOGRAPHY; ECZEMA; EPISTAXIS; ERYTHEMA; EYE DISEASE; FEVER; FOLLOW UP; HEADACHE; HEMATURIA; HERPES SIMPLEX; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; JAPANESE (PEOPLE); LEUKOCYTE COUNT; LIMIT OF QUANTITATION; LYMPHOCYTE COUNT; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; NEUTROPHIL; NORMAL HUMAN; PARALLEL DESIGN; PHARMACOKINETIC PARAMETERS; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECEPTOR BINDING ASSAY; SINGLE DRUG DOSE; ASIAN CONTINENTAL ANCESTRY GROUP; COMPARATIVE STUDY; HALF LIFE TIME; INTRAVENOUS DRUG ADMINISTRATION; METABOLISM; THERAPEUTIC EQUIVALENCE; YOUNG ADULT;

ADULT; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; BIOSIMILAR PHARMACEUTICALS; DOUBLE-BLIND METHOD; FOLLOW-UP STUDIES; HALF-LIFE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; THERAPEUTIC EQUIVALENCY; TRASTUZUMAB; YOUNG ADULT;

EID: 84957536720     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-015-0153-2     Document Type: Article

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