A phase 1, randomized study to assess the pharmacokinetic comparability of siltuximab derived from two different cell lines in healthy subjects

Clinical Pharmacology in Drug Development

Volumn 3, Issue 4, 2014, Pages 328-334

  Xu, Chao ^a   Han, Chao ^a   Marini, Joseph ^a   Ford, Joyce ^a   Marciniak, Stanley ^a   Lopez, Manny ^a   Frederick, Bart ^a   de Vries, Dick ^b   Bandekar, Rajesh ^a   Davis, Hugh M ^a   Zhou, Honghui ^a   Puchalski, Thomas A ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b Janssen Biologics   (Netherlands)

Author keywords

Bioequivalence; Biologics; Manufacturing change; Pharmacokinetics; Siltuximab

Indexed keywords

DRUG ANTIBODY; PLACEBO; SILTUXIMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHO CELL LINE; CONTROLLED STUDY; COUGHING; DISTRIBUTION VOLUME; DOUBLE BLIND PROCEDURE; DRUG CLEARANCE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROENTERITIS; HEADACHE; HUMAN; HUMAN EXPERIMENT; INJECTION SITE BLEEDING; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE MYELOMA CELL LINE; NAUSEA; NEUTROPENIA; NORMAL HUMAN; NOSE OBSTRUCTION; OPEN STUDY; OROPHARYNX PAIN; PARALLEL DESIGN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SINUS CONGESTION; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; ANIMAL; BIOLOGICAL MODEL; BIOSYNTHESIS; CLINICAL TRIAL; COMPARATIVE STUDY; CRICETULUS; CROSSOVER PROCEDURE; HALF LIFE TIME; INTRAVENOUS DRUG ADMINISTRATION; METABOLIC CLEARANCE RATE; MIDDLE AGED; MOUSE; THERAPEUTIC EQUIVALENCE; TUMOR CELL LINE; YOUNG ADULT;

ADULT; ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CELL LINE, TUMOR; CHO CELLS; CRICETULUS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FEMALE; HALF-LIFE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; METABOLIC CLEARANCE RATE; MICE; MIDDLE AGED; MODELS, BIOLOGICAL; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 84893689841     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.86     Document Type: Article

References (11)

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