Ethnic sensitivity assessment - Pharmacokinetic comparability between Japanese and non-Japanese healthy subjects on selected mAbs

Expert Opinion on Drug Metabolism and Toxicology

Volumn 11, Issue 2, 2015, Pages 179-191

  Matsushima, Soichiro ^a   Huang, Yue ^b   Suzuki, Hikoe ^a   Nishino, Junichi ^a   Lloyd, Peter ^c  

^a NOVARTIS PHARMA K K   (Japan)

^b NOVARTIS PHARMA AG   (Switzerland)

^c Kindyn Consulting Ltd   (United Kingdom)

Author keywords

Ethnic sensitivity; Immunogenicity; Japan; mAb; Pharmacokinetics

Indexed keywords

ADALIMUMAB; CERTOLIZUMAB PEGOL; DENOSUMAB; ETANERCEPT; GOLIMUMAB; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; OMALIZUMAB; PALIVIZUMAB; SIRUKUMAB;

AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; ETHNIC DIFFERENCE; HUMAN; IMMUNOGENICITY; INCIDENCE; JAPANESE (PEOPLE); MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOLUME OF DISTRIBUTION; ASIAN CONTINENTAL ANCESTRY GROUP; BIOLOGICAL MODEL; COMPUTER SIMULATION; IMMUNOLOGY; JAPAN; STATISTICAL ANALYSIS;

ANTIBODIES, MONOCLONAL; ASIAN CONTINENTAL ANCESTRY GROUP; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; HUMANS; IMMUNOGLOBULIN G; JAPAN; MODELS, BIOLOGICAL;

EID: 84921275707     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2015.990438     Document Type: Article

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