A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase i studies still needed?

Journal of Clinical Pharmacology

Volumn 54, Issue 5, 2014, Pages 483-494

  Chiba, Koji ^a,b   Yoshitsugu, Hiroyuki ^c   Kyosaka, Yuto ^b   Iida, Satofumi ^d   Yoneyama, Koichiro ^d   Tanigawa, Takahiko ^e   Fukushima, Takashi ^b   Hiraoka, Masaki ^f  

^a YOKOHAMA COLLEGE OF PHARMACY   (Japan)

^b KEIO UNIVERSITY   (Japan)

^c BRISTOL MYERS SQUIBB   (United States)

^d CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^e BAYER PHARMA AG   (Germany)

^f DMCP   (Japan)

Author keywords

Japan; monoclonal antibody preparations; regulatory affairs

Indexed keywords

ABATACEPT; ADALIMUMAB; BASILIXIMAB; BEVACIZUMAB; CANAKINUMAB; CERTOLIZUMAB PEGOL; CETUXIMAB; DENOSUMAB; ECULIZUMAB; ETANERCEPT; GEMTUZUMAB OZOGAMICIN; GOLIMUMAB; IBRITUMOMAB TIUXETAN; INFLIXIMAB; MOGAMULIZUMAB; MONOCLONAL ANTIBODY; NEW DRUG; OMALIZUMAB; PALIVIZUMAB; PANITUMUMAB; RANIBIZUMAB; RITUXIMAB; ROMIPLOSTIM; TOCILIZUMAB; TRASTUZUMAB; USTEKINUMAB;

ADVERSE DRUG REACTION; BODY WEIGHT; CLINICAL EVALUATION; DRUG APPROVAL; DRUG SAFETY; ETHNIC DIFFERENCE; HUMAN; JAPAN; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL (TOPIC); REVIEW; ETHNIC GROUP;

ANTIBODIES, MONOCLONAL; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG APPROVAL; ETHNIC GROUPS; HUMANS; JAPAN;

EID: 84898623954     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.231     Document Type: Review

References (18)

1. International Conferrence on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Ethnic Factors in the Acceptability of Foreign Clinical Data: E5(R1) 1998.
2. Pharmaceutical and Medical Safety Bureau, Ministry of Health, Labour and Welfare, Japan. Notification No. 739 (kyokuchou-tsuuchi). August 11. Tokyo: Ministry of Health, Labour and Welfare; 1998.
3. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Japan. Basic Principles on Global Clinical Trials. Notification no. 0928010; 2007. http://www.pmda.go.jp/ regulatory/file/guideline/new-drug/GlobalClinicalTrials-en.pdf.
4. Ichimaru K, Toyoshima S, Uyama Y., Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Clin Pharmacol Ther. 2010; 87: 362-366.
5. Zhou H, Tsukamoto Y, Davis HM., Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies ? J Clin Pharmacol. 2012; 52: 1273-1276.
6. Wang W, Wang EQ, Balthasar JP., Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008; 84: 548-558.
7. Brambell FW., The transmission of immunity from mother to young and the catabolism of immunoglobulins. Lancet. 1966; 2: 1087-1093.
8. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH., Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010; 49: 493-507.
9. Mould DR, Green B., Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs. 2010; 24: 23-39.
10. Ishii-Watabe A, Saito Y, Suzuki T, et al. Genetic polymorphisms of FCGRT encoding FcRn in a Japanese population and their functional analysis. Drug Metab Pharmacokinet. 2010; 25: 578-587.
11. Smith KG, Clatworthy MR., FcgammaRIIB in autoimmunity and infection: evolutionary and therapeutic implications. Nat Rev Immunol. 2010; 10: 328-343.
12. Takai T., Roles of Fc receptors in autoimmunity. Nat Rev Immunol. 2002; 2: 580-592. (Pubitemid 37328733)
13. Torkildsen O, Utsi E, Mellgren SI, Harbo HF, Vedeler CA, Myhr KM., Ethnic variation of Fc gamma receptor polymorphism in Sami and Norwegian populations. Immunology. 2005; 115: 416-421. (Pubitemid 40896039)
14. Tabrizi MA, Tseng CM, Roskos LK., Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006; 11: 81-88. (Pubitemid 43227856)
15. Arnold FL, Kusama M, Ono S., Exploring differences in drug doses between Japan and Western countries. Clin Pharmacol Ther. 2010; 87: 714-720.
16. Myrand SP, Sekiguchi K, Man MZ, et al. Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: comparison with Korean, Chinese, and Caucasian populations. Clin Pharmacol Ther. 2008; 84: 347-361.
17. Bai S, Jorga K, Xin Y, et al. A guide to rational dosing of monoclonal antibodies. Clin Pharmacokinet. 2012; 51: 119-135.
18. Wang DD, Zhang S, Zhao H, Men AY, Parivar K., Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol. 2009; 49: 1012-1024.