A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?-Reference-Cited by-同舟云学术

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

Published:2014-01-10 Issue:5 Volume:54 Page:483-494
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Chiba Koji¹²,Yoshitsugu Hiroyuki³,Kyosaka Yuto²,Iida Satofumi⁴,Yoneyama Koichiro⁴,Tanigawa Takahiko⁵,Fukushima Takashi²,Hiraoka Masaki⁶

Affiliation:

1. Laboratory of Clinical Pharmacology; Yokohama College of Pharmacy; Yokohama Japan

2. Department of Drug Development and Regulatory Science; Keio University Graduate School of Pharmaceutical Science; Tokyo Japan

3. Discovery Medicine & Clinical Pharmacology, Research & Development; Bristol-Myers Squibb; Princeton NJ USA

4. Clinical Research Planning Department; Chugai Pharmaceutical Co., Ltd.; Tokyo Japan

5. Clinical Sciences; Bayer Pharma AG; Berlin Germany

6. DMCP, Clinical Research; Bristol-Myers K.K.; Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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4. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors;Ichimaru;Clin Pharmacol Ther.,2010

5. Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies;Zhou;J Clin Pharmacol.,2012

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