Present address: Clinical Pharmacology & PPDM, Japan Development, MSD K.K., Tokyo, Japan.
A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?
Version of Record online: 10 JAN 2014
© 2014, The American College of Clinical Pharmacology
The Journal of Clinical Pharmacology
Volume 54, Issue 5, pages 483–494, May 2014
How to Cite
Chiba, K., Yoshitsugu, H., Kyosaka, Y., Iida, S., Yoneyama, K., Tanigawa, T., Fukushima, T. and Hiraoka, M. (2014), A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?. Journal of Clinical Pharma, 54: 483–494. doi: 10.1002/jcph.231
- Issue online: 3 APR 2014
- Version of Record online: 10 JAN 2014
- Accepted manuscript online: 16 NOV 2013 06:33AM EST
- Manuscript Accepted: 7 NOV 2013
- Manuscript Received: 26 SEP 2013
Additional supporting information may be found in the online version of this article at the publisher's web-site.
|jcph231-sm-0003-Suptab-S1.pdf||114K||Table S1. Reasons Why the Sponsors and the PMDA Considered the Pharmacokinetics of mAbs to be “Non-Similar”|
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