Literature DB >> 20107436

Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.

K Ichimaru1, S Toyoshima, Y Uyama.   

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Year:  2010        PMID: 20107436     DOI: 10.1038/clpt.2009.285

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


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  13 in total

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Review 2.  The need for multicentre cardiovascular clinical trials in Asia.

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3.  Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries.

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4.  Application of Physiologically-Based Pharmacokinetic Modeling for the Prediction of Tofacitinib Exposure in Japanese.

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Journal:  Kobe J Med Sci       Date:  2017-05-09

5.  Phase 1 study of the investigational Aurora A kinase inhibitor alisertib (MLN8237) in East Asian cancer patients: pharmacokinetics and recommended phase 2 dose.

Authors:  Karthik Venkatakrishnan; Tae Min Kim; Chia-Chi Lin; Lim Soon Thye; Wee Joo Chng; Brigette Ma; Ming Huang Chen; Xiaofei Zhou; Hua Liu; Virginia Kelly; Won Seog Kim
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6.  Axitinib in metastatic renal cell carcinoma: results of a pharmacokinetic and pharmacodynamic analysis.

Authors:  Brian I Rini; May Garrett; Bill Poland; Janice P Dutcher; Olivier Rixe; George Wilding; Walter M Stadler; Yazdi K Pithavala; Sinil Kim; Jamal Tarazi; Robert J Motzer
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7.  Pharmacokinetics and pharmacodynamics of single-dose oral tolvaptan in fasted and non-fasted states in healthy Caucasian and Japanese male subjects.

Authors:  Susan E Shoaf; Seong Ryul Kim; Patricia Bricmont; Suresh Mallikaarjun
Journal:  Eur J Clin Pharmacol       Date:  2012-05-15       Impact factor: 2.953

8.  Globalization of Alzheimer's disease clinical trials.

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9.  Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians.

Authors:  Tomoko Hasunuma; Masahiro Tohkin; Nahoko Kaniwa; In-Jin Jang; Cui Yimin; Masaru Kaneko; Yoshiro Saito; Masahiro Takeuchi; Hiroshi Watanabe; Yasushi Yamazoe; Yoshiaki Uyama; Shinichi Kawai
Journal:  Br J Clin Pharmacol       Date:  2016-03-14       Impact factor: 4.335

10.  Global population pharmacokinetics of the investigational Aurora A kinase inhibitor alisertib in cancer patients: rationale for lower dosage in Asia.

Authors:  Xiaofei Zhou; Diane R Mould; Takatoshi Takubo; Emily Sheldon-Waniga; Dirk Huebner; Ashley Milton; Karthik Venkatakrishnan
Journal:  Br J Clin Pharmacol       Date:  2017-11-24       Impact factor: 4.335

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