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J.Health Sci., 54(1), 23-29, 2008
Present State of New Chiral Drug Development and Review in Japan
Rumiko Shimazawa,a Naomi Nagai,b
Satoshi Toyoshima,b and Haruhiro Okuda*, c
aFaculty of Pharmaceutical Science, Doshisha Women's College of Liberal Arts, Kodo, Kyotanabe-shi, Kyoto 610-0395, Japan,
bPharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaski, Chiyoda-ku, Tokyo 100-0013,
Japan, and
cDivision of Organic Chemistry, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan
The current situation of chiral drug development in Japan was investigated. The trend in the Japanese pharmaceutical development is increasingly moving towards the development of single isomers rather than racemates. The development of single-enantiomer drugs was made possible by the current technologies of asymmetric synthesis and chiral separation, and encouraged by the guidelines on the development of chiral drugs worldwide. Japan has not issued specific guidelines on the development of chiral drugs, however, the chiral drug development approached in Japan were essentially consistent with the approaches recommended by the U.S.A. and EU guidelines.
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