Journal of Health Science
Online ISSN : 1347-5207
Print ISSN : 1344-9702
ISSN-L : 1344-9702
REGULAR ARTICLES
Present State of New Chiral Drug Development and Review in Japan
Rumiko ShimazawaNaomi NagaiSatoshi ToyoshimaHaruhiro Okuda
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ジャーナル フリー

2008 年 54 巻 1 号 p. 23-29

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抄録
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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© 2008 by The Pharmaceutical Society of Japan
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