Present State of New Chiral Drug Development and Review in Japan

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概要

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• 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.

• 公益社団法人日本薬学会の論文
• 2008-02-01

著者

• OKUDA Haruhiro

  Division of Organic Chemistry, National Institute of Health Sciences (NIHS)

• Okuda Haruhiro

  Division Of Organic Chemistry National Institute Of Health Sciences

• TOYOSHIMA Satoshi

  Pharmaceuticals and Medical Devices Evaluation Center National Institute of Health Sciences

• Toyoshima Satoshi

  Pharmaceuticals And Medical Devices Agency (pmda)

• Shimazawa Rumiko

  Faculty of Pharmaceutical Science, Doshisha Women's College of Liberal Arts

• Nagai Naomi

  Pharmaceuticals and Medical Devices Agency (PMDA)

• Toyoshima Satoshi

  Pharmaceutical And Medical Devices Evaluation Center National Institute Of Health Science

• Shimazawa Rumiko

  Faculty Of Pharmaceutical Science Doshisha Women's College Of Liberal Arts

• Okuda Haruhiro

  Division of Drugs, National Institute of Health Sciences

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