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http://dx.doi.org/10.4333/KPS.2005.35.1.057

Stereochemical Issues in Chiral Drug Development  

Choi, Sun-Ok (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Jung, Sung-Hee (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Um, So-Young (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Jung, Seo-Jeong (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Kim, Joo-Il (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Chung, Soo-Youn (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Publication Information
Journal of Pharmaceutical Investigation / v.35, no.1, 2005 , pp. 57-63 More about this Journal
Abstract
Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.
Keywords
Chiral; Enantiomer; Stereochemistry;
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  • Reference
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