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Regulatory Requirements on the Safety and Efficacy Evaluation for the Development of Stereoisomeric Drugs  

Kim, Kwang-Joon (College of Pharmacy, Chosun University)
Choi, In (Department of Pharmacy, Chosun University Hospital)
Seo, Kyu-Hwa (College of Pharmacy, Chosun University)
Han, Hyo-Kyung (College of Pharmacy, Dongguk University)
Lee, Won-Jae (College of Pharmacy, Chosun University)
Publication Information
YAKHAK HOEJI / v.55, no.5, 2011 , pp. 426-431 More about this Journal
Abstract
This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.
Keywords
stereoisomeric drugs; safety; efficacy; regulatory guideline;
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Times Cited By KSCI : 1  (Citation Analysis)
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