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KMID : 1142220110060010001
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.1 ~ p.7
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Investigation of Guidelines for the Safety and Efficacy Evaluation of Stereoisomeric Drugs
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Kim Kwang-Joon
Choe In
Lee Won-Jae
Han Hyo-Kyung
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Abstract
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This study was performed to propose the proper regulatory guideline of safety and efficacy evaluation in preclinical and clinical process required for the legal permission of stereoisomeric drugs in Korea. For preparation of its guideline, the related documents in major countries (EU, Canada, US, Japan etc) were investigated. 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 4) development of a racemate from an approved single enantiomer 5) development of a non-racemic mixture from an approved racemate or single enantiomer. It is expected that the proposed guidelines will be useful to ensure these safety and efficacy for the regulatory approval of stereoisomeric drugs as well as stereochemical issues in chiral drug development in Korea.
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KEYWORD
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stereoisomeric drugs, guideline, safety, efficacy
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