YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

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

광학이성질체 의약품 개발에서 안전성과 유효성 평가에 대한 규제 요건

  • 김광준 (조선대학교 약학대학 약학과) ;
  • 최인 (조선대학교병원 약제부) ;
  • 서규화 (조선대학교 약학대학 약학과) ;
  • 한효경 (동국대학교 약학대학 약학과) ;
  • 이원재 (조선대학교 약학대학 약학과)
  • Received : 2011.03.28
  • Accepted : 2011.06.29
  • Published : 2011.10.31
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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

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