광학이성질체 의약품 개발에서 안전성과 유효성 평가에 대한 규제 요건

• 영문명: Regulatory Requirements on the Safety and Efficacy Evaluation for the Development of Stereoisomeric Drugs
• 발행기관: 대한약학회
• 저자명: 김광준(Kwang Joon Kim) 최인(In Choi) 서규화(Kyuhwa Seo) 한효경(Hyo-Kyung Han) 이원재(Wonjae Lee)
• 간행물 정보: 『약학회지』제55권 제5호 (2011년), 426~431쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2011.10.31

영문 초록

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.

키워드

stereoisomeric drugs safety efficacy regulatory guideline