광학이성질체 의약품 개발에서 안전성과 유효성 평가에 대한 규제 요건과 의약품 허가신청 자료에 대한 비교 연구

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 Korea, 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. For this study, the regulatory documents adopted in major countries were investigated with the focus on three major categories mentioned above. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submissions documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that the investigated results 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.