http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
- 中文 을 입력하시려면 zhongwen을 입력하시고 space를누르시면됩니다.
- 北京 을 입력하시려면 beijing을 입력하시고 space를 누르시면 됩니다.
RISS 인기검색어
- 검색키워드
- 저자 : 서미경 ( Mikyeong Seo ) (검색결과 1 건)
- 무료
- 기관 내 무료
- 유료
-
약학회담(藥學會談) : 의약품 허가외사용 관리 체계 발전 방안
이인향 ( Iyn Hyang Lee ),서미경 ( Mikyeong Seo ),이영숙 ( Young Sook Lee ),계승희 ( Seunghee Kye ),김현아 ( Hyunah Kim ),이숙향 ( Sukhyang Lee ) 영남대학교 약품개발연구소 2014 영남대학교 약품개발연구소 연구업적집 Vol.24 No.0
This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketeddrugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a bodyof academic literature to explore current regulating trends. We included European Union, United Kingdom, United Statesof America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatorystructure, safety control before and after off-label use, and information management. The findings of the presentinvestigation called for several measures in off-label drug uses: enhancing prescribers` self-regulation, providing up-to-dateinformation to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientificrigor, building an official registering process for off-label use in good quality and extending the role of pharmaceuticalindustry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses bothat national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicantswould submit. We newly introduced an official ‘Off-Label Drug Use Report’ to evaluate the safety and clinical efficacy of agiven off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institutionto help set up the culture of evidence-based practices in off-label drug uses.
연관 검색어 추천
이 검색어로 많이 본 자료
활용도 높은 자료
