지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학위논문
- 저자정보
- 지도교수
- 이경은
- 발행연도
- 2020
- 저작권
- 충북대학교 논문은 저작권에 의해 보호받습니다.
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이 논문의 연구 히스토리 (2)
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- 연관 학술논문 또는 학술발표를 통해 보다 발전된 연구결과를 확인하실 수 있습니다.
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Gender is basic demographic factor for drug effectiveness and safety analysis and it is important to clarify and share the drug information for gender differences in healthcare providers and patients for their correct use of the drug.
This study is to review drug information for gender differences written in drug package insert in several countries and generate drug list not having information for gender differences in Korea. Additionally with this study, policies and guidelines for drug registration and labelling in US, Canada, EU and Korea in regard to gender differences information were reviewed. Also, Korea Adverse Event Report System Database was reviewed for gathering useful information for gender differences for the listed drugs.
As a result, information for gender differences was found in 47% of drugs in Korea among 75 drugs in US and Canada which include gender differences information in their package insert. Additionally, in regard to update the information for gender differences in the package insert in Korea, including the information under package insert of other countries, Korea Adverse Event Report System Database will be also considered as helpful tool to understand basic information for drug gender differences in Korea.
This study is to review drug information for gender differences written in drug package insert in several countries and generate drug list not having information for gender differences in Korea. Additionally with this study, policies and guidelines for drug registration and labelling in US, Canada, EU and Korea in regard to gender differences information were reviewed. Also, Korea Adverse Event Report System Database was reviewed for gathering useful information for gender differences for the listed drugs.
As a result, information for gender differences was found in 47% of drugs in Korea among 75 drugs in US and Canada which include gender differences information in their package insert. Additionally, in regard to update the information for gender differences in the package insert in Korea, including the information under package insert of other countries, Korea Adverse Event Report System Database will be also considered as helpful tool to understand basic information for drug gender differences in Korea.
목차
Ⅰ. 서 론 1Ⅱ. 연구 목적 및 방법 4Ⅲ. 연구 결과 91. 의약품 성별 관련 부작용 차이 정보 제공 관련 국내외 규제당국의 정책 및 가이드라인 분석 92. 국내외 허가사항 내 성별 차이와 관련한 안전성 차이가 확인된 의약품 목록 도출 및 분석 303. 국내 허가사항 중 성별 차이 관련 기술이 부족한 의약품에 대한 문헌검색 결과 정리 484. 의약품별 국내 부작용 발생 현황 확인을 위한 의약품 안전관리원 자료 분석 49Ⅳ. 고찰 및 결론 55참고 문헌 58
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