임신⋅수유 중 약물 표기 규정의 변화

• 영문명: Changes of Labelling Regulation in Pregnancy and Lactation
• 발행기관: 대한모유수유한의학회
• 저자명: KBS한의원(Research Center of Korean Medicine) 동국대학교 한의학연구소(Dong Guk University) 조선영(Sun Young Cho) 정지운(Ji Woon Jeong)
• 간행물 정보: 『대한모유수유한의학회지』제1권 제1호, 11~26쪽, 전체 16쪽
• 주제분류: 의약학 > 한의학
• 파일형태: PDF
• 발행일자: 2015.12.30

영문 초록

Objectives: To examine drug labelling policy changes in pregnancy and breastfeeding is helpful to promote Korean drug policy. Methods: Historical analysis and investigation was selected for show changes of drug labelling. And new changes of FDA in 2015 should be described in contents and meanings of proposition. Results & Discussions: Reproduction toxicity test became necessary to submit the data in drug development process. Drug information in Pregnancy and lactation based on various case and clinical research, reproductive toxicity test data, and safety information can be formed. Pharmaceutical Safety labelling during pregnancy and lactation is helpful when choosing their medicines and medical personnel. New guide from US FDA in 2015 can tell clinical meaning above 5 grades classification and explain scientific data more in detail. Conclusions: To manage confusion of drug labelling, international efforts to improve prenatal medicine should be continued to reflect in policies.

목차

Ⅰ. 서 론

Ⅱ. 연구방법

Ⅲ. 결 과

Ⅳ. 결 론

감사의 글

참고문헌

키워드

pregnancy lactation drug labelling policy