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초록
Unapproved investigational drugs have substantial uncertainty in terms of efficacy and safety. The compassionateuse of investigational drugs, nevertheless, provides a patient with a serious disease or life-threatening condition a pathwayto access unauthorized medications. This has gained significant traction during the Coronavirus 2019 disease pandemic. Wereview the laws and regulations of programs in the United States of America, Australia, the United Kingdom, and SouthKorea, where such programs are currently in effect, specifically on the following aspects: regulations, requirements, eligiblepatients, charges, and patient safety plans. Additionally, we investigated therapeutic-approval cases in South Korea fromJanuary 2016 to March 2021.
키워드
Investigational drug; Therapeutic use; Compassionate use; Health policy; Expanded access
- 제목
- 국내외 임상시험용 의약품의 치료목적 사용제도 현황
- 제목 (타언어)
- Regulations and Guidelines for Therapeutic Approval of Investigational Drugs
- 저자
- 박나영; 민세림; 손영후; 남진현; 권순홍
- 발행일
- 2021
- 저널명
- 약 학 회 지
- 권
- 65
- 호
- 6
- 페이지
- 441 ~ 452