국내외 임상시험용 의약품의 치료목적 사용제도 현황

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...

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Published inYaghag-hoi-ji Vol. 65; no. 6; pp. 441 - 452
Main Authors 박나영(Nayoung Park), 민세림(Serim Min), 손영후(Young Hu Shon), 남진현(Jin Hyun Nam), 권순홍(Sun-Hong Kwon)
Format Journal Article
LanguageKorean
Published The Pharmaceutical Society Of Korea 31.12.2021
대한약학회
Subjects
약학
Compassionate use
Health policy
Investigational drug
Expanded access
Therapeutic use
Online AccessGet full text
ISSN0377-9556
2383-9457
DOI10.17480/psk.2021.65.6.441

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Summary: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. KCI Citation Count: 0
Bibliography:https://doi.org/10.17480/psk.2021.65.6.441
ISSN:0377-9556
2383-9457
DOI:10.17480/psk.2021.65.6.441