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국내 허가 및 긴급사용승인된 코로나19 바이러스감염증 치료제의 허가사항 비교 고찰
최민정(Min Joung Choi),서현옥(Hyun Ok Seo),도희정(Hea Jeong Doh),김영림(Younglim Kim),최경숙(Kyoung Suk Choi),박윤주(Younjoo Park),서경원(Kyung Won Seo),정지원(Jeewon Joung),김지연(Ji Yeon Kim),박인숙(In Suk Park),이원재(Wonjae Lee) 대한약학회 2023 약학회지 Vol.67 No.3
In a situation where the development of various treatments is urgently needed to overcome the global outbreak of coronavirus disease 2019 (COVID-19) and the sequential emergence of new variant viruses, Ministry of Food and Drug Safety (MFDS) made tremendous efforts to promptly supply the safe and effective therapeutics manufactured by local and global companies through accelerated marketing authorization or emergency use approvals. To date, seven products (including overlapped) have received marketing authorization or emergency use approvals from MFDS, and their indicated patient group according to the severity, efficacy, and safety information are different by each products. Therefore, this study is to compare the product information and the major clinical outcomes obtained from clinical studies of COVID-19 treatments authorized or approved for emergency use in Korea and to introduce the MFDS’s efforts for establishment of accelerated approval system for COVID-19 treatment and development of relevant guidelines. It is hoped that this study will serve as a reference for the latecomers who is preparing the development of therapeutics for emerging infectious diseases in the future.
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코로나바이러스감염증-19 유행 대비 요양병원 감염관리 교육 요구도 우선순위 분석: Borich 요구도와 The Locus for Focus Model 활용
최민정 ( Choi Min-jung ),정효선 ( Jeong Hyo-seon ),정용선 ( Joung Yong-sun ),이희영 ( Lee Heeyoung ) 한국보건사회연구원 2021 保健社會硏究 Vol.41 No.1
기저질환을 가지고 있고 면역 기능이 상대적으로 약한 노인이 많은 요양병원은 코로나19 감염자 발생 시 걷잡을 수 없는 상황에 놓일 수 있다. 집단감염 취약시설은 각별한 주의가 필요하며, 적극적인 감염관리 활동과 감염관리 프로그램의 중재가 필요하다. 이에 본 연구는 경기도 요양병원을 대상으로 교육 요구도를 파악하고, 좀 더 발전된 형태로 요구도에 따른 우선순위를 제시하여 코로나19 상황에서 요양병원 감염관리 전담자 대상 교육·훈련 프로그램 개발에 필요한 시사점을 마련해보고자 하였다. 연구 결과, 첫째, ‘감염관리 전담자가 없는 병원’이 28.4%로 나타났으며, 감염관리 전담자가 없는 요양병원은 있는 병원에 비하여 교육 경험률과 교육 내용 이해 수준 모두 낮게 나타났다. 둘째, 총 8개 영역의 31개 내용 중 ‘코로나19 검사 진행 시 개인보호구 사용’, ‘검사 공간을 타 공간과 분리하는 방법’, ‘검사 공간의 환기 기준 및 방법’, ‘검사 공간의 소독 방법’, ‘타 의료기관으로의 환자 이송 방법’, ‘의료기관 내 코로나19 확진자 발생시 역학조사 프로세스’, ‘개인보호구 폐기’ 7개가 교육 최우선 내용으로 조사되었다. 이와 관련한 요양병원 대상 교육 프로그램 개발과 시행이 우선적으로 이루어져야 할 필요가 있으며, 요양병원의 감염관리 활동이 체계적으로 진행될 수 있도록 현실적인 감염관리 전담자 지정 방안과 명확한 수가 기준안 마련 등 추가적인 노력이 필요하다. Infection-vulnerable facilities, such as long-term care hospitals, need special care and active infection control activities and programs. This study attempted to identify the educational needs and priorities of long-term care hospitals in Gyeonggi province, and to seek implications for the development of infection control education programs as it relates to the COVID-19 situation. According to the study, first, 28.4% of long-term care hospitals were found to have no dedicated personnel for infection control. Second, 7 out of 31 educational contents in 8 areas were surveyed as the top priority: Use of personal protective equipment (PPE) when conducting a COVID-19 test, how to separate the test space from other spaces, criteria and methods for ventilation of the test space, how to disinfect the test space, how to transfer patients to other medical institutions, epidemiological investigation process in case of COVID-19 confirmed in medical institutions and disposal of PPEs. Based on these results, the development and implementation of long-term care hospital education programs should be carried out first. In addition, further efforts must be made, such as appointing an infection manager to reflect the reality and establish clear compensation standards, so that infection control activities at long-term medical hospitals can be carried out systematically.
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김지연(Ji Yeon Kim),최민정(Min Joung Choi),기성환(Sung Hwan Ki),이원재(Wonjae Lee) 대한약학회 2022 약학회지 Vol.66 No.4
Plasma-derived medicinal products (PDMPs) are pharmaceuticals prepared using proteins in plasma, a liquid component of blood. Regarding the use of human blood as a raw material in PDMP manufacturing, it has unique characteristics unlike other pharmaceuticals (for example, limitations of scientific identification, finiteness of blood, and risk of infection through disease pathogens, such as the human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in the blood). The safety management policy of PDMPs in Korea started with the enactment of the Blood Management Act in 1970. After that, the current safety management system was established through product approval management according to the Pharmaceutical Affairs Act in 2006, higher standards of safety management for imported source plasma in 2009, and expansion of management standards for source plasma in 2012. The safety management of PDMPs involves several important policies. Public management has been carried out by the Korean Red Cross and national government, and domestic plasma should be used first, while imported plasma may be used only if there is not enough. Additionally, to ensure blood products safety, plasma testing, inventory hold, and plasma master file reporting obligations are being implemented. In addition, it is managed as a subject of national lot release, which should also be quality-confirmed by the country. Because the supply of domestic source plasma, which is the raw material of PDMPs, has shown a decreasing trend in recent years, continuous monitoring and preparation is required. In this study, we describe the history of safety management policies, including the definition and classification of PDMPs, product status, usage status of source plasma, and the related policy guidelines and characteristics.
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