Yakhak Hoeji最新文献

Association of Osteoporosis-related Healthcare Costs with the Use of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in Chronic Hepatitis B Patients: a Population-based National Cohort Study in Korea 慢性乙型肝炎患者使用富马酸替诺福韦二吡呋酯和替诺福韦阿拉非那胺与骨质疏松症相关医疗费用的关系：韩国一项基于人口的全国队列研究

Yakhak Hoeji Pub Date : 2024-02-28 DOI: 10.17480/psk.2024.68.1.26

You Ran Noh, Hae Sun Suh

{"title":"Association of Osteoporosis-related Healthcare Costs with the Use of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in Chronic Hepatitis B Patients: a Population-based National Cohort Study in Korea","authors":"You Ran Noh, Hae Sun Suh","doi":"10.17480/psk.2024.68.1.26","DOIUrl":"https://doi.org/10.17480/psk.2024.68.1.26","url":null,"abstract":"Long-term administration of tenofovir disoproxil fumarate (TDF) for chronic hepatitis B (CHB) may lead to bone mineral density loss. Tenofovir alafenamide (TAF) developed to address these concerns. This study aimed to investigate whether there is a significant difference in osteoporosis-related healthcare costs between CHB patients treated with TDF and TAF. This study is a retrospective cohort study using claims data from the Health Insurance Review and Assessment Service (HIRA) covering the entire population in Korea. The cohort included CHB patients treated with TDF or TAF from November 2017 to April 2022. We applied inverse probability of treatment weighting (IPTW) to balance baseline characteristics observed for one-year preceding prescription date. Osteoporosis-related costs per patient per year (PPPY) included all healthcare costs with an osteoporosis diagnosis code including outpatient and hospitalization costs. 7,172 and 3,837 patients were administered TDF and TAF respectively. After IPTW, TDF group had higher outpatient costs ($11.2) compared to TAF group ($6.1), but the difference was not statistically significant (p=0.1001). The total hospitalization cost was $24.6 in TDF group and $9.8 in TAF group, not statistically significant (p=0.1633). This largescale population-based study found no significant difference in osteoporosis-related healthcare costs between CHB patients treated with TDF and TAF.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"113 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140418428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparative Review of Added Health Benefits of the Drugs Listed through Economic Evaluation Exemption Procedure in Korea: Cases of France, Germany, and Canada 对韩国通过经济评估豁免程序上市的药品的附加健康益处进行比较审查：法国、德国和加拿大的案例

Yakhak Hoeji Pub Date : 2024-02-28 DOI: 10.17480/psk.2024.68.1.62

Eun-Young Bae, Sohee Cha, Hwa-Ryeong Lim, Hyejin Lee, Jihyung Hong

{"title":"Comparative Review of Added Health Benefits of the Drugs Listed through Economic Evaluation Exemption Procedure in Korea: Cases of France, Germany, and Canada","authors":"Eun-Young Bae, Sohee Cha, Hwa-Ryeong Lim, Hyejin Lee, Jihyung Hong","doi":"10.17480/psk.2024.68.1.62","DOIUrl":"https://doi.org/10.17480/psk.2024.68.1.62","url":null,"abstract":"This study assessed the additional health benefits of the drugs listed through the Economic Evaluation Exemption Procedure (EEEP) in Korea. We conducted a comparative review of 32 EEEP drugs listed between May 2015 and July 2022, comparing how they were assessed in France, Germany, and Canada. To collect the data, we reviewed the evaluations conducted by the relevant agency in each country and identified if the additional benefit exists and how significant it is. Additionally, the size of the benefit gains assessed by each agency was categorized as “High” or “Low,” allowing us to evaluate the consistency among these countries. In France, only 38% of the 34 drugs compared demonstrated moderate or higher levels of additional benefit. Germany acknowledged substantial benefit improvement in 27% of the 30 drugs assessed, while 73% showed minor, unquantifiable, or no additional benefits. In Canada, 5 out of 22 cases have been identified as providing significant additional benefit. The level of inter-country consistency in the assessment results from these three countries was somewhat limited. Based on the evaluation results in France, Germany, and Canada, the additional benefits of EEEP drugs over existing treatments were not substantial in many cases. Even though the EEEP was introduced to improve accessibility to high-cost drugs for medical conditions with unmet needs, it is necessary to reconsider whether to allow exceptions for drugs with low therapeutic value.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"57 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140420717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Immunization Status of the 23-Valent Pneumococcal Polysaccharide Vaccine among Elderly Aged 65 and Older in South Korea 韩国65岁及以上老年人23价肺炎球菌多糖疫苗免疫现状

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.277

Jeong Ah Kim, Heehyun Won, Na-Young Jeong, Nam-Kyong Choi

{"title":"Immunization Status of the 23-Valent Pneumococcal Polysaccharide Vaccine among Elderly Aged 65 and Older in South Korea","authors":"Jeong Ah Kim, Heehyun Won, Na-Young Jeong, Nam-Kyong Choi","doi":"10.17480/psk.2023.67.4.277","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.277","url":null,"abstract":"The 23-valent pneumococcal polysaccharide vaccine (PPSV23) was introduced as part of Korea's national immunization program (NIP) in May 2013 for people aged 65 years and older. We aimed to describe the immunization status of Korean elderly aged 65 years and older who had received a first dose of PPSV23 via the NIP and to analyze the cumulative PPSV23 vaccination coverage rates. A descriptive study was conducted using the Korea Immunization Registry Information System. The study included adults aged 65 years and older who received at least one dose of PPSV23 between May 1, 2013, and December 31, 2020. During the study period, 6,705,624 elderly individuals received PPSV23, with 198,236 receiving it concurrently with other vaccines on the same day, most commonly with the influenza vaccine (n=175,118, 88.3%). Although the cumulative PPSV23 vaccination coverage rates for people aged 65 years and older have been steadily increasing, instances of non-adherence to the minimum intervals between pneumococcal vaccines have been observed. Therefore, education and promotion programs aimed at healthcare providers and the general public are needed to increase awareness. Furthermore, ongoing research on PPSV23 vaccination status for individuals aged 65 years and older and people at high risk for pneumococcal infection should be conducted.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87745262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Korean Elderly’s Demand for Supplying Elderly-friendly Dosage Forms Easy to Swallow 韩国老年人对提供易于吞咽的老年人友好剂型的需求

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.244

Eun Joo Lee, Hyun Soon Sohn

{"title":"Korean Elderly’s Demand for Supplying Elderly-friendly Dosage Forms Easy to Swallow","authors":"Eun Joo Lee, Hyun Soon Sohn","doi":"10.17480/psk.2023.67.4.244","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.244","url":null,"abstract":"As the population ages, it has become increasingly important to provide elderly-friendly dosage forms (EFDF) that are easy to take and promote medication adherence to achieve treatment goals. This cross-sectional questionnaire study, conducted during October to November 2021, aimed to investigate the demand for EFDF among elderly individuals aged 65 years or older. Of the 421 respondents, 81.9% were prescription drug users, 34.9% experienced difficulty swallowing pills, and 26.8% had previous experience of not taking medication due to swallowing problems. 64.1% of respondents agreed to necessity of EFDF easy to swallow than oral solid form, their preferred dosage forms were powder (19.7%) and liquid (57.7%). Furthermore, 51.8% showed willingness to pay additional cost for EFDF. The demand for EFDF was significantly higher in women, facility residents such as nursing homes, elderly living alone, and elderly had difficulties in swallowing and experiences of not taking pills. Considering the elderly themselves personal preferences and improvement of medication adherence, we suggest that pharmaceutical industry and government begin further discussion on EFDF more positively.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"55 2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78327380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of Medical and Pharmaceutical Expenses for Lung Cancer Before and After the Introduction of Immunotherapy 肺癌引入免疫治疗前后的医疗药费分析

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.224

Seongmi Jeon, Mi-Hai Park

{"title":"Analysis of Medical and Pharmaceutical Expenses for Lung Cancer Before and After the Introduction of Immunotherapy","authors":"Seongmi Jeon, Mi-Hai Park","doi":"10.17480/psk.2023.67.4.224","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.224","url":null,"abstract":"Lung cancer has been the leading cause of cancer-related deaths in Korea and is considered one of the world’s most costly cancer to treat. Novel insights into the molecular biology of lung cancer discovered in recent years have facilitated the use of targeted therapy and immunotherapy, arousing concerns over the financial burden of patients due to high healthcare costs. Using HIRA-NPS (Health Insurance Review & Assessment Service-National Patient Sample) database from 2015 to 2020, we analyzed lung cancer patients’ both medical and pharmaceutical expenditures. This study focused on targeted therapies and immunotherapies and compared these expenditures before and after the introduction of immunotherapy. In our analysis, the number of patients prescribed targeted drugs and immunotherapies for lung cancer continues to increase yearly, and consequentially pharmaceutical expenses are also on the rise. An interrupted time series analysis showed pharmaceutical expenditures for lung cancer increased immediately after the introduction of immunotherapy and have continued to increase since then, while total medical expenses, medical and pharmaceutical expenses per patient have not shown any further increase after the immediate increase. The number of patients in immunotherapy has increased but there is little change in drug prices, such as drug price cuts or the entry of more expensive drugs, so the spending per patient has not consistently increased.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89620247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Assessment of Educational Needs in the Industry for Training Professionals in the Regulatory Affairs of Pharmaceuticals on the Competency and Knowledge 业界教育需求评估，以培训药品监管事务专业人员的能力和知识

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.231

Daesung Lee, Kyenghee Kwon

{"title":"The Assessment of Educational Needs in the Industry for Training Professionals in the Regulatory Affairs of Pharmaceuticals on the Competency and Knowledge","authors":"Daesung Lee, Kyenghee Kwon","doi":"10.17480/psk.2023.67.4.231","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.231","url":null,"abstract":"Education in regulatory affairs for pharmaceuticals is crucial in order to equip experts with the necessary competency and knowledge to navigate the legal and scientific regulations involved in managing the drug lifecycle. In order to develop the framework which ensures the competency and knowledge, 6 competency requirements and 48 knowledge items were derived from the previous studies. These were then reviewed by 16 experts in three rounds of a Delphi process to assess their validity and reliability in terms of both present and required levels. The Wilcoxon Signed Ranked Test was subsequently conducted to determine whether there was a statistically significant difference between the required and present levels. and Borich's educational needs and the Locus for Focus Model were used to confirm the 12 knowledge and 1 competency areas that were identified as having high priority. Based on the findings of this study, a systematic educational program focusing on the necessary competencies and knowledge required for professionals in regulatory affairs of pharmaceuticals should be developed and established.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"60 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82081056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Identification of Ferroptosis Induction by Treating Atorvastatin in B16F10.OVA Cells 阿托伐他汀治疗B16F10诱导铁下垂的鉴定。卵子细胞

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.261

Min Seok Kim, In Ho Im, Yun Hwa Jeong, Seung Hyun Kim, Young-Chang Cho, Jeong Uk Choi

{"title":"Identification of Ferroptosis Induction by Treating Atorvastatin in B16F10.OVA Cells","authors":"Min Seok Kim, In Ho Im, Yun Hwa Jeong, Seung Hyun Kim, Young-Chang Cho, Jeong Uk Choi","doi":"10.17480/psk.2023.67.4.261","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.261","url":null,"abstract":"In this study, we identified whether atorvastatin could induce ferroptosis or not in B16F10.OVA cells, which is being used to treat hypercholesterolemia. To demonstrate this, we treated the mouse melanoma cell line B16F10.OVA with atorvastatin at varying concentrations, spanning from low to high, followed by a 24-hour culture period. In the group treated with atorvastatin in our experiment, we observed a decrease in cell viability that was dependent on the concentration of the treatment, when compared to the control group. The IC50 value of atorvastatin in B16F10.OVA cells was determined to be 49.89 μM. Compared to the control group, treatment with atorvastatin resulted in a concentrationdependent increase in the generation of reactive oxygen species and the accumulation of iron ions. Moreover, atorvastatin treatment exhibited a concentration-dependent increase in the population of apoptotic cells and the expression of calreticulin, significantly surpassing that of the control group. The analysis of ferroptosis-related protein expression levels revealed a notable decrease in the expression of GPX4 in the group treated with atorvastatin, as compared to the control group. These findings strongly suggest that atorvastatin holds promise as a potent anti-cancer agent capable of inducing ferroptosis in melanoma cells.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"73 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89815595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of Socioeconomic Indirect Cost of Premature Death in Patients with HER2-positive Metastatic Breast Cancer (MBC) using Nationwide Claims Data 使用全国索赔数据分析her2阳性转移性乳腺癌(MBC)患者过早死亡的社会经济间接成本

Yakhak Hoeji Pub Date : 2023-06-30 DOI: 10.17480/psk.2023.67.3.189

Hwa Yeon Ko, Ahhyung Choi, Bin Hong, Ji-Hwan Bae, I. Oh, Sun-Kyeong Park, Yeon-Hee Park, Ju-Young Shin

{"title":"Analysis of Socioeconomic Indirect Cost of Premature Death in Patients with HER2-positive Metastatic Breast Cancer (MBC) using Nationwide Claims Data","authors":"Hwa Yeon Ko, Ahhyung Choi, Bin Hong, Ji-Hwan Bae, I. Oh, Sun-Kyeong Park, Yeon-Hee Park, Ju-Young Shin","doi":"10.17480/psk.2023.67.3.189","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.189","url":null,"abstract":"The premature deaths caused by human epidermal growth factor receptor-2 protein (HER2) positive metastatic breast cancer (MBC) among working age groups result in significant socioeconomic losses. This study aims to quantify the socioeconomic burden of disease in female patients and provide evidence that can inform healthcare policy decisions. We identified deaths from HER2-positive MBC over the period from 2007 to 2021, using nationwide claims data of South Korea. Then, we estimated years of potential life lost (YPLL), years of potential productivity lost (YPPLL), and cost of productivity loss (CPL) to quantify socioeconomic burden of the disease. During the period from 2011 to 2020, a total of 3,576 patients died from HER2-positive MBC. The total YPLL over the period of 10 years from 2011 to 2020 was 128,605 years, corresponding to an average of approximately 36.0 years per deceased patient. The total YPPLL during the same period was 55,608 years, corresponding to an average of approximately 15.6 years per deceased patient. Additionally, total CPL of approximately 310 million won per deceased patient was incurred. All three disease burden indicators were highest among the age group of 40 to 54 years, which are individuals in their most productive time of life.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91096780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Approval Status of COVID-19 Vaccines and Treatments in Korea, the US, and Europe 韩国、美国、欧洲新冠肺炎疫苗和治疗方法批准情况的比较

Yakhak Hoeji Pub Date : 2023-06-30 DOI: 10.17480/psk.2023.67.3.158

Yeon-Kyeng Lee, Eui-Kyung Lee

{"title":"Comparison of Approval Status of COVID-19 Vaccines and Treatments in Korea, the US, and Europe","authors":"Yeon-Kyeng Lee, Eui-Kyung Lee","doi":"10.17480/psk.2023.67.3.158","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.158","url":null,"abstract":"As demand for COVID-19 vaccines and treatments has soared, each country has applied appropriate approval/authorization system according to circumstances, such as emergency use authorization, conditional marketing approval, or other rapid procedures to introduce COVID-19 related items quickly. This study compared and analyzed the approval/authorization status of COVID-19 vaccines and treatments in Korea, the United States, and Europe. There were differences in the number and types of approved vaccines and treatments and also in the approval procedures used across countries. The United States adopted the emergency use authorization system, and Europe utilized the conditional marketing authorisation system, while Korea mainly applied conditional approval for vaccines and emergency use authorization for treatments. After initial approval in the US, Europe, most vaccines and treatments were introduced with delay in Korea. For instance, the average of Drug lag time for vaccines was about two months(61.5days). In the case of treatments, the difference between Drug lag time among items was relatively large. Considering that Korea's review period for drug approval is similar to that of the United States or Europe, it is necessary to proceed more quickly with approval applications and emergency authorization reviews in the event of other public health emergencies in the future.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77054223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Product Information for COVID-19 Treatments Marketing Authorized or Emergency Use Approved in Korea 韩国已批准上市或紧急使用的COVID-19治疗药物的产品信息比较

Yakhak Hoeji Pub Date : 2023-06-30 DOI: 10.17480/psk.2023.67.3.145

Min Joung Choi, Hyun-Ok Seo, H. Doh, Younglim Kim, Kyoung Suk Choi, Younjoo Park, Kyung Won Seo, J. Joung, Ji Yeon Kim, In Suk Park, W. Lee, S. Ki

{"title":"Comparison of Product Information for COVID-19 Treatments Marketing Authorized or Emergency Use Approved in Korea","authors":"Min Joung Choi, Hyun-Ok Seo, H. Doh, Younglim Kim, Kyoung Suk Choi, Younjoo Park, Kyung Won Seo, J. Joung, Ji Yeon Kim, In Suk Park, W. Lee, S. Ki","doi":"10.17480/psk.2023.67.3.145","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.145","url":null,"abstract":"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.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"90 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83896239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0