Yakhak HoejiPub Date : 2023-08-31DOI: 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}
Yakhak HoejiPub Date : 2023-08-31DOI: 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}
Yakhak HoejiPub Date : 2023-06-30DOI: 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}
Yakhak HoejiPub Date : 2023-06-30DOI: 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}
Yakhak HoejiPub Date : 2023-06-30DOI: 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}
Yakhak HoejiPub Date : 2023-06-30DOI: 10.17480/psk.2023.67.3.182
Jung-il Kang, Youri Kim, Hae-Sic Kim, E. Yoo, Hee-kyoung Kang
{"title":"The Effect of Umbraulva japonica on the Stimulation of Anagen Phase","authors":"Jung-il Kang, Youri Kim, Hae-Sic Kim, E. Yoo, Hee-kyoung Kang","doi":"10.17480/psk.2023.67.3.182","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.182","url":null,"abstract":"This study was conducted to evaluate the effects of Umbraulva japonica extract on the hair growth. Treatment with U. Japonica extract significantly increased the proliferation of dermal papilla cells (DPCs), a central regulator of the hair cycle. When isolated rat vibrissa follicles were treated with U. Japonica extract for 21 d, the hair-fiber lengths of the vibrissa follicles increased. When examined the activity of 5α-reductase, which converts testosterone to dihydrotestosterone (DHT), a main cause of androgenetic alopecia, U. Japonica extract did not inhibit the 5α-reductase activity. Moreover, we found that the U. Japonica extract also significantly accelerated anagen phase in vivo. These results suggest that the U. Japonica extract has the potential to treat alopecia via the stimulation of anagen phase.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87195649","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}
Yakhak HoejiPub Date : 2023-06-30DOI: 10.17480/psk.2023.67.3.167
K. Bang
{"title":"A study on Establishment of Stability Test and Biopharmaceutical Analysis Support Center","authors":"K. Bang","doi":"10.17480/psk.2023.67.3.167","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.167","url":null,"abstract":"This study was undertaken to suggest the necessity of establishing stability test and biopharmaceutical analysis support center. Feasibility study on center establishment was performed as online survey to factory manager and person in charge in 39 pharmaceutical companies in Korea. More than seventy percent of 39 companies responded that they need to establish it. Eighty percent of respondents answered that they would entrust the entire test items of stability test and 71.8% of respondents answered that they would entrust biopharmaceutical cell bank and protein analysis. The construction cost of two centers with 2 stories and 1 basement floor and 3000m2 was 6.37 billion won. The stability test center need to 173 EA of 71 types of equipment and 4.086 billion won in budget for equipment purchases. The biopharmaceutical analysis support center need to 169 EA of 77 types of equipment and about 7.2 billion won in budget for equipment purchase. Total cost for construction and equipment purchase was 17.65 billion won. The establishment of two centers with expertise and efficiency would provide the competitiveness of the pharmaceutical industry in Korea.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74403596","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}
Yakhak HoejiPub Date : 2023-06-30DOI: 10.17480/psk.2023.67.3.176
Jun Hyeob Kim, Woojun Kim, Jin Yeon Gil, K. Min, Ji Min Han, K. Lee
{"title":"TEC Genetic Polymorphism is Associated with TNF-α Inhibitor Treatment Response in Rheumatoid Arthritis Patients","authors":"Jun Hyeob Kim, Woojun Kim, Jin Yeon Gil, K. Min, Ji Min Han, K. Lee","doi":"10.17480/psk.2023.67.3.176","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.176","url":null,"abstract":"Numerous genetic and clinical factors influence the progression of rheumatoid arthritis and treatment response. Single nucleotide polymorphisms (SNPs) have been associated with different treatment responses in TNF-α inhibitor users. This study aimed to determine if Tec protein tyrosine kinase (TEC), which belongs to the Tec family of non-receptor protein tyrosine kinases, is associated with treatment response in rheumatoid arthritis (RA) patients. RA patients from three university hospitals were recruited, and clinical data were collected from electronic medical records. One hundred fourteen patients treated with TNF-α inhibitor were included in the analysis. SNP-response associations were evaluated using logistic regression. Among the five SNPs analyzed, rs1472971 and rs11727166 were statistically significant genetic factors of TNF-α inhibitor treatment response. This study provides genetic evidence that TEC polymorphism can be a prognostic marker in treating RA patients.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"2016 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73326650","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}
Yakhak HoejiPub Date : 2023-06-30DOI: 10.17480/psk.2023.67.3.197
Hee-Jin Kang, S. Jang
{"title":"Community Care and Pharmaceutical Care: Focusing on Cheonan and Jeonju","authors":"Hee-Jin Kang, S. Jang","doi":"10.17480/psk.2023.67.3.197","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.197","url":null,"abstract":"As our society enters an aging society, community care is emerging to enable the elderly to spend the rest of their lives in their own neighborhoods. This is a case study of pharmacists who provided home-based pharmaceutical services as part of the leading community care programs in Jeonju and Cheonan city. By interviewing pharmacists who provided home-based pharmaceutical services, we identified the status of pharmaceutical services in community care based on their experiences. Cheonan city has provided pharmaceutical services for poly-pharmacy users, visiting them three to four times a year, and most of the initial recipients have been retained. Jeonju city has provided three types of pharmaceutical services: medication counseling, medication counseling during the transition period after discharge, and medication counseling for diabetics. Both medication counseling and the discharge transition period service were provided twice per patient. The services provided were medication reorganization and medication counseling. The pharmacist thought that they had a better understanding of the senior and could focus on patient care. They had difficulty in preparing for the service in advance due to inadequate records of medication history, and medication reconciliation, and needed various contents to increase patient interest and pharmacist expertise. In order for the visiting pharmacy program to operate more effectively in community care in the future, it is necessary to increase the effectiveness of visiting pharmacy program by establishing an information-sharing platform and developing and disseminating various visiting pharmacy program.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73449064","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}
Yakhak HoejiPub Date : 2023-06-30DOI: 10.17480/psk.2023.67.3.137
Sung-Hyun Kim, Minyoung Seo, Hyung-sik Lim, Jin-Tae Hong
{"title":"Lipid-based Liquid Crystalline Phases for Biocompatible and Versatile Drug Delivery","authors":"Sung-Hyun Kim, Minyoung Seo, Hyung-sik Lim, Jin-Tae Hong","doi":"10.17480/psk.2023.67.3.137","DOIUrl":"https://doi.org/10.17480/psk.2023.67.3.137","url":null,"abstract":"The purpose of the paper was to overview the liquid crystalline phases that can be prepared with various lipids and to assess their characteristics as drug delivery systems for drugs to be administered to various routes. Glyceryl monooleate (GMO) was most frequently employed to deliver the drugs to topical, transdermal, oral, buccal and parenteral routes. In addition to bulk phase such as lamellar and cubic liquid crystalline phases, nano-sized cubosomes of GMO have offered a wide range of chances to administer drugs more precisely to oral and parenteral routes. In addition to GMO different types of lipids including phospholipids, triglycerides, fatty acids and cholesterol were able to form liquid crystalline phases even though most studies employing other lipids than GMO were focused on revealing their phase behaviors and physicochemical characteristics. However, it was expected that more research attempts will be made on utilizing new class of liquid crystalline phases that can be formed with various lipids. Based on the outcome published to date, more versatile drug delivery can be possible if new lipid materials can be developed and used to organize unique molecular orders suitable for a difficult-to-carry drugs.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"121 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79386551","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}