• Title/Summary/Keyword: active safety

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Analytical methods to manage potential impurities in drug substances (의약품 중 잠재적 불순물 관리를 위한 분석법 연구 동향)

  • Park, Kyung Min;Kim, Won Mi;Ahn, Su Hyun;Lee, Ha Lim;Hwang, Su Hyeon;Lee, Wonwoong;Hong, Jongki
    • Analytical Science and Technology
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    • v.35 no.3
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    • pp.93-115
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    • 2022
  • Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.

Pharmacological Effect of Decursin, Decursinol Angelate, and Decursinol Derived from Angelica gigas Nakai (참당귀(Angelica gigas Nakai) 유래 decursin, decursinol 그리고 decursinol angelate의 약리 효과)

  • Kang, Jae Seon
    • Journal of Life Science
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    • v.31 no.12
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    • pp.1128-1141
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    • 2021
  • 'Angelica' is one of the most traditionally consumed medicinal herbs around Northeast Asia including Korea for treatments of various diseases or health care purposes like hematopoiesis, blood circulation for women, sedative, analgesic, and a tonic medicine etc. Angelica gigas Nakai, a Korean native species of Angelica, is clearly different from the others in containing a high concentration of active ingredients like pyranocoumarines including decursin, decursinol, and decursinol angelate. These compounds have various kinds of positive effects such as anti-tumor activity including the precaution of neutropenia occurred during anticancer drug administration, improvements of metabolic disorders, menstrual irregularity, impairment of renal function, respiration improvement, cognition-enhancement, anti-inflammatory effect, anti-oxidative effect, enhancing fertility and so forth. Thus it implies incredible potentialities in future development for foods and drugs. However, certain purity-related qualities and/or overdose in food products can cause side effects like toxicities; therefore, their safety profiles should also be considered. This review focuses on the positive and negative effects of three pyranocoumarines in Angelica gigas Nakai and some possibilities and considerations for future food and drug products development.

U.S. Commercial Space Traffic Management Policy, Yesterday and Today (미국의 민간(상업) 우주교통관리(Space Traffic Management, STM) 정책과 한국에의 시사점)

  • Kim, Syeun;Jung, Yungjin
    • Journal of Space Technology and Applications
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    • v.1 no.1
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    • pp.121-130
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    • 2021
  • Since the 1960s, the United States has developed and implemented policies to encourage commercial space launches. Specifically, national policies have been implementing to expand the role of commercial space actors, which required establishing a process for private space launches. In the early days of the space age, private launches accounted for a small portion of the total launch rate, but, since the 1990s, the proportion has exploded, with private space companies presenting large projects one after another, accounting for more than 50% of the total launch rate. This diversification of space actors and the increase in orbital space objects have led to changes in the perspectives of existing space environmental management processes. During and after the Cold War, when the space age began, civilian actors' actions were limited, and policies limited their actions, too. So they had little impact on government space activities. However, space technology's entry barrier has lowered since, and policies to facilitate commercial space launches have been implemented for a long, and the accumulated amount of space waste over the past 60 years is also threatening the safety, stability, and sustainability of space use. This paper examined how the United States, the most active country in commercial space launches, has managed commercial space launches. The United States has a Space Traffic Management (STM), distributed to departments such as the Department of Defense, Department of Commerce, Department of Transport, NASA, etc. A review of changes in U.S STM management policy could also provide implications for us to manage commercial space launches in Korea.

A Review on Ultrathin Ceramic-Coated Separators for Lithium Secondary Batteries using Deposition Processes (증착 기법을 이용한 리튬이차전지용 초박막 세라믹 코팅 분리막 기술)

  • Kim, Ucheol;Roh, Youngjoon;Choi, Seungyeop;Dzakpasu, Cyril Bubu;Lee, Yong Min
    • Journal of the Korean Electrochemical Society
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    • v.25 no.4
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    • pp.134-153
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    • 2022
  • Regardless of a trade-off relationship between energy density and safety, it is essential to improve both properties for future lithium secondary batteries. Especially, to improve the energy density of batteries further, not only thickness but also weight of separators including ceramic coating layers should be reduced continuously apart from the development of high-capacity electrode active materials. For this purpose, an attempt to replace conventional slurry coating methods with a deposition one has attracted much attention for securing comparable thermal stability while minimizing the thickness and weight of ceramic coating layer in the separator. This review introduces state-of-the-art technology on ceramic-coated separators (CCSs) manufactured by the deposition method. There are three representative processes to form a ceramic coating layer as follows: chemical vapor deposition (CVD), atomic layer deposition (ALD), and physical vapor deposition (PVD). Herein, we summarized the principle and advantages/disadvantages of each deposition method. Furthermore, each CCS was analyzed and compared in terms of its mechanical and thermal properties, air permeability, ionic conductivity, and electrochemical performance.

Ultrasound-optical imaging-based multimodal imaging technology for biomedical applications (바이오 응용을 위한 초음파 및 광학 기반 다중 모달 영상 기술)

  • Moon Hwan Lee;HeeYeon Park;Kyungsu Lee;Sewoong Kim;Jihun Kim;Jae Youn Hwang
    • The Journal of the Acoustical Society of Korea
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    • v.42 no.5
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    • pp.429-440
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    • 2023
  • This study explores recent research trends and potential applications of ultrasound optical imaging-based multimodal technology. Ultrasound imaging has been widely utilized in medical diagnostics due to its real-time capability and relative safety. However, the drawback of low resolution in ultrasound imaging has prompted active research on multimodal imaging techniques that combine ultrasound with other imaging modalities to enhance diagnostic accuracy. In particular, ultrasound optical imaging-based multimodal technology enables the utilization of each modality's advantages while compensating for their limitations, offering a means to improve the accuracy of the diagnosis. Various forms of multimodal imaging techniques have been proposed, including the fusion of optical coherence tomography, photoacoustic, fluorescence, fluorescence lifetime, and spectral technology with ultrasound. This study investigates recent research trends in ultrasound optical imaging-based multimodal technology, and its potential applications are demonstrated in the biomedical field. The ultrasound optical imaging-based multimodal technology provides insights into the progress of integrating ultrasound and optical technologies, laying the foundation for novel approaches to enhance diagnostic accuracy in the biomedical domain.

A study on environmental status, FIM and Illness intrusiveness of home stayed stroke patients (재가 노졸중 환자의 환경상태, 기능적 독립, 질병으로 인한 장애영향에 관한 연구)

  • Kim, Keum Soon;Roh, Kook Hee
    • 한국노년학
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    • v.25 no.2
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    • pp.143-154
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    • 2005
  • This study was conducted to examine the environmental status, FIM(Function Independence Measure), Illness intrusiveness of home stayed stroke patients. Data were collected on 145 patients living in K city and the neighborhood located in southern part of Korea. The data were analyzed by means of SPSS program. Results : In assessment of environmental safety, 46.2%(67) felt unsafe around their residential area. The most dangerous facilities in their residence was stairs(58.2%), gas/electric facilities(14.9%). For sanitary problems, 28.2%(41) felt they have problems at their home. The most important problems were outdoor polluted toilet(22.0%) and scattered and dirty residential circumstances(22.0%). The average FIM score was 74.52(4.14) of total score 126(7). In motor area FIM was lowest at stair walking(3.01) and bathing(3.16). In cognitive area FIM was lowest at social activities(3.36). The mean score of Illness intrusiveness was 58.86(4.52) of total score 91(7). The major area largely impacted by stroke were health(5.61), working(5.68), active leisure activities(5.56). There was significant reverse correlation between FIM and illness intrusiveness(r=-0.66, p=0.00). Conclusion : It was needed environmental improvement and rehabilitation program for stroke patients, and repeated follow up study.

The Possibility of Application of the US CASA Program in Korea - Focusing on comparison of child protection service between USA and Korea (한국에서의 미국 CASA프로그램 적용 가능성 탐색 - 미국과 한국의 아동보호서비스 비교를 중심으로)

  • Sunghae Park
    • Korean Journal of Culture and Social Issue
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    • v.24 no.3
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    • pp.473-489
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    • 2018
  • Our society has an obligation and responsibility to respect and protect the character of the child. Recently, however, Korean society has been suffering from child abuse and abuse that is pouring out every day. In order to protect these children, the child protection system and the judicial system should be fundamentally child-friendly. The CASA(Court Appointed Special Advocates) volunteer program, which is being held in the United States with such a concern, is a continuing program of court attendance and emotional support services for abused children throughout the United States. In Korea, however, there are many similar programs such as mentoring projects, dream co-supporters project similar to the CASA program in various organizations of the region and the enactment of the Act on the Punishment of Child Abuse increases the involvement of the public system in child abuse. There is also an increased awareness of children's rights and strengthened government intervention through active monitoring to prevent recurrence of child abuse. These changes in the Korean society should be actively reviewed by the US CASA program and settled as a national project in the Korean society so that the system of protecting the safety and rights of the victims of child abuse will be established. It is anticipated to be a way to prevent social problems from occurring in advance.

A Study on Occupational Environment Assessment Strategies for Respirable Particulate Matter at Coal-Fired Power Plants (석탄화력발전소 호흡성분진 작업환경 평가 전략 사례에 관한 연구)

  • Eun-Seung Lee;Yun-Keun Lee;Dong-Il Shin
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.33 no.3
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    • pp.375-383
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    • 2023
  • Objectives: Coal-fired power plants feature diverse working conditions, including multi-layered employment structures and irregular work cycles due to outsourcing and non-standardized tasks. The current uniform occupational environment measurement systems have limitations in accurately assessing and evaluating these varied conditions. This study aims to propose alternative measurement and assessment strategies to supplement existing methods. Methods: Major domestic coal-fired power plants were selected as the study targets. To prepare for the study and establish strategies, work processes were identified and existing occupational environment measurement results were compared and analyzed. The study proceeded by employing three strategies: specific exposure groups (SEGs) measurement, continuous monitoring, and supplementary measurements, which were then compared and discussed. Results: Previous exposure index evaluations (5,268 cases) indicated that crystalline silica, a type of respirable particulate matter, had detection limits below the threshold (non-detectable) in 82.6% (4,349 cases) of instances. Exposures below 10% of the exposure limit were observed at a very low concentration of 96.1%. Similar exposure group measurements yielded results where detection limits were below the threshold in 38.2% of cases, and exposures below 10% of the limit were observed in 70.6%. Continuous monitoring indicated detection limits below the threshold in 12.6% of cases, and exposures below 10% of the limit were observed in 75.6%. Instances requiring active workplace management accounted for more than 30% of cases, with SEGs at 11.8% (four cases), showing a higher proportion compared to 3.0% (four cases) in continuous monitoring. For coal dust, exposures below 10% of the limit were highest in legal measurements at 90.2% (113 cases), followed by 74.0% (91 cases) in continuous monitoring, and 47.0% (16 cases) in SEGs. Instances exceeding 30% were most prevalent in SEGs at 14.7% (five cases), followed by legal measurements at 5.0% (eight cases), and continuous monitoring at 2.4% (three cases). When examining exposure levels through arithmetic means, crystalline silica was found to be 104.7% higher in SEGs at 0.0088 mg/m3 compared to 0.0043 mg/m3 in continuous monitoring. Coal dust measurements were highest in SEGs at 0.1247 mg/m3, followed by 0.1224 mg/m3 in legal measurements, and 0.0935 mg/m3 in continuous monitoring. Conclusions: Strategies involving SEGs measurement and continuous monitoring can enhance measurement reliability in environments with irregular work processes and frequent fluctuations in working conditions, as observed in coal-fired power plants. These strategies reduce the likelihood of omitting or underestimating processes and enhance measurement accuracy. In particular, a significant reduction in detection limits below the threshold for crystalline silica was observed. Supplementary measurements can identify worker exposure characteristics, uncover potential risks in blind spots of management, and provide a complementary method for legal measurements.

Policy of Surging Investment to Early Startups Via Boosting up SAFE in Korea (창업초기투자 촉진을 위한 한국형 SAFE 활성화 방안에 대한 연구)

  • Park, Jin;Yang, Youngseok
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.17 no.6
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    • pp.1-12
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    • 2022
  • This paper put the goal on boosting up early startup investment by delivering and positioning SAFE as the main early startup investment type in Korea. In particular, this paper proves the better fitting of SAFE as to the early stage of venture investment than these of Convertible Note. This paper as referring the previous studies of SAFE as the major keystone issues determining active SAFE applying (legal positioning issue, tax treatment issue, failure of inducing the following investment with uncertainty over maturity) proposes boosting up policy of Korean SAFE. First, as to accounting treatment of SAFE, it suggests SAFE to recognize legally as "the capital" on the Korean Venture Investment Act of introducing SAFE actively as venture investment type. Second, as to tax treatment issue, it proposes on amending venture indication rule as the best alternative of resolving tax issue by accepting SAFE as the investment meeting to venture investment requirement. Third, as benchmarking foreign cases, it delivers the method of modifying foreign SAFE Contract Format by adding up more clauses about safety vehicles against the failure of the following investment and fixing maturity date and event. Ultimately, all resolutions of this paper fall on highlighting the role of Korean Venture Investment Act and Ministry of SMEs and Startups.

Indigo Naturalis in Inflammatory Bowel Disease: mechanisms of action and insights from clinical trials

  • Hyeonjin Kim;Soohyun Jeong;Sung Wook Kim;Hyung-Jin Kim;Dae Yong Kim;Tae Han Yook;Gabsik Yang
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.59-69
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    • 2024
  • This study investigates the therapeutic potential of Indigo Naturalis (IN) in treating a Inflammatory Bowel Disease (IBD). The objective is to comprehensively examine the effects and pharmacological mechanisms of IN on IBD, assessing its potential as an novel treatment for IBD. Analysis of 11 selected papers is conducted to understand the effects of IN, focusing on compounds like indirubin, isatin, indigo, and tryptanthrin. This study evaluates their impact on Disease Activity Index (DAI) score, colon length, mucosal damage, and macrophage infiltration in Dextran Sulfate Sodium (DSS)-induced colitis mice. Additionally, It investigate into the anti-inflammatory mechanisms, including Aryl hydrocarbon Receptor (AhR) pathway activation, Nuclear Factor kappa B (NF-κB)/nod-like receptor family pyrin domain containing 3 (NLRP3)/Interleukin 1 beta (IL-1β) inhibition, and modulation of Toll-like receptor 4 (TLR4)/myeloid differentiation primary response 88 (MYD88)/NF-κB and Mitogen Activated Protein Kinase (MAPK) pathways. Immunomodulatory effects on T helper 17 (Th17)/regulatory T cell (Treg cell) balance and Glycogen synthase kinase-3 beta (GSK3-β) expression are also explored. Furthermore, the study addresses the role of IN in restoring intestinal microbiota diversity, reducing pathogenic bacteria, and increasing beneficial bacteria. The findings reveal that IN, particularly indirubin and indigo, demonstrates significant improvements in DAI score, colon length, mucosal damage, and macrophage infiltration in DSS-induced colitis mice. The anti-inflammatory effects are attributed to the activation of the AhR pathway, inhibition of inflammatory pathways, and modulation of immune responses. These results exhibit the potential of IN in IBD treatment. Notably, the restoration of intestinal microbiota diversity and balance further supports its efficacy. IN emerges as a promising and effective treatment for IBD, demonstrating anti-inflammatory effects and positive outcomes in preclinical studies. However, potential side effects necessitate further investigation for safe therapeutic development. The study underscores the need for future research to explore a broader range of active ingredients in IN to enhance therapeutic efficacy and safety.