• Title/Summary/Keyword: Target Level of Safety

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Legislation Status and Legal Issues of Non-Face-to-Face Treatment (비대면진료 관련 입법 현황과 법적 쟁점)

  • Jinsuk, Kim;Eol, Lee
    • The Korean Society of Law and Medicine
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    • v.24 no.4
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    • pp.131-160
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    • 2023
  • An amendment to Medical Law allowing permanent face-to-face treatment has been proposed in the 21st National Assembly, with five different bills introduced. However, each proposed amendment focuses on different aspects, and the issue is currently in a state of 'ongoing review' due to factors such as opposition from the medical profession and political considerations. However, from the perspective that the introduction of non-face-to-face treatment should be institutionalized and legislated prioritizing patient safety, certain directions are proposed. These include focusing on returning patients as the primary target, chronic diseases as the focal conditions, outpatient medical institutions as the implementing agencies, restricting non-face-to-face means primarily to video systems, and legally exempting healthcare professionals from responsibility for incidents beyond their control. The proposed directions also emphasize establishing the right to demand face-to-face treatment. It is suggested to legislate initial standards that ensure a minimum level of safety and gradually expand the scope of non-face-to-face treatment through future research, evaluation, and similar step-by-step approaches.

Development and Research into Functional Foods from Hydrolyzed Whey Protein Powder with Sialic Acid as Its Index Component - I. Repeated 90-day Oral Administration Toxicity Test using Rats Administered Hydrolyzed Whey Protein Powder containing Normal Concentration of Sialic Acid (7%) with Enzyme Separation Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - I. 효소분리로 7% Siailc Acid가 표준적으로 함유된 유청가수분해단백분말(7%)의 랫드를 이용한 90일 반복경구투여 독성시험 평가 연구 -)

  • Noh, Hye-Ji;Cho, Hyang-Hyun;Kim, Hee-Kyong
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.99-116
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    • 2016
  • We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

Biomonitoring Human Exposure to VOCs : Using Individual Susceptibility Markers

  • Kim, Jung-Hyun;Kim, Dae-Seon;Park, Jae-Sung;Kang, Tack-Shin
    • Proceedings of the Korean Environmental Health Society Conference
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    • 2003.06a
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    • pp.187-191
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    • 2003
  • In this study, biomonitoring methods were developed to measure BTEXs exposure level in the air, metabolites of benzene and toluene in human urine, individual susceptibility markers in human blood for evaluation of the health effects about environmental pollution. We have also performed a small-scaled molecular epidemiology study on residents in Chuncheon and workers in workplace for these method applications. The workers in workplace were surveyed as study areas, and the residents in Chuncheon which is in the suburban area were surveyed as comparative areas in this study. Actually, 31 workers in as target group and 33 residences in as control group this epidemiological study. The results obtained from this study were as follows: 1. Benzene is a well-known carcinogen, it's median concentrations were 0.00024∼0.02057ppm at suburban area and 0.002∼00.654ppm at work place, These benzene concentrations were not exceed the OSHA(Occupational Safety and Health Administration) threshold benzene level of 1ppm in the states. 2. Metabolites product of benzene(t,t-Muconic Acid) and toluene(Hippuric Acid) were not significant both in suburban and workplace area. The median concentration of t,t-MA and HA were 0.0122, 1.44277g/g creatinine, respectively. 3. In the case of individual susceptibility markers as CYPlAl, 41.8% of them has homozygous wild type(W) and who has heterozygous variant type(H) was 35.4% and 22.8% of homozygous variant type(M) genetic type. In the case of CYP2E1, 62.82% of them has homozygous wild type(D) type, 34.62% of each has heterozygous variant type (DC) and 2.56% of them has homozygous variant type (CC). Who doesn't have GSTM1 gene was 46.25% and who has GSTM1 gene was 53.75%. Who doesn't have GSTT1 gene was 40.0% in study groups and who has GSTT1 gene was 60.0%. Who has W genetic type, which is homozygous wild type of GSTP1, was 69.18% and H genetic type, which is heterozygous variant type was 28.4%. M genetic type which is homozygous variant type was 2.4%. 4. Concentration differences of metabolites such as t,t-MA and HA in urine, which is generated by individual susceptibility marker of GSTM1, GSTT1, GSTP1 gene of Phase I and CYP1A1, CYP2E1 gene of Phase II, was examined. As a result, GSTP1 and GSTM1 indicate slight differences depend on the amount of metabolites in urine, it was not statistically significant.

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Evaluation of Vehicle and Pedestrian Environments using Grey System Theory (Grey System Theory를 이용한 차량 및 보행환경 통합평가)

  • Lee, Jin-Gak;Son, Yeong-Tae;Han, Sang-Jin;Park, Jin-Yeong;Lee, Sang-Hwa
    • Journal of Korean Society of Transportation
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    • v.28 no.4
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    • pp.141-156
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    • 2010
  • In this paper, understanding there is a limitation with a comprehensive and network approach for the evaluation of existing vehicle and pedestrian environments, the authors focus on developing an integrated approach to assessing these environments. The network evaluation here means the assessment at a three-dimensional level that includes evaluation methods of lines/axes in a spatial concept as well as integration of evaluation indicators being used for vehicles and the walking environment. Grey System Theory (GST) was applied based on the theoretical background for network and comprehensive integrated evaluation, and the evaluation of the vehicle and pedestrian environment was performed by assigning target areas to walking preference zones. As a result of the comprehensive evaluation and analysis by GST, even if the service level is the same as the operating indicators (Highway Capacity Manual) of the vehicle and pedestrian environment, or relatively better, it was identified that the total score could be varied over Grey Category because the observed data are calculated after considering the weights between evaluation indicators by the range of Grey Category on the comprehensive evaluation. Considering comprehensively these points, although the indicators on the operation of roads are relatively good, in the event that the indicators on the safety of roads are bad, it was known that the scores over Grey Category also could be changed. The result is that this evaluation method can be used to evaluate the network concept per lane (per axis) as well as to diagnose the current state by type of urban street in the future.

Development of LiDAR-Based MRM Algorithm for LKS System (LKS 시스템을 위한 라이다 기반 MRM 알고리즘 개발)

  • Son, Weon Il;Oh, Tae Young;Park, Kihong
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.20 no.1
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    • pp.174-192
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    • 2021
  • The LIDAR sensor, which provides higher cognitive performance than cameras and radar, is difficult to apply to ADAS or autonomous driving because of its high price. On the other hand, as the price is decreasing rapidly, expectations are rising to improve existing autonomous driving functions by taking advantage of the LIDAR sensor. In level 3 autonomous vehicles, when a dangerous situation in the cognitive module occurs due to a sensor defect or sensor limit, the driver must take control of the vehicle for manual driving. If the driver does not respond to the request, the system must automatically kick in and implement a minimum risk maneuver to maintain the risk within a tolerable level. In this study, based on this background, a LIDAR-based LKS MRM algorithm was developed for the case when the normal operation of LKS was not possible due to troubles in the cognitive system. From point cloud data collected by LIDAR, the algorithm generates the trajectory of the vehicle in front through object clustering and converts it to the target waypoints of its own. Hence, if the camera-based LKS is not operating normally, LIDAR-based path tracking control is performed as MRM. The HAZOP method was used to identify the risk sources in the LKS cognitive systems. B, and based on this, test scenarios were derived and used in the validation process by simulation. The simulation results indicated that the LIDAR-based LKS MRM algorithm of this study prevents lane departure in dangerous situations caused by various problems or difficulties in the LKS cognitive systems and could prevent possible traffic accidents.

Relationship between Compressive Strength and Dynamic Modulus of Elasticity in the Cement Based Solid Product for Consolidating Disposal of Medium-Low Level Radioactive Waste (중·저준위 방사성 폐기물 처리용 시멘트 고화체의 압축강도와 동탄성계수의 관계)

  • Kim, Jin-Man;Jeong, Ji-Yong;Choi, Ji-Ho;Shin, Sang-Chul
    • Journal of the Korea Concrete Institute
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    • v.25 no.3
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    • pp.321-329
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    • 2013
  • Recently, the medium-low level radioactive waste from nuclear power plant must be transported from temporary storage to the final repository. Medium-low level radioactive waste, which is composed mainly of the liquid ion exchange resin, has been consolidated with cementitious material in the plastic or iron container. Since cementitious material is brittle, it would generate cracks by impact load during transportation, signifying leakage of radioactive ray. In order to design the safety transporting equipment, there is a need to check the compressive strength of the current waste. However, because it is impossible to measure strength by direct method due to leakage of radioactive ray, we will estimate the strength indirectly by the dynamic modulus of elasticity. Therefore, it must be identified the relationship between of strength and dynamic modulus of elasticity. According to the waste acceptance criteria, the compressive strength of cement based solid is defined as more than 3.44 MPa (500 psi). Compressive strength of the present solid is likely to be significantly higher than this baseline because of continuous hydration of cement during long period. On this background, we have tried to produce the specimens of the 28 day's compressive strength of 3 to 30 MPa having the same material composition as the solid product for the medium-low level radioactive waste, and analyze the relationship between the strength and the dynamic modulus of elasticity. By controling the addition rates of AE agent, we made the mixture containing the ion exchange resin and showing the target compressive strength (3~30 MPa). The dynamic modulus of elasticity of this mixtures is 4.1~10.2 GPa, about 20 GPa lower in the equivalent compressive strength level than that of ordinary concrete, and increasing the discrepancy according to increase strength. The compressive strength and the dynamic modulus of elasticity show the liner relationship.

Safety Evaluation of Ethanol Extract from Unripe Fruit of Bitter Melon (Momordica Charantia L.) in Sprague-Dawley Rats (랫드를 이용한 여주 추출물의 안전성 평가)

  • Ryu, Hyeon Yeol;Lee, Somin;Ahn, Kyu Sup;Yong, Yeon;Kim, Hye Jin;Kim, Seong-Eun;Lee, Hak Sung;Hong, Su-Young;Kim, Hyun-Kyu;Hwang, In Guk;Song, Kyung Seuk
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.46 no.4
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    • pp.490-500
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    • 2017
  • This study was performed to evaluate repeated dose oral toxicity upon administration of the test substance 1,2-benzisothiazolin-3-one for 90 days and to determine NOAEL (no observed adverse effect level) and target organs in Sprague-Dawley rats. Single, 2-week repeated, and 13-week repeated oral dose toxicity studies were conducted in Sprague-Dawley rats. The dose levels of groups were 1,250, 2,500, and 5,000 mg/kg/d. All dose groups were compared with the vehicle control group. The animals were observed for clinical signs and weekly body weight. Urinalysis, hematology, and serum biochemistry analyses were conducted. Subsequently, animals were sacrificed and subjected to histopathological examination. For the result, NOAEL of ethanol extract from unripe fruit of bitter melon had an optimal dose of 5,000 mg/kg/d and acceptable daily intake up to 3,000 mg/man. There was no target organ detected. Therefore, bitter melon, which contains a variety of bioactive substances, could be widely used as a health functional food ingredient.

Fate Analysis and Impact Assessment for Vehicle Polycyclic Aromatic Hydrocarbons (PAHs) Emitted from Metropolitan City Using Multimedia Fugacity Model (다매체거동모델을 이용한 대도시 자동차 배출 Polycyclic Aromatic Hydrocarbons (PAHs) 거동 해석 및 영향평가)

  • Rhee, Gahee;Hwangbo, Soonho;Yoo, ChangKyoo
    • Korean Chemical Engineering Research
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    • v.56 no.4
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    • pp.479-495
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    • 2018
  • This study was carried out to research the multimedia fate modeling, concentration distribution and impact assessment of polycyclic aromatic hydrocarbons (PAHs) emitted from automobiles, which are known as carcinogenic and mutation chemicals. The amount of emissions of PAHs was determined based on the census data of automobiles at a target S-city and emission factors of PAHs, where multimedia fugacity modeling was conducted by the restriction of PAHs transfer between air-soil at the impervious area. PAHs' Concentrations and their distributions at several environmental media were predicted by multimedia fugacity model (level III). The residual amounts and the distributions of PAHs through mass transfer of PAHs between environment media were used to assess the health risk of PAHs at unsteady state (level IV), where the sensitivity analyses of the model parameter of each variable were conducted based on Monte Carlo simulation. The experimental result at S-city showed that Fluoranthene among PAHs substances are the highest residual concentrations (60%, 53%, 32% and 34%) at all mediums (atmospheric, water, soil, sediment), respectively, where most of the PAHs were highly accumulated in the sediment media (more than 80%). A result of PAHs concentration changes in S-city over the past 34 years identified that PAHs emissions from all environmental media increased from 1983 to 2005 and decreased until 2016, where the emission of heavy-duty vehicle including truck revealed the largest contribution to the automotive emissions of PAHs at all environment media. The PAHs concentrations in soil and water for the last 34 years showed the less value than the legal standards of PAHs, but the PAHs in air exceeded the air quality standards from 1996 to 2016. The result of this study is expected to contribute the effective management and monitoring of toxic chemicals of PAHs at various environment media of Metropolitan city.

A Study on the Improvement of Flexible Working Hours (유연근로시간제 개선에 대한 연구)

  • Kwon, Yong-man;Seo, Ei-seok
    • Journal of Venture Innovation
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    • v.4 no.2
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    • pp.97-108
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    • 2021
  • Labor contracts appear in form as an exchange relationship between labor products and wages, but since they transcend the level of simple barter, they can be economically identified as "trading" and can be identified as "rental." From a legal point of view, a legal device that legally supports and imposes binding force on commodity exchange relations is a contract. Such a labor contract led to a relationship in which wages were received and a certain amount of time was placed under the direction and supervision of the employer as a counter benefit to the receipt of wages. Since working hours are subordinate hours with one's labor under the disposition authority of the employer, long hours of work can be done for the health and safety of workers and furthermore, it can be an act that violates the value to enjoy as a human being. The reduction of working hours needs to be shortened in terms of productivity and enjoyment of workers' culture so that they can expand and reproduce, but users' corporate management labor and production activities should also be compatible compared to those pursued by capitalist countries. Working hours can be seen as individual time and time in society as a whole, and long hours of work at the individual level are reduced, which is undesirable at the individual level, but an increase in products due to an increase in production time at the social level can help social development. It is necessary to consider working hours in terms of finding the balance between these individual and social levels. If the regulation method of working hours was to regulate the total amount of working hours, flexibility and elasticity of working hours are a qualitative regulation method that allows companies to flexibly allocate and organize working hours within a certain range of up to 52 hours per week. Accordingly, it is necessary to shorten working hours, but expand and implement the flexible working hours system according to the situation of the company. To this end, it is necessary to flexibly operate the flexible working hours system, which is currently limited to six months, handle the selective working hours by agreement between employers and workers, and expand the target work of discretionary working hours according to the development of information and communication technology and new types based on the 4th industrial revolution.

Human Papillomavirus Vaccine Awareness, Acceptability, and Decision-Making Factors among Chinese College Students

  • Wang, Shao-Ming;Zhang, Shao-Kai;Pan, Xiong-Fei;Ren, Ze-Fang;Yang, Chun-Xia;Wang, Zeng-Zhen;Gao, Xiao-Hong;Li, Man;Zheng, Quan-Qing;Ma, Wei;Zhao, Fang-Hui;Qiao, You-Lin;Sivasubramaniam, Priya
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.7
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    • pp.3239-3245
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    • 2014
  • Background: College students are recommended as the target groups for catch-up human papillomavirus (HPV) vaccination. Systematical exploration of awareness, acceptability, and decision-making factors of HPV vaccination among Chinese college students has been limited. Materials and Methods: A multi-center survey was conducted in mainland China between November 2011 and May 2012. College students aged 18-22 years were stratified by their grade, gender, and major for sampling. Socio-demographic and HPV-related information such as knowledge, perceptions, acceptability, and attitudes were collected through a questionnaire. Results: A total of 3,497 undergraduates completed the questionnaire, among which 1,686 were males. The acceptability of the HPV vaccine was high (70.8%). Undergraduates from high-level universities, at lower grade, or with greater prior knowledge of HPV vaccines showed higher acceptability of HPV vaccination ($p_{trend}$ <0.001). Additionally, undergraduates with vaccination experience outside the National Expanded Program on Immunization (OR=1.29; 95%CI: 1.10-1.51) or fear of HPV-related diseases (OR=2.79; 95%CI: 2.28-3.41) were more willing to accept HPV vaccination. General knowledge of HPV vaccine was low among undergraduates, and safety was a major concern (71.05%). The majority of students wished to pay less than 300RMB for HPV vaccine and chose the Chinese Center for Disease Control and Prevention as the most appropriate venue for vaccination. Conclusions: Although most undergraduates demonstrate positive attitudes towards HPV vaccination, challenges pertaining to introduction exist in China. Corresponding proactive education and governmental subsidy to do so are urgently needed by this age-group population. Suggestions and potential strategies indicated may help shape the future HPV vaccination program in China.