• Title/Summary/Keyword: standard regulations

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Establishment of Quantitative Method for Generic Drugs in Korea Pharmaceutical Codex Monograph (공정서 수재 의약품의 정량법 개선에 관한 연구)

  • Song, JaeYong;Jang, JinSeob;Jang, SeungEun;Kim, SunHoi;Kim, InKyu;Lee, GilBong;Lee, JeaMan;Kim, YongHee
    • YAKHAK HOEJI
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    • v.56 no.5
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    • pp.288-292
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    • 2012
  • The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

Effect of Pectinase Treatment on the Extraction Yield Improvement from Rubus coreanus Juice and Physicochemical Characteristics during Alcohol Fermentation (Pectinase 처리가 복분자 과즙의 추출 수율 향상과 알코올 발효 중 이화학적 특성에 미치는 영향)

  • Jeong, Eun-Jeong;Kim, Hyeong-Eun;Shin, Dong-Hwa;Kim, Yong-Suk
    • Food Science and Preservation
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    • v.14 no.6
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    • pp.702-708
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    • 2007
  • The effects of pectinase treatment and other processing conditions on juice yield from Rubus coreanus, and physicochemical changes during alcohol fermentation, were investigated. The yield from R. coreanus increased by 8.60% with Pectinex 100L treatment (500 ppm, 30 min) compared to a control group. The soluble solid content in the group fermented at $24^{\circ}Brix$ by addition of sucrose (24B-group), and the group fermented at $8^{\circ}Brix$ by addition of 16% sucrose after 4 days of fermentation (8B-group) decreased to $8.2{\sim}8.3$ and $7.7{\sim}8.0%$ after 10 days of fermentation, respectively, and no significant differences were observed with Pectinex 100L treatment. Initial titratable acidity in the enzyme treatment was slightly higher ($1.18{\sim}1.22%$) than for the control group (1.02%). The initial $L^*$ and $b^*$ values of R. coreanus juice decreased with enzyme treatment, and the $a^*$ value increased, but the color difference (${\Delta}E$) between the control and enzyme treatment gradually decreased with fermentation time. The ethanol contents in the 24B-group and the 8B-group were $16.01{\sim}16.22%$ and $13.29{\sim}13.52%$, respectively, after 10 days of fermentation. The methanol contents in the enzyme treatment and the control were $0.359{\sim}0.404$ and $0.520{\sim}0.604$ mg/mL, respectively, and within standard regulations (1 mg/mL).

Changes in the Training Conditions of Residents by Enforcement of Medical Residents Act (전공의법 시행에 따른 전공의 수련환경 변화)

  • Oh, Su-Hyun;Kim, Jin-Suk
    • Journal of Digital Convergence
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    • v.17 no.12
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    • pp.427-434
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    • 2019
  • The Medical Residents Act was enacted in December 2016 to protect the rights of residents, and to ensuring the safety of patients, and nurturing good medical human resources. This study analyzed the changes of training conditions according to the enforcement of The Medical Residents Act by comparing the results of two surveys conducted in 2015(1,793 Residents) and 2017(1,768 Residents). As a result, Residents worked over 80 hours per week on average('15=92.4h, '17=87.3h) and they worked twice as many times as 36 hours('15=89.4h, '17=70.1h). Female residents' leave before and after childbirth('15=78.5day, '17=82.2day), Preparation of Standard training contract('15=19.3%, '17=40.8%), Delivery of training contract('15=12.4%, '17=36.1%) did not comply with the regulations. The training conditions of the residents is directly related to the safety of patients and the public's health. National support is needed for the support of substitute workforces, fair training evaluation conditions and incentives based on the evaluation results, labor costs for residents and supervising medical specialists, and the cost of making training programs.

A Study on the Mediation and Arbitration of Lease Dispute (임대차 분쟁의 조정과 중재에 관한 연구)

  • Nam, Seon-Mo
    • Journal of Arbitration Studies
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    • v.25 no.4
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    • pp.119-136
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    • 2015
  • The contracting parties must be provided a litigation scheme in order to resolve a dispute. This means taking advantage of effective measures for mediation or arbitration. A lease transaction is likely to occur mainly after a dispute. It is necessary to take the appropriate measures in advance. In general, when a variety of contracts are created, conflicts arise and disputes have to be resolved through mediation and arbitration documents, and adjustment or intervention is called for. Arbitration system is a system that is established based on the trust of the arbitral tribunal. For such system, quality education for enhancing professionalism required of the arbitrator is important. A party responding to an arbitration agreement presents a problem. The current system must ensure that there are no disadvantaged parties. However, a party must depend on an arbitration agreement that is part of the law rescue system. A litigation support by the local Bar Association must be carried out. It should be notified of the contents of the contract to select a strategy that will best resolve the conflict. In the case of lease transactions, there is a need to create a scheme to make a standard agreement that inserts an arbitration clause. Lease sale and purchase agreement or lease agreement is a form of contract that has been frequently used. Here, the arbitration agreement clause for a lawyer that will serve as arbitrator should be inserted. It is a scheme that can be activated for individuals in poor areas. In addition, it is possible to see it taking a scheme to take advantage of the lawyer system for the future of the town. The Attorney System of a town is a system that the Korean Bar Association, Legal Department has put in place since 2013. If a real estate trade dispute occurs, the role of the intermediary attorney should be to carry out his duties efficiently. In the case of real estate transaction conflicts, the lawyer of the village should be registered as the arbitrator. It is important to establish a basis of regulations through this type of real estate transaction accident analysis. Before proceeding with various adjustment systems, it is desirable to expand the arbitration region. Now we need a realtor amendment. It is the part where fragmentation of intermediary qualification is required, along with the eligibility of a subdivision.

Determination of PFOS in LDPE and the Result for Proficiency Testing (LDPE 중 PFOS의 분석법 개발과 비교숙련도 결과)

  • Jung, Jae Hak;Lee, Young Kyu;Myung, Seung Woon;Cheong, Nam Yong
    • Journal of the Korean Chemical Society
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    • v.57 no.1
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    • pp.40-51
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    • 2013
  • In order to develop a quantitation method for Perfluorooctanesulfonic acid(PFOS) contained in plastics that are mainly used in electric and electronic equipment, this study consisted of conducting method validations with LDPE samples using soxhlet solvent extraction and LC/MS. As a result, the limits of detection and quantitation (LOD, LOQ) were $2.58{\mu}g/L$ and $7.82{\mu}g/L$, respectively. Additionally, the recovery was 96-102%. For the correlation coefficient of LC/MS, the $r^2$ value was 0.9992 in the concentration range of $7.82-100{\mu}g/L$, which confirmed its linearity. Furthermore, for the standardization of the analysis method for PFOS in electric and electronic equipment to correspond to EU environmental regulations, we conducted a proficiency test with a number of domestic and international testing laboratories. Three of the ten testing laboratories that participated in the proficiency test submitted outliers. Accordingly, we examined the cause of the outliers using the $^{19}F$ NMR, finding that the main cause was an error in the processing of the results for isomers in PFOS that existed in standard solutions and samples.

A Quality Management Model for Consumer-oriented Spatial Information (사용자 관점의 융·복합 공간정보 품질관리 방안 연구)

  • Choi, Jae-Yeon;Kim, Eun-Hyung
    • Journal of Cadastre & Land InformatiX
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    • v.50 no.1
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    • pp.47-62
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    • 2020
  • As demands and applications of spatial information increase, different aspects of quality management have been raised as an important issue. This study suggests a quality management method for consumer-oriented spatial information, providing the consumer satisfaction. As opposed to the demands mentioned, less attention has been paid on the quality for the spatial information. So far, most of spatial information producers have kept their own independent quality management system and standard. Because of this unconscious response, it has been difficult to reflect the consumer's various and flexible demands from the silo structure of the quality management systems and regulations. The explosive increase of spatial information products creates quality-related problems such as limited time and budget for the consumer-oriented quality management. To solve these problems this study suggests to use a minimum number of the basic spatial information products which can guarantee better qualities when other products are combined. Because each of the spatial information product can include several other sub-products inside, it can have intrinsic characteristics such as geographic accuracy relationships between the products when combined and a hierarchical structure in each product in terms of the quality management mentioned. To prove the usability of the model, a case of the National Spatial Data Infrastructure Center is used because the Center collects and distributes an enormous amount of spatial information to the public and private sector.

A Study on the Problem and Improvement of Screening System of Low Price Subcontracting by Analyzing a Standard of Judgement Criteria (원도급자 측면에서의 저가하도급 판정기준의 문제점과 개선방안)

  • Kim, Soon-Young;Han, Choong-Hee;Baek, Tae-Ryong;Kim, Kyoon-Tai;Lee, Jun-Bok
    • Korean Journal of Construction Engineering and Management
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    • v.10 no.6
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    • pp.107-116
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    • 2009
  • As the Fundamentals of Construction Business Act was revised in December 2004 and its implementing ordinances and enforcement regulations were adjusted in June 2005, the screening system of low price subcontracting has been an obligation to the public owners, having brought about arguments for and against since it enacted in 1983. The statutes for low price subcontracting have been reinforced from this year; for example, it underlines to submit to a project and builds an information network of subcontracting works. The system's original intention was that prevents shoddy and fraudulent constructions caused by low price subcontracting and precludes disturbances of fair trade by screening that whether it satisfies the conditions or not in advance. But, the criterion for the existing low price subcontracting has several issues having held up a true mirror to the real situation. It is arguable to discharge an important task with the primary purpose. This dissertation have researched the problem with a deposit of subcontract and the low price subcontracting basic rate are being used by the criteria for deciding whether it is a low price subcontracting or not, so showing the plan of reformation based on the findings, it wishes to contribute toward making the most of the system's essential intent.

Evaluation of Hydraulic Stability Using Real Scale Experimental on Porous Concrete Revetment Block (다공성콘크리트 호안블록의 실규모 실험을 통한 수리안정성 평가)

  • Kim, Bong-Kyun;Seo, Dae-Seuk;Park, Jun-Seok;Kim, Yun-Yung
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.20 no.2
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    • pp.122-130
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    • 2016
  • The past few decades of industrialization enabled human-centered stream developments, which in turn resulted in constructing straight or covered streams, which are used only for sewage disposal purpose. However, these types of streams have become the cause of flood damages such as localized heavy rain. In response, various construction methods have been implemented to prevent stream and embankment damages. However, regulations regarding these measures only lay out minimum standards such as the height of slopes and the minimum angle of inclination. Moreover, examination of tractive force, the most crucial factor in preventing flood damage, is nonexistent. Therefore, this study evaluates various tractive forces by implementing a porous concrete tetrapod at a full scale artificial stream for experiment, controlling the rate of inflow, and measuring the velocity and depth of the stream under different experiment conditions. The test results of the compressive strength, and porosity and density of rock of the porous concrete tetrapod was between 16.6 and 23.2 MPa, and the actual measurement of air void was 10.1%, thus satisfying domestic standard. The result of tractive force experiment showed a limiting tractive force of $47.202N/m^2$, not satisfying the tractive force scope of $67N/m^2$ the stream design working expertise proposes. However, there was neither damage nor loss of blocks and hardpan. Based on previous researches, it can be expected that there will be resistance against a stronger tractive force. Therefore, it is necessary to conduct another experiment on practical limiting tractive force by adjusting some experimental conditions.

Power Generation Cost Comparison of Nuclear and Coal Power Plants in Year 2001 under Future Korean Environmental Regulations -Sensitivity and Uncertainty Analysis- (미래의 한국의 환경규제여건에 따른 2001년도의 원자력과 석탄화력 발전단가비교 -민감도와 불확실도 분석-)

  • Lee, Byong-Whi;Oh, Sung-Ho
    • Nuclear Engineering and Technology
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    • v.21 no.1
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    • pp.18-31
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    • 1989
  • To analyze the impact of air pollution control on electricity generation cost, a computer program was developed. POGEN calculates levelized discounted power generation cost including additional air pollution control cost for coal power plant. Pollution subprogram calculates total capital and variable costs using governing equations for flue gas control. The costs are used as additional input for levelized discounted power generation cost subprogram. Pollution output for Rue Gas Desulphurization direct cost was verified using published cost data of well experienced industrialized countries. The power generation costs for the year 2001 were estimated by POGEN for three different regulatory scenarios imposed on coal power plant, and by levelized discounted power generation cost subprogram for nuclear power. Because of uncertainty expected in input variables for future plants, sensitivity and uncertainty analysis were made to check the importance and uncertainty propagation of the input variables using Latin Hypercube Sampling and Multiple Least Square method. Most sensitive parameter for levelized discounted power generation cost is discount rate for both nuclear and coal. The control cost for flue gas alone reaches additional 9-11 mills/kWh with standard deviation less than 1.3 mills/kWh. This cost will be nearly 20% of power generation cost and 40% of one GW capacity coal power plant investment cost. With 90% confidence, the generation cost of nuclear power plant will be 32.6-51.9 mills/kWh, and for the coal power plant it will be 45.5-50.5 mills/kWh. Nuclear is favorable with 95% confidence under stringent future regulatory requirement in Korea.

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The Study on the Integrated Monitoring of Water Quantity and Quality Data (수량 및 수질관측 통합연계 운영 연구)

  • Yi, Jae-Eung;Kim, Mun-Mo;Park, Sung-Je
    • Journal of the Korean Society of Hazard Mitigation
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    • v.9 no.5
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    • pp.115-123
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    • 2009
  • Integrated information to water quantity and quality is essential for planning water resources management as well as operating water-related infrastructures. Because data collection process including monitoring and maintenance is separated in different governmental agencies in Korea, integrating quantity and quality may provide effective and better management implementation. In this study, a number of suggestions regarding integration of water monitoring were concluded in terms of technological, legal and institutional implications. First, it is necessary to discuss national water monitoring plan, national water information management plan, agreement of standard terms of monitoring between ministries, and to revise the law(river law and water quality management law). Present stations for water monitoring should be used for both of quantity and quality monitoring. If station is newly installed or relocated, it is better that one single agency maintain monitoring frequency and data management as well. In addition, a monitoring protocol need to be agreed by each of parties. In order to develop integrated monitoring system, quality assurance of the collected data should be properly maintained. Since many purposes haven been concerned using of data analysis and assessment so far, it may not be easy to integrate water quantity and quality monitoring in a short period. However, the alternatives including enhancing institutional regulations and programs, advanced technology may promote an efficient integrated water monitoring.