• Title/Summary/Keyword: standard regulations

Search Result 708, Processing Time 0.022 seconds

Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial (생물학적 동등성 시험을 위한 2×k 교차설계법의 통계적 고려)

  • Noh, So-Young;Park, Sang-Gue
    • The Korean Journal of Applied Statistics
    • /
    • v.26 no.4
    • /
    • pp.675-686
    • /
    • 2013
  • The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

A Study on the Management & Utilization of School Drinking Water (학교음용수 관리 및 이용실태)

  • Hong, Jung-Ha;Park, Young-Soo
    • The Journal of Korean Society for School & Community Health Education
    • /
    • v.1 no.2
    • /
    • pp.87-104
    • /
    • 2000
  • The purpose of this study was to obtain the basic data as a improvement method through the fact-revealing concerning the drinking water management of school and utilization of student. The problems of the research are as follows: First, to investigate status of management of drinking water by area and school. Second, to investigate student's utilization of drinking water by area and school. 1,400 students was selected at 45 elementary and middle-high schools located in Kang-won province, and this study was constituted of two questionnaires(for school's questionnaire and student's questionnaire). The results was analyse through the frequency analysis, $x^2$-test on the basis of the above research problem by SPSS program. The findings of this research are as follows; 1) The Management of School Drinking Water First, the source of school drinking water was mostly piped water. Inspection of water quality has been fulfilled under four times a year, in the other hands, from the result inspection, the schools which was given inadequate determination was 22.2%. Second, reservoir cleaning and hygiene inspection failed far short of the regulations. Especially, reservoir cleaning was managed by exterior consignment industry not low-level officials. Third, school water drinking was the most supplied through the type of water purifier. Water purifier has been distributed to city-located and middle-high school highly, factually the water from water purifier was served with water cup. Fourth, the selection standard of water drinking manager showed slightly differently by school, accordingly there need to develope integrated system with the respective to its effective systematic management. Fifth, water cup was mostly treated by only water clear, which is to vindicate the problems concerning hygiene management. 2) Utilization of school student on Drinking Water First, Disbelief on drinking water of school student was very high. Especially, proportion of middle-high school student's disbelief of drinking water was higher than elementary school student, also girls higher than boys. Many of student have heard to don't drink water from around people. And there were showed meaningful differences by area and school. Second, It was showed many student recognize had to utilize water purifier, boiled water. However, they have still drunken the tap water or portable water from their home. Third, Many of student showed negative response with the respective to the management conditions of drinking water in classroom, There were showed meaningful differences by area and school. From the fact-revealing of water cup management, Students mostly answered to 'only water clear' and the answer of 'None use' or 'With personal cup' was higher. Fourth, In bad experience of Drinking Water, student mostly answered to 'occasionally' and there were showed meaningful differences by school. student's disease experience with school drinking water was few and there were showed meaningful differences by area and gender.

  • PDF

Application for Fire Protection Regulation based on Risk-Informed and Performance-Based Analysis (위험도 및 성능기반 분석방법에 의한 원전 화재방호규정 적용 방안)

  • Jee, Moon-Hak;Lee, Byung-Kon
    • Fire Science and Engineering
    • /
    • v.20 no.3 s.63
    • /
    • pp.65-70
    • /
    • 2006
  • From the beginning of the construction stage, the fire protection regulation for the nuclear power plants conforms to the design requirements for the acquisition of the license permit. This regulation is based on the plant status of the normal operation, but it is not enough to be used as an application standard for fire protection at the transient mode of the plant and the outage time for refueling as well as for the plant decommissioning. While the advanced fire protection requirement that has been developed in America recently suggests the performance-based requirement and management rule applicable to the overall life time of the plant, it simply represents the conceptual application. It means that it can not be treated as appropriate standards because it does not deal with the qualitative and quantitative approach in specific ways. By the way, with the use of the performance-based fire risk analysis, the dynamic behavior of the heat and smoke at the fire compartment of the nuclear power plants can be analyzed and the thermal effect to the safety-related equipment and cables can be evaluated as well. At this paper, it suggests the ways to change the applicable fire protection regulations and the required evaluation items for the fire risk resulted from the plant configuration change with an intent to introduce the state-of-the-art quantitative fire risk analysis technology at the domestic nuclear power plants.

The Actual Condition and Development Direction of A Community Child Center (전라북도 지역아동센터 현황과 발전방안)

  • Yee, Young Hwan
    • Korean Journal of Childcare and Education
    • /
    • v.7 no.3
    • /
    • pp.67-100
    • /
    • 2011
  • This study assesses the current status of community child centers in Jeollabuk-do by analyzing data from evaluations of 225 centers in 2009. The results are as follows. First, as of 2004, there was a total of 37 Jeollabuk-do community child centers; the number has been increasing at a rate of 20~40% yearly. The number of community child centers has been increasing since government funding was implemented, especially as an authorization is not required to open a center. In order to prevent an excessive amount of childcare centers, and to ensure that new centers meet a standard of quality, it is necessary to examine replacing the current reporting system with an authorization system. Second, out the 6,144 children in the 255 centers, 1,711 children (27.8%) were not from low-income families. This may be positive in that children from various income level families are learning together. However, in order for the community child centers to operate as they were intended, it is necessary to reinforce the itemized regulations. Third, the community child centers scored relatively poorly in utilizing community and human resources. This is because although most Jeollabuk-do childcare centers are using volunteer personnel, they are not fully utilizing community resources. The governments of the cities and counties should support the community child centers by promoting their services and roles, and thereby enable the centers to develop a network of professionals in the community.

Analysis of Fulfillment Status on Environment·Landscape Damage Reduction and Disaster Prevention in Quarry Related to Mountainous Districts Management Act (산지관리법에 명시된 토석채취지의 환경·경관피해 및 재해저감 관련 법 조항의 이행실태 분석)

  • Park, Jae-Hyeon;Kim, Ki-Dae;Bae, O-Jang
    • Journal of Korean Society of Forest Science
    • /
    • v.106 no.2
    • /
    • pp.196-203
    • /
    • 2017
  • Quarrying industry is typical industry that troubled between the market and government regulations in the forestry. Especially, it is difficult to consider aspects of economics and environment, landscape, disaster at the same time. Therefore, Quarrying industry need revised statutes according to regulatory reform and mitigation. This study conducted to provide basic data for regulatory reform and mitigation in quarrying industry. We surveyed 22 article of mountainous districts management act and lower statutes to employers and business interests on quarry 55 places in the Republic of Korea. As a result, fulfillment status of environmental damage reduction and disaster prevention were satisfactory. But fulfillment status of landscape damage reduction were not applicable. This result is due to the social mood that emphasizes the forest landscape. But there is need to improve the efficiency of grit chamber through present standard on effluent(water pollution prevention). In conclusion, policies should be established for realistic regulation and developed industry to quarrying industry.

A Study for the Development of Standardized Management Manuel in Sanhujoriwon - Centered on the Management of Women & Newborn - (산후조리원의 표준화 관리 지침을 위한 연구 - 산모와 신생아 관리현황을 중심으로 -)

  • Jung, Eun-Sil;Yoo, Eun-Kwang
    • Women's Health Nursing
    • /
    • v.8 no.2
    • /
    • pp.301-313
    • /
    • 2002
  • The purpose of this study was to develop the frame for standardized manual for Sanhujoriwon by finding out the status of the management of women & newborn in Sanhujoriwon, like postpartum care center. The subjects were 95 staffs of 22 Sanhujoriwon agreed on oral consent, in Seoul and Bundang, Korea. Data were collected from Sep. 15 to Oct. 24, 2001. The instrument used for this study was a structured questionnaire consisted of 16 items of general characteristics & educational characteristics about postpartum care, 31 items of degree of management of women's postpartum care (Cronbach's $\alpha$.93 ), 24 items of degree of management of newborn's care(Cronbach's $\alpha$.94 ), 10 items of methods of management of women's postpartum care, 8 items of methods management of newborn's care. The data were analyzed by the SPSS/PC+ program using frequency, percentage, mean, standard deviation, t-test, ANOVA and Pearson correlation coefficient. The results of the study were as follows ; 1. The mean of the degree of management for postpartum women was 4.1. The mean score for the degree of management of general postpartum care for women was 4.00 & traditional postpartum care(Sanhujori) was 4.20. The degree of management of traditional postpartum care was higher than general postpartum care for women. 2. The degree of management for newborn : The mean score for the degree of management of newborn was 4.37. 3.There was a strong positive correlation between general postpartum care and traditional postpartum care($r=.744^{**}$), and postpartum mother care and newborn care($r=.798^{**}$). 4.The basic frame for the management of the women and newborn in Sanhujoriwon. 1) For women: Integrated postpartal care Physical management : Vital sign & BP check, contraction of uterus, form and amount of lochia, management of personal hygiene, management of breast & breast-feeding, management of postpartum exercise, prevention of infection, symptom & sign of high risk and prevention & management of high risk condition; Emotional-psychological management: assessment and management of mother-baby attachment, emotional state; Educational management : education of vaccination schedule, urinary incontinence, rearing infant, breast-feeding ; and Environmental management : temperature, humidity, disinfection, cleaning, light, infection control integrated with 6 principles of Sanhujori. 2) For newborn Physical management : check of vital sign, management of umbilical cord, jaundice, prevention of infection, management of diaper rash; Emotional-psychological management : assessment of sleep, crying, activity, response of mother-baby attachment; and Environmental management : temperature, humidity, disinfection, cleaning, light, infection control integrated with 6 principles of Sanhujori. In conclusion Sanhujoriwon must be health care center for the postpartum women and newborn. Therefore, the establishment of various laws and regulations in such a way to meet the realistic needs of Sanhujoriwon as a health care center for women and infants future health should be done. The standardized management manual based on the results is absolutely required above all.

  • PDF

A Study on Korean Twill Fabrics in the 17th Century (17세기 한국 능(綾)직물 연구)

  • Cho, Hyo-Sook;Lee, Eunjin
    • Journal of the Korean Society of Costume
    • /
    • v.63 no.4
    • /
    • pp.56-69
    • /
    • 2013
  • This study studies the fabrics from excavated 17th century tombs of Mrs. Min from Yeoheung family(1586~1656), Yeo-on Kim(1596~1665) and Won-rip Choi(1618~1690) and attempts to clarify the relationship between the fashion trend in fabrics of those times and the background behind it by viewing and examining the proportion of twill fabrics to the total silk fabrics and the characteristics of its weave and patterns. Looking into fabrics from the above tombs, twill fabrics accounted for 10.4%(13 pieces) 19.3%(16 pieces) and 9.2%(9 pieces) of total silk fabrics in each of the respective tombs. This forms a remarkable contrast with the fact that there was only one piece of twill silk fabrics(0.5%) and not any from the 16th century tombs of Mrs. Yoon from Papyeong family (0.5%) and Soo-ryoon Sim(0%). In particular, the percentage of hwamun-neung(patterned twill fabrics) in each of the tombs is 8.0%(10 pieces), 13.3%(11 pieces), 9.2%(9 pieces), which is much higher than that of non-patterned one. This is common to the twill fabrics from above three 17th century tombs. Patterns of hwamun-neung(patterned twill), simplified small flower patterns or geometrical figures, from the three excavated tombs are mostly arranged sporadically with blank space. It is supposed that these figurative characteristics reflected the aesthetic sense of the gentry at that time which valued simplicity and moderation for their Confucian standard. This phenomenon of increased use and production of twill fabrics in the 17th century resulted from different factors such as wars like Japanese Invasion of Korea(1592~1598), economic difficulty, government regulations against the production of high-class fabrics, development of weaving skill and its fixation, changes of fabric production environments, and changes of aesthetic sense preferring naive and moderate things to showy ones. As for the weaving characteristics of twill fabrics from the three 17th century tombs 3 leaf warp-faced twill was often used for the ground texture and 4 leaf warp-faced one was occasionally used. For pattern texture 6 leaf weft-faced twill was frequently used, 4 leaf weft-faced twill and 3 leaf weft-faced twill were used at times, and floating one was occasionally used as well.

Material Tests for the Evaluation of Safety Aspects for Recycled Plastic 'Tarai' as a Food Container (재활용플라스틱 다라이의 식품용기로서의 안전성 평가를 위한 재질 시험)

  • Lee, Keun-Taik;Lee, Jung-Pyo;Choi, Won-Sun;Woo, Moon-Jea;Lee, Jae-Rock
    • Journal of the Korea Organic Resources Recycling Association
    • /
    • v.12 no.2
    • /
    • pp.41-51
    • /
    • 2004
  • Recycled plastic containers, so-called 'Tarai' in Korea which are often used as food containers, were collected from 23 domestic manufacturers. Then, their components were analyzed to find out whether they are safe for the use of food-contact material, to meet the standards and specifications of Korean hygienic regulations, the 'Food Code.' The components of the material were analyzed by using Fourier Transform-Infrared (FT-IR), Differential Scanning Calorimeter (DSC), and Elementary Analyzer (EA). The analysis of the FT-IR and the DSC showed that the main component of the samples was polyethylene. Furthermore, the analysis of the EA for 'Tarai' sample revealed the same ratio of C and H elements as in the case of polyethylene which was 1 to 2. Phenol and formaldehyde were not detected in all the samples. As for the antioxidant tests, Irganox 1010, Irganox 1076 and Irganox 1330 were detected in various samples. With regard to the material test for heavy metals, 7 out of 23 samples exceeded the limit value of 100 mg/kg in lead contents. No standard and specification is yet prescribed in the 'Food Code' for the material of 'Tarai' as plastic containers for food. This study suggests that the use of 'Tarai' as a food container should be strictly controlled.

  • PDF

Analysis of Substitutability of 2D Electronic Drawing Using the BIM Model -Focusing on the Electronic Delivery System in Road Field- (BIM 모델을 활용한 2D 전자도면 대체 가능성 분석 -도로분야 전자납품체계를 대상으로-)

  • Seo, Myoung-Bae;Ju, Ki-Beom;Kim, Nam-Gon
    • The Journal of the Korea Contents Association
    • /
    • v.13 no.11
    • /
    • pp.441-450
    • /
    • 2013
  • With the recent increase in BIM orders in civil engineering, project owners are supplied with BIM-based products. Due to the lack of related guidelines, however, and the vague regulations on the creation and level of drawings as well as on the products list, many owners receive BIM-based products along with the existing 2D products. This can lead to task overlapping by designers or contractors and can cause the owners to have more data to maintain. If the existing 2D-based electronic supply system is changed to a BIM ordering system to reduce such a burden, it is necessary to examine the 2D products that can be extracted from or substituted for the BIM model so as to minimize the overlapping products. Therefore, in this study, BIM modeling of road construction projects whose enforcement plan by the Ministry of Land and Transportation has been completed was conducted, and based on the study results, the possibility of extracting 2D drawings from a total of 3,767 drawing items was determined. The results showed that 2,549 drawing items (67%) could be extracted as 2D drawings from the BIM model, and in particular, drawing items related to general connection work, earthwork, and amenities work could be most effectively substituted. The results of this study can be used as the base data for reducing the number of 2D drawings or substituting them in developing a BIM-based product supply system in the future.

Development of the Model for Evaluation of Medical device manufacturer's Quality Management System against international standards and industry environment's change (국제기준 및 산업환경 변화에 대응한 의료기기 제조기업 품질경영 평가모델 개발)

  • Yoon, Do-Sik
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.19 no.6
    • /
    • pp.382-390
    • /
    • 2018
  • This study developed a model to evaluate the quality management system of a medical device manufacturing company, and applied it to medical device manufacturers to understand the impact on business performance in response to international regulations and industry's change. This study prepared preliminary items, defined four (4) major factors (Plan-Do-Check-Act) that consist of the evaluation layers and items per category according to prior research review and expert interview, and calculated the weight and importance using AHP. The study results showed that responsibility & authority and quality objective in Planning Category, product-related requirement and R&D in Doing Category, Measuring and monitoring in Check Category, and review of meeting Regulatory and regulation in Action Category are relatively more important factors. The evaluation model developed based on the calculated weight and importance to business performance was applied to medical device manufacturers to investigate and analyze the implementation level of QMS and its impact on business performance according to each category. Most medical device manufacturers to be studied showed a reasonable level of QMS and effective business performance. Almost all the evaluation layers and items in the four (4) factors had a significant influence on business performance. Although the medical device quality management system is aimed mainly at license acquisition, it is important that management environment factors not related directly to licensing and authorization are important to business performance, and it is effective when these factors are integrated and operated within and outside the manufacturer.