• 제목/요약/키워드: regulation criteria

검색결과 311건 처리시간 0.031초

The Process of JP Publication in relation with Drug Regulation in Japan and International Harmonization

  • Kojima, Shigeo
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.35-37
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    • 2003
  • Efficacy and safety of drugs are evaluated in the process of drug registration along with the basis of setting test method and acceptance criteria for assuring quality of the drugs. Quality of drugs plays a key role to guarantee the efficacy and safety of drugs approved in the evaluation process at the marketing stage after approval. Most important role of pharmacopoeia is to give the basis of assuring the quality of drugs. (omitted)

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겨울철 잠옷이용실태와 구매시 평가기준 (Using and Evaluative Criteria for Purchasing of Sleepwear in Winter)

  • 권수애;최종명;김은영
    • 한국생활과학회지
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    • 제10권1호
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    • pp.101-111
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    • 2001
  • The purpose of this study was to investigate using and evaluative criteria for purchasing of sleepwear in winter. Subjects were 523 males and females aged from twenties to fifties, living in Chongju and Taejon. For data analysis, frequency, descriptive analysis, t-test, and F-test were used. The results are as follows. First, the ownership of sleepwear was sweat suits with zippered top, pajamas, T-shirts/pants, underwear, and nightgown in order. The mean of using sweat suits was used the highest, and subjects used more home wear than sleepwear in winter. Second, the using or sleepwear had a significant difference in cold-sensitiveness and body types. Cold-sensitive group used sweat suit and T-shirts/pants more than cold-insensitive group. Also, groups who are thin wore sweat suit the most while groups who are corpulent, used underwear the most when they slept. Third, subjects, who are married women and use bed, used nightgown, but pajamas were used by groups who are older, married, and professional. Sweat suits and T-shirts/pants were used the most by single aged twenties. Forth, consumers considered the wearing comfort when they purchased sleepwear for winter, and they evaluated washing/management, fabric, design/style, economic, service, brand, and others' response in order, for judging the quality of sleepwear. Also, the evaluative criteria had a significant difference in demographic variables such as sex, occupation, and marital state. These results implied that sleepwear would be needed for winter in terms of behavioral temperature regulation. Especially, cold-sensitive and thin group would wear knitted and two-piece sleepwear for thermal comfort when they sleep in winter. Also, Using and evaluative criteria of sleepwear would be different in demographic characteristics. For winter, sleepwear should be develop based on physiologic as well as demographic variables.

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유독물질 상위 및 하위규정수량의 기준 및 위험 범주 선정 방안 (Determination Method of the Criteria and the Hazard Category for Upper and Lower Tier Qualifying Quantities of the Toxic Substance)

  • 김효동;박교식
    • 한국안전학회지
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    • 제37권6호
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    • pp.9-17
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    • 2022
  • Qualifying quantities (upper tier (UT) and lower tier (LT)) are designated for the regulation of toxic substances. In this study, we aimed to establish systematic criteria for the qualifying quantities by comparing the South of Korea chemical control act with the European Seveso III Directive (Seveso III). In Seveso III, qualifying quantities are defined as "hazard categories" applying GHS (Globally Harmonized System of Classification and Labelling of Chemicals), and LTR (lower-tier requirements) and UTR (upper-tier requirements) are determined. The Pro HC (proposed hazard categories) were relevant to the GHS classification of toxic substances and were compared with the currently regulated qualifying quantities. Furthermore, we estimated the Pro LTR (proposed lower-tier requirements) and Pro UTR (proposed upper-tier requirements) corresponding to each Pro HC. Consequently, it was supposed that LT and UT were selected based on GHS like those of Seveso III. Therefore, designation criteria for qualifying quantities should be established by setting the Pro HC such as in Seveso III, rather than designating the qualifying quantities of toxic substances by itself individually. In addition, qualifying quantities should not be delegated to GHS classifications (H302, H341, H411) that do not meet the criteria for the designation of toxic substances, and the corresponding substances should be excluded from classification as toxic substances. This study provides insights into the selection of hazard categories and criteria for qualifying quantities of toxic substances.

민간 무인항공기시스템 카테고리 분류에 관한 연구 (A Study of Civil Unmanned Aerial System Category Classification)

  • 안효정
    • 한국항공우주학회지
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    • 제43권7호
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    • pp.657-667
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    • 2015
  • 전 세계적으로 무인기 기술이 발전하고, 민간 수요가 증가함에 따라 각국에서도 제도마련 및 보완을 위해 적극적으로 대응하고 있다. 하지만 무인기 기술은 사용 목적에 따라 다양한 형태, 운용범위, 성능 및 운용방법 등으로 개발되고 있어 각각의 경우에 대한 안전 규정을 적용하는데 어려움이 있다. 이에 민간 무인기 분류를 위한 합리적인 기준을 마련하고, 그에 따른 범주를 구분하여 적합한 규정을 개발해야 할 필요가 있다. 현재는 무인기 분류에 있어서 국가별로 다양한 기준과 방법이 고려되고 있으며, 국제민간항공기구(ICAO)에서도 국제 표준을 마련하기 위한 노력을 진행 중이다. 본 논문에서는 전 세계적으로 무인기 카테고리를 분류하는 방식 및 관련 연구 현황을 분석하고, 이와 관련하여 국내 관련 제도의 보완점 및 민간 무인기 분류방안에 대해서 고찰해 보았다.

학령전기 아동을 위한 감각처리 평가도구의 체계적 고찰 (Assessment Tools of Sensory Processing for Preschool-Aged Children: A Systematic Review)

  • 김명희;신현희;김경미
    • 대한감각통합치료학회지
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    • 제13권1호
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    • pp.1-12
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    • 2015
  • 목적 : 본 연구의 목적은 학령전기 아동의 감각처리 능력을 측정하기 위해 사용되고 있는 평가도구의 종류를 알아보고 심리측정학적 특성을 평가하는 것이다. 연구방법 : 감각처리 평가도구는 PubMed, Cochrane, CINAHL, PsycINFO와 같은 전자 데이터베이스를 사용하여 논문을 검색한 뒤, 초록과 원문 검토를 통해 포함기준에 적합한 평가도구를 최종적으로 선택하였다. 결과 : 총 38개의 논문이 최종적으로 분석되었으며, 8개의 평가도구가 확인되었다. 가장 많은 신뢰도와 타당도가 검증된 도구는 Sensory Processing Measure-Preschool(SPM-P)이었으며 신뢰도와 타당도 검증이 부족한 도구로 는 Sensory Experiences Questionnaire(SEQ), Sense & Self-Regulation Checklist(SSRC), 그리고 Sensory Processing Scale Assessment(SPSA)가 있었다. 결론 : 본 연구결과는 임상가와 연구자들이 학령전기 아동에게 적합한 감각처리 평가도구를 선정할 때 근거자료가 될 것이다.

고속 측면 충돌 감지 알고리즘의 개발 (Development of Fast Side-impact Sensing Algorithm)

  • 박서욱;김현태
    • 한국자동차공학회논문집
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    • 제8권3호
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    • pp.163-170
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    • 2000
  • Accident statistics shows that the portion of fatal occupant injuries due to side impacts is considerably high. The side impact usually leads to a severe intrusion of side structure into the passenger compartment. Furthermore, the safety zone for the side impact is relatively small compared to the front impact. Those kinds of physics for side impact frequently result in a fatal injury for the occupant. Therefore, NHTSA and EEVC are trying to intensify the regulation for the occupant protection against side impact. Both the regulation and recent market trends are asking for an installation of side airbag. There are several types of system configuration for side impact sensing. In this paper, we adopt the acceleration-based remote sensing method for the side airbag control system. We mainly focus on the development of hardware and crash discrimination algorithm of remote sensing unit. The crash discrimination algorithm needs fast decision of airbag firing especially for high-speed side impact such as FMVSS 214 and EEVC tests. It is also required to distinguish between low-speed fire and no-fire events. The algorithm should have a sufficient safety margin against any misuse situation such as hammer blow, door slam, etc. This paper introduces several firing criteria such as acceleration. velocity and energy criteria that use physical value proportional to crash severity. We have made a simulation program by using Matlab/Simulink to implement the proposed algorithm. We have conducted an algorithm calibration by using real crash data for 2,500cc vehicle. The crash performance obtained by the simulation was verified through a pulse injection method. It turned out that the results satisfied the system requirements well.

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자란만 해역의 굴 양식어업 적정시설량 평가에 기초한 경제성 분석 (Economic Analysis based on Estimation of Optimal Facilities of Oyster Aquaculture in Jaran Bay)

  • 정민주;백진이;이주현
    • 수산경영론집
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    • 제49권4호
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    • pp.99-108
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    • 2018
  • Maintaining a certain level of fisheries production is due to the increase in aquaculture production. In recent years, aquaculture plays an important role in fishery production in Korea. Nevertheless, aquaculture should be carefully managed by regulations because it also causes environmental load which can threat sustainability of aquaculture. For this reason, Korean government has regulated density of culturing facilities with the Fisheries Law and its adjective decrees. The regulatory compliance of fisheries businesses is very low because the criteria for the regulation of the density were not enacted with scientific research. Thus, this research was aimed to obtain scientific criteria for the regulation of oyster aquaculture in Jaran Bay with economic assessment. For this research, we collected the data necessary for the assessment on five investigation points in the bay for two years. With the data, simulation for the growth rate of oyster was performed and the result showed that at least 25.5% of facilities should be reduced. Also, it was revealed that removing 2 long lines would be most beneficial. The NPV of the best measurement was 35,120,300 won and IRR was 11.7%. With this research, the government will gain more accurate regulatory compliance due to the scientific approach. Moreover, fisheries businesses in oyster aquaculture can obtain flexibility to cope with market fluctuation.

옥상녹화 적용확대를 위한 녹색건축인증제도 개선방안 연구 - 미국 LEED 및 영국 BREEAM의 비교·분석을 중심으로 - (Study on Improvement Measures of Green Standard for Energy and Environmental Design for Expansion of Applying Green Roof - Focused on LEED in the USA and BREEAM in the UK -)

  • 김지현;권혁삼;김정곤;이범식
    • 대한건축학회논문집:구조계
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    • 제34권2호
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    • pp.75-82
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    • 2018
  • Green roof in Korea has been recognized as part of landscape area and local governments enacted municipal ordinance for supporting green roof thereby assisting part of expenses spent for green roof within a range of budget for buildings which are eligible for the green roof support of existing buildings. However, it is necessary to enforce a regulation of mandatory green roof for new buildings in order to expand green roof application and provide a variety of assistances such as subsidy payment, tax relief, and mitigation of floor area ratio-related regulation as done in other advanced nations. In particular, LEED(Leadership in Environmental and Energy Design) in the USA applies additional point directly for green roof in terms of the reduction in heat island effects. For example, the following items are beneficial to have additional points: habitat preservation or restoration, external space, rainwater management, reduction in outdoor water usage, minimum energy performance, and optimum energy performance. In addition, the BREEAM(Building Research Establishment Environmental Assessment Method) in the UK specifies green roof as one of assessment items to be complied in terms of diversity of species. As such, LEED and BREEAM reflect direct and indirect effects of green roof on assessment criteria, which suggest a direction to green building certification criteria in Korea where only additional points are given for green roof according to soil depth.

PCBs 함유 절연유의 처리 후 부산물 배출특성 연구 (Determination of byproducts after treatment in PCBs-containing transformer oils)

  • 신선경;박진수;강영렬;황승률;김영식
    • 분석과학
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    • 제21권3호
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    • pp.201-211
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    • 2008
  • 본 연구에서는 PCBs 함유 폐기물의 분해 전후의 처리효율을 검토하고 반응 부산물을 확인하고자 물리화학적 처리기술을 적용한 전자빔과 탈염소화 처리 전후의 시료를 분석하였다. 전자빔으로 물리적 처리를 한 시료는 절연유 중의 PCBs 피크패턴을 유지하고 있지 않아 폐기물공정시험방법으로 정량하기 어려워 HRGC/HRMS을 이용하여 정량한 결과, PCBs의 제품이 가지고 있는 피크패턴이 분해되어 저염화물인 3-chlorobiphenyls이 생성되는 것으로 확인 되었다. 또한, 탈염소화 분해로 화학적 처리한 경우에도 PCBs 농도는 폐기물관리법 및 잔류성유기물질 관리법의 규제기준 이하로 POPs 관리법의 처리 종료 기준을 만족하는 것으로 나타났으며, PCBs 함유 폐기물을 물리화학적으로 처리하는 과정 중 분석 대상 모든 시료에서 다이옥신류가 불검출되어 다이옥신은 생성되지 않는 것으로 나타났다.

국외 음악정서조율 연구의 음악 논거 및 충실도 분석 (Analysis of Music Rationale and Fidelity in Music Emotion Regulation Studies)

  • 정현주;김보현;김현주
    • 인간행동과 음악연구
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    • 제21권1호
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    • pp.89-113
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    • 2024
  • 음악이 지닌 정서 반응에 대한 관심과 함께 음악의 조율적 기제에 대한 연구가 지속적으로 수행되고 있다. 이에 본 연구에서는 정서 조율을 위한 음악 중재 연구의 음악 선곡 근거, 활동구성 항목과 실행 논거에 대한 충실도를 분석하고자 하였다. 선정 기준에 부합한 총 45편의 국외 연구를 수집하여 연구의 전반적 특성을 검토하고, 음악이 사용된 시간, 곡 수, 선곡 논거 및 주체(참여자 vs. 연구자) 등 관련된 기준과 실행 논거를 분석하였다. 분석 결과 연구 목표가 음악의 정서 조율 효과를 알아보기 위한 연구임에도 불구하고 대다수의 연구가 사용된 음악에 대한 구체적인 정보와 일관된 통제가 부족했음이 확인되었다. 또한 음악 활동, 음악 선곡 및 음악 사용 시간에 대한 타당한 근거가 제시되지 않았고, 음악의 정서 조율 기제에 대한 이론적 기반이 부족하였다. 본 연구 결과는 음악정서조율(Music Emotion Regulation: MER)이라는 주제가 연구 영역으로 자리 잡기 위해서는 음악의 정서 조율의 기제에 대해 논거 충실도를 갖추어야 할 필요성을 암시한다. 이러한 엄격한 충실도는 음악이 지닌 치료적 고유성에 대한 연구 재현성 및 내실도를 높이는 데에 기여할 것이다.