• 제목/요약/키워드: Quality control guidelines

검색결과 248건 처리시간 0.028초

큐란 정(염산라니티딘 150 mg)에 대한 수도염산라니티딘정의 생물학적동등성 (Bioequivalence Of SudoTM Ranitidine Hydrochloride Tablet to CuranTM Tablet (Ranitidine Hydrochloride 150 mg))

  • 이선녀;고연정;강승우;윤서현;박무신;이예리;이경률;이희주
    • Journal of Pharmaceutical Investigation
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    • 제36권3호
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    • pp.193-199
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    • 2006
  • A bioequivalence study of $Sudo^{TM}$ Ranitidine HCI tablet (Sudo Pharma. Ind. Co., Ltd.) to $Curan^{TM}$ tablet (Il Dong Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the ranitidine hydrochloride dose of 150 mg in a 2x2 crossover study. There was a one week wash-out period between the doses. Plasma concentrations of ranitidine were monitored by a high-turbulent liquid chromatography (HTLC) for over a period of 12 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found far all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Sudo^{TM}$ Ranitidine $HCl/Curan^{TM}$ were 0.92-1.00 and 0.90-1.03, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Sudo^{TM}$ Ranitidine HCI and $Curan^{TM}$ with respect to the rate and extent of absorption.

시판 음식의 조리 단계별 HACCP 설정을 위한 연구 (I) 탕류(갈비탕, 설렁탕, 장국)의 위해분석 (Hazard Analysis and Critical Control Point of Korean Soups prepared at Korean Restaurants: Hazard Analysis of Tang (Galbitang, Sullungtang, Jangkuk))

  • 계승희;문현경
    • 한국식생활문화학회지
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    • 제10권1호
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    • pp.35-44
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    • 1995
  • A hazard analysis which included watching operations, measuring temperatures of foods throughout preparation and display, and sampling and testing for microorganisms of total plate counts and coliform bacteria was conducted in various phases of product flow of Korean soups (Galbitang, Sullungtang, Jangkuk) prepared at Korean restaurants. Cooked foods were sometimes held at room temperature long enough to permit multiplication of bacteria that might have been present. This was confirmed by the finding of large numbers of aerobic mesophilic colonies ($10^6$) in samples of such foods after handling and holding for several hours before served. These bacteria decreased down to $10^1{\sim}10^2$ while the contaminated Tang were served. And internal temperature of Tang served was approximately $70^{\circ}C$. Critical control points identified were, pre-preparation, handling after cooking and holding on display. Guidelines were suggested for effective quality control of Tang (Korean soups) production. Handlers of these foods need to be informed of the hazards and appropriate preventive measures.

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서울, 경기지역 도시락 제조업체의 위생실태 및 도시락 생산의 품질개선을 위한 연구 (A Study for the Improvement of the Sanitary Condition and the Quality of Packaged Meals(Dosirak) Produced in Packaged Meal Manufacturing Establishments in Seoul city and Kyungki-do Province)

  • 계승희;윤석인;박희순;심우창;곽동경
    • 한국식품위생안전성학회지
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    • 제3권3호
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    • pp.117-129
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    • 1988
  • 서울·경기지역 도시락 제조업체의 작업환경 및 도시락의 부식인 동태전 생산과정의 위생상태를 위생 점검표 및 미생물 검사를 토대로 분석, 평가한 결과는 다음과 같다. 1) 주방의 위생 상태는 향상 가능성이 있는 보통상태로 나타났고, 종업원의 위생습관은 대·중규모 업체는 향상가능성이 있는 보통상태이었으며 소규모 업체는 위험요인이 존재하는 불량상태로 나타났다. 2) 도시락 제조업체별로 동태전의 생산과정에서 원재료와 전처리 후의 재료는 미생물적인 품질이 낮았다. 3) 조사결과 조리한 음식을 실온에서 보관하는 단계와 출고하기 전까지 조합하고 포장하는 동안 실온에서 방치하는 단계는 온도 및 소요시간이 미생물 증식에 적합한 환경이 되는 위험한 단계이었다. 4) 각 업체에서 사용하는 칼, 도마 ,행주의 미생물 수치가 높아 cross contamination의 가능성이 높았다. 5) 도시락 제조업체에서 동태전의 생산 과정중의 critical control points 는 전처리단계 , 보관단계, 조합과 포장단계 및 기구로 지적되었다.

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데이터 마이닝을 이용한 시멘트 소성공정 질소산화물(NOx)배출 관리 방법에 관한 연구 (A Study on NOx Emission Control Methods in the Cement Firing Process Using Data Mining Techniques)

  • 박철홍;김용수
    • 품질경영학회지
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    • 제46권3호
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    • pp.739-752
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    • 2018
  • Purpose: The purpose of this study was to investigate the relationship between kiln processing parameters and NOx emissions that occur in the sintering and calcination steps of the cement manufacturing process and to derive the main factors responsible for producing emissions outside emission limit criteria, as determined by category models and classification rules, using data mining techniques. The results from this study are expected to be useful as guidelines for NOx emission control standards. Methods: Data were collected from Precalciner Kiln No.3 used in one of the domestic cement plants in Korea. Thirty-four independent variables affecting NOx generation and dependent variables that exceeded or were below the NOx emiision limit (>1 and <0, respectively) were examined during kiln processing. These data were used to construct a detection model of NOx emission, in which emissions exceeded or were below the set limits. The model was validated using SPSS MODELER 18.0, artificial neural network, decision treee (C5.0), and logistic regression analysis data mining techniques. Results: The decision tree (C5.0) algorithm best represented NOx emission behavior and was used to identify 10 processing variables that resulted in NOx emissions outside limit criteria. Conclusion: The results of this study indicate that the decision tree (C5.0) can be applied for real-time monitoring and management of NOx emissions during the cement firing process to satisfy NOx emission control standards and to provide for a more eco-friendly cement product.

Penn Korean Treebank: Development and Evaluation

  • Han, Chung-hye;Han, Na-Rae;Ko, Eon-Suk;Martha Palmer;Heejong Yi
    • 한국언어정보학회:학술대회논문집
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    • 한국언어정보학회 2002년도 Language, Information, and Computation Proceedings of The 16th Pacific Asia Conference
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    • pp.69-78
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    • 2002
  • This paper discusses issues in building a 54-thousand-word Korean Treebank using a phrase structure annotation, along with developing annotation guidelines based on the morpho-syntactic phenomena represented in the corpus. Various methods that were employed for quality control and the evaluation on the Treebank are also presented.

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산욕기 산모와 신생아의 가정간호 알고리즘 개발 (Development of algorithms for the home care of postpartum mothers and infants)

  • 방경숙
    • 가정∙방문간호학회지
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    • 제4권
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    • pp.65-75
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    • 1997
  • The needs for the home care of postpartum mothers and their infants are increasing, but the quality control of home care nurses is not developed yet. The objective of this study is to develop assessment - intervention algorithms for the home care of postpartum mothers and their infants. We can use these algorithms when we assess the client's condition, and find appropriate nursing interventions. Also, these algorithms can offer guidelines for home care nurses, so that standardization of home care can be attained. Common problems for postpartum mothers are postpartum hemorrhage, abnormal vaginal discharge(endometritis), episiotomy pain, breast problems, breastfeeding difficulty, edema, urinary dysfunction and defecation difficulties. Also, commom problems for infants are abnormal body temperature, tarchycardia, respiratory problem, neonatal jaundice, cord problem, abnormal stool, breast feeding, and bathing. These algorithms can be used as a basis for the development of computerized infomation system for the home health care.

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산업체 단체급식소의 관리 개선을 위한 실태조사 (Assessment of the industry foodservice management practices in Seoul city area)

  • 이영란
    • 대한가정학회지
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    • 제25권4호
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    • pp.73-83
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    • 1987
  • This study was conducted to evaluted the industry foodservice management practices, and to suggest guidelines for the effective foodservice management. The results of the study can be summarized as follows: 1) Feeding numbers among the types of industry were varied widely, and foodservice personnels were insufficient when comparing with the feeding numbers. 2) Effective recording as well as management system were not fully established in menu planning, food production, assembly and service. Thermal retention equipments were not provided to control food quality. 3) Convenience food items such as frozen beef cutlet, hambergar patty, retail cuts of meat, and canned fish were seldom used. 4) Sanitary conditions of kitchen and dining areas were evaluated as unsatisfactory comdition. 5) Equiped rate of facilities in surveyed foodservice operations were 52.7 percentage of the required standards.

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철도시스템의 안전관리를 위한 인적요소 분야의 표준에 대한 연구 (Review of International Standards Related to Human Factors for Managing Railway System Safety)

  • 박홍준;김사길;변승남
    • 한국철도학회:학술대회논문집
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    • 한국철도학회 2009년도 춘계학술대회 논문집
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    • pp.1347-1350
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    • 2009
  • Rail human factors research has grown rapidly in both quantity and quality of output over the past few years. The continual influences of safety concerns, new technical system opportunities, reorganisation of the business, needs to increase effective, reliable and safe use of capacity, and increased society, media and government interest have now accelerated rail human factors research programmes in several countries. In this paper we review international standards and guidelines on rail human factors, covering driving, signalling and control, maintenance, reporting systems, passenger interests, management, planning and technical systems change. The purpose of this study is to define the criteria regarding human factors for managing railway system safety. Therefore, some rail human factors suggested in this study may be used as basic data for supporting the Korean railway system safety.

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Over Current Protection Schemes for Active Filters with Series Compensators

  • Lee, Woo-Cheol;Lee, Taeck-Kie
    • KIEE International Transaction on Electrical Machinery and Energy Conversion Systems
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    • 제4B권3호
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    • pp.134-145
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    • 2004
  • This paper presents and analyses protection schemes for a series active compensator, which consists of a Unified Power Quality Conditioner (UPQC) or a hybrid active power filter. The proposed series active compensator operates as a high impedance "k(D)" for the fundamental components of the power frequency during over current conditions in the distribution system. Two control strategies are proposed in this paper. The first strategy detects the fundamental source current using the p-q theory. The second strategy detects the fundamental component of the load current in the Synchronous Reference Frame (SRF). When over currents occur in the power distribution system momentarily, the proposed schemes protect the series active compensator without the need for additional protection circuits, and achieves excellent transient response. The validity of the proposed protection schemes is investigated through simulation and compared with experimental results using a hybrid active power filter systems.

Guidelines for Manufacturing and Application of Organoids: Brain

  • Taehwan Kwak;Si-Hyung Park;Siyoung Lee;Yujeong Shin;Ki-Jun Yoon;Seung-Woo Cho;Jong-Chan Park;Seung-Ho Yang;Heeyeong Cho;Heh-In Im;Sun-Ju Ahn;Woong Sun;Ji Hun Yang
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.158-181
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    • 2024
  • This study offers a comprehensive overview of brain organoids for researchers. It combines expert opinions with technical summaries on organoid definitions, characteristics, culture methods, and quality control. This approach aims to enhance the utilization of brain organoids in research. Brain organoids, as three-dimensional human cell models mimicking the nervous system, hold immense promise for studying the human brain. They offer advantages over traditional methods, replicating anatomical structures, physiological features, and complex neuronal networks. Additionally, brain organoids can model nervous system development and interactions between cell types and the microenvironment. By providing a foundation for utilizing the most human-relevant tissue models, this work empowers researchers to overcome limitations of two-dimensional cultures and conduct advanced disease modeling research.