• 제목/요약/키워드: Standardization Procedure

검색결과 140건 처리시간 0.03초

수산나프로닐 캡슐 및 염산트라마돌 캡슐의 용출시험에 관한 연구 (Development of the Dissolution Tests for Nafronyl Oxalate Capsules and Tramadol Hydrochloride Capsules)

  • 황정분;문현주;고서연;장기욱;이규하;손경희;김인규;조대현
    • 약학회지
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    • 제55권5호
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    • pp.411-418
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    • 2011
  • The dissolution test method and an analytical procedure by HPLC were developed and validated for nafronyl oxalate capsules and tramadol hydrochloride capsules. These drugs were not yet characterized by the dissolution specifications in the Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for nafronyl oxalate capsules was carried out under sink conditions as follows: dissolution medium phosphate buffer pH 6.8, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 80% of its label amount was released within 30 min in this method. Also the dissolution test for tramadol hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 15 min in this method. The dissolution samples were analyzed with a validated HPLC analytical procedure. The analytical methodology showed acceptable values in terms of specificity, linearity, precision and accuracy. The dissolution test methods described above were adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of nafronyl oxalate capsules and tramadol hydrochloride capsules. Furthermore, the outcomes of this study were expected to help create an environment where safe and high quality drugs would be distributed on the domestic market making contributions to advancing public health.

유도객담검사의 시행과 해석: 전문가 의견서 (KAAACI Standardization Committee report on the procedure and application of induced sputum examination)

  • 김민혜;김미영;임경환;양민석;송우정;이정민;서동인;신유섭;권재우;김세훈;김상헌;이병재;조상헌;정재우;대한천식알레르기학회 표준화위원회
    • Allergy, Asthma & Respiratory Disease
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    • 제5권6호
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    • pp.307-311
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    • 2017
  • Induced sputum and sputum cell count analysis is a test for the diagnosis of various respiratory diseases. In particular, it has long been used as an important biomarker in the diagnosis or characterization of asthma or eosinophilic bronchitis. Despite a relatively long history of this test, there has been no consensus report for conducting and interpreting the analyses in Korea. Based on this awareness and necessity, the Korean Academy of Asthma, Allergy and Clinical Immunology launched the Standardization Committee to review the international guidelines and the literature and to develop a consensus report on the diagnostic procedure and interpretation of the sputum induction test.

IPTV 단말 프로비저닝 절차의 구현과 표준화에 관한 연구 (Implementation and Standardization of an IPTV Terminal Provisioning Procedure)

  • 조성수;김경열;최현기;김형수
    • 한국통신학회논문지
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    • 제37C권12호
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    • pp.1230-1244
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    • 2012
  • IPTV 서비스의 활성화를 위해 IPTV 단말의 사업자 이동성 확보 방법이 제기되었다. 사업자 이동성이 확보되면 서비스 이용자가 IPTV 단말을 시중에서 직접 구매 후 자신이 서비스를 제공받고자 하는 사업자를 스스로 선택하여 IPTV 서비스를 제공받을 수 있다. 이를 위해, IPTV 단말은 서비스를 제공받기 전 일련의 프로비저닝(provisioning) 과정을 거쳐야 한다. 한국정보통신기술협회(이하 TTA)는 IPTV 단말의 프로비저닝 절차에 관한 표준 기술 규격인 TTAK.KO-08.0026을 제정하였다. 본 논문에서는 이의 개정 문서인 TTAK.KO-08.0026/R2의 내용과 그에 기반하여 구현한 IPTV 단말 프로비저닝 시스템의 구성, 기능, 동작 절차, 파라미터 및 이슈 사항 등에 관해 소개하고, IPTV 단말 프로비저닝 절차의 파급 효과와 표준화의 발전 방향에 대해 논하고자 한다.

군용 피복류의 투습도 시험방법 표준화 연구 (A Study on Standardization of Test Method for Water Vapour Permeability of Textiles Fabrics)

  • 이민희;홍성돈;정일한
    • 한국산학기술학회논문지
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    • 제17권10호
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    • pp.27-33
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    • 2016
  • 군수품은 방한복을 중심으로 투습방수성 소재 적용이 확대되고 있다. 특히 혹한기에는 장병의 생존성 확보를 위해 피복의 투습방수 기능이 더욱 중요한데, 체온의 손실을 예방하기 위해 땀은 외부로 빨리 발산하고 외부의 수분은 인체로 침투되지 않도록 해야 하기 때문이다. 한편, 한국군은 투습방수 소재의 성능을 내수도와 투습도로 평가하고 있다. 투습도는 규정된 온도 및 습도 하에서 직물을 통과하는 수증기의 증발 양을 측정하는 것으로, 이 중 아세트산포타슘을 이용한 방법(KS K 0594)이 주로 적용되고 있다. 그러나 이 방법은 시약의 준비 절차가 간략히 제시되어 공인시험기관별로 시험에 대한 준비과정 등이 상이하게 적용되고 있으며 이로 인해 결과의 편차가 크게 발생되고 있다. 따라서 본 연구에서는 공인시험기관별로 아세트산포타슘을 이용한 투습도 시험의 절차를 비교하고, 결과에 영향을 미치는 인자를 분석하여 투습도의 차이를 없애기 위한 개선안을 도출한다. 개선안에 대해 공인시험기관별 투습도에 대한 결과의 차이를 분석하기 위해 유의수준(0.05)을 바탕으로 일원배치법으로 분석한 결과 투습도의 편차가 감소한 것을 확인하였다.

A study for production simulation model generation system based on data model at a shipyard

  • Back, Myung-Gi;Lee, Dong-Kun;Shin, Jong-Gye;Woo, Jong-Hoon
    • International Journal of Naval Architecture and Ocean Engineering
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    • 제8권5호
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    • pp.496-510
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    • 2016
  • Simulation technology is a type of shipbuilding product lifecycle management solution used to support production planning or decision-making. Normally, most shipbuilding processes are consisted of job shop production, and the modeling and simulation require professional skills and experience on shipbuilding. For these reasons, many shipbuilding companies have difficulties adapting simulation systems, regardless of the necessity for the technology. In this paper, the data model for shipyard production simulation model generation was defined by analyzing the iterative simulation modeling procedure. The shipyard production simulation data model defined in this study contains the information necessary for the conventional simulation modeling procedure and can serve as a basis for simulation model generation. The efficacy of the developed system was validated by applying it to the simulation model generation of the panel block production line. By implementing the initial simulation model generation process, which was performed in the past with a simulation modeler, the proposed system substantially reduced the modeling time. In addition, by reducing the difficulties posed by different modeler-dependent generation methods, the proposed system makes the standardization of the simulation model quality possible.

추나의학 용어 표준화 필요성 연구 (A Study for the Necessity of Terminology Standardization in Chuna Medicine)

  • 권정주;김민우;박경무;장건;조현철;남항우;신병철;임형호;송윤경
    • 척추신경추나의학회지
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    • 제7권1호
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    • pp.1-13
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    • 2012
  • Objectives: Although chuna medicine has progressed distinguishingly, yet chuna medical terminology hasn't been standardized. So there are a lot of difficulties in translating chuna related book and their meaning cannot be conveyed properly. For this reason, we could say standardization of chuna medical terminology is very essential. Purpose of our study was to develope a standard database of concept terms for chuna medicine, in addition, we considered establishing fundamental principles of chuna medical terminology. Methods: To select standard chuna medical terms, we sorted important chuna medical index words. Then we sorted those words into a group that has same meanings and united to one single term. In the meantime, we extracted index words from 26 domestic and foreign manual technique related books and sorted them out and based on these word, we translated chuna medical terms to Korean terms. In the case of chuna technique terms, we searched chuna text books for term those were wrongly used, and corrected them by suggesting fundamental principles of terminology. Results: 664 chuna words were selected as standard chuna terms and have been translated to English terms. In the process, adscititious words such as anatomical terms and title of books were exempted and selected only important words that could be used as index of chuna terms. In deciding essential elements of chuna technique terms, patient position, contact point, segmental contact point, malposition, procedure method were selected. Conclusions: Correcting chuna medical terms in a sort period could cause confusion, but in long term perspective, in the aspect of conveying the meaning clearly and education purpose, standardizing of chuna medical terminology must be done. From this study, standardization of chuna medical terms were chosen in large category, but further studies must be followed in order to standardize terms of subdivisional categories.

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The Effect of Uncertainty in Sea Trial Measurement System on Speed-Power Performance

  • Seo, Dae-Won;Noh, Jackyou
    • 해양환경안전학회지
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    • 제26권3호
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    • pp.269-276
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    • 2020
  • Sea trial tests are necessary to verify speed-power performance, and are an import contract between ship owners and shipyards. The International Organization for Standardization (ISO) published ISO 15016:2015, which specifies the correlation method between model and full-scale ships. The results of sea trials have been questioned because of the uncertainty of speed and power measurements, especially when sea conditions differ from ideal calm water conditions. In this paper, such uncertainties were investigated by utilizing the standard speed-power trial analysis procedure defined in ISO 15016:2015 through Monte Carlo simulations. It was found that the expanded uncertainty of the delivered power (PDid) at 95 % confidence interval (k = 2) was ±1.5 % under 75 % MCR conditions.

과학 추론능력과 과학 탐구능력에 영향을 미치는 학습자 변인 분석$^{1)}$ (The Analysis of Learner탐s Variables Affecting on Scientific Reasoning and Science Process Skills)

  • 김영신;정완호;이진희
    • 한국초등과학교육학회지:초등과학교육
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    • 제20권1호
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    • pp.1-7
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    • 2001
  • The purpose of this study is to examine the learner's variables affecting on scientific thinking and scientific process skills. To study this purpose, through the procedure study, the learner's variables were divided into cognitive variable, ego variable, and affective variable, then the questionaire survey through the reconstruction of standardization instrument was made over 120 elementary school fifth grade student in Seoul, Anyang, and Pajoo. The results of this study were as follows: 1) The learner's variables affecting on scientific thinking were cognitive variable and for female students, also affect affective variable. The subordinated catagories of statistically significant degree of explanation were achievement motivation, cognitive level, and cognitive style and another statistically significant correlation were meta-cognition, self regulated learning, self efficacy, and muliple intelligence. 2) The learner's variables affecting on science process skills were cognitive variable and affective variable. And the subordinated catagories of statistically significant degree of explanation were achievement motivation, and cognitive level. And another statistically significant correlation were meta-cognition, self regulated loaming, self efficacy, multiple intelligence, and attribution.

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파이프 프루버의 측정불확도에 관한 연구 (A Study on the Measurement Uncertainty of Pipe Prover)

  • 임기원
    • 대한기계학회논문집B
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    • 제24권10호
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    • pp.1388-1398
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    • 2000
  • A pipe prover is a flowmeter calibrator used in flow measurement field. Gravimetric and volumetric methods were applied to determine the basic volume of the pipe prover. Uncertainty of its basic volume measurement was evaluated in accordance with the procedure recommended by International Organization for Standardization. The combined standard uncertainty of determining the basic volume was estimated from the sensitivity coefficient and the standard uncertainty of independent variables. It was found that the uncertainties of the weighing and volume measurements have dominant influence on that of the basic volume determination. With the quantitative analysis of the sensitivity coefficient, the contribution of the each variable uncertainty to the combined standard uncertainty of the basic volume is shown clearly.

침의 한국산업규격(KS) 도입 필요성에 대한 고찰 (Need for Korean Industrial Standards (KS) for Acupuncture Needle)

  • 장인수;박종배;서정철
    • Journal of Acupuncture Research
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    • 제21권5호
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    • pp.149-162
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    • 2004
  • Quality assurance with high safety profile is one of the most critical issues to medical device manufacturing. In general, this issue was not paid proper attention with respect to acupuncture needle and its related devices. Acupuncture needles are manufactured through various standards ranging from purely hand-made, partially hand-made and partially machine-made, to fully machine-made mainly in China, Korea, and Japan. There is a large difference in quality between needles from different manufacturers. In order to provide a standard manufacturing guideline, it seems necessary to make a Korean Industrial standard (KS). The authors review this topic from an historical view point, investigate the current situation of the standardization of acupuncture needles in other developed countries, and inspect the general procedure to establish a KS in Korea in order to suggest a KS for acupuncture needles.

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