• 제목/요약/키워드: New Trial

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Regulatory innovation for expansion of indications and pediatric drug development

  • Park, Min Soo
    • Translational and Clinical Pharmacology
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    • 제26권4호
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    • pp.155-159
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    • 2018
  • For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

도시철도차량 운영 및 발주관련 프로그램의 RIMS 적용 (A Study on Application of RIMS for City Rail-road Management and Ordering Programs.)

  • 전서탁;김현철;이도선
    • 한국철도학회:학술대회논문집
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    • 한국철도학회 2008년도 춘계학술대회 논문집
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    • pp.1301-1307
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    • 2008
  • The Seoul-Metro is the first city railroad corporation to operate RIMS(Rolling-stock Information Maintenance System). The development of "RIMS Project" and trial running task were started from Mar 29, 2001. Finally, this project was completed successfully on Dec 31, 2005, as integrated systems including light or heavy maintenance works in Ji-Chuk and Chang-Dong Rolling-stock Offices. After that, from 2006 to Dec 31, 2007, we promoted a this new program to other four rolling-stock offices (Su-Seo, Gun-Ja, Sin-Jeong) and the headquarter. For the duration of trial running, we developed and applied new complementary program having made up for the weak points or defects. The series of new program which were newly developed and applied are comprised of an operation management, trouble management, wheel management, heavy maintenance table automatic creation programs and ordering prediction programs to purchase goods smoothly. The Seoul-Metro have registered these programs(RIMS) to Computer Program Protection Committee. We'd like to introduce a composition of program for enhancement of a city railroad Information Systems.

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ON LIMIT BEHAVIOURS FOR FELLER'S UNFAIR-FAIR-GAME AND ITS RELATED MODEL

  • An, Jun
    • 대한수학회지
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    • 제59권6호
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    • pp.1185-1201
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    • 2022
  • Feller introduced an unfair-fair-game in his famous book [3]. In this game, at each trial, player will win 2k yuan with probability pk = 1/2kk(k + 1), k ∈ ℕ, and zero yuan with probability p0 = 1 - Σk=1 pk. Because the expected gain is 1, player must pay one yuan as the entrance fee for each trial. Although this game seemed "fair", Feller [2] proved that when the total trial number n is large enough, player will loss n yuan with its probability approximate 1. So it's an "unfair" game. In this paper, we study in depth its convergence in probability, almost sure convergence and convergence in distribution. Furthermore, we try to take 2k = m to reduce the values of random variables and their corresponding probabilities at the same time, thus a new probability model is introduced, which is called as the related model of Feller's unfair-fair-game. We find out that this new model follows a long-tailed distribution. We obtain its weak law of large numbers, strong law of large numbers and central limit theorem. These results show that their probability limit behaviours of these two models are quite different.

Mies van der Rohe 건축에서 나타난 재료의 표현특성에 관한 연구 (The Study on the Characteristics of Material appeared in the Architecture of Mies van der Rohe)

  • 이병욱;김용승;박용환
    • 한국실내디자인학회논문집
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    • 제13권6호
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    • pp.12-19
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    • 2004
  • Mies van der Rohe is still known as the architect whose influence is the largest among modem architects. As his work is typical of modern architecture, the architecture of Mies shows an interest in materials and techniques, even though It established the new architectural world by glass and iron, and only transparency is emphasized with glass. So it is blame for the loss of peculiarity a result of thinking In the way of sachlich with expression and structure of material and hierarchical relation. Vincent Scully has insist on that an appearance of modem architecture be occur not by simply a technical request of a technician but by reflection of the times and times' spirit. In this means, the works of Mies is the trial to express the new times' spirit that the new times order and an understanding of material properties about glass with new material of modern. For that, this study tries to consider that Mies'work is the new trial through reflection of material to express about the bstraction beyond the limit of sachlich expression, on the point of expresslonal characteristics of material shown in plan of the Barcelona Pavilion and skyscraper and on the basis of the theory of Gottfried Semper and Karl Boetticher that architectural surface Is a medium which can define space and also express mass.

종합항법장치 및 GPS를 이용한 실선시운전 선박조종성능의 계측 (Measurement of ship's maneuverabilities using Integrated Navigation System and GPS)

  • 이덕수
    • 한국항해학회지
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    • 제20권1호
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    • pp.11-26
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    • 1996
  • On this paper, the traditional methods for the measurement of ship's maneuverabilities during the sea-trial of newly built ship are summarized and new methods for the same measurement using Integrated Navigation System and GPS are introduced. After various sea-trials of training ship "HANNARA" which are equipped with modern INS and GPS system, the results are compared and analysed. The purpose of this paper is to present more accurate methods of measurement of ship's maneuverabilities during sea-trial using INS and GPS which are gradually becoming the basic navigational equipments on many newly constructed vessels.d vessels.

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대학수학능력시험에서 과학탐구 영역의 분석 (An Analysis of The Science Inquiry Items in Scholastic Ability Test for College)

  • 김상철;권재술
    • 한국과학교육학회지
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    • 제14권2호
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    • pp.214-224
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    • 1994
  • The Ministry of Education established the plan to adopt a new college enterance examination system, so called Scholastic Ability Test for college, from 1994. The National Board of Educational Evaluation had carried out 7 experimental trials for the new examination system. Eventhough, the governmental officials advertised the purpose and characteristics of the new examination system, many students and parents did not understand the essential point very well. In this study the researcher tried to analyze the 7 trial examination items and the first Scholastic Ability Test for college carried out 1993. In this study, the researcher tried to find out all the items appeared in the 7 trials. In the analysis, all the individual items from the 1st trial to the 7th trial were used. The research results showed that the items were evenly distributed in all the four areas(Physics, Chemistry, Biology and Earth Science) of science content; however, they were heavily concentrated on data or information analysis categoris in the inquiry domain. In the domain of context, laboratory context was the major item context. The scores were also analyzed. The results showed that no significant difference between male and female students. However, science track students showed higher achievement scores than the non-science track student. The examination result showed high correlation with the tests routinely have carried out in schools. The over all analysis showed the new examination system showed very different characteristics to the conventional tests. Therefore, for the student to get successful result in the Scholastic Ability Test, they should change the way of study. They should try to understand scientific concepts rather than to memorize them. They should invest their time to carry out real experiments rather than to focus on the princples and laws of science. One of the most important thing would be for the student to apply what they learned to real life situations.

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ICSID 중재판정 취소제도 (Annulment System of ICSID Arbitral Award)

  • 김상찬
    • 한국중재학회지:중재연구
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    • 제25권2호
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    • pp.71-96
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    • 2015
  • This paper deals with the annulment of the ICSID(International Centre for Settlement of Investment Disputes) arbitral award. The annulment of the ICSID is characterized by the fact that it can be made possible through the special committee of ICSID only. The annulment of the ICSID was constructed on the premise that it is not an appeal procedure. However in the initial period, it was strongly criticized as it allowed new trials or duplicated many of the functions of an appeal and it broke down the boundary between the two systems. Although the trend seemed to be corrected through its 2nd and 3rd generations, it was still criticized for functioning as a new trial. It is approaching its 4th generation. On the other hand, with the activation of investment agreement arbitration based on ICSID and FTA, a certain degree of consistency is required for the ICSID arbitralaward. Also, with the emphasis on the public features of the arbitration for the investment agreement, the necessity of an appeal system is presented. The ICSID Secretariat published the "Opinion on the Appeal Procedure" in 2004 but as the system was criticized as too early due to the cost allocation problem and others, its adoption of an appeal procedure has been delayed. This paper focuses on how the currently incomplete ICSID arbitration judgment annulment system shall be used. Although it is still hardto expect the quality and consistent arbitral award annulment in the ICSID, this paper suggests that the "annulment without the actual new trial" using the restricted authority of a special commission in a creative way shall be pursued rather than just the actual new trial with or without annulment, thus going back to the original concept of the ICSID arbitral award annulment.

제1상 임상시험에서 Stopping Rule을 이용한 두 단계 MTD 추정법 (Two-Stage Maximum Tolerated Dose Estimation by Stopping Rule in a Phase I Clinical Trial)

  • 이나미;김동재
    • Communications for Statistical Applications and Methods
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    • 제19권1호
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    • pp.57-64
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    • 2012
  • 제 1상 임상시험에서 주목표는 부작용이 발생하지 않고 피험자가 견딜 수 있는 한도 내에서 최대 용량인 최대허용용량(Maximum Tolerated Dose; MTD)을 결정하는 것이다. 최대허용용량을 결정하는 방법에는 SM방법, CRM방법 등이 있는데 본 논문에서는 기존의 Stopping rule을 변형한 두 단계 MTD 추정방법을 제안하였다. 기존의 방법들을 본 논문에서 제안한 방법과 모의실험을 통하여 비교하였다.

사장교용 FRP-콘크리트 합성바닥판의 시험시공 (Trial Construction of FRP-Concrete Composite Deck for Cable-Stayed Bridge)

  • 김성태;박성용;조근희;조정래;김병석
    • 한국콘크리트학회:학술대회논문집
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    • 한국콘크리트학회 2010년도 춘계 학술대회 제22권1호
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    • pp.43-44
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    • 2010
  • 본 연구는 사장교에 적용이 용이하도록 프리캐스트화한 FRP-콘크리트 합성 바닥판 개발에 대한 것이다. 개발된 바닥판에 대해서 구조상세 별로 성능실험을 완료한 후, 실제 중차량이 통과하는 공사용가교 상에 시험시공을 수행하였으며 구조적 성능 및 현장 적용성을 살펴보았다.

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적외선탐사기를 사용한 외벽열화평가 시스템의 구축 (The trial Test for the Estimation System of Deterioration of Exterior Wall by Infrared Theromography)

  • 권영진;서천충;오상근;박득곤;최롱
    • 한국콘크리트학회:학술대회논문집
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    • 한국콘크리트학회 1996년도 봄 학술발표회 논문집
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    • pp.398-401
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    • 1996
  • It is the aim of this study to introduce the application method for the new estimation system of deterioration caused performance decrement of exterior wall by infrared theromography. With this help of this trial test, the defect such as void and honeycomb of esveria wall can be shown easily. Espicially by selecting the weathering condition, it becomes easier to identify defect than with original image. It was confirmed that this trial monitoring system is very useful to identify the defect of exterior wall.

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