• 제목/요약/키워드: Phase II design

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심리스 제2상/제3상 임상시험에서 다중가설검정방법과 결합검정방법의 비교연구 (A comparison of multiple hypothesis testing methods and combination methods in seamless Phase II/III clinical trials)

  • 한송;유한나;이재원
    • 응용통계연구
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    • 제32권1호
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    • pp.1-13
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    • 2019
  • 최근에 제안된 심리스(seamless) 제 2상/제 3상 임상시험 디자인은 기존의 임상시험 디자인들과 비교하여 피험자수를 줄일 수 있을 뿐만 아니라 임상 개발 시간을 단축시킬 수 있다는 장점을 가지고 있어 임상시험연구자들의 많은 관심을 끌고 있다. 또한 제 3상 시험을 단독으로 진행 하였을 때보다 더 높은 검정력을 가질 수 있으므로 임상시험에서 매우 효율적이라 말할 수 있다. 본 논문에서는 제 2상에서 최고효과 용량군을 선정하기 위한 여러 가지 다중가설 검정방법들을 제시하고 제 2상에서 최고효과 용량군을 선정한 후에 제 2상과 제 3상을 결합하는 여러 가지 유의확률 결합검정방법들을 제시하였다. 또한 모의실험을 통해서 심리스 제 2상/제 3상 임상설계가 적용되었을 때 여러 가지 방법들을 비교함으로써, 제 2상/제 3상 표본의 크기 조합이나 분산의 크기가 다른 여러 가지 상황에서 가장 적절한 방법을 선택하는 가이드라인을 제시하고자 한다.

Effect of Carbohydrate Sources in Phase I and Phase II Pig Starter Diets

  • Kim, I.B.;Allee, G.L.
    • Asian-Australasian Journal of Animal Sciences
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    • 제14권10호
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    • pp.1419-1424
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    • 2001
  • Previous research in our laboratory has demonstrated the importance of lactose in phase I and II pig starter diets. Two experiments were conducted to evaluate the use of a carbohydrate by-product (food by-products) as a replacement for lactose. In Exp. I, 120 weaned pigs ($14{\pm}2d$ and 5.65kg) were allotted in a randomized complete block design (RCBD) to 10 replications with four pigs per pen. This experiment evaluated three carbohydrate sources (lactose, carbohydrate by-product, and 50-50 blend of the carbohydrate by-product and lactose). The carbohydrate sources were added at 26% in the phase I diets and 15% in the phase II diets. Phase I diets contained 7.5% spray dried plasma protein (SDP). The phase I diets were fed from d 0 to 14 and the phase II diets from d 15 to 28. There were no significant differences between carbohydrate sources on pig performance in phase I. However, during phase II pigs fed the diet with lactose had an improved gain/feed ratio (G/F) (p=0.06) compared to pigs fed the carbohydrate by-product. For the entire 28 d trial ADG, ADFI and G/F were similar for the 50-50 blend and those fed lactose. Total replacement of lactose with the carbohydrate byproduct resulted in a reduced G/F (p=0.09). Exp. 2 used 100 weaned pigs ($17{\pm}2d$ and 4.75kg) with five replications with five pigs per pen. This experiment evaluated four carbohydrate treatments (lactose, carbohydrate by-products, 50-50 blend, and corn). All phase I diets contained 3.5% SDP with the carbohydrate sources included at 15%, and were fed d 0 to 14. The phase II diets contained 7.5% of the carbohydrate sources and were fed d 15 to 27. A common phase III diet was fed d 28 to 42. During all phases pigs fed com tended to have a lower ADG than pigs fed the other carbohydrate sources with the 50-50 blend resulting in the highest ADG. The results of both experiments suggest that this carbohydrate by-product can replace at least 50% of the lactose in phase I and phase II pig starter diets.

인간공학 기준에 의한 차세대형 주제어실 조명설계 및 조도 휘도 분석- 중국 광동 Ling Ao Phase II NPP MCR 환경디자인을 중심으로- (A Study on Lighting Design and Illumination and Luminance of in Advanced type Control Room by the Standard of Ergonomics - Focused on Ling Ao Phase II NPP MCR Environmental Design in Guangdong, China-)

  • 백승경;이승훈
    • 대한인간공학회지
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    • 제27권2호
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    • pp.73-82
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    • 2008
  • Currently an office in information society is advanced to a digitalized VDT office. The VDT office has a natural luminous system prioritizing visual perception and so importance of lighting design by artificial lighting is emphasized in the VDT office. The purpose of the study is to analyze Illumination and Luminance for lighting design by the standard of ergonomics in the VDT office. The study analyzed Illumination and Luminance in the main control room of an nuclear power plant needing a design of ergonomics ACR(Advanced Control Room) type Ling Ao phase II NPP MCR in Guangdong, China. The study examined the relativity of ACR characteristics to its operator's duties and set up an outline of lighting design, the standard of ergonomics and input data for the analysis. Thus, the study examined appropriateness with the standard of ergonomics setting up the analyzed Illumination and Luminance and drew a conclusion.

Phase II two-stage single-arm clinical trials for testing toxicity levels

  • Kim, Seongho;Wong, Weng Kee
    • Communications for Statistical Applications and Methods
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    • 제26권2호
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    • pp.163-173
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    • 2019
  • Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. A concern of safety studies is too many patients who experience an adverse event. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. Given the type I and II error rates and the proportion of adverse events experienced in the first stage cohort, we prescribe a procedure whether to terminate the trial or proceed with a stage 2 trial by recruiting additional patients. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint as well as use simulation studies to ascertain their properties. We provide a real-life application and a free R package gen2stage to facilitate direct use of two-stage designs in a safety study.

Maximum Tolerated Dose Estimation Applied Biased Coin Design in a Phase I Clinical Trial

  • Kim, Yu Rim;Kim, Dongjae
    • Communications for Statistical Applications and Methods
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    • 제19권6호
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    • pp.877-884
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    • 2012
  • Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

설비용량을 고려한 계층적 네트워크의 설계 및 분석 (Designing hierarchical ring-star networks under node capacity constraints)

  • 이창호;윤종화;정한욱
    • 한국경영과학회지
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    • 제19권1호
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    • pp.69-83
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    • 1994
  • This paper deals with a capacitated ring-star network design problem (CRSNDP) with node capacity constraints. The CRSNDP is formulated as a mixed 0-1 integer problem, and a 2-phase heuristic solution procedure, ADD & VAM and RING, is developed, in which the CRSNDP is decomposed into two subproblems : the capacitated facility location problem (CFLP) and the traveling sales man problem (TSP). To solve the CFLP in phase I the ADD & VAM procedure selects hub nodes and their appropriate capacity from a candidate set and then assigns them user nodes under node capacity constraints. In phase II the RING procedure solves the TSP to interconnect the selected hubs to form a ring. Finally a solution of the CRSNDP can be achieved through combining two solution of phase I & II, thus a final design of the capacitated ring-star network is determined. The analysis of computational results on various random problems has shown that the 2-phase heuristic procedure produces a solution very fast even with large-scale problems.

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신규고속철도차량(KTX-II)의 시스템엔지니어링 적용 (KTX-II development using systems engineering)

  • 차재완;정인수;조광우
    • 시스템엔지니어링학술지
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    • 제4권1호
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    • pp.31-34
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    • 2008
  • As a supply contract for 100 new high-speed rolling stocks(KTX-II) was made 8th June 2006, System Engineering process has been applied to introduce the high-speed rolling stocks successfully and to manage the total life cycle systematically from Pre-concept Phase, Contract Phase, Preliminary and Critical Design Review, Production, Test and Verification, Acceptance and Operation to assurance for a flaw.

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한국형발사체 시스템 설계 형상에 대한 공력 특성 및 하중 해석 (A Numerical Analysis of Aerodynamic Characteristics and Loads for KSLV-II Configuration at the System Design Phase)

  • 이준호;옥호남;김영훈;김인선
    • 항공우주기술
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    • 제12권1호
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    • pp.73-80
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    • 2013
  • 한국형발사체 시스템설계 형상에 대해 전산유동해석(CFD) 기법을 이용하여 공력 특성 및 하중을 예측하였다. 이전 형상에 비하여 엔진 카울이 없어짐에 따라 축력과 수직력이 감소하였으며, 압력 중심이 전방으로 크게 이동하였다. 그리고 하중 해석을 위해 비행 중 및 발사대 대기 중의 공력 하중을 산출하였다. 공력 계수 및 공력 하중 해석 결과는 다음 설계 단계의 임무 설계 및 구조 해석 분야에 활용된다.

슬링을 이용한 경부관절 운동이 고문생존자의 수면장애, 두통, 경부 기능장애에 미치는 영향 : 단일사례연구 (Effects of Cervical Exercise with Sling Program on Sleep Disturbance and Headache, Neck Disfunction in Torture of Survivor : Single Case Study)

  • 유성훈
    • 대한통합의학회지
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    • 제5권1호
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    • pp.11-18
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    • 2017
  • Purpose : The purpose of this case study was to clinical effects of cervical exercise with sling program using on torture of survivor with sleep disturbance and Headache, neck disfunction. Methods : This study selects 1 subjects for 55 years old who were diagnosed with torture of survivor with sleep disturbance and headache. The Design is ABA of single-subject study design. Baseline(A) and TypeII Baseline(A : 6weeks) phases were received with musculoskeletal disease of prevention education, Intervention(B : 6weeks) phase provided with 65 minute exercise with sling program using in a session twice a week. In order to analyze the measure results of PSQI-K(korean version of the pittsburgh sleep quality index), VAS(visual analog scale), NDI(neck disability index), FABQ(fear-avoidance beliefs questionnaire) in torture of survivor during baseline, intervention and typeII baseline phase. Result : A significant differences in PSQI-K during baseline, intervention, typeII baseline. A significant differences in VAS during baseline, intervention, typeII baseline. A significant differences in NDI during baseline, intervention, typeII baseline. A significant differences in FABQ during baseline, intervention, typeII baseline. Conclusion : In conclusion, The intervention method to applied cervical exercise with sling program on torture of survivor effectively improve on sleep disturbance and neck function, headache.

체계적 접근방법에 의한 환경설계과정에 대한 고찰 (Environment Design Process Based on Systems Approach)

  • 이재익
    • 디자인학연구
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    • 제2권1호
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    • pp.99-106
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    • 1989
  • Environmental designers face a wide range of problems to be solved in their day-to-day works. The scale and number of problems and so enormous that designers should be a way out to meet these complex situation. Lately, environmental design process based on systems a.pproach is chosen for design methodology. It is a very complicated procedure with many alternatives. It is a evolutionary process that establishes the solution of a series of problems. This study attempt to tell the designer how to find design solution to problems and how to organize form as solution problems. The model of this design process is largely composed of three phases; Phase I : Problem definition and existing system analysis. Phase II : design goals and objectives, design criteria Phase III : creative process of design form.

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