• Title/Summary/Keyword: Phase II design

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

  • Han, Song;Yoo, Hanna;Lee, Jae Won
    • The Korean Journal of Applied Statistics
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    • v.32 no.1
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    • pp.1-13
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    • 2019
  • An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.

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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    • v.14 no.10
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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.

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- (인간공학 기준에 의한 차세대형 주제어실 조명설계 및 조도 휘도 분석- 중국 광동 Ling Ao Phase II NPP MCR 환경디자인을 중심으로-)

  • Back, Seong-Kyung;Lee, Seung-Hoon
    • Journal of the Ergonomics Society of Korea
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    • v.27 no.2
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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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    • v.26 no.2
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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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    • v.19 no.6
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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.

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

  • 이창호;윤종화;정한욱
    • Journal of the Korean Operations Research and Management Science Society
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    • v.19 no.1
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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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KTX-II development using systems engineering (신규고속철도차량(KTX-II)의 시스템엔지니어링 적용)

  • Cha, Jae-Hwan;Chung, In-Soo;Jo, Kwang-Woo
    • Journal of the Korean Society of Systems Engineering
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    • v.4 no.1
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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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A Numerical Analysis of Aerodynamic Characteristics and Loads for KSLV-II Configuration at the System Design Phase (한국형발사체 시스템 설계 형상에 대한 공력 특성 및 하중 해석)

  • Lee, Joon Ho;Ok, Honam;Kim, Younghoon;Kim, Insun
    • Aerospace Engineering and Technology
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    • v.12 no.1
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    • pp.73-80
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    • 2013
  • In this study, a numerical analysis based on CFD methods has been conducted to predict the aerodynamic coefficients and aerodynamic loads of KSLV-II configuration designed at the system design phase. By the effects of exclusion of engine cowls of prior configuration, axial force and normal force decreased and center of pressure was much moved to the nose direction. Also, aerodynamic loads at flight and on the launch pad were predicted for structural load analysis. The computed results will be used for mission analysis and structural analysis at the next design phase.

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

  • Yu, Seonghun
    • Journal of The Korean Society of Integrative Medicine
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    • v.5 no.1
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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.

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

  • 이재익
    • Archives of design research
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    • v.2 no.1
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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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