• 제목/요약/키워드: Phase III design

검색결과 57건 처리시간 0.028초

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
    • /
    • 제32권1호
    • /
    • pp.1-13
    • /
    • 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.

심장재활 프로그램(Phase III)이 심근경색증 노인의 심혈관과 심폐기능에 미치는 효과 (Effects of Cardiac Rehabilitation Programs(Phase III) on Cardiovascular and Cardiorespiratory Function of the Elderly with Myocardial Infarction)

  • 김정선;김영주;정명호
    • 성인간호학회지
    • /
    • 제21권2호
    • /
    • pp.212-224
    • /
    • 2009
  • Purpose: The purpose of this study was to examine the effects of the cardiac rehabilitation program(Phase III) on cardiovascular and cardiorespiratory function in the elderly (age, ${\geq}$ 60) who experienced acute myocardial infarction. Methods: The design of research was nonequivalent control group pretest-posttest design. Subjects were 10 people in the experimental group and 10 in the control group. The intervention program was the cardiac rehabilitation program(Phase III), and was performed for 50 ~ 60 minutes, twice a week for 8 weeks. The dependent variables were the cardiovascular and cardiorespiratory function. Results: Significant differences were shown in RHR, RSBP, SRPP, SBS, BMI, PT of the experimental group after the intervention. As for the differences in the amount of changes, there were differences among groups in RHR, RSBP, SRPP, SBS, PMET, and PT of the experimental group. Conclusion: The cardiac rehabilitation program(Phase III) may be effective in improving cardiovascular function and enhancing cardiorespiratory function in elderly patients with acute myocardial infarction.

  • PDF

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

  • 이재익
    • 디자인학연구
    • /
    • 제2권1호
    • /
    • pp.99-106
    • /
    • 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.

  • PDF

분산 테이타베이스를 위한 양식을 이용한 분산 설계 방법론 (A Form Based Distribution Design Methodology for Distributed Databases)

  • 이희석;김희진;김영삼
    • Asia pacific journal of information systems
    • /
    • 제5권2호
    • /
    • pp.101-129
    • /
    • 1995
  • This paper proposes a form-based distributed database design methodology ($FD^3$). The methodology consists of five design phases such as (i) form requirement analysis (ii) schema integration (iii) distribution analysis (iv) distribution design, and (v) local logical/physical design. In the $FD^3$, all the important design information for each phase is obtained by using an organizations forms, Users requirements are analyzed by using forms that contain logical and quantitative information for distribution design. $FD^3$ resolves naming conflicts by employing SQLs based on the form field data in the schema integration phase. Furthermore, $FD^3$ enhances the quality of distributed database design by incorporating communication costs into the design model. A real-life case is illustrated to demonstrate the usefulness of the $FD^3$.

  • PDF

Maxillary protraction using customized mini-plates for anchorage in an adolescent girl with skeletal Class III malocclusion

  • Liang, Shuran;Xie, Xianju;Wang, Fan;Chang, Qiao;Wang, Hongmei;Bai, Yuxing
    • 대한치과교정학회지
    • /
    • 제50권5호
    • /
    • pp.346-355
    • /
    • 2020
  • The treatment of skeletal Class III malocclusion in adolescents is challenging. Maxillary protraction, particularly that using bone anchorage, has been proven to be an effective method for the stimulation of maxillary growth. However, the conventional procedure, which involves the surgical implantation of mini-plates, is traumatic and associated with a high risk. Three-dimensional (3D) digital technology offers the possibility of individualized treatment. Customized mini-plates can be designed according to the shape of the maxillary surface and the positions of the roots on cone-beam computed tomography scans; this reduces both the surgical risk and patient trauma. Here we report a case involving a 12-year-old adolescent girl with skeletal Class III malocclusion and midface deficiency that was treated in two phases. In phase 1, rapid maxillary expansion and protraction were performed using 3D-printed mini-plates for anchorage. The mini-plates exhibited better adaptation to the bone contour, and titanium screw implantation was safer because of the customized design. The orthopedic force applied to each mini-plate was approximately 400-500 g, and the plates remained stable during the maxillary protraction process, which exhibited efficacious orthopedic effects and significantly improved the facial profile and esthetics. In phase 2, fixed appliances were used for alignment and leveling of the maxillary and mandibular dentitions. The complete two-phase treatment lasted for 24 months. After 48 months of retention, the treatment outcomes remained stable.

미즈나미 지하처분연구시설 결정질암에 대한 부지 특성규명 기술 개발 -지표기반 조사단계- (Development of Site Characterization Technologies for Crystalline Rocks at Mizunami Underground Research Laboratory (MIU) - Surface-based Investigation Phase -)

  • 하마다 카츠히로
    • 방사성폐기물학회지
    • /
    • 제11권2호
    • /
    • pp.115-131
    • /
    • 2013
  • 미즈나미 지하처분연구시설 프로젝트는 일본원자력연구개발기구가 결정질암 내의 심부 지하 환경에 관해 종합적으로 연구하는 프로젝트이다. 미즈나미 프로젝트는 3개의 중첩되는 단계로 구성된다: 지표기반 조사단계 (단계 1), 건설단계 (단계 2), 운영단계 (단계 3)의 총 20년. 미즈나미 프로젝트의 1단계에서 3단계까지의 전체 목표는 1) 심부지질환경을 조사, 분석, 평가하기 위한 기술 정립, 2) 심부 지하 활용을 위한 일련의 공학적 기술 개발이다. 전체 목표 1을 달성하기 위하여, 1단계 목표를 굴착 전에 지질환경을 모사하고 굴착거동을 예측하는 모든 지표기반 조사결과로부터 지질환경 모델을 구축하는 것으로 설정하였다. 전체 목표 2를 달성하기 위하여, 2단계 목표는 지하시설을 위한 상세 설계 개념과 건설 계획을 수립하는 것으로 설정하였다. 본 논문은 결정질암내 지하수의 수리지화학적 특성을 조사하고 평가하기 위한 지질통합적 방법을 소개한다.

데이터베이스 분산 설계 지원 시스템 개발: 관계형 스키마를 입력으로 (Developing a Design Support System for Database Distribution : Relational Schema as an Input)

  • 이희석;지정강;김태훈;여지영
    • Asia pacific journal of information systems
    • /
    • 제6권1호
    • /
    • pp.165-194
    • /
    • 1996
  • Data distribution is one of the most important steps in distributed database design. This paper proposes a methodology for distributing database by using a relational schema as an input. A design support system called DBDD (Database Distribution Design) is implemented within the framework of this methodology. The methodology consists of three phases such as (i) schema analysis, (ii) fragmentation, and (iii) allocation. In the schema analysis phase, all the table names are acquired from a global relational schema. In the fragmentation phase, fragments are generated according to transaction retrieval patterns. Furthermore, DBDD enhances the design quality by allocating fragments in a progressive manner. A real-life case is illustrated to demonstrate the practical usefulness of the DBDD.

  • PDF

KSR-III 과학로켓의 자세제어기 설계와 비행시험 (Attitude Controller Design and Flight Test of KSR-III Sounding Rocket)

  • 노웅래;조현철;안재명;최형돈
    • 한국항공우주학회지
    • /
    • 제32권3호
    • /
    • pp.88-94
    • /
    • 2004
  • KSR-III 로켓은 액체추진 엔진을 사용한 과학로켓이며, 추력 비행중 피치 및 요 자세제어를 위해 추력벡터제어 방식을 사용하고, 롤 자세를 제어하기 위해 냉가스 추력기를 사용하였다. 본 논문은 KSR-III 로켓의 3축 자세제어를 위해 설계된 자세제어기의 구조와 이득 스케쥴링, 자세 안정성 분석결과에 대해 소개한다. 설계된 자세제어기는 국산화 개발된 관성 항법시스템의 비행소프트웨어로 구현되었는데 비행시험에서 완벽히 작동하였다. 비행에서 측정된 데이터는 시뮬레이션 결과와 거의 일치되었다.

The Development of an ADDIE Based Instructional Model for ELT in Early Childhood Education

  • MARIAM, Nuzhat;NAM, Chang-woo
    • Educational Technology International
    • /
    • 제20권1호
    • /
    • pp.25-55
    • /
    • 2019
  • The core purpose of the study is to develop and validate an ADDIE model based instructional model for English Language Teaching (ELT) in early childhood classroom in Bangladesh as an aid to teachers to reconstruct their knowledge and experience more strategically, and for them to design and implement their instruction more structurally. This study is developmental in nature which has been divided in five phases as follows. Phase I: Existing methods and instructional strategy review, Phase II: Instructional model development, Phase III: Delphi 1st round, Phase IV: Delphi 2nd round and Phase V: Model validation. After reviewing relevant literature and existing strategy in phase I, the 1st version of instructional model is made phase II. Next in phase III and phase IV, two rounds of Delphi have been conducted where experts related to different concerning areas of this study reviewed the 1st version and gradually the final version of the instructional model is made. Finally, the instructional model for English teachers of early childhood classroom in Bangladesh got validated by the same Delphi panelists in Phase V. In respect with each phases of ADDIE, the instructional model elaborates the 1) representative key points, 2) instructors' activities prescribed for the instructors, 3) supporting strategies. Both the conceptual and procedural models are included in this study for clearer identification of the whole process. Lastly the study provides some recommendations for instructors and practitioners on choosing the instructional model like doing prior need analysis, incorporating teacher training programs, training students, keeping on researching for finding effective teaching technique and tools and being open to changes etc. In addition, the study also acknowledges its limitations like not being able to consider the psychological factors due to time limitation. Finally, at the end the study points out the areas that welcome further research.

Heteroscedasticity of Random Effects in Crossover Design

  • 안철환
    • 한국통계학회:학술대회논문집
    • /
    • 한국통계학회 2002년도 추계 학술발표회 논문집
    • /
    • pp.79-83
    • /
    • 2002
  • A phase III clinical trial of a new drug for neutropenia induced by chemotherapy is presented and consider adding random effects in crossover design which was used in the clinical study. The diagnostics for its heteroscedasticity based on score statistic is derived for detecting homoscedasticity of errors in crossover design. A small simulation study is peformed to investigate the finite sample behaviour of the test statistic which is known to have an asymptotic chi-square distribution under the null hypothesis.

  • PDF