• Title/Summary/Keyword: Trial Subject

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Establishing Rationale for the Clinical Development of Cell Therapy Products: Consensus between Risk and Benefit

  • Seunghoon Han;Hyeon Woo Yim;Hyunsuk Jeong;Suein Choi;Sungpil Han
    • International Journal of Stem Cells
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    • v.16 no.1
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    • pp.16-26
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    • 2023
  • Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

A statistical analysis of wh-scope responses to embedded wh-phrases in Gyeongsang Korean

  • Weonhee Yun
    • Phonetics and Speech Sciences
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    • v.16 no.2
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    • pp.1-9
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    • 2024
  • This study investigates the fixed and random factors affecting response patterns of wh-scope interpretations in Gyeongsang Korean. It employed logistic mixed-effects regression models to analyze responses from 24 participants who listened to 40 pre-recorded stimuli from 40 different speakers. The stimuli consisted of an embedded wh-phrase and an interrogative ending marker, "-nkiko," thereby forming a wh-question, specifically a matrix wh-scope. Participants repeated the test three times. The study found that the prominence level of a prosodic phrase composed of an embedded verb and a complementizer was inversely related to responses with wh-questions, as demonstrated through multiple regression analysis in Yun. The test trial significantly impacted the number of responses with wh-questions, increasing from 50.3% in the first trial to 58.8% and 61.2% in subsequent trials. Examination of random subject effects revealed two main factors influencing responses: morpho-syntactic constraints and prosodic structural integrity. These two factors demonstrated the potential to be inversely weighted. Analysis of random stimulus effects suggested that the prominence level had limited effects on response patterns with each stimulus primarily eliciting one type of responses across trials.

Objectives Analysis of the Another Subject Education for Construct of Education Goals of computer in Elementary School (초등학교 컴퓨터 교육목표의 구성을 위한 타 교과 교육목표 분석)

  • Kim, Woon-Sik;Han, Sun-Kwan
    • 한국정보교육학회:학술대회논문집
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    • 2004.08a
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    • pp.28-37
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    • 2004
  • The purpose of this paper is Inflect ICT in each subject class of common school by effort about education Information that was regularized with enforcement of the seventh training courses and arrived in visual point that realize education information concretely. But, such realistic that specific discussion and research about actual ICT introduction direction or practical use way consisted enough up to now despite Is urgent example difficult. Decide target connected with Information Technology by classified grade-class and plan that teach learners systematically may have to flow fair discussion and trial run success or failure of education and point that is connected directly problem that establish date or the level and target that it is very as itself value how. Therefore, this research wished to premise computer-aided education target in primary school by analyze education target of each subject that come out in primary grade subject and abroad training courses.

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A Study of an Instructional Design Strategy for Improving the Collaborative Teaching Between School Librarians and Subject Teachers in Library-Assisted Instruction (도서관 활용수업에서 사서교사와 교과교사의 협동수업 향상을 위한 교수설계 전략에 대한 연구)

  • Song, Gi-Ho
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.21 no.2
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    • pp.111-127
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    • 2010
  • This study aims for developing an instructional design strategy to improve collaborative teaching between teacher librarians and subject teachers in library-assisted instruction. Collaborative teaching is an important management activity enhancing teaching role of teacher librarians in their school community. But in the actual condition the level of the library-assisted instruction as its practical strategy is cooperation and subject teachers are leading teaching and learning except for selecting resources. Because library-assisted instruction is resource-based learning, the procedural knowledge of information literacy curricula and topics of subject specific curricula should be designed as a whole. Also, there must be possibilities of reducing trial and error and expanding successes. From these sides, the collaborative design strategy for library-assisted instruction can be planned like 'statement of learning situation-co designing-co teaching-co evaluating'.

The Kinematic Analysis of the Last Approach Stride and Take-off Phase of BKH Athlete in the High Jump (남자 높이뛰기 BKH 선수를 중심으로 한 도움닫기 마지막 1보와 발구름 국면의 운동학적 분석)

  • Yoon, Hee-Joong;Kim, Tae-Sam;Lee, Jin-Taek
    • Korean Journal of Applied Biomechanics
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    • v.15 no.3
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    • pp.105-115
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    • 2005
  • This study was investigated the kinematic factors of the last approach strides and. take off motion for the skill improving of BKH elite male athlete. 'The subjects chosen for the study were BKH and. KASZCZYK Emillian male athletes who were participated in 2003 Dae-Gu Universiad Games. Three high speed video cameras set in 60frames/s setting were used. for recording from the last approach strides to the apex position. After digitizing motion, the Direct Linear Transformation(DLT) technique was employed to obtain 3-D position coordinates, The kinematic factors of the distance, velocity and angle variable were calculated for Kwon3D 3.1. The following conclusions were drawn; 1. It showed longer stride length, as well as faster horizontal and lateral velocity than the success trial during the approach phase. For consistent of the approach rhythm, it appeared that the subject should a short length for obtain the breaking force by the lower COG during the approach phase. 2. The body lean angle showed a small angle by a high COG during the take-off phase. For obtain the vertical displacement of the COG and a enough space form the bar after take-off, it appeared that the subject should increase the body lean angle. 3. For obtain the vertical force during the takeoff phase, it appeared that the subject should keep straight as possible the knee joint. Therefor, the subject can be obtain a enough breaking force at the approach landing.

A Study on the Supplementation of Different Levels of Iron for the Nutritional Improvement of Pre - school Children (취학전아동(就學前兒童)의 영양개선(營養改善)을 위(爲)한 철분첨가(鐵分添加) 급식효과(給食效果)에 대(對)한 연구(硏究))

  • Kang, Ji-Hee;Ju, Jin-Soon;Park, Myung-Yun
    • Journal of Nutrition and Health
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    • v.16 no.3
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    • pp.216-227
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    • 1983
  • As an attempt to improve the nutritional status of Korean rural pre-school children, anthropometry, clinical examination, and hematological parameters(Hb, Ht, and serum albumin) are measured. Six kinds of diet supplemented with 0, 2.5, 5.0, 7.5, 10.0 and 20.0 mg Fe(as ferrous sulfate) were used for 10 weeks. Subjects were 349 pre- school children aged from 1 to 5 years old living in An-gam-my-on and Bong-dang-myon, Hwa-seung-goo, Kyong-gi-duo, and the supplementary diet was a product of the Model Nutritional Enterprise Factory in Wuen-sueng-goon, Gang-won- duo. The results obtained were as follows : 1) Physical development of subject children were within normal range during the feeding trial period of 9 weeks. 2) From the results of clinical examination, no children showed nutritional deficiency signs. 3) Iron free supplementary diet group( control group ) among other subject children also showed some improvement of hemoglobin level ana frequency of anemia. 4) The amount of iron fortified as supplemental diet was effective in 5.0-7.5 mg Fe per child per day, no further effect was observed by adding of more iron. 5) The values of hematocrit and serum albumin also improved by providing the supplementary diet.

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배경조건에 따른 Visual Field에서의 Stationary Field의 변화

  • 기도형;정의승;신용탁
    • Proceedings of the Korean Operations and Management Science Society Conference
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    • 1994.04a
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    • pp.375-384
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    • 1994
  • Depending upon the eye and head movement, the visual field is often classified into three categories; stationary field, eye field and head field. To investigate the effect of background condition on the size of stationary field, an experiment was conducted, in which the subject was instructed to search a target with distinct orientations. In each trial, a single target was presented on the rear-view screen projected by the two-field tachistoscope, with the visual angle subtended 4.3.deg. vertically and horizontally. Density, meridian and subject showed a significant effect on stationary field at .alpha.=0.01, where density was inversely proportional to the size of stationary field. The size of the stationary field on horizontal axis was larger than that on vertical axis, and that on right and below meridian also larger than on left and lower meridian. The shape was found to be horizontally oriented oval and statistically asymmetric with respect to horizontal and vertical axes. The regression equation to predict stationary field on the given background condition was suggested. These results were expected to be used as a designing guideline when arranging displays and controls on panels such as automobile display panels, cockpits, etc. In addition, it can be inferred from the results that eye field and head field are also subjected to the influence of background condition.

Generation of a practical visual field for the design and evaluation (제품설계와 평가를 위한 시각영역의 생성)

  • 기도형
    • Journal of the Ergonomics Society of Korea
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    • v.14 no.1
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    • pp.59-67
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    • 1995
  • Depending upon the eye and head movement, the visual field is often classified into three categories ; stationary field, eye field and head and eye field. To investigate the effect of background condition on the size of the visual field, an experiment was conducted, in which the subject was instructed to search a target with distinct orientations. In each trial, a single target was presented on the perimeter modified to cover the range of 330 .deg. around the fixation point, with the visual angle subtended 1.4 .deg. vertically and horizontally. Nontarget density, meridian, size contrast and subject showed a significant effect on the visual field at .alpha. =0.01, where density was inversely proportional to the size of the visual field, and size contrast linearly proportional to the size of the visual field. The size of the visual field on horizontal axis was larger than that on vertical axis, and that on right and upper meridian was also larger than on left and lower meridian. The shape was found to be horizontally oriented oval and statistically asymmetric with respect to horizontal and vertical axes. In addition, the regression equations to predict the visual field on the given background condition were suggested. These results were expected to be used as a design guideline when arranging displays and controls on panels such as automobile display panels, cockpits, etc.

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The Effects of SW Development Project with Social Collaboration tool on Inter-relationship Change of Women's University Students (소셜협업도구를 활용한 소프트웨어 개발 프로젝트가 여대생의 대인관계변화에 미치는 영향)

  • Kim, Hee Yeong;Kim, Su Sun
    • Journal of Engineering Education Research
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    • v.20 no.5
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    • pp.43-49
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    • 2017
  • This paper deals with inter-relationship change of women's university students on the process of SW development project using social collaboration tool. Inter-relationship is one of the basic vocational competency in NCS(National Competency Standards) of Korea. We redesigned the curriculum of "Software Engineering" subject for this study and composed the project teams of students to develop software. The details of inter-relationship are satisfaction, communication, faith, friendliness, sensitivity, openness and consideration. From the result of this study, faith, openness and consideration have positive effect but satisfaction, communication, friendliness and sensitivity have no meaningful effect. The surveys were conducted in the beginning of semester and the same surveys were conducted again in the end of semester. The results were verified by paired t-test with SPSS 18.0. It is significant that the using of social collaboration tool for team project has positive effect on inter-relationship change, especially faith of women's university students. This study has some limitations for generalization but has meaning as new trial to enlarge the basic vocational competency of students in major subject, "Software Engineering". We expect new study for inter-relationship change of students to evaluate generality based on the proposed method in this paper.

Detecting an Outlier in 2X2 Bioequivalence Trial (2X2 생물학적 동등성 시험에서 이상치 검출을 위한 통계적 방법)

  • Jeong, Gyu-Jin;Park, Sang-Gue;Woo, Hwa-Hyoung
    • Communications for Statistical Applications and Methods
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    • v.16 no.5
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    • pp.745-751
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    • 2009
  • Outlying or extreme observations are defined to be subject data for which one or more bioavailability measures are discordant with corresponding data for that subject and/or for the rest of the subjects in a study. The presence of outlying observations can have very serious consequences on the conclusions resulting from a bioequivalence study. Two statistical methods are proposed by generalizing the current well known methods and an illustrated example is presented with discussion.