• 제목/요약/키워드: Preliminary Validation

검색결과 244건 처리시간 0.023초

CB6F1-Tg rasH2 Mouse Carrying Human Prototype c-Ha-ras Gene As an Alternative Model For Carcinogenicity Testing For Pharmaceuticals

  • Usui, T.;Urano, K.;Suzuki, S.;Hioki, K.;Maruyama, Ch.;Tomisawa, M.;Ohnishi, Y.;Suemizu, H.;Yamamoto, S.
    • Toxicological Research
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    • 제17권
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    • pp.293-297
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    • 2001
  • The international pharmaceutical and regulatory communities had been recognizing the limited utility of conventional rodent carcinogenicity study particularly on the second species, mouse, after intense investigation of carcinogenicity data base worldwide, and a new scheme for carcinogenicity testing for pharmaceuticals was proposed at the Expert Working Group on Safety in the International Conference on Harmonization (ICH) in 1996. CB6F 1-Tg rasH2 mouse carrying human prototype c-Ha-ras gene with its own promoter/enhancer is one oj the new carcinogenicity assay model for human cancer risk assessment. Studies have been conducted since 1992 to validate the transgenic (Tg) mice for rapid carcinogenicity test-ing, short term (26 weeks) studies with genotoxic (by Salmonella), non-genotoxic carcinogens, genotoxic non-carcinogens, non-genotoxic non-carcinogens revealed relatively high concordance oj the response of the Tg mouse with classical bioassay across classes of carcinogenic agents. Mechanistic basis for carcinogensis in the model are being elucidated in terms of the role of overexpression and/or point mutation of the transgene. This report review the initial studies of validation of the model and preliminary results of on-going ILSI HESI ACT project will be presented.

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Variation in Nutritive Value of Commercial Broiler Diets

  • Ru, Y.J.;Hughes, R.J.;Choct, M.;Kruk, J.A.
    • Asian-Australasian Journal of Animal Sciences
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    • 제16권6호
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    • pp.830-836
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    • 2003
  • The classical energy balance method was used to measure the apparent metabolisable energy (AME) of four batches of broiler starter and finisher diets produced by two commercial feed companies. The results showed there was little variation in protein content between batches, but NDF content varied from 13.3% to 15.5% between batches of diet. The batch variation in chemical composition differed between feed manufacturers. While there was no difference in AME and feed conversion ration (FCR) between batches of starter diets produced by company A, FCR and AME ranged from 1.76-1.94 (p<0.001) and 11.38-11.90 MJ/kg air dry (p<0.05), respectively, for diets produced by company B. Similar results were found in a second experiment. There was no difference in AME, dry matter digestibility (DMD) and FCR between batches for finishing diet produced by company B, but a large variation occurred for the finisher diets from company A (p<0.01), where the ranges of FCR, AME and DMD were 1.95-2.30, 10.5-12.3 (MJ/kg air dry) and 58-68%, respectively. FCR was correlated with AME. AME was negatively related to the content of fibre in the diet, but positively related to DMD. The preliminary results based on 24 samples showed that near infrared spectroscopy (NIR) has the potential to predict FCR, intake, AME and DMD of commercial broiler diets, with $R^2$ being 0.93, 0.89, 0.95 and 0.98, respectively. The standard error of cross validation was below 0.2 for AME and only 0.06 for FCR.

프레임워크를 이용한 연료공급 및 냉각계통 예비설계 프로그램 개발 (A Development on Conceptual Design Tool of Fuel Supply and Cooling System for High-speed Vehicles using Fluid-thermal System Design Framework)

  • 최세영;박수용;현석호;최원;박정배
    • 항공우주시스템공학회지
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    • 제12권4호
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    • pp.90-97
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    • 2018
  • 고속 비행체의 연료공급 및 냉각계통의 통합설계를 위한 프로그램을 개발하고 이를 이용하여 예비설계 및 검증을 수행하였다. 개발된 설계 도구는 상용 열유체 시스템 설계 프로그램을 프레임워크로 이용하여 모듈 통합과 입출력 처리 등이 개선되었다. 모델의 형상 및 열환경 변수를 입력하여 구성품의 상태량을 계산하고 모사를 통하여 설계 요구조건 충족을 확인할 수 있다. 이 프로그램을 사용하여 시스템의 세부 구성품 규격 선정에 적절하게 사용할 수 있음을 나타내었다.

중환자실 간호사의 인간중심 간호 측정도구 개발 (Development and Validation of a Measurement to Assess Person-centered Critical Care Nursing)

  • 강지연;조영신;정연진;김수경;윤선영;심미영
    • 대한간호학회지
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    • 제48권3호
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    • pp.323-334
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    • 2018
  • Purpose: The purpose of this study was to develop a scale to measure person-centered critical care nursing and verify its reliability and validity. Methods: A total of 38 preliminary items on person-centered critical care nursing were selected using content validity analysis of and expert opinion on 72 candidate items derived through literature review and qualitative interviews. We conducted a questionnaire survey with 477 nurses who worked in intensive care units. The collected data were analyzed using exploratory factor analysis (EFA) and confirmative factor analysis (CFA) with SPSS and AMOS 24.0 program. Results: EFA was performed with principal axis factor analysis and Varimax rotation. The 15 items in 4 factors that accounted for 50.8% of the total variance were identified by deleting the items that were not meet the condition that the commonality should be .30 or more and the factor loading over .40. We named the factors as compassion, individuality, respect, and comfort, respectively. The correlation coefficient between this scale and the Caring Perception Scale was r=.57 (p<.001), which determined concurrent validity. The item-total correlation values ranged from .39 to .63, and the internal consistency for the scale was Cronbach's ${\alpha}=.84$. Conclusion: The reliability and validity of the 15 item person-centered critical care nursing scale were verified. It is expected that the use of this scale would expand person-centered care in critical care nursing.

Reliability and Validity of the Korean Translation of Quantitative Checklist for Autism in Toddlers: A Preliminary Study

  • Park, Subin;Won, Eun-Kyung;Lee, Ji Hyun;Yoon, Soyoung;Park, Eun Jin;Kim, Yeni
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • 제29권2호
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    • pp.80-85
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    • 2018
  • Objectives: We aimed to assess the test-retest reliability, internal consistency, and validity of the Korean version of the Quantitative Checklist for Autism in Toddlers (Q-CHAT). Methods: The Korean version of the Q-CHAT and the Korean version of the Child Behavior Checklist (CBCL) 1.5-5 were completed by parents of 24 toddlers and preschoolers with autism spectrum disorder (ASD) and 80 unselected toddlers and preschoolers. Parents of the ASD group also completed the Social Communication Questionnaire (SCQ), and Childhood Autism Rating Scale (CARS) scores were obtained from medical records. Results: The ASD group scored higher on the Q-CHAT than the unselected group. The Cronbach's alpha coefficient of the Q-CHAT was 0.658, and test-retest reliability was calculated to be 0.836. The estimated area under the curve was 0.793. The total scores of the Q-CHAT in the ASD group demonstrated significant positive correlations with findings regarding pervasive development problems in the CBCL, SCQ, and CARS. A total score of 33.5 may be a useful cutoff point to use when identifying toddlers at risk of ASD. Conclusion: The Korean version of the Q-CHAT has good reliability and validity and can be used as a screening tool in order to identify toddlers and preschool children at risk of ASD.

미성숙 랫드에 있어서 경구 및 피하투여에 의한 Ethinyl estradiol의 자궁증식효과 (Uterotrophic Activity of Ethinyl Estradiol by Gavage and Subcutaneous Administration in Immature Female Rats)

  • 정문구;임광현;김종춘;김영희;서정은;하창수
    • Toxicological Research
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    • 제16권3호
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    • pp.201-209
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    • 2000
  • In association with the international validation program to establish a rodent uterotrophic assay, we conducted preliminary uterotrophic assay proposed by GECD using immature female rats. In the present study, oral and subcutaneous routes were chosen to compare the effects of estrogenic com-pounds in the two dosing regimens. The reference compound ethinyl estradiol (EE) and the antagonist ZM189154(ZM) were administered by gavage or subcutaneously (s.c.) to immature female SD rats from 20 to 22 days of age. For each study, sixty-six female rats were randomly assigned to eleven groups: Untreated control, EE 0,0.01, 0.03, 0.1, 0.3, 1.0,3.0 and 10.0 $\mu\textrm{g}$/kg, EE 3.0 $\mu\textrm{g}$/kg(gavage)/0.3 $\mu\textrm{g}$/kg(s.c) & ZM 0.1 mg/kg, and EE 3.0 $\mu\textrm{g}$/kg(gavage)/0.3 $\mu\textrm{g}$/kg (s.c) & ZM 1.0 mg/kg. There were no treatment-related changes in clinical signs, body weights, food consumption, and necropsy findings in any groups of two studies. The wet and blotted uterus weights increased dose-dependently. Histopathological examination revealed that diameter of uterine duct, height of uterine luminal epithelium. and height oj vaginal epithelium increased dose-dependently. The proliferating cell nuclear antigen (PCNA) immunoreactive cells were increased in number dose-dependently. The estrogenic effects observed in the present studies occurred at $\geq$ 0.3 $\mu\textrm{g}$/kg of oral dose and $\geq$ 0.1 $\mu\textrm{g}$/kg of s.c. dose. An antagonistic effect of ZM against EE was found in both uterus weight and histopathological parameters. From the results obtained, it can be concluded that dose-dependence of the uterotrophic assay using EE and ZM was well demonstrated by gavage and subcutaneous administration and that the estrogenic effects of EE by s.c. dose were higher than those by gavage administration. In addition, blotted uterus weight was more sensitive than wet uterus weight and vaginal epithelial height was found to be the most sensitive parameter among the parameters examined.

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Effect of traditional dry cupping therapy on heavy menstrual bleeding in menorrhagia: A preliminary study

  • Sultana, Arshiya;Rahman, Khaleeq Ur
    • 셀메드
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    • 제2권4호
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    • pp.33.1-33.3
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    • 2012
  • Menorrhagia (kasrate tams) is the most common gynecologic complaint in contemporary gynecology, affecting 10 to 15% of the adult female population. It can occur at any age. In the Unani system of medicine, since antiquity, dry cupping therapy (hijamat bila shurt) has been used to treat menorrhagia. An effort was made to evaluate the usefulness of dry cupping on excessive menstrual blood loss in menorrhagia with a well validated menstrual pictogram. This study was conducted on 15 patients at the National Institute of Unani Medicine, Hospital Bangalore, from January 2010 and July 2010. Unmarried or married patients aged 17 - 47 year with a history of excessive or prolonged bleeding per vaginum were included. Two large cups (with 5.7 cm internal diameter) were applied below each breast for 15 min, only once during the menstrual period when the patient reported to the outpatient department. If the menstrual flow was not reduced, the next day again dry cupping was repeated. The outcome was to assess the efficacy of dry cupping on the reduction in the amount of menstrual blood loss. The data was analyzed by the Wilcoxon matched test. The mean scores of menstrual blood loss before and after the treatment was 400.26 (277.95) and 48.4 (32.082) ml respectively, p = 0.002, considered statistically significant. A dry cupping therapy is a useful treatment modality in decreasing the amount of menstrual blood flow in menorrhagia. Further randomized controlled clinical trials and validation are needed in a large population.

지진에 대비한 기초분리 교량의 설계법에 관한 연구(II) (A Study of Seismic Resistant Design for Base-Isolated Bridges(II))

  • 이상수;유철수
    • 한국강구조학회 논문집
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    • 제9권4호통권33호
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    • pp.637-647
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    • 1997
  • 제1편에서 언급한 바와 같이 기초분리 장치의 사용은 지진의 위험으로부터 구조물의 안전을 유지시키고, 지진 응답 감소에 필요한 비선형 거동은 교체가 용이한 분리장치에 국한 함으로써 구조물의 중요 부재들은 탄성 거동을 확보할 수 있다. 본 연구는 강재 Damper를 사용한 교량의 지진 응답에 대하여 연구하였다. 강재 Damper의 특성에 따른 응답을 분리 장치의 매개 변수 영향 별로 분리하여 검토 함으로써 지진시 거동을 파악하고, 적정한 분리 장치를 선정 할 수 있는 기준과 단순화된 설계 방법을 제시하였다. 제시된 시방서 형식의 설계 방법은 비선형 스펙트럼에 의한 모드 해석법으로, 관성력 또는 기초 분리 장치를 포함한 연결부 및 하부 구조의 높이별 설계력을 비교적 정확하게 평가될 수 있다. 따라서 제시된 설계 방법은 기초 분리된 교량의 기본 또는 최종 설계용으로 사용될 수 있을 것이다. 또한, 설계 방법의 타당성 검증을 위해 bilinear 이력의 강재 Damper를 사용한 P.C 교량에 대해 인공 지진파를 이용한 비선형 시간 이력 해석과 설계 응답 스펙트럼에 의한 탄성 수치 해석을 수행하여 단순 설계 방법과 비교 검토하였다.

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수학교사의 테크놀로지 교수 내용 지식(TPACK) 측정 도구 개발 및 타당화 (Development and Validation of TPACK Measurement Tool for Mathematics Teachers)

  • 이다희;황우형
    • 한국수학교육학회지시리즈A:수학교육
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    • 제56권4호
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    • pp.407-434
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    • 2017
  • The purpose of this study is to develop and verify the TPACK measurement tool for middle and high school mathematics teachers in the Korean context. Also, by clarifying the relationship between subordinate factors of Mathematics teachers' TPACK, an attempt was made to provide suggestions on the designs and directions for the in-service and pre-service teacher education and the programs for improving mathematics teachers' TPACK in the future. In order to achieve this goal, TPACK factors of mathematics teachers were extracted by reviewing literature on PCK, MKT, and TPACK. Then, content validity, basic statistical survey, reliability verification, exploratory factor analysis, confirmatory factor analysis, and structural equation model verification were conducted sequentially. At first, preliminary analysis was carried out on 79 mathematics teachers, and 76 items excluding the items with extreme value and reliability were included in the basic statistical analysis. And secondly, an exploratory factor analysis was conducted on 376 mathematics teachers, and this instrument consisted of 7 subordinate factors(CK, PK, TK, PCK, TCK, TPK, TPACK) and 61 items. Also by conducting confirmatory factor analysis and structural equation model test with 254 mathematics teachers, the measurement tool was confirmed the validity and reliability through statistically significant analysis. Then, the importance of integrated knowledge was confirmed by looking at the relationship between the TPACK factors of in-service mathematics teachers. The integrated knowledge(PCK, TCK, TPK) has played a crucial role in the formation of TPACK rather than the knowledge of CK, PK, and TK alone. Finally, the validity of TCK was confirmed through the structural equation modeling of TPACK. TCK not only directly affected TPACK, but also indirectly through TPK. According to these affirmative results, this measurement tool is claimed to be suitable for measuring the factors of Mathematics teachers' TPACK, and also the structural equation model can be regarded as a suitable model for analyzing the structural relationship of mathematics teachers' TPACK.

노인의 당뇨병 관리 자기효능감 측정도구 개발 및 평가 (Development and Validation of the Diabetes Management Self-efficacy Scale for Older Adults (DMSES-O))

  • 송미순;최수영;김세안;서경산;이수진;김은호
    • 근관절건강학회지
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    • 제21권3호
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    • pp.184-194
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    • 2014
  • Purpose: The purpose of this study was to develop and validate a diabetes management self-efficacy scale for older adults (DMSES-O). Methods: A preliminary DMSES-O of 22 items was derived from a literature review and seven domains of self-management behaviors. Content validity was confirmed by experts in diabetes self-management education. To test the reliability and validity of the DMSES-O, data were collected from 150 older adults with type 2 diabetes. The data were analyzed using exploratory factor analysis, and Cronbach's ${\alpha}$ and Pearson's correlation coefficients were calculated. Results: From the exploratory factor analysis, 17 significant items in six subscales were derived. Factors derived were named "problem solving for hypoglycemia and self-monitoring blood glucose," "problem solving for hyperglycemia," "coping with psychological distress and taking medication," "reducing risks of diabetes complications," "appropriate exercise," and "healthy eating." The criterion-related validity of the DMSES-O was established by its correlation with the Summary of Diabetes Self-care Activities Questionnaire. Cronbach's ${\alpha}$, a measure of internal consistency, was .84 for the overall scale and ranged from .54 to .80 for the subscales. Conclusion: The DMSES-O is a reliable and valid instrument to measure selfefficacy for diabetes self-management among older adults.