• Communications for Statistical Applications and Methods
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• v.19 no.1
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• pp.47-55
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• 2012

The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.

• Journal of the Korean Society of Physical Medicine
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• v.6 no.4
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• pp.475-488
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• 2011

Purpose: The aims of the study were to develop and to establish reliability in Korean versions of World Health Organization Disability Assessment Schedule 2.0(KWHODAS 2.0): 12 item-self(12-self) and 12 item-interviewer(12-interviewer) versions. Methods: KWHODAS 2.0: 12-item versions were developed in idiomatic modern Korean with a process involving independent translation, synthesis of the translations, independent back translation, and review by an expert committee to achieve equivalence with the original English. 88 participants were included in the study. 33 of participants filled the 12-self version twice to examine test-retest reliability and 55 of participants were assessed simultaneously by four interviewers using the 12-interviewer version. Intra-rater reliability was evaluated using the intra-class correlation coefficient(ICC) and inter-rater reliability was evaluated using both the ICC and k statistic. Results: Test-retest reliability for the 12-self version was excellent with $ICC_{(2,1)}$ value ranged from 0.94(CI 0.88-0.98) to 0.96(CI 0.90-0.98). Inter-rater reliability for the 12-interviewer version showed excellent agreement with $ICC_{(2,1)}$ from 0.94(CI 0.91-0.96) to 1(CI 1.0-1.0). K value was observed from 0.95 to 1. Conclusion: KWHODAS 2.0: 12-self and 12-interviewer versions were successfully translated and both scales showed excellent reliability. It is now suitable for use in clinical and research applications.

• Toxicological Research
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• v.17
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• pp.167-171
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• 2001

The introduction of genetically modified crops has raised concerns regarding safety issues over the insertion of foreign genes into plant genomes using recombinant DNA technology. Since 1991 in Japan, 29 foods and 6 food additives have been evaluated, based on the "Guideline for Safety Assessment", before these foods were marketed. The MHW, however, decided that safety assessment of such foods and food additives should be legally imposed. because soon such foods and food additives are expected to circulate globally and a new system for assessing safety of such foods and food additives at a pre-market stage is necessary, in order to avoid the distribution of any genetically modified foods that have had no safety assessment. The MHW published relevant announcements to amend existing regulations on 1 May 2000. "Standards for safety assessment of seed plant" is established based on a concept of substantial equivalence, and applicable to the products which are regarded as equivalent to the existing products used as foods and food additives. The characterization of the food products entails consideration of the molecular characterization. phenotypic and compositional characteristics, key nutrients and toxicants, and toxicity and allergenicity of the introduced proteins, and if there are indications of unintended effects of the modification, whether further safety testing (animal studies etc.) is needed should be considered. Safety and wholesomeness studies with whole foods should be care fully designed in order to avoid nutritional imbalances causing artifacts and uninterpretable results as was the case of Dr. Pusztaiis report. A case study of genetically modified soybeans (glyphosate-tolerant soybeans) on the immune system of rats and mice is shown. Chemical compositions were also compared with those of the non-GM soybeans. The studies failed to detect any differences in immuno-toxic activity.muno-toxic activity.

• Journal of Korean Academy of Nursing
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• v.42 no.7
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• pp.974-983
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• 2012

Purpose: The purpose of this study was to translate the Spiritual Perspective Scale (SPS) and Self-transcendence Scale (STS) into Korean and test the psychometric properties of the instruments with Korean elders. Methods: A cross-sectional survey design was used to implement the three stages of the study. Stage I consisted of translating and reviewing the scales by six experts. In Stage II, equivalence was tested by comparing the responses between the Korean and English versions among 71 bilingual adults. Stage III established the psychometric properties of the Korean versions SPS-K and STS-K among 154 Korean elders. Results: Cronbach's alpha of the SPS-K and the STS-K .97, and .85 respectively with Korean elders. Factor analysis showed that the SPS-K had one factor; the STS-K had four factors with one factor clearly representing self-transcendence as theorized. Both scales showed good reliability and validity for the translated Korean versions. However, continued study of the construct validity of the STS-K is needed. Conclusion: Study findings indicate that the SPS-K and the STS-K could be useful for nurses and geriatric researchers to assess a broadly defined spirituality, and to conduct research on spirituality and health among Korean elders. Use of these scales within a theory-based study may contribute to further knowledge about the role of spirituality in the health and well-being of Korean people facing health crises.

• Korean Journal of School Psychology
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• v.9 no.3
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• pp.485-503
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• 2012

Academic engagement has been known as a strong predictor of students' cognitive and affective outcomes in an educational context. Despite increasing interest and theoretical usefulness of this construct, a few researchers seem to be interested in the validation of instruments to measure academic engagement for Korean students. Thus, this study would like to introduce one of academic scales widely used, UWES-S(Utrecht Work Engagement Scale-Student) (Schaufeli et al., 2002a: 2002b) and to validate the UWES-S for Korean college students. To validate the Korean version of the UWES-S, 651 college students (285 for Field Trial, 366 for Main Study) were used. The procedure is as follows. First, we used an integrated adaptation procedure to produce a Korean version of the UWES-S. Second, EFA(exploratory factor analyses) was applied to explore the factor structure of the UWES-S on the field trial data. Third, the psychometric properties of the UWES-S items were examined by graded response model(GRM). Also CFA(confirmatory factor analysis) was used to examine its internal construct validity for the data from the main study. Finally, the external validity of the UWES-S was scrutinized with the related variables such as academic motivation and satisfaction. As a result, the Korean version of the UWES-S with 13 items was accepted that the four items were excluded from its original version. Second, the internal validity was supported that the 3 factor CFA model(vigor, dedication, absorption) fit the data well. Third, we supported the partial mediation model that academic engagement played as a mediating variable between academic motivation(internal/external) and academic satisfaction. Finally, the differences between a validation of UWES-S for Korean college and high school students, the necessity of construct equivalence testing, and direction for future research of scale validating were discussed.