• Communications for Statistical Applications and Methods
• /
• 제19권1호
• /
• pp.47-55
• /
• 2012

식품의약품안전청에서는 제제간의 생물학적 동등성의 입증이 실패했을 경우 추가시험을 허용하는 시험 기준을 2008년 7월부터 시행하고 있다. 생물학적 동등성 시험의 추가시험규정은 원시험에서의 동등성 평가가 불충분한 시험 예수 때문에 실패했을 때 별도의 재시험 시험계획서를 제출하지 않고 피험자수를 증가시켜 다시 시험하여 제제간의 동등성을 평가할 수 있는 근거를 마련한 점에 긍정적이다. 하지만 최근 추가시험의 규정에 따라 군당 12명 이상의 피험자를 사용했을 경우 오히려 추가시험의 일관성 검정 규정을 만족하지 못하여 추가시험이 실패되는 경우가 자주 발생하고 있어 추가시험규정에 대한 불만이 고조되고 있다. 본 연구에서는 이러한 상황이 발생되는 통계적 원인을 살펴보고 현 기준을 일본 규정처럼 조금 더 일반화하게 되면 추가시험을 더 폭넓게 사용할 수 있는 것을 제안하고자 한다.

• 대한물리의학회지
• /
• 제6권4호
• /
• pp.475-488
• /
• 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
• /
• 제17권
• /
• pp.167-171
• /
• 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.

• 대한간호학회지
• /
• 제42권7호
• /
• pp.974-983
• /
• 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.

• 한국심리학회지:학교
• /
• 제9권3호
• /
• pp.485-503
• /
• 2012

본 연구의 목적은 학업수행과 성취결과에 주요한 예측변인 중 하나인 학업참여(academic engagement)를 측정하는 UWES-S(Utrecht Work Engagement Scale-Student)(Schaufeli et al., 2002a; 2002b) 척도를 타당화 하고, 학업참여와 학업동기 및 학업 만족도 간의 구조적인 관계를 파악하는 것이다. 본 연구의 타당화 표본은 우리나라 대학생들로써, 예비검사 285명, 본검사 366명으로 구성되었고, 그 절차는 다음과 같다. 첫째, UWES-S의 17개 문항에 대한 기술통계치 검토 및 척도의 요인구조 탐색을 위한 탐색적 요인분석을 실시하였다. 둘째, 문항의 심리측정학적 특성을 검토하기 위하여 등급반응모형에 기반한 문항 특성치를 추정하였다. 셋째, 척도의 내적타당도를 검증하기 위해 확인적 요인분석이 실시되었으며, 외적 타당도 확보를 위해서는 학업동기 및 학업만족 변인을 포함한 구조방정식 모형이 활용되었다. 이에 따른 연구결과는 다음과 같다. 첫째, 예비검사의 자료를 활용한 기술통계치 검토 및 탐색적 요인분석 결과 3요인 구조가 지지되었으며, 4개의 문항이 제거된 최종 13개 문항이 제안되었다. 둘째, 등급반응모형에 의해서 추정된 문항 특성치들을 검토한 결과, 최종 문항의 양호도는 수용 가능한 수준이었고, 또한 학업참여 척도의 3요인 모형(열정, 헌신, 몰두)은 자료에 잘 부합하는 것으로 나타났다. 또한 외적타당도 검증 결과, 학업참여는 학업동기와 학업만족을 부분매개 하는 것으로 나타났다. 마지막으로 본 연구에서 타당화 된 대학생용 UWES-S와 기존에 타당화 된 고등학생용 UWES-S(추헌택, 손원숙, 2011)와의 차이점을 논의하고, 표본별 학업참여 구인의 동등성 검증의 필요성 및 추후 척도 타당화 연구를 위한 제언을 포함하였다.