• Journal of Digital Convergence
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• v.15 no.6
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• pp.305-314
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• 2017

The purpose of this study was to examine relationships among resilience and job Stress, turnover intention and vitality in general hospital nurses and to provide the basic data for the development of resilience intervention programs. The data were collected from 140 nurses working in the four general hospital located S and Y city using self-reported questionnaires and February 1 2017 to February 17 2017. The data were analyzed by descriptive statistics, T-test, ANOVA, Pearson's correlation coefficient, and multiple regression with SPSS 20.0 program. Resilience was found to be in a significant positive correlation with job stress, turnover intention and vitality. The result of the multiple regression indicates that work pattern and vitality predict 31%(F=10.01, p<.001) of resilience. Therefore it is necessary to develop convergence program to strengthen the resilience of clinical nurses'.

• The Korean Journal of Applied Statistics
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• v.29 no.2
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• pp.279-289
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• 2016

Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $3{\times}3$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.

• The Korean Journal of Applied Statistics
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• v.24 no.6
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• pp.1055-1076
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• 2011

This paper reviews the definition of highly variable drug(HVD), the present regulatory recommendations and the approaches proposed in the literature to deal with the bioequivalence issues of HVD. The concept and the statistical approach of scaled average bioequivalence(SABE) is introduced and discussed with the current regulatory methods. The recommendations for SABE approach are proposed and the further study topics related to HVDs are also presented.

• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Journal of Korean Academy of Nursing
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• v.37 no.5
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• pp.676-683
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• 2007

Purpose: This study was conducted to understand the degree of vitality, meaning in life and self-efficacy and to elucidate the factors influencing this vitality in the nurses of Korea. Method: A cross-sectional survey of nurses from 4 hospitals was conducted by convenience sampling. Data collection was conducted through the use of questionnaires which were constructed to include a Vitality Self Test, Purpose in Life Test and Self-efficacy Scale. Results: The degree of vitality in nurses was in the middle range. The nurses of this study had few goals towards meaning in life, and an existential vacuum state. A positive relationship was found between vitality and the research variables. The significant predictors influencing vitality in nurses were meaning in life, self-efficacy, and clinical career, and these variables accounted for 28.7% of the variance in vitality. Conclusions: This results support that vitality is an important link with meaning in life and self-efficacy. There should be a comprehensive study in the future for in-depth understanding of the vitality of nurses.

• Journal of Korean Academic Society of Home Health Care Nursing
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• v.21 no.1
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• pp.5-13
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• 2014

Purpose: This study aimed to identify on the factors that influence vitality, by surveying the level of vitality, perceptive health condition, depression, family support, leisure activities, and religious activities of the elderly people using the welfare facilities for the aged. Methods: The subjects were 200 elderly people using welfare facilities for the aged such as senior welfare center or silver hall in Y city. Data was collected from December 1, 2012 to January 31, 2013, using a self-report structured questionnaire. Data was analyzed using the SPSS 20.0 for Windows, and analyses such as frequencies (percentage), means(standard deviation), t-test, Pearson's correlation coefficient, and Multiple Linear Regression, were conducted. Results: The participants exhibited a mean vitality score of $3.36{\pm}0.65$ out of 5. Means for the other measures were as follows: perceptive health condition, $3.32{\pm}0.65$; depression, $3.25{\pm}0.84$; family support, $3.64{\pm}0.64$; leisure activities, $2.97{\pm}0.65$; and religious activities, $3.05{\pm}0.92$ points. These factors explained 73.2% of the total variance. Conclusion: Further research is needed on vitality of the elderly people using care facilities for the aged. Moreover, I suggest that vitality and depression are examined as psychological aspects in the operational elements of elderly care facilities.

• The Korean Journal of Applied Statistics
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• v.28 no.2
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• pp.289-294
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• 2015

Linear mixed models are commonly used in the clinical pharmaceutical studies to analyze repeated measures such as the crossover study data of bioequivalence studies. In these models, random effects describe the correlation between repeated outcomes and variance-covariance matrix explain within-subject variabilities. Bioequivalence analysis verifies whether a 90% confidence interval for geometric mean ratio of Cmax and AUC between reference drug and test drug is included in the bioequivalence margin [0.8, 1.25] performed using linear mixed models with period, sequence and treatment effects as fixed and sequence nested subject effects as random. A Levofloxacin study is referred to for an example of real data analysis.

• Korean Journal of Breeding Science
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• v.40 no.3
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• pp.303-307
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• 2008

We bred a new green-kerneled glutinous rice variety that can be cultivated in the whole area of Korea, because only one native green-kerneled glutinous rice cultivar, "Saengdongchalbyeo", has been cultivated in the southern coastal area due to its late heading. The seeds of "Saengdongchalbyeo" were irradiated with 200 Gy of gamma ray in 1995. A promising mutant variety, "Nogwonchalbyeo" ("Wonnong 17") was selected through line selection and regional yield trials. In particular, the new variety revealed at the earlier mid of August compared to that of "Saengdongchalbyeo", the early of September, and it was considerably tolerant to a field lodging due to its shortened culm length. Also, "Nogwonchalbyeo" had a higher ripened grain ratio and 1,000 grain weight compared to the original variety. The brown grain yield of the new variety was about 5.40 MT/ha, which was 11.3% higher than that of the original variety, in the regional yield trials at 3 different fields during 2000~2001. The brown and milled grains of the new rice variety contained 20 to 65% higher amount of total amino acids, respectively than that of the original and two checks. For chlorophyll -a, -b and total chlorophyll, the new variety showed nearly two-fold higher than the checks, and for the carotenoid, it had 5.3 - 7.6 times higher amount. These results showed that the new variety can be cultivated as a special green-kerneled glutinous rice with high functional compounds.

• Journal of the Korean Institute of Educational Facilities
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• v.26 no.5
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• pp.37-39
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• 2019

• 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.