• Title/Summary/Keyword: efficacy evaluation

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Regulatory Requirements on the Safety and Efficacy Evaluation for the Development of Stereoisomeric Drugs (광학이성질체 의약품 개발에서 안전성과 유효성 평가에 대한 규제 요건)

  • Kim, Kwang-Joon;Choi, In;Seo, Kyu-Hwa;Han, Hyo-Kyung;Lee, Won-Jae
    • YAKHAK HOEJI
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    • v.55 no.5
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    • pp.426-431
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    • 2011
  • This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.

The Moderating Effects of Core-Self Evaluation on the Relationship Between Entrepreneurial Self-Efficacy and Entrepreneurial Intention, Job-Seeking Stress (대학생의 창업효능감과 창업의도 및 취업스트레스 관계에서 핵심자기평가의 조절효과 연구)

  • Hyun, Sun Hae;Seo, Moon Kyo;Kwon, In Su
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.11 no.6
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    • pp.39-49
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    • 2016
  • As university students' job seeking stress and entrepreneurial intentions increase, the importance of variable research that can be applied to both concepts. However, recent studies researchers looked at only the influence variables in each concept. So they thought about the difference between entrepreneurship and employment. To solve these problems in this study was to verify the moderating effects of core-self evaluation in the relationship between entrepreneurial self-efficacy and entrepreneurial intention, job-seeking stress of university students. The data of 349 university students in korea were collected for the study. The collected data were analyzed with multi-regression modeling. All data collected from the survey were analyzed using with SPSS 21.0 The findings of the study were as follows. First, results showed that entrepreneurial self-efficacy affect entrepreneurial intention directly. Second, core-self evaluation affect job-seeking stress of university students. Finally, it was also found that there was moderating effect of core-self evaluation in relationship between entrepreneurial self-efficacy and job-seeking stress of university students. On the other hand it was found there was no moderating effect of core-self evaluation in relationship between entrepreneurial self-efficacy and entrepreneurial intention. Based on what has been learned through the analyses, The results of this study suggest that an educational system and institutional are needed to increase entrepreneurial efficacy. And It can be seen that the recognition of core self-evaluation is effective for the job seeking stress. Also, the implications and the limitations of the study were presented including some directions for future studies.

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Effects and Development of Clinical Competency Evaluation using Standardized Patients among Nursing Students: Based on Abdominal Surgical Patients (표준화 환자를 활용한 임상수행능력 평가방법 개발 및 적용효과: 복부수술 후 환자간호)

  • Sok, So-Hyune R.;Kang, Hyun-Sook;Kim, Won-Ok;Hyun, Kyung-Sun;Lee, Ji-A;Park, Sun-Hee
    • Korean Journal of Adult Nursing
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    • v.21 no.5
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    • pp.468-476
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    • 2009
  • Purpose: This study was to develop the clinical competency evaluation, and to examine the effects of the developed evaluation by comparing it with existing evaluation on clinical competency, communication skill, and self-efficacy of nursing students. Methods: Design was a randomized control group post-test design. The subjects were 102 senior nursing students(Experimental group: 48, Control group: 54) at K university in seoul, Korea. The experimental group took the clinical competency evaluation using standardized patients and the control group took the existing evaluation using a doll. The clinical competency and communication skills were measured by evaluators, and self-efficacy was self reported by the nursing students. Results: The experimental group had higher scores in clinical competency, communication skills, and self-efficacy than those in the control group. Conclusion: Through these results, practice education of nursing education programs need to activate the clinical competency evaluation using standardized patients.

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The Factors Affecting Smartphone User's Intention to use Mobile Anti-Malware SW (스마트폰 이용자의 악성코드용 모바일 백신 이용 의도에 영향을 미치는 요인)

  • Jang, Jaeyoung;Kim, Jidong;Kim, Beomsoo
    • Journal of Information Technology Services
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    • v.13 no.2
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    • pp.113-131
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    • 2014
  • Smartphone security threat has become an important issue in Information Science field following the wide distribution of smartphones. However, there are few studies related to such. Therefore, this study examined the factors affecting the intention of smartphone users to use the mobile vaccine against malware with the Protection Motivation Theory. To secure the reliability of the study, a surveying agency was commissioned. A total of 263 respondents, excluding 37 respondents who are users of iOS, which does not have mobile vaccine in the smart phone, or who gave invalid responses, were surveyed. The results showed that perception of the installed mobile vaccine significantly affected the Response Efficacy and Self-efficacy, and that the Perceived Severity, Perceived Vulnerability, Response Efficacy, and Self-efficacy significantly influenced the intention to use the mobile vaccine. On the other hand, Installation Perception of mobile vaccine itself did not affect the Perceived Severity and Perceived Vulnerability. This study is significant since it presented the new evaluation model of threat evaluation and response evaluation in the Protection Motivation Theory in accepting the security technology and raised the need for the promotion and exposure of mobile vaccine, since perception of mobile vaccine installation affects the response evaluation. It also found that the promotion must consider the seriousness of smartphone security, outstanding attribute of mobile vaccine, and user-friendliness of mobile vaccine above all.

Differences in the Evaluation of Clothing Products according to Self-Efficacy in Purchasing Clothes (의복구매효능감에 따른 의류제품평가의 차이)

  • Ko, Sun-Young
    • Journal of the Korean Society of Clothing and Textiles
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    • v.35 no.7
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    • pp.775-786
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    • 2011
  • This study examines whether there are differences in the evaluation of clothing products according to self-efficacy in purchasing clothes. A total of 300 surveys were distributed and 231 were used for analysis. The data were analyzed by regression and factor analysis. The results are as follows. First, there were significant differences in the product attributes considered according to self-efficacy in purchasing clothes. The consumers with high self-efficacy considered diverse product attributes comprehensively when making purchase decisions and had significantly higher score in perceived value and post-purchase satisfaction level than the consumers with low self-efficacy. Second, there were differences in the attributes of clothing products that effects perceived value according to self-efficacy in purchasing clothes. The attributes of 'clothes that I like' and 'necessary clothes' had a significant effect on perceived value for both consumers. The attributes of 'design that suits me' and 'inexpensive price' had significant effect on perceived value on consumers with high self-efficacy while the attributes of 'harmony with other clothes' had a significant effect on perceived value for consumers with low self-efficacy. Third, there were differences in product attributes and the perceived value that influenced post-purchase satisfaction level according to self-efficacy in purchasing clothes. The attributes of 'design that suits me' and perceived value had a direct effect on the post-purchase satisfaction level four consumers with a high self-efficacy. For the consumers with low self- efficacy, the attributes of 'clothes I like', 'necessary clothes', and 'design similar to that of usually purchased products' had a direct effect on post-purchase satisfaction level; however, the effect of perceived value was not found.

A Structural Model for Aquatic Exercise Adherence of Patients with Arthritis (관절염 환자의 수중운동 지속에 관한 구조 모형)

  • Kang, Hyun-Sook
    • Journal of muscle and joint health
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    • v.8 no.1
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    • pp.5-26
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    • 2001
  • Many studies have reported that regular aquatic exercise can lead to improvement of health for patients suffering from arthritis. In spite of these benefits, the adherence rate has shown as few as 26% of patients with arthritis who had completed the aquatic exercise education program. Moreover, when patients with arthritis begin an aquatic exercise, 47% withdraw within the first 6 month. No study has been found that constructs model to explain aquatic exercise adherence of patients with arthritis. The purpose of this study were to identify the factors influencing exercise adherence and to construct and test a structural model to explain aquatic exercise adherence of patients with arthritis. Hypothesized model was constructed on the basis of Bandura's social cognitive theory and literature review. Exogenous latent variables included in this model are group cohesion and barrier, endogenous latent variables are self-efficacy, outcome expectancy and self-evaluation. Empirical data used was collected through individual interviews with the structural questionnaire on 249 patients with arthritis who had completed the 6-week aquatic exercise education program of Korean Rheumatology Health Professionals Academy. The interviews were performed from September 6, 1999 through October 8, 1999. A model tested by the covariance structural analysis with LISREL 8.12a program and by descriptive statistics and correlation with SAS 6.12 program. The results are summarized as follows: First, hypothesized model showed a good fit to the empirical data. In the modified model added one new path showed a much better fit. Second, group cohesion had a direct, indirect positive effects, self-efficacy and self evaluation had a direct positive effects on exercise adherence. Barrier had a direct, indirect negative effects on exercise adherence. Outcome expectancy had a direct negative effect, indirect positive effects through self-evaluation on exercise adherence, but total effects was not significant. Total effect size of the variables were group cohesion, self-efficacy, barrier and self evaluation in order. All variables accounted for 54% of the total variance of exercise adherence in the model. In conclusion, this model confirmed to be proper in explaining of aquatic exercise adherence. Group cohesion, self-efficacy, outcome expectancy, self-evaluation, barrier contributed to the aquatic exercise adherence of patients with arthritis. The results of this study suggested that improvement of group cohesion, self-efficacy and self-evaluation, motivation of outcome expectancy through self-evaluation, and reduction of the barrier should be included in the strategy of nursing intervention for the aquatic exercise adherence of patients with arthritis.

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Development and psychometric evaluation of Clinical Practice Self-Efficacy Scale for nursing students (간호대학생을 위한 임상수행 자기효능감 척도 개발 및 타당도, 신뢰도 검증)

  • Choi, Heejung;Kim, Sueun;Jeong, Harim
    • The Journal of Korean Academic Society of Nursing Education
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    • v.28 no.3
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    • pp.236-247
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    • 2022
  • Purpose: The COVID-19 pandemic has increased the importance of nurses' clinical performance, and accordingly, nursing educators have emphasized students' clinical practice and performance. This study developed a Clinical Practice Self-Efficacy Scale for nursing students and examined its psychometric properties. Methods: The authors reviewed instruments for selecting items for the scale in the areas of clinical skills, communication, infection control, safety, and nursing process. After preliminary items were selected, ten experts consisting of nursing professors and clinical nurses reviewed the items considering Korean clinical and educational situations. The data for the psychometric evaluation was collected from 257 nursing students in their 2nd, 3rd, and 4th years and then analyzed. Results: The confirmatory factor analysis showed that the goodness of fit of this scale with five factors represented by 40 items was appropriate. The significant positive correlations with general self-efficacy indicated sound construct validity. The senior nursing students showed higher scores than others, as we expected. Cronbach's alpha was .94. Conclusion: The Clinical Practice Self-Efficacy Scale is appropriate for measuring Korean nursing students' self-efficacy of clinical practice. It is expected to act as a good tool to measure the effects of clinical practice education.

Effect of a Self-Evaluation Method Using Video Recording on Competency in Nursing Skills, Self-Directed Learning Ability, and Academic Self-Efficacy (비디오 녹화를 통한 자가평가 학습법이 간호술기 수행능력과 자기주도적 학습능력, 학업적 자기효능감에 미치는 영향)

  • Song, So-Ra;Kim, Young-Ju
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.22 no.4
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    • pp.416-423
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    • 2015
  • Purpose: The purpose of this study was to evaluate the effect of a self-evaluation method using video recording on competency in nursing skills, self-directed learning ability, and academic self-efficacy in nursing students. Methods: The study design was a non-equivalent pre-post quasi-experimental design. The experimental and control groups were randomly assigned with 35 participants in each group. Interventions for the experimental group were video recording and students' self-evaluation of what they did. Nursing skills included in the study were tube feeding, intradermal injection, subcutaneous injection, and intramuscular injection. Competency in nursing skills was measured one time at the end of the study using a checklist. Self-directed learning ability and academic self-efficacy were measured 3 times (pre-, mid-, and post-intervention) over the 8 weeks. Independent t-test, chi-square test, and repeated measures ANOVA were used for data analyses. Results: There was no statistically significant difference for competency in nursing skills and self-directed learning ability over the 8 weeks of the practice session. There was a significant difference in academic self-efficacy by groups over time. Conclusion: Results indicate that self-evaluation method using video recording is an effective learning way to improve academic achievement in nursing students.

Factors Influencing Aquatic Exercise Adherence of Patients with Arthritis (만성관절염 환자의 수중운동 지속에 영향을 미치는 요인)

  • Kang, Hyun-Sook
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.15 no.3
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    • pp.350-359
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    • 2008
  • Purpose: The purpose of this study was to identify change in the exercise behavior and to identify factors influencing long-term adherence to aquatic exercise in patients with arthritis as a follow-up study after five years. Method: Baseline data had been collected using a structured interview 6 months after participants completed the aquatic exercise educational program. This second follow-up data collection included 133 participants from the original baseline study and was done 5 years after the original baseline study. Data was analyzed using SPSS 16 Win program. Results: The stage of change for the participants was as follows: Precontemplation (44.3%), Contemplation (24.1%), Preparation (3.0%), Action (0%) and Maintenance (adherence, 28.6%). The adherers (N=38) had significantly higher scores than non-adherers (N=91) in self-efficacy, outcome expectancy, group coherence and self-evaluation, and significantly lower scores in barriers to exercise. In logistic regression analysis, self-efficacy, group cohesion, barriers to exercise and self-evaluation were associated with exercise adherence (Chi Square=17.14, p=.002). Group cohesion (OR=2.5871, 95% CI=1.094-6.113, p= .030) was the most important factor. Conclusion: Self-efficacy, group cohesion, barriers to exercise and self-evaluation need to be considered in planning exercise programs to improve exercise adherence.

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