• Title/Summary/Keyword: clinical efficacy

Search Result 3,347, Processing Time 0.031 seconds

Current Status and Strategies of the Efficacy and Safety Evaluation in Drug Approval Process

  • Park, In-Sook;Park, Chang-Won
    • Proceedings of the PSK Conference
    • /
    • 2003.10a
    • /
    • pp.22-24
    • /
    • 2003
  • This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

  • PDF

Evidence-based herbal medicine in efficacy and safety assessments

  • Park, Jin-Han
    • Advances in Traditional Medicine
    • /
    • v.8 no.2
    • /
    • pp.103-110
    • /
    • 2008
  • Herbal medicine is the use of medicinal plants for prevention and treatment of diseases: it ranges from traditional and popular medicines of every country to the use of standardized and tritated herbal extracts. Generally cultural rootedness enduring and widespread use in a traditional medical system may indicate safety, but also efficacy of treatments, especially in herbal medicine where tradition is almost completely based on remedies containing active principles at very low and ultra low concentrations or relying on magical-energetic principles. The efficacy and safety assessments of medicines, whether modern or herbal, invariably encounter challenges or problems during the course of pre-clinical and clinical research. Some of the challenges in evidence-based herbal medicinal research are unique, and the researcher must be cognizant of them in order to safeguard the quality of the data obtained. Key challenges are: the quality of raw materials; appropriateness of biological/pharmacological activity assessment methodology, and data interpretation; standardization methodology; pharmacokinetics and bioavailability of active constituents and metabolites; clinical dosage formulation/production; and clinical study designs and outcome measures.

Influences of Job Stress, Coping, Self-efficacy on Burnout of Clinical Nurses (임상간호사의 소진에 직무스트레스, 대처, 자기효능감이 미치는 영향)

  • Lee, Ji-Won
    • Journal of Fisheries and Marine Sciences Education
    • /
    • v.26 no.5
    • /
    • pp.1003-1012
    • /
    • 2014
  • The purpose of this study was to understand the clinical nurses' burnout, job stress, coping, self-efficacy and to identify the factors that influence on burnout. A quantitative, descriptive design was used to study 140 clinical nurses in B and U city, recruited from June to July, 2012. The data were analyzed SPSS 20.0 program using descriptive statistics, t-test, ANOVA, Pearson correlation coefficients and stepwise multiple regression. The mean score for burnout was 2.28 points(range: 1-4). Burnout was significantly correlated with job stress, coping and self-efficacy. These variables accounted for 37.4% of burnout. Based on the results, the sorts of strategies to reduce the burnout are required by offering job stress, coping and self-efficacy management.

Efficacy of Terbinafine in Guinea Pigs Experimentally Infected with Microsporum gypseum Isolated from Naturally Infected Dog II. Clinical and Mycological Efficacy (자연감염된 개에서 분리한 Microsporum gypseum을 인공감염시킨 기니픽에서 Terbinafine의 효과 II. 임상적 ald 진균학적 효과)

  • 임채형;이창우
    • Journal of Veterinary Clinics
    • /
    • v.17 no.1
    • /
    • pp.6-12
    • /
    • 2000
  • 알비노 기니픽의 피부에 Microsporum gypseum을 접종한 후 체중 kg당 20, 40 및 80mg의 terbinafine을 접종 당일부터 9일간 연속 투여하였다. 대조군의 피부는 인설과 가피를 동반한 현저한 염증이 발생되었다. 이와 대조적으로 terbinafine을 경구투여한 처치군에서는 피부 증상이 현저하게 차도를 보였다. 진균학적인 평가를 위해 모근침범시험을 실시 하였다. 체중 kg 당 20∼80mg의 terbinafine을 경구투여한 처치군은 진균학적으로 97∼100%의 치료효과를 나타냈으며, 대주군에서는 치료효과가 전혀 없었다.

  • PDF

Factors Affecting Clinical Practicum Stress of Nursing Students: Using the Lazarus and Folkman's Stress-Coping Model (간호대학생의 임상실습 스트레스 영향요인에 관한 경로분석: Lazarus와 Folkman의 스트레스-대처 모델 기반으로)

  • Kim, Sung Hae;Lee, JuHee;Jang, MiRa
    • Journal of Korean Academy of Nursing
    • /
    • v.49 no.4
    • /
    • pp.437-448
    • /
    • 2019
  • Purpose: This study was conducted to test a path model for the factors related to undergraduate nursing students' clinical practicum stress, based on Lazarus and Folkman's stress-coping model. Methods: This study utilized a path analysis design. A total of 235 undergraduate nursing students participated in this study. The variables in the hypothetical path model consisted of clinical practicum, emotional intelligence, self-efficacy, Nun-chi, and nursing professionalism. We tested the fit of the hypothetical path model using SPSS/WIN 23.0 and AMOS 22.0. Results: The final model fit demonstrated a satisfactory statistical acceptance level: goodness-of-fit-index=.98, adjusted goodness-of-fit-index=.91, comparative fit index=.98, normed fit index=.95, Tucker-Lewis index=.92, and root mean square error of approximation=.06. Self-efficacy (${\beta}=-.22$, p=.003) and Nun-chi behavior (${\beta}=-.17$, p=.024) were reported as significant factors affecting clinical practicum stress, explaining 10.2% of the variance. Nursing professionalism (${\beta}=.20$, p=.006) and self-efficacy (${\beta}=.45$, p<.001) had direct effects on emotional intelligence, explaining 45.9% of the variance. Self-efficacy had indirect effects on Nun-chi understanding (${\beta}=.20$, p<.001) and Nun-chi behavior (${\beta}=.09$, p=.005) through emotional intelligence. Nursing professionalism had indirect effects on Nun-chi understanding (${\beta}=.09$, p=.005) and Nun-chi behavior (${\beta}=.09$, p=.005) through emotional intelligence. The variables for self-efficacy and nursing professionalism explained 29.1% of the Nun-chi understanding and 18.2% of the Nun-chi behavior, respectively. Conclusion: In undergraduate nursing education, it is important to identify and manage factors that affect clinical practicum stress. The findings of this study emphasize the importance of Nun-chi, self-efficacy, emotional intelligence, and nursing professionalism in the development of an educational strategy for undergraduate nursing students.

Impact of Role Conflict, Self-efficacy, and Resilience on Nursing Task Performance of Emergency Department Nurses (응급실 간호사의 역할갈등, 자기효능감, 회복탄력성이 간호업무 수행능력에 미치는 영향)

  • Jo, Mi Jeong;Sung, Mi-Hae
    • Korean Journal of Occupational Health Nursing
    • /
    • v.27 no.1
    • /
    • pp.59-66
    • /
    • 2018
  • Purpose: This study aimed to identify the effect of role conflict, self-efficacy, and resilience on the nursing task performance of emergency department (ED) nurses. Methods: Data were collected from 140 ED nurses working in 6 general hospitals, using self-reporting questionnaires. Data were analyzed using SPSS 23.0, and the analyses included descriptive statistics, a t-test, an ANOVA, the Pearson's correlation coefficient test, and a stepwise multiple regression. Results: Nursing task performance differed significantly in terms of the following general characteristics of the participants: age, marital status, total clinical experience, clinical experience in the ED, and position at the hospital. Nursing task performance was positively correlated with role conflict, self-efficacy, and resilience. Self-efficacy, role conflict, clinical experience in the ED, and resilience were significant predictors of nursing performance, and they accounted for 36.9% of the variance. Conclusion: Self-efficacy was identified as the most significant factor affecting the nursing task performance of ED nurses. Therefore, it is necessary to develop programs to improve the self-efficacy of ED nurses.

The Effects of Structured Self-Debriefing Using on the Clinical Competency, Self-Efficacy, and Educational Satisfaction in Nursing Students after Simulation (시뮬레이션 후 구조화된 자가 디브리핑이 간호대학생의 임상수행능력, 자기효능감 및 교육 만족도에 미치는 효과)

  • Ha, Eun-Ho;Song, Hyo-Suk
    • The Journal of Korean Academic Society of Nursing Education
    • /
    • v.21 no.4
    • /
    • pp.445-454
    • /
    • 2015
  • Purpose: The purpose of this study was to identify the effects of structured self-debriefing using 3S models on the clinical competency, self-efficacy, and educational satisfaction in nursing students after simulation. Methods: For this study, 76 third-year undergraduate nursing students from S university were invited. They were divided into two groups, which consisted of a self-debriefing (SDG=41) group and an instructor-led debriefing group (ILDG=35). Collected data was analyzed using Chi-square, t-test, and an independent t-test with the PASW statistics 18.0 for Windows Program. Results: Clinical competency was generally high in the SDG, and statistically significant differences between the SDG and the ILDG occurred after simulations 3, 4, and 5. There were no statistically significant differences in self-efficacy and educational satisfaction between the SDG and the ILDG. However, educational satisfaction in the SDG was slightly higher, while self-efficacy was low compared to the ILDG. Conclusion: The results indicate that the method of structured self-debriefing using a 3S model can be effective in improving clinical competency. Further studies need to be investigated.

Effects of Emotional Labor, Nursing Organizational Culture on Self-efficacy in Clinical Nurses (임상간호사의 감정노동과 간호조직문화가 자아효능감에 미치는 영향)

  • Kwon, Myoung-Jin;Kim, Keum-Sook;Ahn, Sung-Yun
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.15 no.4
    • /
    • pp.2225-2234
    • /
    • 2014
  • The objective of this study was to the effects of emotional labor and nursing organizational culture on the self-efficacy among clinical nurses. The subjects of this study were the clinical nurses working at 6 general hospitals in C & D city. The self-reported questionnaires were administered to 475 clinical nurses. The levels of self-efficacy, nursing organizational culture and emotional labor of the subjects were revealed moderate to high. Self-efficacy and emotional labor, emotional labor and nursing organizational culture showed a negative correlation, Self-efficacy and nursing organizational culture showed a positive correlation. Nursing organizational culture affects the self-efficacy that is significant explanatory variables, of which variables are in general education, job satisfaction, and employee turnover experience. The findings suggested that Nurses' self-efficacy for managing environmental management programs with interventions seem to be necessary.

Awareness of Disabled Person and Analysis of Factors Related to the Awareness among Nursing Students (간호학생의 장애인에 대한 인식과 영향요인)

  • Mo, Jin-A
    • The Korean Journal of Rehabilitation Nursing
    • /
    • v.14 no.1
    • /
    • pp.32-38
    • /
    • 2011
  • Purpose: The purpose of this study was to investigate the level of awareness toward disabled persons among nursing students and to identify associating factors for their awareness of disabled persons. Method: 410 nursing students completed the survey on the awareness and frequency of contacts toward disabled persons, self-efficacy, and clinical practice satisfaction. Results: The scores in awareness, contact, clinical practice satisfaction was $50.53{\pm}7.53$, $52.41{\pm}10.61$, $79.21{\pm}10.88$ and $67.04{\pm}9.47$, respectively, indicating. Awareness of disabled persons had significant positive correlations with frequency of contact (p<.001), satisfaction with nursing major (p=.045), satisfaction with clinical practice (p<.001) and self-efficacy (p=.029). Conclusion: To improve awareness of disability, we need to improve student's satisfaction with nursing major and clinical practice by modifying the curriculum. Thereby awareness toward disabled and the weak can improve naturally.

A Review of Anticancer Efficacy Outcome Measures in Clinical Trials of Herbal Medicine for Cancer Patients (한약을 사용한 암환자 대상 임상시험에서의 항암 효능 평가변수 고찰)

  • Chunhoo Cheon;Min Jun Kang;Wonbin Shin;;Hyunsuk Park;Unho Yang;Unseog Yeo
    • Journal of Society of Preventive Korean Medicine
    • /
    • v.28 no.1
    • /
    • pp.119-130
    • /
    • 2024
  • Objectives : The objective of this review is to examine the variety of evaluation parameters utilized in clinical trials that assess the anticancer efficacy of herbal medicine, focusing on the importance of including both symptomatic management and direct anticancer effectiveness. Methods : A detailed literature review was conducted across PubMed, Embase, and the Cochrane Library to identify clinical trials investigating the antitumor efficacy of herbal medicine. The search was performed on February 22, 2024. This review specifically examined the employed outcome measures, which were then categorized and analyzed to understand their relevance and application in evaluating the anticancer properties of herbal medicine. Results : From an initial search of 900 records, 15 clinical trials were selected for in-depth analysis after deduplication and screening. These studies evaluated the efficacy of herbal medicine across various cancers, including hepatocellular carcinoma, colorectal cancer, and breast cancer, using outcome measures such as survival rates, disease control rates, and quality of life improvements. The research spanned multiple countries, primarily in East Asia and the United States, reflecting a global interest in herbal medicine as a complementary approach to cancer treatment. The present study demonstrated that herbal medicine, especially when used alongside standard treatments, potentially improved clinical outcomes and patient well-being. Conclusions : The findings of this review highlight the need for a broader focus on the full range of therapeutic capabilities of herbal medicine, including its direct anticancer effects, in the management of cancer patients. Future oncology research involving herbal medicine should integrate a wide spectrum of clinical endpoints to fully ascertain its impact on cancer treatment and patient health.