• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.239-247
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• 2013

Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

• The Journal of Korean Medicine
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• v.24 no.3
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• pp.45-50
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• 2003

Background and Purpose : Chunghyul-dan has been widely used in the Department of Cardiovascular ＆ Neurologic Diseases, Kyung Hee Oriental Medical Center to prevent stroke by lowering serum cholesterol level. Previous experimental and clinical studies revealed that Chunghyul-dan had therapeutic effects on hyperlipidemia by inhibiting HMG-CoA reductase and pancreatic lipase. It was also reported that Chunghyul-dan showed an anti-oxidation effect by scavenging free radicals and inhibiting nitric oxide synthesis. Therefore, we examined the safety of Chunghyul-dan on all subjects who had been treated with it. Methods : We performed a retrospective study by reviewing the medical records of those who had been administrated Chunghyul-dan at Kyung Hee Oriental Medical Center from February 8,2001 to December 31,2002. The subjects' general characteristics (gender, age, medical history, and present illness), recorded adverse effects, and the results of laboratory findings were obtained and analyzed to assess the clinical safety of Chunghyul-dan. Results : Six hundred fifty six subjects were treated with Chunghyul-dan. Clinical adverse effects appeared in 13 subjects, the major symptom being indigestion (8 subjects). The apparent frequency of adverse effects was much lower than that in previous reports on the safety of certain medications. On investigation of laboratory findings, we could not find any hepatic or renal toxicity. Conclusion : We suggest that our results contribute towards confirming the safety of Chunghyul-dan by offering clinical evidence.

• Korean Journal of Radiology
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• v.21 no.1
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• pp.42-57
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• 2020

Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• Journal of the Korean Applied Science and Technology
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• v.38 no.1
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• pp.88-98
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• 2021

This study was conducted to identify the factors affecting the self-confidence in performing patient safety management in nursing students. As a result of the analysis, 7.0 points in knowledge of patient safety management, 3.86 points in attitude of patient safety management, 3.47 points in clinical decision making ability, and 4.15 points in self-confidence in performing patient safety management. Self-confidence in performing patient safety management was positively correlated with knowledge of patient safety management(r=.216, p<.01) and attitude of patient safety management(r=.375, p<.01), clinical decision making ability(r=.467, p<.01). The self-confidence in performing patient safety management was influenced by clinical decision making ability(β=.409, p<.001) and attitude of patient safety management(β=.198, p=.011), explanatory power was 26.3%.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.22-24
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• 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)

• Advances in Traditional Medicine
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• v.8 no.2
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• pp.103-110
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• 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.

• The Journal of Korean Academic Society of Nursing Education
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• v.20 no.1
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• pp.5-14
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• 2014

Purpose: The purpose of this study was to determine undergraduate students' level of knowledge, attitude, and confidence toward patient safety. Methods: A descriptive survey design was used. The subjects consisted of 932 senior nursing students who have had clinical practice in nursing schools in a metropolitan city in Korea. The data were collected from March 4th to 28th in 2011. Knowledge, attitude, and confidence on patient safety were measured using self administered questionnaires. Data were analyzed with SPSS 18.0 using descriptive statistics, t-test, One-Way ANOVA, and Pearson correlation coefficient. Results: Knowledge of patient safety was relatively low and attitude and confidence were at moderate level. There were statistically significant differences in knowledge, attitude, and confidence toward patient safety according to gender, educational system, grades, satisfaction with nursing major or clinical practice, and experience of patient safety education or patient safety campaign. There was a significant positive correlation among knowledge, attitude and confidence on patient safety. Conclusion: The study findings suggests that concept and skills on patient safety need to be educated systematically during undergraduate curriculum linked with clinical practicum.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.35-41
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• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

• Journal of the Korea Safety Management & Science
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• v.19 no.4
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• pp.125-132
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• 2017

The purpose of this study was to assess the correlation between attitude of Patient Safety Management(PSM) and practice of PSM and clinical practice satisfaction of nursing students, also identified how these factors attitude and practice of PSM influence on clinical practice satisfaction, eventually aimed to develop education programs to strengthen practice of PSM in nursing students. A descriptive design was used in the study. The multiple regression was used for the study to prove the factors how the attitude and practice of PSM were affected to the clinical practice satisfaction. The study subjects were 226 nursing students. The results show that attitude of PSM mean was 3.71, practice of PSM mean 3.97, the clinical practice satisfaction mean 3.31. Among the general characteristics, clinical practice satisfaction showed significant differences in satisfaction of major(F=5.10, p=.001), the existence of role model(t=2.64, p=.009). Significant positive correlation was found between attitude of PSM, practice of PSM and the clinical practice satisfaction. Practice of PSM(${\beta}=.39$) was shown as the most important factor to affect on the Satisfaction on clinical practice, also the explanation power of value for this study was found 41.1%. Consequently, this study indicates to develop the education program to strengthen practice of PSM. Also process the additional study for the nursing students in other areas.