• The Journal of Korean Institute of Communications and Information Sciences
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• v.39C no.10
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• pp.896-908
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• 2014

The electrical medical device market have been expanded since the public interest in healthy living that has deepened together with the global health trend of the aging population. The external hand-held ultrasonic probe is a frequently approved medical device and it is commonly used in the clinical field. However, there is no obvious standard or a guideline in Korea on regarding evaluation of performance of such external hand-held ultrasonic probe for approval and quality management. In this study, local and foreign reference standards were reviewed to propose performance test standards and methods after conducting characteristic of probe, market, and permission status. In addition, such proposed test items were validated to develop a draft guideline that is internationally harmonized for performance evaluation. This study is expected not only improve the quality and performance of the external hand-held ultrasonic probe but also contribute to securing consistency of permission and evaluation works for approval.

• Journal of the Korea Organic Resources Recycling Association
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• v.26 no.2
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• pp.95-103
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• 2018

As a guideline for desulfurization and dehumidification pretreatment facility for optimizing utilization of biogas, the $H_2S$ concentration is set at 150 % which can be treated with iron salts, dehumidification is the optimum value for generator operation, and the relative humidity applied at the utilization of biogas in EU is set at 60 %. We have set up the generator facility guidelines to optimize utilization of biogas. The appropriate amount of biogas should be at least 90 % of the total gas generation, and the capacity of generator facility should be set at 20~30 %. In order to equalize the pressure of the incoming gas the generator, a gas equalization tank should be installed and the generator room average temperature should be kept at $45^{\circ}C$ or less. Since the gas is not produced at a certain methane concentration in the digester, the efficiency is lowered. Therefore, it is required to install an air fuel ratio control system according to the change in methane concentration. Therefore, it is necessary to compensate for the disadvantages of biogasification facilities of organic waste resources and optimize utilization of biogas and improve operation of facilities. This study was conducted to optimize biogas utilization of type of organic waste(containing sewage sludge and food waste, animal manure), investigate the facilities problem and propose design, operation guidelines such as pre-treatment facilities and generators.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• Journal of the Korea Organic Resources Recycling Association
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• v.27 no.1
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• pp.77-85
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• 2019

Biogasification is a technology that uses organic wastes to reproduce as environmental fuels containing methane gas. Biogasification has attracted worldwide attention because it can produce renewable-energy and stable land treatment with prohibit from landfilling and ocean dumping of organic waste. Biomethane is produced by refining biogas. It is injected into natural gas pipeline or used transportation fuel such as cars and buses. 90 bio-gasification facilities are operating in 2016, and methane gas production is very low due to it is limited to organic wastes such as food waste, animal manure, and sewage sludge. There are seven domestic biomethane manufacturing facilities, and the use of high value-added such as transport fuels and city-gas through upgrading biogas should be expanded. On the other hand, the rapid biogasification of organic wastes in domestic resulted in frequent breakdowns of facilities and low efficiency problems. Therefore, the problem is improving as technical guidance, design and operational technical guidance is developed and field experience is accumulated. However, while improvements in biogas production are being made, there is a problem with low utilization. In this study, the problems of biomethane manufacturing facilities were identified in order to optimize the production and utilization of biogas from organic waste resources. Also, in order to present the design and operation guideline of the gas pretreatment and the upgrading process, we will investigate precision monitoring, energy balance and economic analysis and solutions for on-site problems by facility.

• YAKHAK HOEJI
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• v.55 no.2
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• pp.131-137
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• 2011

The dissolution test method and an analytical procedure by HPLC were developed and validated for dobesilate calcium tablets and acepifylline tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for dobesilate calcium tablets was carried out under sink conditions as following: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for acepifylline tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of dobesilate calcium tablets and acepifylline tablets.

• The Korean Journal of Food And Nutrition
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• v.21 no.4
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• pp.536-544
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• 2008

The principal objectives of this study were to identify diet problems associated with dining out, and to suggest dining out strategies for groups with diet problems. The data collected from adults(all over 20 years old) from the third Korea National Health and Nutrition Examination Survey III(KNHANES III), conducted in 2005, were used in this study. A total of 6,497 data were included in our statistical analyses, using SPSS 14.0. The results of this study demonstrated that there were significant differences in dining out frequency between different genders(p<0.001), ages(p<0.001), and economic status (p<0.001). With the crosstabulation analysis using the Chi-square statistics, the middle class males aged $20{\sim}29$(p<0.05), and lower class females aged 65 and over evidenced different degrees of compliance with the following guidelines. 'Eat a variety of foods' varied by frequency of dining out. In addition, the degree of compliance with the guidelines 'Increase activity and eat an adequate amount of foods for weight control', 'Enjoy the Korean traditional diet', and 'Control consumption of alcohol' also differed by dining out frequency in certain populations. With these results, dining out strategies were suggested for the groups with diet problems associated with dining out.

• Journal of Nutrition and Health
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• v.32 no.6
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• pp.713-725
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• 1999

Women have a greater incidence of coronary heart disease(CHD) after menopause. It relates to hormone imbalance-induced changes in known CHD risk factors, especially hyperlipidemia. Accordingly, once women are diagnosed, the rate of morbidity and mortality is greater than for men. Thus, preventive strategies are critical to improve the quality oflife in the later years for women. The purpose of ths study was to explore the difference of anthropometric, environmental factors and food behaviors between normocholesterolemia and hypercholesterolemia within postmenopausal women. The subjects were classified as normocholesterolemia and hypercholesterolemia based on the Guideline for Korean Hyperlipidemia. The results obtained are summarized as follows. The distributions of general characteristics such as age, family income, occupation status, age at menarche, and menopausal period were not significantly different between the normocholesterolemia group and hypercholesterolemia group. The anthropometric factors such as body mass index(BMI) and waist hip ratio(WHR) were not significantly different between the normocholesteroemia group and the hypercholesterolemia group but odds ratio of hypercholesterolemia group was higher than that of normocholesterolemia but not significant. Aerobic activity more than 1hours/day was significantly related to low serum cholesterol concentration. Eating behaviors related to regular meal time, regular breakfast habit, and slow meal speed were related to low serum cholesterol concentration. Eating the chicken without skin was significantly related to low serum cholesterol concentration. Our data indicate that desirable eating habit, aerobic activity more than 1hr/day are important factors of serum cholesterol concentrations in postmenopausal women. The result of this study provide information that is important in designing appropriate dietary guidelines for hypercholesterolemia in postmenopausal women.

• Journal of Pharmaceutical Investigation
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• v.39 no.2
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• pp.127-131
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• 2009

Hydrogels for medical devices such as hydrophilic dressing, moisturizing healing band, hydrophilic intravenous catheter and soft contact lens were evaluated for their cytotoxicity according to the International Organization for Standardization (ISO) procedures. To test indirect cytotoxicity of hydrogel products, dissolution medium and dissolution condition were selected based on the guideline for medical devices. Cytotoxicity was low in all the case of hydrogel products. Soft contact lens showed no significant difference in dissolution between complete medium and saline. Currently, there is no specific guidelineto test hydrogel for medical devices in Korea with consideration of characteristics of hydrogel. Thus, proper method of cytotoxicity evaluation should be selected depending on the characteristics and usages of hydrogels for medical devices.

• Journal of the Korean Dietetic Association
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• v.7 no.4
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• pp.373-384
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• 2001

The purpose of this study was to compare with in fatty acid intakes between hypercholesterolemia group and normocholesterolemia group, aged between 30 to 65 years old in women. The subjects were classified as hypercholesterolemia group and normocholesterolemia group based on The Guideline for Korean Hyperlipidemia. Dietary intakes of fatty acids were by means of a 24-hr recall method with food models and measuring tools. We analyzed both data sets together using analysis of variance the chi-square test and student's t-test(SPSS for WINDOWS, version 7.5). Significance was defied as a P value <0.05. The results obtained are summarized as follows. Mean age, BMI and percentage of postmenopausal women in hypercholesterolemia group were significantly higher than those of normocholesterolemia group. Percent of total energy from fat in hypercholesterolemia group tended to be higher than that in normocholesterolemia group. C16:0(Palmitic acid) and saturated fatty acids(SFA) intake of hypercholesterolemia group was significantly higher than that of normocholesterolemia group. Therefore, women who suffered from hypercholesterolemia were recommended to control body weight and consume foods containing low SFA and cholesterol.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.22 no.1
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• pp.33-44
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• 2018

Objectives This study aimed to perform a cross-cultural translation of 5 kinds of pattern identification questionnaires from Korean to English: questionnaires for seven emotions, fatigue and malaise, phlegm, food retention, and blood stasis. Methods We followed the strict guideline on the cross-cultural translation of healthcare evaluation tool. Total five stages of study were conducted. First, translations of two individual translators. Second, synthesizing of the two results. Third, two back translations from synthesized version to Korean. Fourth, expert committee reviewed with the original version, synthesized version, back translated versions to make a pre-final version. Last, with the pre-final version, 5 Americans evaluated face validity of the pre-final version. We made a final version after the above-mentioned 5 stages. Result and conclusion International versions of the 5 kinds of pattern identification questionnaires were completed. We can expect this versions are widly used for clinical usage and following academical researches.