• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• The Journal of Korean Medicine
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• v.43 no.3
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• pp.150-163
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• 2022

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• Toxicological Research
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• v.17 no.3
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• pp.203-213
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• 2001

We investigated the toxic effects of propylthiouracil (PTU) In Sprague-Dawley (SD) rats to develop and validate an enhanced Protocol for Test Guideline 407 as OECD Project. Twenty male and female SD rats,7 weeks old, were treated with PTU in corn oil at levels of 0, 0.1, 1 and 10 mg/kg/day for 4 weeks orally. Clinical observation, body weight changes, food uptake, water consumption, urinalysis, estrus cycle and sperm analysis, serum chemist교, autopsy findings and histopathological findings were evaluated in this study. No clinical signs and mortality were observed in the study. The body weights and food uptakes in the group treated with 10 mg/kg/day were reduced from 3 weeks after the initiation of the treatment. The levels of 3,5,3'-triiodothyronine (T3) and thyroxine (T4, 3,5,3',5'-tetraiodothyrosine) were also significantly decreased in the group treated with 10 mg/kg/day. Also, the relative and absolute organ weights of thymuses were decreased. Thyroid glands of rats in the group treated with PTU 10 mg/kg/day were bigger than those of rats in the control group. In the histopathological examination, diffuse hyperplasia and hypertrophy of thyroid follicular cells were observed in all treatment groups, leading to the reduction of lumen size and papillary enfolding of lining epithelium. The degree of lesion was increased in a dose-dependent manner. The results suggested that PTU would cause toxicity in thyroid gland and decrease the levels of T3 and T4 in SD rats. However there were no effects on the other organ including testis and uterus especially in spermatogenesis and estrus cycle. On the basis of the results, enhanced protocol for Test Guideline (TG) 407 may be sensitive and reliable to detect endocrine-active substances like PTU.

• 한국환경농학회:학술대회논문집
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• 2009.07a
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• pp.344-344
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• 2009

• Journal of Food Hygiene and Safety
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• v.22 no.4
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• pp.338-345
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• 2007

This study surveyed on the actual conditions of using sanitizers and disinfectants for improvements of sanitization on food utensils at 105 school and 20 industry foodservice operations. The questionnaire which was administered to 125 foodservices was used as a mail or visitation method. The answers of asking "Perception on temporary authorization system of sanitizers and disinfectants on food utensils" were 75% in contract managed school foodservices, 81.8% in self operated school foodservices, and 50% in industry. Main factors to choose sanitizers were sterilizing power (38.6%, 28.6%, 38.9%) and safety (32.6%, 46.1%, 33.3%) at every foodservices. Keeping ratio of sanitizers and disinfectants guidelines in contract managed school, self operated school and industry foodservices were 64.8%, 52% and 73.7%, respectively. If easy and practical guideline is developed, most foodservices replied to use if for disinfection of foodservices. Most of the foodservices were not only knowing sanitizers and disinfectants but also possessing a guideline. However, they didn't perform disinfection according to the guideline due to its complexity. Consequently, we suggest that it is necessary to provide an easy and practical "sanitizers and disinfectants guideline" and useful information.

• Culinary science and hospitality research
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• v.22 no.1
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• pp.141-152
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• 2016

Recently, not only development of curriculum associated directly with job, the development of new education model is in great need. So, the purpose of this study is to develop the instructional design guideline utilizing goal-based scenario(GBS) for college students who major in culinary arts. First, to achieve this goal, we recognized the 7 core elements(learning goal, mission, cover story, role activity, scenario operating, resource, feedback) composing GBS through literature review and case study. Second, we drew a conclusion about the problem and guideline for traditional culinary practice course by conducting inspection about culinary practice environment and needs with professors who are teaching culinary arts. Third, we applied the instructional design guideline for culinary practice to regular classes according to GBS's factors, and then we did formative evaluation with content experts and educational technology expert. Finally, we designed the final instructional design guideline for culinary practice by modifying early model reflected the result of formative evaluation. The results of this study are as following. First, when we applied GBS to culinary practice, professors have to focus on process of materialization by developing easy scenario to students. Also, they have to prepare the class circumstance to feel about sense of realism in advance. Second, to give a conjugally new skill at working, professors's effort is important. culinary practice education at college has responsibility to carry out the vocational training that has competitiveness and difference with labor market's needs. Therefore, it is necessary for us to develop the teaching and learning model for culinary practice which is suitable for major based on the manpower demand for industry without causing job mismatch from demand for industry.

• Journal of radiological science and technology
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• v.39 no.2
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• pp.263-271
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• 2016

The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

• Journal of Pharmaceutical Investigation
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• v.35 no.6
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• pp.471-481
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• 2005

In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

• The Korean Journal of Food And Nutrition
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• v.27 no.4
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• pp.660-672
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• 2014

The purpose of this study was to evaluate dietary habit and nutritional status by household income in female adults, using data from the $4^{th}$ Korea National Health and Nutrition Examination Survey (2007~2009). Subjects were 8,356 women over the age of 20 years. The subjects were classified into 4 groups by household income level. Dietary data from 24 hr recall methods were used to analyze nutritional status. The obesity rate of the low income group was significantly higher than the rates of other income groups. Additionally, the nutritional status of the low income group was worse than those of other groups. The percentage of carbohydrate in total energy intake was higher and food security status was lower in the low income group than in other groups. Awareness and adherence to dietary guidelines were also lower in the low income group. Adherence to a dietary guideline of 'avoiding salty foods and trying to eat foods with bland taste' and 'eating a variety of foods from each food group' were lower than those of other groups. However, the frequency of skipping breakfast among the low income group was lower than that of others. Therefore, this study suggested that low income women should decrease the percentage of carbohydrate in total energy intake and adhere to dietary guidelines, especially those of avoiding salty foods and eating a variety of food groups, in order to improve their nutritional status.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.529-540
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• 2004

After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.