• Journal of Biomedical Engineering Research
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• v.31 no.6
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• pp.434-437
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• 2010

For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

• Journal of the Korean Society of Food Culture
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• v.25 no.6
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• pp.734-745
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• 2010

"Sikui-simgam ("食醫心鑑", Book for Alimentotherapist)" written by Jameun, a doctor of Tang (唐) in the 9th century, propagated alimentotherapy in Korea, China, and Japan for a long time. In this study, Sikui-simgam medical theories were studied and the medicinal ingredients and types of food therapy were analyzed to understand alimentotherapy characteristics. "Sikui-simgam" is the first food therapy formulary diverged from herbal therapy forms. Various ingredients from "Sikui-simgam" show the food culture of the Tang age and report much about cooking and cultural history. Many prescriptions in the books are the origins of present-day food culture; thus, they are important clues to understand the present food culture. This book also describes actual prescriptions in detail. Various types of prescriptions with different ingredients are unique characteristics of food therapy and show the various possibilities for food therapy prescriptions. The food therapy prescriptions of "Sikui-simgam" were designed for medical specialists, as the book contains doses and incompatibilities for food therapy. Such food therapy prescriptions were used to treat diseases, so they were used with strict standards.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.123-128
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• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

• Journal of the Korean Society of Food Culture
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• v.25 no.4
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• pp.357-365
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• 2010

The study surveyed care giver's perceptions of baby food and evaluated the quantitative and qualitative aspects of Korean websites related to the baby food for atopic dermatitis infants. Sources of care giver information about baby food were the internet (93%), clinics (57%), television (52%), oriental clinics (37%), and neighbors (6%). The five most commonly-used internet search engines (Daum, Google, Nate, Naver and Yahoo) were searched using the terms "atopic dermatitis", "weaning food" and "baby food". The searched websites included oriental medical clinics (38.8%), online merchant companies (13.4%), corporations (13.4%), medical clinics (11.9%), related associations (11.9%), public health centers (4.4%) and personal sites (4.4%). Website food and nutrition information included medical information about baby food for atopic dermatitis (92.6%), baby food for atopic dermatitis (67.6%), related community (58.8%), product information (32.4%) and baby food preparation for atopic dermatitis (23.5%). Qualitative evaluation was conducted based on the American Library Association website checklist; Website operator and information sources were provided for 62.7% and 38.8% of the websites, respectively. The purpose of a website was more explicitly stated in medical clinic sites than nonmedical sites. Only 24.2% of websites had a title that appropriately reflected the site's purpose. The majority (92.5%) of the sites were easy to read and understand. Information was judged to be sufficient in 65% of the medical sites and 74.1% of non-medical sites. A feedback menu and search function were enabled in 85.1% and 28.4% of the sites, respectively. The mean score for quality grade was 14.64 (range 9-19). In conclusion, in order to improve the information of baby food for atopic dermatitis infants in websites, accurate information by experts and continuing monitoring are highly required.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.4
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• pp.2407-2412
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• 2013

Background and Objectives: Data on associations between soy food intake after cancer diagnosis with breast cancer survival are conflicting, so we conducted this meta-analysis for more accurate evaluation. Methods: Comprehensive searches were conducted to find cohort studies of the relationship between soy food intake after cancer diagnosis and breast cancer survival. Data were analyzed with comprehensive meta-analysis software. Results: Five cohort studies (11,206 patients) were included. Pooling all comparisons, soy food intake after diagnosis was associated with reduced mortality (HR 0.85, 95%CI 0.77 0.93) and recurrence (HR 0.79, 95%CI 0.72 0.87). Pooling the comparisons of highest vs. lowest dose, soy food intake after diagnosis was again associated with reduced mortality (HR 0.84, 95%CI 0.71 0.99) and recurrence (HR 0.74, 95%CI 0.64 0.85). Subgroup analysis of ER status showed that soy food intake was associated with reduced mortality in both ER negative (highest vs. lowest: HR 0.75, 95%CI 0.64 0.88) and ER positive patients (highest vs. lowest: HR 0.72, 95%CI 0.61 0.84), and both premenopausal (highest vs. lowest: HR 0.78, 95%CI 0.69 0.88) and postmenopausal patients (highest vs. lowest: HR 0.81, 95%CI 0.73 0.91). In additioin, soy food intake was associated with reduced recurrence in ER negative (highest vs. lowest: HR 0.64, 95%CI 0.44 0.94) and ER+/PR+ (highest vs. lowest: HR 0.65, 95%CI 0.49 0.86), and postmenopausal patients (highest vs. lowest: HR 0.67, 95%CI 0.56 0.80). Conclusion: Our meta-analysis showed that soy food intake might be associated with better survival, especially for ER negative, ER+/PR+, and postmenopausal patients.

• Nutritional Sciences
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• v.8 no.4
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• pp.231-236
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• 2005

This study investigated the changes in the neuronal nitric oxide synthase (nNOS) and nicotinamide adenine dinucleotide phosphate-diaphorase (NADPH-d) activities during food restriction in the rat brain such as cerebral cortex, cerebellum, caudate pautamen and hypothalamus. The rats were placed on a restricted feeding schedule consisting of half the ad libitum quantity for 3 days and 1, 2, 4, 6 and 9 weeks, and a free feeding schedule for 4 weeks. The loss of body weight peaked after 1 week of food restriction and persisted during the entire 9-week period of food restriction. The dramatic weight change in the first week ($12\%$) and the reduction in weight changes thereafter suggest that major adaptation changes occur early and body maintenance occurs subsequently. In the hypothalamus, the optical densities of the NADPH-d and nNOS immunoreactivities were found to be significantly higher in the 1-week and lower in the 9-week food restricted group than in the ad libitum fed control rats. In contrast, in the cerebral cortex, the optical densities of the NADPH-d- and nNOS-positive neurons were not changed significantly during the period of food restriction. This study provides the morphological evidence showing that food restriction has a significant effect on the nitric oxide synthesizing system of the hypothalamus.

• 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 Society of Food Science and Nutrition
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• v.25 no.3
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• pp.415-422
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• 1996

This study was conducted to evaluate the necessity of clinical nutrition education in the medical school curriculum. One hundred and eighty five medical school students, residents, nurses, and forty undergraduate students majoring in food science and nutrition were involved in this study. The survey included questions about nutritional knowledge, necessity of nutrition counseling, necessity of clinical nutrition and nutritional attitudes. The nutritional knowledge scores of the subjects in medical school and residents were significantly lower than those of the students majoring in food science and nutrition. Subjects of 91.3% strongly agreed to the necessity of nutrition counseling for patients ; 78.9% agreed that the present nutrition education in medical schools was inadequate. Most subjects (94.1%) agreed that clinical nutrition was an important field in the treatment of diseases. The medical profession is facing the challenges of the 1990s with the shift to outpatient care and preventative services. Clinical nutrition is an essential element in the process of curriculum change. The nutrition educator will be expected to take a leading role in integrating clinical nutrition into medical school curriculum.

• Journal of Ginseng Research
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• v.40 no.3
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• pp.300-303
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• 2016

The result of USRG-12 indicated that ultrasonication-processed ($100^{\circ}C$, 12 h) red ginseng extracts had the highest amount of ginsenosides Rg3 (0.803%), Rg5 (0.167%), and Rk1 (0.175%).

• Natural Product Sciences
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• v.21 no.2
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• pp.93-97
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• 2015

The purpose of this study was to develop a new ginseng (Panax ginseng) flower buds extract with the high concentration of ginsenoside Rg3, Rg5, Rk1, Rh1 and F4, the Red ginseng special component. Chemical transformation from the ginseng saponin glycosides to the prosapogenin was analyzed by the HPLC. The ginseng flower buds were processed at the several treatment conditions of the ultrasonication (Oscillator 600W, Vibrator 600W) and vinegar (about 14% acidity). The result of UVGFB-480 was the butanol fraction of ginseng flower buds that had been processed with ultrasonication and vinegar for 480 minutes gained the highest amount of ginsenoside Rg5 (3.548%), Rh1 (2.037%), Rk1 (1.821%), Rg3 (1.580%) and F4 (1.535%). The ginsenoside Rg5 of UVGFB-480 was found to contain 14.3 times as high as ginseng flower buds extracts (GFB, 0.249%).