• YAKHAK HOEJI
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• v.53 no.3
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• pp.107-113
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• 2009

Since 2006, the Computerized Restricted Antibiotic Control Program (CRACP) has been incorporated to facilitate a more efficient approval process of vancomycin use at the Chonbuk National University Hospital. The purposes of the study were to evaluate proper use of vancomycin and to examine if there is any improvement when administering the CRACP. The use of vancomycin was retrospectively reviewed by a medical record review based on the American Society of Hospital Pharmacists (ASHP) criteria (i.e., indication, use of critical process indicators and use of outcome measurements) and compared before (Group I) and after the CRACP (Group II). Two hundred fifty six patient records were evaluated (138 in Group I and 118 in Group II). There was a statistically significant improvement in the report of justification for vancomycin use after CRACP (42.0% vs. 62.7%, p=0.001). Out of eight critical process indicators, two indicators (appropriate cultures prior to medication [68.8% vs. 85.6%, p=0.002] and serum vancomycin level measurement [0% vs. 7.6%, p=0.001]) were significantly improved after CRACP. The total incidence of adverse effects was decreased from 14.5% to 6.8%. In addition, there was a statistically significant difference in WBC count reduction within normal range (52.8% vs. 73.1%, p=0.024). The CRACP appears to be a promising approach to improve use of vacomycin in a hospital setting. However, further evaluation for the long-term period should be performed to confirm the performance of the program.

• The Journal of the Korean dental association
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• v.48 no.4
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• pp.256-262
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• 2010

bone grafting is indicated in the case of bony defects and is classified into autograft, allograft, and xenograft. Synthetic bone graft is contrasted with these three categories in that it has a different donor source. Autograft is most prominent as it is known as a gold standard of all grafting procedures. Its principles and practices are well established via accumulated informations and clinical experiences, which imposes no regulations or restrictions in its clinical use. On the other hand, other bone graft procedures are under tight control for the safety and effectiveness of each product. Food and Drug Administration of the United States has a system in which the information on the approvals and clearances of bone graft materials on their internet homepage. All the bone graft materials that are under the regulations of the United States are classified into the category of medical devices, which includes allogenic bone, xenogenic bone, and synthetic bone graft materials. Each bone graft material has its own indication and the FDA approvals and clearances of medical devices contain the item of "intended use" to specify the indications of each bone graft materials. US dentists, as users of the specific bone graft materials, are provided with adequate information on the approved materials they are to utilize. As an user of these materials, Korean dentists are less provided with the information on the bone graft materials they want to use. Medical providers of the bone graft materials have to be able to provide their users with the essential information such as the intended use of the regulatory approval. Dentists must also be active in gathering informations on the material of their interest, and the system must be built in which both of the medical providers and users of bone graft materials can be satisfied in providing and getting the information, respectively.

• Journal of Ginseng Research
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• v.29 no.4
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• pp.206-214
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• 2005

The health function food law has been carried into effect from January 31, 2004 just after the proposal of 'a draft of a proposed law concerning the health function foods for the promotion of a nation health' on November 29, 2000 in Korea. After enforcement of health functional food law, there have been difficult market penetration with overall stagnancy of business activities and the current of health functional food within the country divided two groups. In standardized health functional foods the present condition, nutrition supplementary products (938 items) and red ginseng products (351 items) are prevalent and total 32 products are registered containing lactobacilli (297 items), glucosamine (295 items), ginseng (182 items), yeast(136 items) so on. In 2005, five products (products containing green tea extract, soybean protein, plant sterol, fructooligo sugar and Monascus sp. products are newly notified and raw material or component of total 21 products containing xylitol, teanin extract, sardine peptide are recognized as individual authorized health functional foods. Efficacies of ginseng are studied in many-sided researches but benefits of the ginseng in the health functional food law limited to 3 items (staminaresume, immune enhancement, nourishment robustness). To enlarge functionalities of ginseng it needs raw material and ingredient approval through data application to Korea Food and Drug Administration and this procedure acts as barrier of the functional food development in the ginseng industry. It is necessary to develop the authorized health functional foods for leading health functional food market in the future.

• 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.

• Clinical and Experimental Vaccine Research
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• v.12 no.3
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• pp.179-192
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• 2023

The world has watched the emergence of numerous animal viruses that may threaten animal health which were added to the perpetual growing list of animal pathogens. This emergence drew the attention of the experts and animal health groups to the fact that it has become necessary to work on vaccine development. The current review aims to explore the perspective vaccines for emerging viral diseases in farm animals. This aim was fulfilled by focusing on modern technologies as well as next generation vaccines that have been introduced in the field of vaccines, either in clinical developments pending approval, or have already come to light and have been applied to animals with acceptable results such as viral-vectored vaccines, virus-like particles, and messenger RNA-based platforms. Besides, it shed the light on the importance of differentiation of infected from vaccinated animals technology in eradication programs of emerging viral diseases. The new science of nanomaterials was explored to elucidate its role in vaccinology. Finally, the role of Bioinformatics or Vaccinomics and its assist in vaccine designing and developments were discussed. The reviewing of the published manuscripts concluded that the use of conventional vaccines is considered an out-of-date approach in eliminating emerging diseases. However, these types of vaccines are considered the suitable plan especially in countries with few resources and capabilities. Piloted vaccines that rely on genetic-based technologies with continuous analyses of current viruses should be the aim of future vaccinology. Smart genomics of emerging viruses will be the gateway to choosing appropriate vaccines, regardless of the evolutionary rates of viruses.

• Dementia and Neurocognitive Disorders
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• v.21 no.2
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• pp.45-58
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• 2022

Recently, aducanumab, a beta amyloid targeted immunotherapy, has been approved by the US Food and Drug Administration for the treatment of Alzheimer's dementia (AD). Although many questions need to be answered, this approval provides a promising hope for the development of AD drugs that could be supported by new biomarkers such as blood-based ones and composite neuropsychological tests that can confirm pathologic changes in early stages of AD. It is important to elucidate the complexity of AD which is known to be associated with other factors such as vascular etiologies and neuro-inflammation. Through the second international conference of the Korean Dementia Association (KDA), researchers from all over the world have participated in the exchange of opinions with KDA members on the most up-to-date topics. The Academic Committee of the KDA summarizes lectures to provide the depth of the conference as well as discussions. This will be an important milestone to widen the latest knowledge in the research of AD's diagnosis, therapeutics, pathogenesis that can lead to the establishment of future directions.

• Asian-Australasian Journal of Animal Sciences
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• v.14 no.3
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• pp.402-413
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• 2001

Food safety is a term broadly applied to food quality that may adversely affect human health. These include zoonotic diseases and acute and chronic effects of ingesting natural and human-made xenobiotics. There are two major areas of concern over the presence of residues of antibiotics in animal-derived foodstuffs with regard to human health. The first is allergic reactions. Some antibiotics, such as penicillins can evoke allergic reactions even though small amounts of them are ingested or exposed by parenteral routes. The second is development of antibiotic resistance in gut bacteria of human. Recently multi-resistant pneumococcal, glycopeptide-resistant enterococci and gram negative bacteria with extended-spectrum $\beta$-lactamases have spread all over the world, and are now a serious therapeutic problem in human. Although it is evident that drugs are required in the efficient production of meat, milk and eggs, their indiscriminate use should never be substituted for hygienic management of farm. Drug should be used only when they are required. In addition to veterinary drugs, environmental contaminants that were contaminated in feed, water and air can make residues in animal products. Mycotoxins, heavy metals, pesticides, herbicides and other chemicals derived from industries can be harmful both to animal and human health. Most of organic contaminants, such as dioxin, PCBs and DDT, and metals are persistent in environment and biological organisms and can be accumulated in fat and hard tissues. Some of them are suspected to have endocrine disrupting, carcinogenic, teratogenic, immunodepressive and nervous effects. The governmental agencies concerned make efforts to prevent residue problems; approval of drugs including withdrawal times of each preparation of drugs, establishment of tolerances, guidelines regarding drug use and sanitation enforcement of livestock products. National residue program is conducted to audit the status of the chemical residues in foods. Recently HACCP has been introduced to promote food safety from farm to table by reducing hazardous biological, chemical and physical factors. Animal Production Food Safety Program, Quality Assurance Programs, Food Animal Residue Avoidance Databank are para- or non-governmental activities ensuring food safety. This topic will cover classification and usage or sources of chemical residues, their adverse effects, and chemical residue status of some countries. Issues are expanded to residue detection methodologies, toxicological and pharmacokinetic backgrounds of MRL and withdrawal time establishments, and the importance of non-governmental activities with regard to reducing chemical residues in food.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.3
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• pp.137-146
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• 2020

Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.29 no.2 s.43
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• pp.67-77
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• 2003

Two categories of cosmetic products, cosmetics and quasi-drugs, have been established by the Ministry of Health, Labor and Welfare (MHLW) in Japan. Japanese pharmaceutical law has defined that products categorized as cosmetics do not exhibit any effects on human skin. In fact, cosmetic products are not permitted to claim any efficacy. On the other hand, products in the quasi-drug category can claim several efficacies such as anti-inflammatory effects, whitening/lightning effects, hair growth effects and so on. Unfortunately, the Japanese MHLW has not yet approved the efficacy of anti-aging/anti-wrinkle effects as a claim point. However, the population is aging, and the demand for anti-aging/anti-wrinkle products is increasing year by year. Japanese cosmetic companies have proposed to the MHLW that anti-aging/anti-wrinkle agents be approved as a claim concept of a quasi-drug. However, unified evaluation methods for anti-aging/anti-wrinkle effects have not been established. Currently, each company evaluates the efficacy of products/materials using their own original methods. Thus, to request approval of the MHLW, the establishment of a unified evaluation method is needed. Consequently, the Japan Cosmetic Industry Association (JCIA) has established a task force to develop guidelines for evaluating anti-wrinkle effects in 1998. In conclusion, the JCIA would like to adopt visual and image analysis scales to evaluate the anti-wrinkle effects objectively. Generally, wrinkles are roughly classified into three groups as fine wrinkles, linear deep wrinkles and crow's feet. However, academic societies of dermatology or cosmetics have not yet established a definition of wrinkles in Japan. Thus, in advance of setting up an evaluation method, the definition of wrinkles f3r evaluation must be decided. Wrinkles are defined by the task force of the JCIA as follows; furrows that people can recognize visually and that appear on the forehead, the corners of the eyes and the backs of the neck with aging. In addition, furrows are emphasized by exposure to solar light and by dry conditions. Visual evaluation is the most sensitive method and can be applied to most types of wrinkles. However, visual evaluation is hard to express digitally as results. Besides, in the case of image analysis, comparisons of data obtained from distinct examinations can not be done, because data from image analysis are relative values. Thus, to enhance the reliability of the evaluations, the adoption of an objective scale was required. The principle of the evaluation method is to analyze images taken from silicone replicas of wrinkle areas using several parameters, such as the proportion of the wrinkle $area({\%})$, the mean depth of the wrinkles (mm), the mean depth of the deepest wrinkle (m) and the deepest point on the deepest wrinkle. Lights are shown on the skin replica from an orthogonal direction of the main orientation of the wrinkle, and the resulting shadow images are quantified by the image analysis method. To increase the precision of the data or to allow comparisons of independent examinations, a scale with furrows of several depths, 200, 400, 600, 800, and $1000{\mu}m$, is adapted in the evaluation system. I will explain the guidelines established by the JCIA in the presentation.

• Microbiology and Biotechnology Letters
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• v.42 no.1
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• pp.1-10
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• 2014

Most microorganisms have been used for foods for such a long period of time with no question posed for their safety. However, the progress of food processing technology has activated international food trades, and the consumers and authorities of import countries have come to question the safety of microorganisms used in foods. At present, the most widely known safety standards are Generally Recognized as Safe (GRAS) status from the US Food and Drug Administration (FDA) and Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). GRAS status is not for the safety of microorganisms themselves but for the permissibility of strains or cultures in specific food uses. QPS provides a qualified generic approval to a defined taxonomic unit. The increase of commercialized traditional fermented foods in Korea has spurred the starter development for traditional food fermentations. However, starter development in Korea has been carried out based on the technological properties of microorganisms with no research on developing a standardized tool for safety assessment. In the globalization of traditional Korean fermented foods, technological properties as well as safety of future starters should be guaranteed, and establishment of the safety assessment regulation for microorganisms used for foods is necessary.