• 한국환경농학회지
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• 제40권2호
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• pp.127-133
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• 2021

BACKGROUND: Dithiocarbamte fungicides have been used in crop cultivation for diseases protection and treatment. And cultivated agricultrual products were used as feedstuff, and residual pesticides are likely to be absorbed and transferred to livestock. But the maximum residue limits (MRLs) were not established for dithiocarbate fungicides in livestock products, and thus an analysis method was developed and validated for dithiocarbamate fungicides to establish MRLs. METHODS AND RESULTS: Samples were prepared using CS₂ trap method and detected with UV/VIS spectrophotometer. Calibration line (0.1 ~ 10 ㎍/mL) was linear with r² > 0.99. For validation, the recovery tests were carried out at three fortification levels (MLOQ, 10 MLOQ and 50 MLOQ) from livestock samples (egg, milk, beef, pork, and chicken). The results for mancozeb, propineb, and thiram ranged between 76.8 to 109.6%, 79.4 to 108.8%, and 80.2 to 107.8%, respectively and % RSD (relative standard deviation) values were below 9.5%. Furthermore, inter-laboratory analysis was performed to validate the method. CONCLUSION: All values were corresponded with the criteria ranges requested by both the CODEX (CAC/GL 40-1993, 2003) and MFDS guidelines (2016). This might be used as an official analytical method for determination of dithiocarbamate fungicides at established MRLs and monitoring.

• 대한기관윤리심의기구협의회지
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• 제3권2호
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• pp.28-36
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• 2021

Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

• 한국식품영양학회지
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• 제32권4호
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• pp.379-384
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• 2019

This study was to investigate the sorbic acid, benzoic acid and sulfur dioxide in commonly consumed beverages, snacks and instant ramens in Korea. A total of 150 food samples including 50 beverages, 50 snacks and 50 instant ramens were examined using the Korea Food Code method. Sorbic and benzoic acid were analyzed by the HPLC method, whereas sulfur dioxide was measured by Monnier-Williams method. Our results indicated that benzoic acid was detected in six beverages samples, and its concentration was in the range of 3.08-11.94 mg/kg. The contents of both sorbic and benzoic acid in 50 beverage samples did not exceed the residue allowance standards set by the Ministry of Food and Drug Safety (MFDS). Sulfur dioxide was detected in 12 beverages samples, but its content was lower than the detection limit specified in the method by the Korea Food Code. On the other hand, sorbic acid was not detected all samples. These results provide a basic data regarding sorbic acid, benzoic acid and sulfur dioxide in commonly consumed beverages, snacks and instant ramens in Korea.

• 한국정보통신학회논문지
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• 제23권3호
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• pp.276-281
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• 2019

푸드 프린터는 반드시 식품의약품안전처의 허가를 받은 식용 잉크 카트리지를 사용해야한다. 잉크 카트리지의 정품 여부를 판독하기 위해 2D 바코드를 사용하는데 색소가 열압력에 의해 발산하여 인쇄가 되기 때문에 바코드에 오염이 발생한다. 본 논문에서는 라떼 아트 프린터에서 식용 색소 분진에 의한 정품 인증 바코드의 오염 문제를 해결하고자 다양한 모폴로지 연산에 기반한 전처리(pre-processing) 알고리즘을 제안하였다. 오염된 바코드 이미지들을 QR코드 리더기로 인식시키기 전에 본 알고리즘을 적용하면 기존의 리더기 대비 인식이 가능한 오염도가 25%에서 40%로 증가함을 알 수 있었으며 45%의 오염도에서도 50%의 확률로 인식이 되는 것을 확인하였다.

• Toxicological Research
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• 제35권2호
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• pp.119-129
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• 2019

As the use of cosmetics has greatly increased in a daily life, safety issues with cosmetic ingredients have drawn an attention. Drometrizole [2-(2'-hydroxy-5'-methylphenyl)benzotriazole] is categorized as a sunscreen ingredient and is used in cosmetics and non-cosmetics as a UV light absorber. No significant toxicity has been observed in acute oral, inhalation, or dermal toxicity studies. In a 13-week oral toxicity study in beagle dogs, No observed adverse effect level (NOAEL) was determined as 31.75 mg/kg bw/day in males and 34.6 mg/kg bw/day in females, based on increased serum alanine aminotransferase activity. Although drometrizole was negative for skin sensitization in two Magnusson-Kligman maximization tests in guinea pigs, there were two case reports of consumers presenting with allergic contact dermatitis. Drometrizole showed no teratogenicity in reproductive and developmental toxicity studies in which rats and mice were treated for 6 to 15 days of the gestation period. Ames tests showed that drometrizole was not mutagenic. A long-term carcinogenicity study using mice and rats showed no significant carcinogenic effect. A nail product containing 0.03% drometrizole was nonirritating, non-sensitizing and non-photosensitizing in a test with 147 human subjects. For risk assessment, the NOAEL chosen was 31.75 mg/kg bw/day in a 13-week oral toxicity study. Systemic exposure dosages were 0.27228 mg/kg bw/day and 1.90598 mg/kg bw/day for 1% and 7% drometrizole in cosmetics, respectively. Risk characterization studies demonstrated that when cosmetic products contain 1.0% of drometrizole, the margin of safety was greater than 100. Based on the risk assessment data, the MFDS revised the regulatory concentration of drometrizole from 7% to 1% in 2015. Under current regulation, drometrizole is considered to be safe for use in cosmetics. If new toxicological data are obtained in the future, the risk assessment should be carried out to update the appropriate guidelines.

• 한국군사과학기술학회지
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• 제24권3호
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• pp.348-355
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• 2021

Hantaan virus(HTNV) causes hemorrhagic fever with renal syndrome(HFRS) with a case fatality rate ranging from <1 to 15 % in human. Hantavax^Ⓡ is a vaccine against the Hantavirus, which has been conditionally approved by the Ministry of Food and Drug Safety(MFDS). However, only 50 % of volunteers had neutralizing antibodies 1 year following the boost. Effective antiviral treatments against HTNV infection are limited. Hantaviruses generally cause asymptomatic infection in adult mice. On the other hand, infection of suckling and newborn mice with hantaviruses causes lethal neurological diesease or persistant infection, which is different from the disease in humans. The development of vaccines and antiviral strategies for HTNV has been partly hampered by the lack of an efficient lethal mouse model to evaluate the efficacy of the candidate vaccines or antivirals. In this report, we established a lethal mouse model for HTNV, which may facilitate in vivo studies on the evaluation of candidate drugs against HTNV. The median lethal dose value of HTNV was calculated by probit analysis of deaths occurring within two weeks. Five groups of ten ICR mice were injected intracranially with serial 2-fold dilutions (from 50 to 3.125 PFU/head) of HTNV. Mice injected with HTNV began to die at 8 days post-infection. The lethal dose required to kill 50 % of the mice (LD₅₀) was calculated to be 2.365 PFU/head.

• Journal of Microbiology and Biotechnology
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• 제31권11호
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• pp.1552-1558
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• 2021

The diverse microbial communities in kimchi are dependent on fermentation period and temperature. Here, we investigated the effect of enterotoxigenic Escherichia coli (ETEC) during the fermentation of kimchi at two temperatures using high-throughput sequencing. There were no differences in pH between the control group, samples not inoculated with ETEC, and the ETEC group, samples inoculated with ETEC MFDS 1009477. The pH of the two groups, which were fermented at 10 and 25℃, decreased rapidly at the beginning of fermentation and then reached pH 3.96 and pH 3.62. In both groups, the genera Lactobacillus, Leuconostoc, and Weissella were predominant. Our result suggests that microbial communities during kimchi fermentation may be affected by the fermentation parameters, such as temperature and period, and not enterotoxigenic E. coli (ETEC).

• 대한방사선기술학회지:방사선기술과학
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• 제45권2호
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• pp.127-134
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• 2022

In order to overcome the image quality limitations of the conventional C-arm, a flat panel detector (FPD) is used to enhance spatial resolution, detective quantum efficiency, frame rate, and dynamic range. Three-dimensional (3D) visualized information can be obtained from C-arm computed tomography (CT) equipped with an FPD, which can reduce patient discomfort and provide various medical information to health care providers by conducting procedures in the interventional procedure room without moving the patient to the CT scan room. Unlike a conventional C-arm device, a C-arm CT requires different basic safety and essential performance evaluation criteria; therefore, in this study, basic safety and essential performance evaluation criteria to protect patients, medical staff, and radiologists were derived based on International Electrotechnical Commission (IEC) standards, the Ministry of Food and Drug Safety (MFDS) standards in Korea, and the rules on the installation and operation of special medical equipment in Korea. As a result of the study, six basic safety evaluation criteria related to electrical and mechanical radiation safety (leakage current, collision protection, emergency stopping device, overheating, recovery management, and ingress of water or particulate matter into medical electrical (ME) equipment and ME systems: footswitches) and 14 essential performance evaluation criteria (accuracy of tube voltage, accuracy of tube current, accuracy of loading time, accuracy of current time product, reproducibility of radiation output, linearity and consistency in radiography, half layer value in X-ray equipment, focal size and collimator, relationship between X-ray field and image reception area, consistency of light irradiation versus X-ray irradiation, performance of the mechanical device, focal spot to skin distance accuracy, image quality evaluation, and technical characteristic of cone-beam computed tomography) were selected for a total of 20 criteria.

• 한국산업보건학회지
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• 제32권1호
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• pp.53-63
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• 2022

Objectives: This study was designed to evaluate the filtration efficiency, inhalation resistance, and liquid resistance of commercial reusable masks in comparison to the performance of KF-AD masks (reference masks). Methods: Thirty-six masks were purchased from an online market. Filtration efficiency and inhalation resistance were determined in the same manner as in MFDS certification testing, respectively using TIL/IL & Filter Test 1300S (SFP Services, UK) and Breathing Resistance Analyzer DA2001 (Lambda Ray, South Korea). Results: Most of the filtration efficiencies found for the 19 masks were far lower than the test standard for KF-certified masks. Four masks met KF94 and three masks even met KF80. Most inhalation resistances were also much lower than the standard, with many almost one-half of the standard. In addition, all the masks except KF-AD masks did not pass the liquid resistance test. Conclusions: Although most of the filtration efficiency performance results found in this study for the reusable masks, which emerged as an alternative, were lower than the standard for health masks, multi-use masks can be used with a replacement filter inserted.

• Mass Spectrometry Letters
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• 제13권3호
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• pp.58-83
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• 2022

We developed analytical methods using high performance chromatography (HPLC) and liquid chromatography tandem mass spectrometry (LC-MS/MS) for the simultaneous determination of 80 unapproved compounds in dietary supplements. The target compounds for analysis were unapproved ingredients (e.g., pharmaceuticals) that have potential adverse effects on consumers owing to accidental misuse, overuse, and interaction with other medication in dietary supplement. Two analytical methods were tested to identify the optimal validation results according to AOAC guideline. As a result, limit of quantification (LOQ) was 0.14-0.5 ㎍ mL^-1; linearity (r²) was ≥ 0.99; accuracy (expressed as recovery) was 78.9-114%; precision (relative standard deviation) was ≤ 4.28% in the HPLC method. In the LC-MS/MS method, LOQ was 0.01-2 ng mL^-1, linearity (r²) was ≥0.98, accuracy was 71.7-119%; precision was ≤ 12.5%. The developed methods were applied to 51 dietary supplements collected from 2019 to 2021 through MFDS alert system. Based on our previous monitoring study, major compounds were icariin, sibutramine, yohimbine, sildenafil, tadalafil, sennosides (A, B), cascarosides (A, B, C, D), and phenolphthalein. In this study, we re-analyzed samples of detected compounds, and evaluated the statistical difference using Bland-Altman analysis to compare two analytical approaches between HPLC and LC-MS/MS. These results showed a good agreement between two methods that can be used to monitor the unapproved ingredients in dietary supplements. The developed two methods are complementarily suitable for monitoring the adulteration of 80 unapproved compounds in dietary supplements.