• Journal of Animal Science and Technology
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• v.54 no.1
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• pp.59-63
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• 2012

Bovine serum contains various nutrients and growth factors that can be potentially used in biological experiments, drug manufacturing process and food industry. However, almost all the bovine blood has been wasted during slaughter process in Korea, thus there is a high demand for alternative uses of the wasted sera. In order to produce high quality and safe sera, it is necessary to screen zoonotic pathogens as well as other microbial contaminants to prevent any downstream contamination. The present research has been undertaken to assess biological safety of Hanwoo sera by determining microbiological contamination during slaughtering and handling processes. Serological tests have been performed to detect bacteria, mycoplasma and virus contamination in total of 52 Hanwoo sera. No sera were found to be contaminated with mycoplasma or virus, but only two sera were found to be contaminated with Bacillus thuringiensis. The present result shows that Hanwoo sera obtained from slaughtering process are biologically safe and have potentials to be developed as a biological reagent. Moreover, the methods employed in our study may provide basic standard for microbiological screening methods once wasted Hanwoo sera gain industrial values.

• Journal of Radiation Protection and Research
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• v.30 no.4
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• pp.175-183
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• 2005

Dose distribution of Korean radiation workers classified by occupational categories was analyzed. Statistics of the occupational radiation exposure(ORE) in 2002 of the radiation workers in diagnostic and dental radiology were obtained from the Korea Food and Drug Agency(KFDA) who maintains the database for individual radiation dose records. Corresponding statistics for the rest of radiation workers were obtained by processing the individual annual doses provided by the Korea Radioisotope Association(KRIA) after deletion of individual information. The ORE distribution was classified in term of 28 occupational categories, annual individual dose levels, age groups and gender of 52733 radiation workers as of the year of 2002. The total collective dose was 66.4 man-Sv and resulting average individual ORE was 1.26 mSv. Around 80% of the workers were exposed to minimal doses less than 1.2 mSv. However, it appeared that the recorded doses exceeded 20 mSv for 43 workers in the industrial radiography and for 147 workers in the field of radiology. Particularly, recorded doses of 23 workers in radiology exceeded the annual dose limits of 50 mSv, which is extraordinary when the working environment is considered. It is uncertain whether those doses are real or caused by careless placing of dosimeters in the imaging rooms while the X-ray units are in operation. No one in the workforce of 16 operating nuclear power plant units was exposed over 20 mSv in 2002. Number of workers was the largest in their 30's of age and the mean individual dose was the highest in their 20's. Women were around 20% of the radiation workers and their average dose was around one half of that of man workers.

• Korean Journal of Microbiology
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• v.55 no.2
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• pp.143-148
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• 2019

The synthesis of captopril as an important chiral drug in commerce needs expensive resolution process of racemic mixture. Microorganisms, producing a thermostable esterase that catalyzes the stereo-selective hydrolysis of methyl DL-${\beta}$-acetylthioisobutyrate (DL-ester) to D-${\beta}$-acetylthioisobutyric acid (DAT) were screened from soils. Among the strains tested, strain No CJ-317 and strain No CJ-187 with highest activity were selected as the best DAT producer. The newly isolated microorganisms were identified respectively, as Klebsiella pneumoniae and Pseudomonas putida. The cell activity of esterase from K. pneumoniae CJ-317 and P. putida CJ-187 were showed an optimal reaction activity at $75^{\circ}C$ and $60^{\circ}C$, respectively. Also the cell activity of K. pneumoniae CJ-317 was stable up to $80^{\circ}C$ for 1 h, while that of P. putida CJ-187 was not over $60^{\circ}C$. By varying the concentration of DAT in the reaction mixture, the cell activity of P. putida CJ-187 showed about 55% and 80% of product inhibition in the presence of 2.5% (w/v) and 5.0% of DAT respectively. K. pneumoniae CJ-317 had less product inhibition than P. putida CJ-187 by about 35% and 44% at the same concentrations respectively. The esterase of newly isolated K. pneumoniae CJ-317 could be useful for the stereo-selective hydrolysis of DL-ester to DAT.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• Korean Journal of Clinical Laboratory Science
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• v.54 no.1
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• pp.23-27
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• 2022

Disposable wet wipes provided by general restaurants in the Jeju Special Self-Governing Province were evaluated for compliance with the labeling requirements and the degree of bacterial contamination set by the Ministry of Food and Drug Safety. Of the 32 types of disposable wipes, five types of disposable wipes did not indicate the name and location of the business office of the manufacturer. Only 12 types of wet wipes were marked with the date of manufacture and expiration date. Bacterial contamination was seen in 9 types of wet wipes through bacterial culture but these were absent in the remaining 23 types (71.9%). The results of the antimicrobial susceptibility test for the 9 identified strains showed no methicillin-resistant coagulase-negative staphylococci (MRCNS) or multidrug-resistant bacteria. Through this study, it is recommended that the date of manufacture and expiration date must be indicated on the surface of disposable wet wipes designated as hygiene products, and clean uncontaminated wet wipes must comply with storage standards. In addition, the results are expected to contribute to the enhancement and improvement of hygiene management supervision, personal hygiene management, and an improvement in national health.

• The Korean Journal of Rehabilitation Nursing
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• v.5 no.1
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• pp.7-17
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• 2002

The purpose of this study was to investigate the effect of taping therapy on activities of daily livings (ADL), hand function and range of motion in poststroke-hemiplegic patients. Sample were selected from 20 poststroke-hemiplegic patients at public health center in the period from September 5 to November 21, 2001. The research design was one group pretest-posttest design. The hemiplegia period of the participants was from one year to five years. The pretest and posttest included measuring activity of daily livings(ADL), instrumental activity of daily livings(IADL), hand function, range of motion, quality of life. In this research design, a treatment were to expose taping therapy who were received self-help management program. This self-help management program was composed of five sessions and each session had health education on stroke, diet, risk factor, ROM exercise and recreation. 20 patients were treated with kinesio taping(Nippon Sigmax Co., Ltd., Benefact(r), width 50mm). Tapes were applied to the Deltoid, Supraspinatus, Infraspinatus, Brachioradialis with paralyzed upper extremity. The taping therapy was performed once a week for 5 weeks. SPSS Win 8.0 was used for the data analysis. The results of this study were as follows: 1) The score of BADL was increased from 30.5 to 33.95 after program, and that was statistically significant(p=.019). 2) The score of IADL was increased from 11.6 to 12.75 after program, but that was statistically insignificant(p=.161). 3) The score of hand function was increased from 17 to 20.35 after program, and that was statistically significant(p=.026). 4) The shoulder's ROM(p=.000) and wrist's ROM(p= .004) were significantly increased. According to the results of this study, taping therapy is effective for improving ADL, hand function, ROM, quality of life. However, this study found no significant differences in IADL. Consequently, these findings showed that the taping therapy was effective in improvement of physical aspects(BADL, hand function, upper extremity's ROM) in poststroke-hemiplegic patients.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.42 no.1
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• pp.65-73
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• 2016

Korea Food and Drug Administration (KFDA) has officially announced 2,4-dinitrophenylhydrazine (DNPH) derivatization - high performance liquid chromatography (HPLC) methods for analysis of formaldehyde. This study was conducted to develop a convenient derivatization method for cosmetics by improving complex pre-treatment procedures included in KFDA method. To simplify pre-treatment procedures of KFDA method, reaction conditions including pH, time and temperature were optimized. This pre-treatment method does not require complicate pre-treatment steps of KFDA method such as pH adjustment of test solution with acetate buffer (pH 5.0), solvent-solvent partitioning with dichloromethane and concentrating procedure with vacuum evaporator. Formaldehyde-dinitrophenylhydrazone (formaldehyde-DNP) product produced by derivatization reaction was separated and quantified with a reversed-phase HPLC, which was slightly modified with KFDA method. The linearity test showed good results with 0.9999 of correlation coefficient ($r^2$) in the range of 2 ~ 40 ppm of standard solutions. In this method, limit of detection (LOD) and limit of quantitation (LOQ) values for formaldehyde were 0.2 ppm and 0.5 ppm, respectively. In addition, recovery test demonstrated that the method was also accurate and reproducible. Therefore, the proposed method can be applicable to rapid analysis of formaldehyde in cosmetics.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.15
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• pp.6275-6281
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• 2014

Nasal-type extranodal natural killer (NK)/T-cell lymphoma (ENKL) is a highly invasive cancer with a poor prognosis. More effective and safer treatment regimens for ENKL are needed. Pegaspargase (PEG-Asp) has a similar mechanism of action to L-asparaginase (L-Asp), but presents lower antigenicity. The aim of the present research was to evaluate the safety profile and the latent efficacy of a PEG-Asp-based treatment regimen in patients with ENKL. Data collected from 20 patients with histologically confirmed ENKL, admitted to the Third Affiliated Hospital of Sun Yat-Sen University from January 2009 to August 2013, were included in the study. All patients received $2500IU/m^2$/IM PEG-Asp on day 1 of every 21-day treatment cycle. Patients received combination chemotherapy with CHOP (n=5), EPOCH (n=7), GEMOX (n=7) or CHOP with bleomycin (n=1). After 2-5 treatment cycles (median, 4 cycles) of PEG-Asp-based chemotherapy, five patients (25%) showed a complete response (CR), and the overall response rate (ORR) was 60%. Grade 3/4 neutropenia occurred in fourteen patients (70%). Grade 3 alanine aminotransferase (ALT) elevation was observed in two. Grade 1-2 non-hematological toxicity consisted of activated partial thromboplastin time (APTT) elongation (n=9), hypofibrinogenemia (n=6), hypoproteinemia (n=17), hyperglycemia (n=3), and nausea (n=6). No allergic reactions were detected. No treatment related death was reported. Our results suggested that PEG-Asp-based chemotherapy presented an acceptable tolerance and a potential short-term outcome in patients with nasal-type ENKL.

• The Journal of the Korea Contents Association
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• v.15 no.6
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• pp.290-296
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• 2015

The purpose of this study was to derive the proposals and to suggest the exposure dose reduction scheme on pediatric head CT scan by analyzing and comparing CT dose index (CTDI) and the national diagnostic reference levels. From January 2014 to December, 231 children under 10years who were requested a pediatric head CT scan with head injury were examined. Research methods were to research and analyze the general characteristics kVp, mA test coverage $CTDI_{vol}$ and DLP referring to dose reports and electronic medical record (EMR). As a result, 7.4%(17 patients) of the total subjects in $CTDI_{vol}$ showed a national diagnostic reference levels exceeding. For DLP 41.6%(96 patients) in excess was relatively higher than $CTDI_{vol}$. DLP was exceeded more than about 60% that is higher than the CT dose index presented by Korea Food & Drug Administration. it is cause of high DLP that scan range increased more than about 30% wider than the standard test coverage presented in Health Insurance Review & Assessment Service. In conclusion, it is able to significantly lower the dose if it is complied with checking the baseline scan range of pediatric head CT scan and appropriately adjusting the protocol.

• The Journal of the Acoustical Society of Korea
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• v.39 no.4
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• pp.303-317
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• 2020

Extracorporeal Shock Wave Therapy (ESWT) is an innovative treatment in chronic musculoskeletal pain management and cardiovascular diseases. In this study, we surveyed the acoustic shock wave outputs from the domestically used focal type ESWT devices. The survey data were collected through 30 technical documents registered to the Ministry of Food and Drug Safety (MFDS), Rep. Korea. The results show that the focusing geometry varies largely, 5 mm to 65 mm in the focal length, 3 mm to 30 mm in focal width, and 4 mm to 108 mm in focal depth. The maximum positive pressure (P+) ranges from 7 MPa to 280 MPa, the focal Energy Flux Density (EFD) from 0.0035 mJ/㎟ to 35 mJ/㎟, and the energy per pulse (E) from 0.737 mJ to 80.86 mJ. All domestic PE-type (five) and one EM-type domestic devices included in the analysis of the correlation between P+ and EFD are shown to be far beyond the usual ranges and do not comply with expected correlation so that the reliability of their data was suspected. For the suspected, post-performance tests are required by a recognized testing agency. MFDS guidelines need to be revised so that the pass criteria for the shock wave acoustic outputs can be based on the clinical tests for indications.