• Journal of the Institute of Electronics Engineers of Korea SC
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• v.49 no.2
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• pp.55-62
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• 2012

Convergence of information technology (IT) and medical devices enables people to measure health-related information ubiquitously, such as measuring blood glucose at home and checking cardiac signals during exercise and it allows us to access to medical care anywhere and anytime. Nowadays, the market for U-healthcare medical devices is growing rapidly, but guidelines for the evaluation of safety and effectiveness of such devices remain to be formulated. We performed a study on the development of safety and performance evaluation method for portable, hand-held, U-healthcare medical devices. We reviewed current guidelines and standards for home-health devices from the Korea Food and Drug Administration (KFDA) and related international committees such as the ISO/IEEE and CE. We summarized the test methods and items for the evaluation of safety and performance related to U-healthcare medical devices from the above guidelines and standards. We defined requirements for a U-healthcare medical device to demonstrate good performance. In conclusion, we propose an evaluation method for U-healthcare medical devices, which will help improve the safety and reliability of these devices.

• Korean Journal of Environmental Agriculture
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• v.28 no.3
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• pp.281-288
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• 2009

The strobilurin fungicides, azoxystrobin and kresoxim-methyl, were investigated to know the biological half-lives and dissipation patterns in Korean melon under plastic film house condition. Used pesticides for field application were 20% azoxystrobin of suspension concentrate and 47% kresoxim-methyl of water dispersible granule. Two pesticides were sprayed at recommended and double dose rate. Pesticide residues in Korean melon were analyzed until 14 days after application. The azoxystrobin was analyzed by HPLC equipped with UV detector after cleanup with florisil glass column. Initial residue concentrations of azoxystrobin in Korean melon at recommended and double dose rate were 0.09 mg/kg and 0.14 mg/kg, respectively. Those were less than 0.2 mg/kg maximum residue limit of Korean melon established by KFDA. The biological half-lives of azoxystrobin in Korean melon were 4.7 days at recommended dose rate and 7.8 days at double dose rate. Initial concentrations of kresoxim-methyl which was analyzed by GLC-ECD in Korean melon at recommended and double dose rate were 0.10 mg/kg and 0.23 mg/kg, respectively. Those were less than 1.0 mg/kg, MRL. The biological half-lives of kresoxim-methyl in Korean melon were 4.1 days at recommended dose rate and 4.8 days at double dose rate. The residue amounts of both pesticide was lower than MRL and biological half-lives were not so long. Because the weight of Korean melon under plastic film house condition was fast increased during cultivation.

• Journal of Food Hygiene and Safety
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• v.19 no.2
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• pp.84-96
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• 2004

This study aims at developing an easily-applicable Sanitation Standard Operating Procedure(SSOP) program for Fresh raw-fish manufacturing. It compares the sanitation inspection results of SSOP-program-applied procedure and non-applied procedure. The samplings for bacteriological examination were collected from the touching surface of food and from the personal workers. The sanitation status was recorded in the check-up list. The results were statistically analyzed to ascertain the efficiency of the SSOP program. The present official KFDA check-up list for sanitation inspection is composed of 51 items. Each item is judged to be fit or unfit to the standards. When the unfit items are more than 6, the work-place is judged to be insanitary. But in this study, the results of sanitation inspection are scaled in points in the 70％ allotment, and the results of bacteriological examination are scaled in points in 30％, totaling 100％. Below 60 scores are judged to be insanitary and administratively punished; 61-75 scores are judged to be average; 76-85 good; above 86 excellent. The sanitation inspection scores by the improved check-up list went up by two grades from 71.8 (before SSOP program) to 88.6 (after SSOP program). The results of bacteriological examination also improved from 57.5 to 98.2. The total scores of both results converted in the allotment of 70％ and 30％ also showed an improvement by two grades from 66.4 (before SSOP program) to 93.4 (after SSOP program). The above results show that the manufacturers participated in this study are following the 8 essential sanitary procedures which are needed to anchor the HACCP system.

• Food Science of Animal Resources
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• v.31 no.6
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• pp.960-965
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• 2011

The content of benzo[a]pyrene from 69 smoked meat products commonly consumed in Korean food market was analysed with high performance liquid chromatography. Smoked meat products including smoked chicken, pork, turkey and duck were saponified, extracted and cleaned up to analyze the benzo[a]pyrene content. As a result of analysis from smoked meat products, the mean benzo[a]pyrene content was 0.42 ${\mu}g$/kg and the highest content of benzo[a]pyrene was 2.87 ${\mu}g$/kg detected in smoked chicken product. All somked meat products contained benzo[a]pyrene below the limit regulated by Korean Food and Drug Administration (KFDA). Exposure assessment of benzo[a]pyrene from smoked meat products ingestion was calculated by using National Health and Nutrition Survey (NHNS). The estimated lifetime average daily intake of benzo[a]pyrene was 0.187 ng/kg bw/d. Margin of exposure of benzo[a]pyrene was ranged from 1,657,754 to 3,957,219.

• Progress in Medical Physics
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• v.17 no.4
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• pp.246-251
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• 2006

The purpose of this study was to evaluate SUV (standard uptake value) using different reconstruction methods in whole body PET/CT Imaging. PET/CT studies were peformed with and without correction for effect of contrast media. The patients data were acquired using GE DSTe commercial PET/CT system. The liver disease (hepatocellular carcinoma, HCC) and renal disease (renal ceil carcinoma, RCC) patients were selected for this study, The PET/CT data were reconstructed using post CT scan with and without correction for effect of contrast media. We selected ROIs (region of Interest) at the same location and same area for the same patient to compare SUVs in these two methods. For HCC and RCC, the average differences of SUVs were measured as $1.5{\pm}1.2%\;and\;1.0{\pm}0.9%$, respectively. For HCC and RCC, the maximum differences of SUVs were measured as 4.3% and 1.9%, respectively. We observed that SUVs without correction for effect of contrast media were higher than SUVs with correction for effect of contrast media. However the differences of SUVs were very minimal. These results may be limited to HCC and RCC and further studies will be Heeded for other organs or diseases to see any changes in SUV with and without correction for effect of contrast media.

• Journal of Korean Ophthalmic Optics Society
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• v.11 no.4
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• pp.299-310
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• 2006

The eye irritant test of lens washing agent, $SOLOCARE^{TM}$ was conducted using Draize methods according to KFDA Guidelines 1999-61. In addition, to test the potential toxicity of test articles the ratio of inflammatory cells and non-inflammatory epitheloid cells were also observed using smear cytology methods against ocular discharge. At sacrifice, the histopathological changes on Cornea, Iris, Retina and Sclera were also observed in all animals. Slight (1~2 degrees) irritancy of cornea and conjunctiva were observed at 1, 2 and 3 days after dropping in non-washing group. The MIOI of these points are detected as 4.33, 3.33 and 2.00, respectively. In washing group, slight irritancy of cornea and conjunctiva were restricted to 1 and 2 days after dropping with MIOI as 3.00 and 1.33, respectively. Therefore, $SOLOCARE^{TM}$ was also considered as non-irritating materials because the MIOI is detected below 5.00 throughout the whole experimental periods in both washing and non-washing groups and the IAOI is also detected as 4.33 (1 day after dropping). No meaningful changes on smear cytology of ocular discharges are observed in this study compared to that of non-treated intact eyes. In addition, no abnormal histopathological changes on the cornea, iris, retina and sclera were also detected in $SOLOCARE^{TM}$ dropping group compared to that of non-treated intact eyes.

• Journal of Korean Ophthalmic Optics Society
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• v.19 no.1
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• pp.59-67
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• 2014

Purpose: The present study was aimed to compare the results of disinfection efficacy tested by membrane filtration method with dilution-neutralization method to develop the standard methods for evaluating disinfection efficacy of contact lens care products and to provide the result of disinfection efficacy of commercially available contact lens care products in domestic market. Methods: The results of disinfection efficacy against Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Candida albicans evaluated by membrane filtration method as a FDA standard and dilution-neutralization method as newly being a KFDA standard were compared and the disinfection efficacy of 16 multi-purpose solutions was further evaluated. Results: The disinfectants and contact lens care products having strong disinfection efficacy showed same results in both membrane filtration method and dilution-neutralization method. In case of contact lens care products having weak disinfection efficacy, the number of micro-organisms was not able to count since the colony was aggregated when evaluated by membrane filtration method. However, the number of micro-organisms was able to exactly count when evaluated by dilution-neutralization method. In addition, some commercially available contact lens care products did not meet disinfection standard and especially, their disinfection effect was often weak against Serratia marcescen and Candida albicans. Conclusions: It is concluded that dilution-neutralization method will be useful to evaluate disinfection efficacy since it is possible to count micro-organisms more precisely even with small amount of sample and check the results faster compared with membrane filtration method.

• Journal of Pharmaceutical Investigation
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• v.31 no.1
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• pp.49-55
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• 2001

Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, $Nicetile^{TM}$ (Dong-A pharmaceutical Co., Ltd.) and $Neurocetil^{TM}$ (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, $22.80{\pm}2.76$ year in age and $63.07{\pm}7.98\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 500 mg of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets were 2.72%, -0.65% and -8.42%, respectively, when calculated against the $Nicetile^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 94.87% and 87.17%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 15.58% and 19.16% $AUC_t\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g., $-11.84{\sim}6.41$ and $-10.57{\sim}11.88$for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Neurocetil^{TM}$ tablet is bioequivalent to $Nicetile^{TM}$ tablet.

• Korean Journal of Pharmacognosy
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• v.46 no.1
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• pp.44-51
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• 2015

The objective of this study is to characterize a toxicity of Polygalae Radix (PR) in F344 rats and to find a dose levels for the 13 weeks toxicity study. PR is well known as medicinal herb in many Asian countries for treatment of expectorant, tonic, tranquillizer, antipsychotic agent and functional diet for improving memory. However, there is insufficient background information on toxicological evaluation of PR extract to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and KFDA guideline in this study. The extract of PR was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500 and 5000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no treatment PR-related adverse changes in food consumption, hematology, clinical chemistry, urinalysis, gross finding at necropsy, organ weight examination. Four males at 5000 mg/kg/day were found dead during the treatment period. These animals showed salivation. The cause of death is still under investigation. The animals treated at 500, 1000, 2000, 3500 and 5000 mg/kg/day showed salivation and all animals at 5000 mg/kg/day exhibited lower body weight and cumulative weight gain in compared to those of control animals. Therefore, we recommend that a dose group of 3500 mg/kg/day is a highest treatment group in 13-week exposure study.

• Korean Journal of Veterinary Research
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• v.39 no.1
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• pp.1-11
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• 1999

This investigation was carried out to study morphological and chronological aspects of the development of the Harderian gland in the Mongolian gerbil(Meriones unguiculatus). Male and female Mongolian gerbils were sacrificed on days 1, 3, 5, 10, 30 and 60 after birth and their Harderian glands were processed for light microscopic observation. The results obtained were summarized as follows; 1. In 1-day-old Mongolian gerbil, Harderian gland was well distinguished from other tissue structures. It was composed of several immature tubules, and these tubules were separated each other by undifferentiated mesenchymal connective tissues. 2. In 3-day and 5-day-old Mongolian gerbils, the arrangement of tubules in the gland was more condensed than that of 1-day-old Mongolian gerbil. The excretory ducts started to appear in the connective tissues located between lobes. 3. In 10-day-old Mongolian gerbil, small lipid vacuoles began to be found in the cytoplasm of the secretory cells of the Harderian gland. There were some mucus-secreting cells within the epithelium of the excretory duct found in the interlobar connective tissues. 4. In 30-day-old Mongolian gerbil, there was markedly increased number of the tubules in the glands. The epithelial cells of the tubules were typically columnar in shape. Most of the columnar epithelial cells contained many small lipid vacuoles, although a few cells contained large lipid vacuoles. 5. In 60-day-old Mongolian gerbil, the Harderian gland exhibited the typical structural characteristics of the adult gland. The mature glandular structures were more distinct than those of 30-day-old animals.