• Journal of the Korea Safety Management & Science
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• v.12 no.3
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• Journal of Embryo Transfer
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• v.22 no.3
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• pp.161-165
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• 2007

Oxytocin is a neurohypophyseal hormone which has multiple functions in mammals. Mainly, oxytocin regulates milk ejection and has an effect on uterine contraction and is related to maternal behavior. Maternal behavior is believed to be suppressed by stress and facilitated by oxytocin. In the cesarean section, oxytocin may be administrated into uterus to promote uterine involution. The present study aimed to test the effect of oxytocin into uterus on maternal behavior of rats with cesarean section. It was measured the effects on maternal behavior of oxytocin infused into uterus in rats with cesarean section as a stressor. In the first experiment, pup survival rate of between a control group and a group with laparotomy as a stress in natural parturition rats was compared. In the second experiment, survival rate for 2 weeks and maternal pup searching behavior (MPSV) were observed in one cesarean sectioned group without oxytocin and the other cesarean sectioned group with oxytocin. Infanticide was observed in stressed group in the first experiment while a normal maternal behavior was observed in a control one. In the second experiment, MPSV was only observed in a cesarean sectioned group with oxytocin and infanticide was observed in two groups except one rat which is thought to be affected by oxytocin as operated relatively late. This is the first study to show that the administration of oxytocin into uterus in the cesarean section is not involved in the regulation of maternal behavior in rats. In conclusion, this study proves the needs of oxytocin into brain in cesarean section related rats model and further study of maternal behavior list, like MPSV.

• Journal of Biomedical Engineering Research
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• v.31 no.4
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• pp.280-284
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• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

• Progress in Medical Physics
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• v.19 no.4
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• pp.276-284
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• 2008

A computed tomography (CT) is a powerful system for the effectively fast and accurate diagnosis. The CT system, therefore, has used substantially and developed for improving the performance over the past decade, resulting in growing concerns over the radiation dose from the CT. Advanced CT techniques, such as a multidetector row CT scanner and dual energy or dual source CT, have led to new clinical applications that could result in further increases of radiation does for both patients and workers. The objective of this study was to review the international guidelines of the shielding requirements for a CT facility required for a new installation or when modifying an existing one. We used Google Search Engine to search the following keywords: computed tomography, CT regulation or shield or protection, dual energy or dual source CT, multidetector CT, CT radiation protection, and regulatory or legislation or regulation CT. In addition, we searched some special websites, that were provided for sources of radiation protection, shielding, and regulation, RSNA, AAPM, FDA, NIH, RCR, ICRP, IRPA, ICRP, IAEA, WHO (See in Table 1 for full explanations of the abbreviations). We finally summarized results of the investigated materials for each country. The shielding requirement of the CT room design was very well documented in the countries of Canada, United States of America, and United Kingdom. The wall thickness of the CT room could be obtained by the iso-exposure contour or the point source method. Most of documents provided by international organizations were explained in importance of radiation reduction in patients and workers. However, there were no directly-related documents of shielding and patient exposure dose for the dual energy CT system. Based international guidelines, the guideline of the CT room shielding and radiation reduction in patients and workers should be specified for all kinds of CT systems, included in the dual energy CT. We proposed some possible strategies in this paper.

• The Korean Journal of Applied Statistics
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• v.26 no.4
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• pp.675-686
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• 2013

The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

• Journal of Pharmacopuncture
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• v.12 no.3
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• pp.61-72
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• 2009

Objectives : This experimental study was performed to investigate the safety and efficacy of Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. To identify the use of it as eye drop, the eye irritation test of rabbits and the antibacterial test of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans were performed. Methods : 1. The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Bovis Calculus pharmacopuncture solution was administered in the left eye of the rabbits, eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 2. After administering Bovis Calculus pharmacopuncture solution on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis, MIC(Minimum Inhibition Concentration) and the size of inhibition zone were measured. Anti-bacterial potency was also measured using the size of inhibition zone. Results : 1. After Bovis Calculus pharmacopuncture solution was administered in the left eye of the rabbits, it was found that none of nine rabbits have abnormal signs and weight changes. 2. After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, no eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 3. There was no response to MIC on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) after Bovis Calculus pharmacopuncture solution was medicated. Conclusions : The present study suggests that Bovis Calculus pharmacopuncture solution is a nontoxic and non-irritant medicine, which does not cause eye irritation in rabbits, but dosen't have antibacterial effects on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis. These study result recommends that more research on other herbal medicines of eye drop for Keratitis are required.

• Journal of Pharmacopuncture
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• v.15 no.1
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• pp.23-28
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• 2012

Objective: This experimental study was designed to investigate the safety and the effectiveness of Samjeong pharmacopuncture solution (SPS) manufactured by using a the lowtemperature extract on process. Methods: To identify the safety and the effectiveness of using SPS as eye drops, we performed applied eye irritation tests on rabbits and antibacterial tests for Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans. The eye irritation test was performed according to the toxicity testing regulation of the Korea Food & Drug Administration (2009. 8. 24, KFDA 2009-116). After SPS had been applied on the left eye of the rabbits, eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. After SPS had been dropped on bacterial species that cause keratitis, the minimum inhibition concentration and the size of the inhibition zone were measured. The anti-bacterial potency was also measured by taking the size of inhibition zone. Results: After SPS had been administered on the left eye of the rabbits, none of nine rabbits were found to show abnormal signs or weight changes. After SPS had been administered on the left eye of the rabbits, no eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. No specific response was detected in MIC for bacterial species Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans after SPS had been applied. Conclusions: This study suggests that SPS is a non-toxic and non-irritant medicine that does not cause any of eye irritation in rabbits, but it has no antibacterial effects on bacterial species that are well known to cause keratitis. These results suggest that more research is required on extracts from herbal medicines for treating keratitis.

• Journal of Pharmacopuncture
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• v.12 no.1
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• pp.21-33
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• 2009

Objective : This experimental study was performed to investigate the safety of Soyeom Pharmacopunture solution manufactured by extraction of alcohol and water. To identify the use of it as eyedrops, the eye irritation test of rabbits and antibacterial test of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans was performed. Methods : 1. The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Soyeom pharmacopuncture solution was administered in the left eye of the rabbits, eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 2. After administering Soyeom Pharmacopuncture solution on bacterial species (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis, MIC(Minimum Inhibition Concentration) and the size of inhibition zone were measured. Anti-bacterial potency was also measured using the size of inhibition zone. Results : 1. After Soyeom pharmacopuncture solution was administered in the left eye of the rabbits, it was found that none of nine rabbits have abnormal signs and weight changes. 2. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, no eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 3. There was no response to MIC on bacterial species (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) after Soyeom pharmacopuncture solution was medicated. Conclusions : The present study suggests that Soyeom pharmacopuncture solution is a non-toxic and non-irritant medicine, which does not cause eye irritation in rabbits, but dosen't have anti-bacterial effects on bacterial species which cause Keratitis. These study result recommends that more research on other herbal medicines of eye drop for Keratitis are required.

• Korean Journal of Medicinal Crop Science
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• v.18 no.5
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• pp.338-344
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• 2010

Our paper shows the results of 302 samples of herb medicines about fungal contamination at Yakyeang markets in Seoul. The sample medicines were treated VICAM pretreatment and analysed by post column derivatisation procedure(PHRED-HPLC) with a fluorescence detector. Aflatoxin B1 was founded from 50.3% of samples, aflatoxin B2 was 39.7%, aflatoxin G1 was 21.2% and aflatoxin G2 was 23.5%. The detected ranges of aflatoxin B1, B2, G1 and G2 were from 0.1 to $57.2\;{\mu}g/kg$, 0.1 to $42.6\;{\mu}g/kg$, 0.1 to $23.5\;{\mu}g/kg$ and 0.1 to $9.5\;{\mu}g/kg$ respectively. Among total samples, 26 samples contained aflatoxin B1 violated the regulation (less than 10 ug/kg) for aflatoxin B1 of KFDA. From the result, we could presumed that more than a half of samples were contaminated by aflatoxins. Therefore, it seems to be necessary that the new safety giudeline will be established aflatoxin B2, G1 and G2 from herb medicines as aflatoxin B1.

• The Korea Journal of Herbology
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• v.29 no.3
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• pp.35-42
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• 2014

Objectives : Since single extract powders was released at 1987, the insurance fee has not been changed, but the price of raw material has been increasing. According to this, Pharmaceutical company couldn't invest on quality of the product, so, the quality of single extracts went down and lost the consumer's trust. We checked the contents of marker ingredients in single extract thereby to recover the reliability of insurance-covered herbal preparations. Methods : we bought total twelve products of eight different single extracts of two main pharmaceutical companies among total 65 kinds of single extract powder stipulated in KHP (The Korean Herbal Pharmacopoeia) monograph III at Jan. 2013. Assays of selected single extract powders are performed by KHP regulation. And we surveyed price fluctuation of relevant herb raw materials from 2005 to 2012. Results : Among twelve products, eight single extract powders were suitable by the KHP regulation. But four products didn't reach the content amount of KHP. Marker contents in the single extracts product of Pueraria Root, Licorice, Peony root and Scutellaria Root of A company were 70%, 1%, 23.7% and 75.1%, respectively. Conclusions : We can acertain whether there's a quality problem in the insurance-covered single extract powders. But, A company is no longer producing these improper single extract powders. As a medicine, single extract powders needs to be strictly quality controlled by the company, and regularly monitored by the KFDA.