Kim, Myoung Ock;Kim, Young Lan;Hong, Suk Young;Heo, Gwi Suk;Lim, Hyun Woo;Choe, Seoung Hun;Lee, Won Suk;Han, Jin Seok;Kim, Kum Hee
Analytical Science and Technology
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v.26
no.3
/
pp.165-173
/
2013
To establishment of PT Program for Indoor air quality field that manufacture of confidential development PTMs (proficiency testing materials) and examined of proficiency testing evaluation included sampling process whether or not that is valid. Confirmation of homogeneity and stability of PTMs prepared. PTMs were confirmed to be homogeneous enough to be used as proficiency testing materials since withinbottle homogeneities of the RMs were lower than 0.3 times of targeted standard deviation of proficiency testing. The result of this study showed that the Robust RSD of proficiency testing for VOCs (volatile organic compounds) appeared 23~43% in concentration of 50~320 ${\mu}g/m^3$ for Method A(Distribution by adsorption in Tenax-tube of VOCs), but less 13~42% in concentration of 200~1200 ${\mu}g/m^3$, 16~31% in concentration of 100~450 ${\mu}g/m^3$ for Method B (distribution by VOCs of gas phase in 10L Tedalr bag), C (directly sampling of cylinder with high pressure) respectively. The result of this study showed that method C with sampling is most adequate to the proficiency testing for VOCs in indoor air.
The quality of school education is a key element for national education development. An important factor that determines the quality of school education is qualities of teachers who are in responsible for school education in the field. Therefore, it is necessary to hire competent teachers in the teacher appointment exam for the secondary school. This necessity is evident especially for vocational high schools and Meister high schools with the introduction of 2015-revised curriculum based on NCS that separates each three subjects, "Electrical, Electronics Communication" resulting in the change of question mechanism, which requires new designing of assessment and content area. So, this study analyzes curriculum in college of education for "Electrical", "Electronics", "Communication", 2015-revised curriculum based on NCS and the development of standards for teacher qualifications and assessment area and evaluation of teaching ability in the subjects of the teacher appointment exam, "Electrical, Electronics Communication" Engineering" in 2009. The assessment area and content elements of "Electrical", "Electronics", "Communication are extracted from the analyzed results and they are verified by experts' consultation and presented as follows; First, the assessment area and content elements of the "Electrical" subject were designed to evaluate the NCS - based 2015 revised curriculum by presenting the NCS learning module to the evaluation area and content element in the basic subject "Electrical and Electronics Practice". Second, the section of "Electronics" presented the assessment area and content elements applying the Electronic Circuit, basic subject of the NCS and it also added "Electromagnetics", which is the basic part of Electronics in the Application of Electromagnetic waves that could be applied to the assessment. Third, the assessment area and content elements of "Communication" consist of the communication-related practice that is based on "Electrical" and "Electronic", considering the characteristics of "Communication Engineering". In particular, "Electrical and Electronics practice" which adds network construction practice and communication-related practice makes it to be able to evaluate the communication-related practical education.
Kim, Hyun-Ji;Kim, Jung-Min;Choi, In-Seok;Yoon, Yong-Su;Seo, Deok-Nam;Kim, Jung-Su;Kim, Dae-Young;Park, Sung-Yong
Journal of radiological science and technology
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v.36
no.1
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pp.1-10
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2013
IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.
Maeng, Chi Hoon;Kang, Su Jin;Lee, Sun Ju;Yim, Hyeon Woo;Choe, Byung-in;Shin, Im Hee;Huh, Jung-Sik;Kwon, Ivo;Yoo, Soyoung;Lee, Mi-Kyung;Shin, Hee-Young;Kim, Duck-An
The Journal of KAIRB
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v.2
no.1
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pp.23-31
/
2020
Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.
Ji hoon KANG;Sang Min SHIN;Young Si PARK;Hea Ji KIM;Hwa Youn JANG
Korean Journal of Clinical Laboratory Science
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v.56
no.2
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pp.147-155
/
2024
Gallium-68-prostate-specific membrane antigen-11 (68Ga-PSMA-11) is a positron emission tomography radiopharmaceutical that labels a Glu-urea-Lys-based ligand with 68Ga, binding specifically to the PSMA. It is used widely for imaging recurrent prostate cancer and metastases. On the other hand, the preparation and quality control testing of 68Ga-PSMA-11 in medical institutions takes over 60 minutes, limiting the daily capacity of 68Ge/68Ga generators. While the generator provides 1,110 MBq (30 mCi) nominally, its activity decreases over time, and the labeling yield declines irregularly. Consequently, additional preparations are needed, increasing radiation exposure for medical technicians, prolonging patient wait times, and necessitating production schedule adjustments. This study aimed to reduce the 68Ga-PSMA-11 preparation time and optimize the automated synthesis system. By shortening the reaction time between 68Ga and the PSMA-11 precursor and adjusting the number of purification steps, a faster and more cost-effective method was tested while maintaining quality. The final synthesis time was reduced from 30 to 20 minutes, meeting the standards for the HEPES content, residual solvent EtOH content, and radiochemical purity. This optimized procedure minimizes radiation exposure for medical technicians, reduces patient wait times, and maintains consistent production schedules, making it suitable for clinical application.
Park, Jae-Soo;Kim, Ki-Ho;Kim, Hae-Keum;Choi, Sang-Il
Korean Journal of Soil Science and Fertilizer
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v.45
no.2
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pp.293-300
/
2012
This study was to investigate the unsuitable rate of the storage facilities, the changes in corrosion process over time after installation according to the status, the time to install the facilities, years elapsed after facilities installation, inspection of methods and motivation, and so on, based on the results of the inspection at the petroleum storage facilities conducted by domestic soil-relate specialized agency to derive optimal management plans which meet the status of soil contamination facilities. The results showed that the facilities more than 5 years after the initial leak test at the time of the installation need to be inspected periodically by considering costs of leak test and remediation of polluted soil. The inspection period can be decided by cost and leak test methods showing discrepancies for the results obtained from individual test whether it was direct or indirect. To compensate these matters, we suggested that the direct inspection method on regular schedule is recommended. On the other hand, the inspection can be voluntarily completed to ease burden of the results by inspection or equivalent level to this inspection method. Also, it may need improved construction supervision and performance test system to minimize the occurrence of the nature defects in installing the facilities as well as the upgrade program for the facilities during intervals of inspection period.
5-Hydroxytryptamine(5-HT; serotonin) system has been implicated in the modulation of male sexual behaviors and the secretion of reproductive hormones. In human males, selective serotonin re-uptake inhibitors(SSRIs) are known to improve the major male sexual dysfunction, premature ejaculation, through the central nervous system-mediated pathways. As numerous hormone and local factors, 5-HT may have peripheral role in the regulation of male sexual function. The expression of 5-HT receptor subtypes in the target tissue, however, has not been explored yet. The present study was undertaken to test whether the 5-HT receptor subtypes are expressed in the reproductive tissues of male rat, especially in ejaculatory machinery such as seminal vesicle and vas deferens. To do this, reverse transcription-polymerase chain reaction(RT-PCR) and Southern blot analysis were employed. The transcripts for the 1A, 1B and 2C subtypes of 5-HT receptor were amplified in all the tested tissues. The present study demonstrated the expression of 5-HT receptor in the rat ejaculatory machinery, suggesting that 5-HT may play a pivotal role in the male sexual function via not only central pathway but also peripheral route. Further study on the receptor subtype-specific effect and their harmonized mode of action will be needed to establish the understanding of ejaculation mechanism and drug design.
Fluoxastrobin a fungicide developed from Strobilurus species mushroom extracts, can be used as an effective pesticide to control fungal diseases. In this study, we optimized the extraction and purification of fluoxastrobin according to its physical and chemical properties using the QuEChERS method and developed an LC-MS/MS-based analysis method. For extraction, we used acetonitrile as the extraction solvent, along with MgSO4 and PSA. The limit of quantitation of fluoxastrobin was 0.01 mg/kg. We used 0.01, 0.1, and 0.5 mg/kg of five representative agricultural products and treated them with fluoxastrobin. The coefficients of determination (R2) of fluoxastrobin and fluoxastrobin Z isomer were > 0.998. The average recovery rates of fluoxastrobin (n=5) and fluoxastrobin Z isomer were 75.5-100.3% and 75.0-103.9%, respectively. The relative standard deviations (RSDs) were < 5.5% and < 4.3% for fluoxastrobin and fluoxastrobin Z isomer, respectively. We also performed an interlaboratory validation at Gwangju Regional Food and Drug Administration and compared the recovery rates and RSDs obtained for fluoxastrobin and fluoxastrobin Z isomer at the external lab with our results to validate our analysis method. In the external lab, the average recovery rates and RSDs of fluoxastrobin and fluoxastrobin Z isomer at each concentration were 79.5-100.5% and 78.8-104.7% and < 18.1% and < 10.2%, respectively. In all treatment groups, the concentrations were less than those described by the 'Codex Alimentarius Commission' and the 'Standard procedure for preparing test methods for food, etc.'. Therefore, fluoxastrobin is safe for use as a pesticide.
There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.
The purpose of this study is to evaluate the accuracy of IMRT in our clinic from based on TG119 procedure and establish action level. Five IMRT test cases were described in TG119: multi-target, head&neck, prostate, and two C-shapes (easy&hard). There were used and delivered to water-equivalent solid phantom for IMRT. Absolute dose for points in target and OAR was measured by using an ion chamber (CC13, IBA). EBT2 film was utilized to compare the measured two-dimensional dose distribution with the calculated one by treatment planning system. All collected data were analyzed using the TG119 specifications to determine the confidence limit. The mean of relative error (%) between measured and calculated value was $1.2{\pm}1.1%$ and $1.2{\pm}0.7%$ for target and OAR, respectively. The resulting confidence limits were 3.4% and 2.6%. In EBT2 film dosimetry, the average percentage of points passing the gamma criteria (3%/3 mm) was $97.7{\pm}0.8%$. Confidence limit values determined by EBT2 film analysis was 3.9%. This study has focused on IMRT commissioning and quality assurance based on TG119 guideline. It is concluded that action level were ${\pm}4%$ and ${\pm}3%$ for target and OAR and 97% for film measurement, respectively. It is expected that TG119-based procedure can be used as reference to evaluate the accuracy of IMRT for each institution.
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