• YAKHAK HOEJI
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• v.45 no.2
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• pp.227-236
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• 2001

The complexity and variability of both the biologicals and the bioassays used to test them led to the use of the reference standard- a sample of the product of defined purity and potency, against which all preparations of that product must be calibrated. In order to prepare and establish KFDA reference standard for recombinant human growth hormone (somatropin), somatropin substance was filled in ampoules in National Institute for Biological Standards and Control (NIBSC). The candidate KFDA reference standard for somatropin (designated as 98/674) was evaluated to determine the suitability of serving as a KFDA reference standard for somatropin by the collaborative study, in which 10 laboratories participated. Physicochemical analysis and in vivo bioassay were performed by direct comparison with the international somatropin standard 88/624. 98/674 was identified as somatropin by SDS-PAGE, IEF, peptide mapping, and HPLC. Determination of somatropin content by SE-HPLC yielded a mean estimate of 2.01 mg somatropin per ampoule. Data from the study also yielded mean values of 0.39 $\pm$ 0.26% for high molecular weight impurities by SE-HPLC and mean values of 2.13 $\pm$ 1.29% for somatropin related proteins by RP-HPLC. Estimates of relative potency by weight gain bioassay in the hypophysectomised rats showed that relative potency of KS 98/674 was 1.07 aganist IS 88/624. Based on the results of the collaborative study, the candidate reference standard for somatropin is suitable to serve as a KFDA reference standard for somatropin.

• Journal of Korean Society on Water Environment
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• v.29 no.4
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• pp.568-573
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• 2013

In this study, we conducted whole effluent toxicity (WET) proficiency testing based on the results which $EC_{50}$ value of 3 types (A, B, C) unknown samples calculated from 32 water quality measurement agencies in Korea. WET proficiency testing was expected to their improve of analysis skill and ensure reliability of analysis results. Ultimately, it is intended to promote the reliable enforcement of WET. WET proficiency testing was evaluated using the z-score, robust z-score and the results showed that 30 participating agencies were "compliance". In addition, $EC_{50}$ values of "unknown sample A" were the normal distribution. Therefore, "unknown sample A" was considered as the most suitable standard toxicity substance.

• YAKHAK HOEJI
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• v.59 no.3
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• pp.98-106
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• 2015

Analytical method for related substances can be categorized into two methods depending on the necessity of reference standard (RS). The analytical method of related substances with RS is fast and accurate, but it's very expensive and technically difficult to synthesize RS due to their complicated structure. Another method is using relative retention time (RRT) and relative response factor (RRF) which are already validated with RS. Validation of this method is not easy and time consuming, but once it has been developed, it can save cost and time. In this study, we developed the analytical method for related substances of fenofibrate using RRT and RRF. We validated the method by evaluating specificity, linearity, accuracy and precision according to the "Manual for Guideline Application for Validation of Analytical Procedures" of MFDS. Also, we calculated RRT and RRF between fenofibrate and fenofibrate related substances. The results of this study showed high specificity for fenofibrate and fenofibrate related substances. Correlation coefficient(r) of all substances were more than 0.99, and the recovery of fenofibrate, fenofibrate related substance I, II and III were 99.44%, 100.84%, 99.14% and 101.58%, respectively. Precision of fenofibrate and its related substances were ranged between RSD 0.29% and 0.93%. Quantification limits of fenofibrate, fenofibrate related substance I, II and III were determined to be $0.03{\mu}g/ml$, $0.05{\mu}g/ml$, $0.04{\mu}g/ml$ and $0.02{\mu}g/ml$, respectively by confirming signal to noise ratio of each chromatogram. The RRT for fenofibrate related substance I, II and III were determined to be 0.35, 0.41 and 1.34, respectively. Also, the RRF for fenofibrate related substance I, II and III were determined to be 1.28, 0.98 and 0.79, respectively. The developed method was applied to determine contents for fenofibrate related substances in commercial fenofibrate (active pharmaceutical ingredient). As a result, developed analytical methods of related substances will be used for revising the monograph of fenofibrate in Korean Pharmacopoeia revision and contribute quality control of drugs by improving cost and time consuming problem of RS.

• Environmental Engineering Research
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• v.21 no.2
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• pp.140-144
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• 2016

Owing to the kinetic differences in ammonia oxidation among ammonia-oxidizing microorganisms (AOM), there is no standard set of kinetic values that can be used as a representative set for nitrifying wastewater treatment plant (WWTP) design. As a result, this study clarified a link between the half-saturation constants for ammonia oxidation (Ks) and the dominant ammonia-oxidizing bacterial (AOB) groups in sludge from full-scale WWTPs and laboratory-scale nitrifying reactors. Quantitative polymerase chain reaction analyses revealed that AOB affiliated with the Nitrosomonas oligotropha cluster were the dominant AOM groups in the sludge taken from the low-ammonia-level WWTPs, while AOB associate with the Nitrosomonas europaea cluster comprised the majority of AOM groups in the sludge taken from the high-ammonia-level WWTPs and nitrifying reactors. A respirometric assay demonstrated that the ammonia Ks values for the high-ammonia-level WWTPs and nitrifying reactors were higher than those of the low-ammonia-level plants. Using the Ks values of available AOM cultures as a reference, the Ks values of the analyzed sludge were mainly influenced by the dominant AOB species. These findings implied that.different sets of kinetic values may be required for WWTPs with different dominant AOM species for more accurate WWTP design and operations.

• Journal of the Korean Society of Safety
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• v.25 no.5
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• pp.27-32
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• 2010

This study is to investigate and compare domestic hazardous toys with harmful substances with foreign toys so that we can find out management criteria for in cognitive infants. Actually, commercially used toys have been collected and tested to find out more effective management standard. it is tried to produce evaluation criteria of environmentally harmful substance but variety of product is needed for overcoming actual barrier due to lot of difficulty huge cost, time, objectiveness. Therefore, This study does not cover all the above. Establishment of evaluation criteria for product harmfulness made by Government or Local government should be continued to improve. Foreign reference material for toy product in Europe, USA, Japan have been investigated and domestic product have been collected and tested for containing heavy metals, formaldehyde, phthalate in the study. All the test have been made in accordance with KSM ISO 2124 to measure heavy metal transfer into body. Toy product used for the study have been purchased in the real market and some of them contains harmful elements with over standard. Post management system such as RAPEX to control periodically should be established for plastic toy with low quality product.

• Korean Journal of Clinical Laboratory Science
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• v.38 no.3
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• pp.184-188
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• 2006

The purpose of the recovery experiment in clinical chemistry is performed to estimate proportional systematic error. We must know all measurements have some error margin in measuring analytical performance. Proportional systematic error is the type of error whose magnitude increases as the concentration of analyte increases. This error is often caused by a substance in the sample matrix that reacts with the sought for analyte and therefore competes with the analytical reagent. Recovery experiments, therefore, are used rather selectively and do not have a high priority when another analytical method is available for comparison purposes. They may still be useful to help understand the nature of any bias revealed in the comparison of kit experiments. Recovery should be expressed as a percentage because the experimental objective is to estimate proportional systematic error, which is a percentage type of error. Good recovery is 100.0%. The difference between 100 and the observed recovery(in percent) is the proportional systematic error. We calculated the amount of analyte added by multiplying the concentration of the analyte added solution by the dilution factor(mL standard)/(mL standard + mL specimen) and took the difference between the sample with addition and the sample with dilution. When making judgments on method performance, the observed that the errors should be compared to the defined allowable error. The average recovery needs to be converted to proportional error(100%/Recovery) and then compared to an analytical quality requirement expressed in percent. The results of recovery experiments were total protein(101.4%), albumin(97.4%), total bilirubin(104%), alkaline phosphatase(89.1%), aspartate aminotransferase(102.8), alanine aminotransferase(103.2), gamma glutamyl transpeptidase(97.6%), creatine kinase(105.4%), lactate dehydrogenase(95.9%), creatinine(103.1%), blood urea nitrogen(102.9%), uric acid(106.4%), total cholesterol(108.5), triglycerides(89.6%), glucose(93%), amylase(109.8), calcium(102.8), inorganic phosphorus(106.3%). We then compared the observed error to the amount of error allowable for the test. There were no items beyond the CLIA criterion for acceptable performance.

• Analytical Science and Technology
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• v.16 no.2
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• pp.134-142
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• 2003

Comparison of a microwave-assisted extraction with sonication extraction was performed for arsenic speciation in fish tissue with chromatographic separation and inductively coupled plasma mass spectrometry detection. The detection limits of arsenicals with ultrasonic nebulizerand cross-flow nebulizer were shown to be similar. The arsenicals investigated were arsenobetaine (AsB), arsenite [As(III)], dimethylarsine acid (DMA), monomethylarsonic acid (MMA), arsenate [As(v)], and phenylarsonic acid (PAA). Quantitative extraction of arsenicals from dogfish muscle, DORM-2, standard reference material of NRCC (National Research Council of Canada) was achieved using 50% (v/v) methanol-water in both extraction methods. Extraction efficiency of arsenobetaine in both methods is greater than 82% with RSDs on replicates of less than 5%. The concentrations of AsB determined in extract of microwave assisted extraction and sonication methods were $14.18{\pm}0.42mg\;kg^{-1}$ and $13.54 {\pm}0.84mg\;kg^{-1}$, respectively. And the concentrations of DMA were $0.45{\pm}0.06mg\;kg^{-1}$ and $0.44{\pm}0.06mg\;kg^{-1}$, respectively.

• The Korean Journal of Nuclear Medicine Technology
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• v.16 no.1
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• pp.108-114
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• 2012

Purpose: Immunosorbent assay most commonly used in the laboratory and commercial third-party quality control material is a substance that provided by BIO-RAD. However, in Reference Sheet by radioimmunoassay test kit or a measuring device for the mention of Acceptable Range is somewhat lacking. Radioimmunoassay for the inspection of test results by setting Acceptable Range to increase the objectivity of the recommendations on the data accumulated by the manufacturer listed in the Reference Sheet is to be issued. Materials and Methods : In our hospital since 2009 partially BIO-RAD using quality control materials in 2011, excluding certain items, some items were most of the BIO-RAD third-party quality control materials are used. Thus, internal quality control data accumulated BIO-RAD's Unity Real Time program by using the items were measured. Results : BIO-RAD using quality control material items were about 50 of the 20 Point Data averages, standard deviations, variation coefficients were calculated to measure the Acceptable Range of kit, automated immunoassay attributed Roche Elecsys / E170 / cobas e Systems the measures and compared. Conclusions : BIO-RAD QC materials commonly used hospital and peer group by setting the measurement kit, suitable for laboratory equipment for radioimmunoassay of Acceptable Range manufacturer recommendation to increase the objectivity of the test results by national and international recognition for radioimmunoassay should seek to increase.

• The Korean Journal of Nuclear Medicine Technology
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• v.16 no.2
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• pp.139-148
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• 2012

Purpose : Since standard solution is the one that knows its exact concentration, the curve of the dissolution has been determined according to the amount of the solution, compared to the amount of the unknown sample. Therefore, the antigen that makes up standard materials should be made in a pure form. The configuration of the standard substance solution in the kit we use is a freeze-dried material, or made and comes as a liquid. Lyophilized reference material is used after dissolving in usually D.W. (Distilled Water), and if the antigen to use is too sensitive, reagents should be freeze-dried. Furthermore, when freeze-dried reference has to be frozen again after being dissolved, it should be kept under $-20^{\circ}C$ until the expiration date according to the reports. Since it is not expressed in the experiment if it is safe or stable to reuse the solution which was dissolved a few times, thus, this time it is tested and evaluated that the changes of the standard solution by freezing and melting several times, and its results and the effectiveness of it were compared to the solution which was kept in a fridge. Materials and Methods : Among Vitro diagnostic kits on the market made by radioimmunoassay, parathyroid hormone (PTH), adrenocorticotropic hormone (ACTH), luteinizing hormone (LH) are made of freeze-dried standard solution and all composed of the same Lot.NO. These hormones melted in D.W. and were separated into three groups. In the first group, melting and freezing were repeated, and in the second group, The solution only for one time use was put into a test tube after melting and freeze it. The third group was kept in the refrigerator. This experiment has been conducted from January to February in 2012. January to 2012. PH test was employed because ph is prone to changing depending on the change of protein. Each group of the standard solution, cpm (counter per minute), and the patient relative concentration values were compared by date, and Through the correlation coefficient and Paired t-test, the significant level of each group was analyzed. Results : ACTH, PTH, LH pH values were too subtle denaturation rather than numerical changes in the protein. In addition, when the standard solution of ACTH, PTH, LH was refrigerated, after 3 days and 7 days, there was a significant difference observed between the solution being kept in a refrigerator and a freezer within a significance level. Conclusion : Standard solution should be kept in a freezer, and being kept in a fridge, it is recommended to use the solution as soon as possible.

• Journal of Practical Engineering Education
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• v.15 no.1
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• pp.1-11
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• 2023

The purpose of this study is to develop and validate a tool that measures the satisfaction of virtual training learners' use of virtual training content. To this end, 491 copies of the basic questions derived from the satisfaction questions used by the K University Online Lifelong Education Center were used for the final analysis by conducting an online survey of learners who accessed STEP, the K University Online Lifelong Education Center portal. The 491 copies of data finally used were analyzed by methods such as basic question analysis, exploratory factor analysis, reliability analysis, and confirmatory factor analysis. First, in the basic question analysis, there were no questions that exceeded the acceptance criteria of an average of 4 points or more, skewness ±2, and kurtosis ±4. Second, the correlation coefficient for each sub-factor of virtual training content satisfaction derived after exploratory factor analysis was good as r=.682 to .822 (p<.01). The reliability coefficient for each sub-factor is content .849, content utilization .922, System and Operations Support .841, Intention to Continue Utilization .920, the overall reliability is. It was very high at .956 Fifth, as a result of confirmatory factor analysis, the compositional conceptual diagram is. It was .842 to .926, higher than the recommended standard of .7, and the average variance extraction degree. It appears to be .640 to .796, higher than the recommended standard of .5, which can be seen as representative of each constituent concept. As a result of verifying the validity of virtual training learners' content satisfaction recruitment, four factor models were derived: content substance, content utilization, system and operation support, and intention to continue use. This study is meaningful in that it empirically developed a tool to measure content satisfaction of virtual training learners and provided a reference frame and criteria.