• Toxicological Research
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• v.34 no.3
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• pp.191-197
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• 2018

In 2015, a candidate for the second national reference standard (NRS) of Gloydius snake venom was produced to replace the first NRS of Gloydius snake venom. In the present study, the potencies of the candidate were determined by a collaborative study, and the qualification of the candidate was estimated. The potencies of the candidate were determined by measuring the murine lethal titers and lapine hemorrhagic titers of venom against the regional working reference standard (RWRS) for antivenom using the methods described in the previous report for the first NRS of Gloydius snake venom. Three Korean facilities contributed data from a total of 30 independent assays. Subsequently, two foreign national control research laboratories contributed to this collaborative study. The results were calculated using the Reed-Muench method for lethality and determined using a mixed-effects model for hemorrhage. The general common potencies of the lethal and hemorrhagic titers were obtained from the results of the 30 tests performed at three Korean facilities. The results are expressed in micrograms for 1 test dose (TD) with a 95% confidence interval as follows: a lethal titer of $90.13{\mu}g/TD$ (95% confidence interval = $87.39{\sim}92.86{\mu}g$) and a hemorrhagic titer of $10.80{\mu}g/TD$ (95% confidence interval = $10.46{\sim}11.14{\mu}g$). In addition, the candidate preparation showed good quality evaluation according to the results of the quality estimation of the candidate and is judged to be suitable to serve as the Korean NRS for snake venom. In conclusion, the second NRS of Gloydius snake venom was established in this study and will be used for national quality control, including a national lot release test of Korean antivenom products.

• Korean Journal of Environmental Agriculture
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• v.35 no.3
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• pp.223-233
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• 2016

BACKGROUND: This study was to develop a analytical reference material including twenty pesticides in tomato. To use it for proficiency test, the suitability of homogeneity, storage stability, assigned values and uncertainty for analytical reference material were important.METHODS AND RESULTS: In order to develop a analytical reference material of tomato for multi-residue analysis of pesticides, twenty-pesticides were treated in tomato and the samples were frozen and homogenized. The homogeneity, stability, assigned value and uncertainty were calculated according to the requirements of the KS A ISO Guide 35, KS Q ISO 13528 and EURL-PT protocol. The values of the within-bottle standard variation(s_wb) and the between-bottle standard variation(s_bb) were 0.9~6.5% of assigned value and the uncertainty(u*_bb) due to inhomogeneity was also calculated as 0.6~1.9% for all pesticides. This indicated that it was satisfactory to be used as a analytical reference material. The storage stabilities of twenty-pesticides at room temperature and freezing conditions were assessed according to the requirement of the KS Q ISO Guide 35. All pesticides were stable at room temperature (20~30℃) for 8 days and freezing (-20℃) for 23 days.CONCLUSION: The feasibility of analytical reference material for pesticide multi-residue analysis in a tomato matrix was investigated. Homogeneity of within/between-bottle, uncertainty and stabilities at room temperature and freezing condition were satisfactory for a use of proficiency test and quality control. From these results, a analytical reference material would be applicable to monitor the proficiency test of pesticide analysis organizations to improve the reliability and consistency.

• Korea Trade Review
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• v.42 no.1
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• pp.257-281
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• 2017

It becomes a common feature of business practices in International Trade to use a standard terms for the formation of their contracts. However, because of differences in legal systems, business practices and so on in their own countries, there have been many conflicts and disputes happening between parties concerned in International Trade. The CISG, which has long been used as the governing law in many cases of International Trade, could not be free from those conflicting issues in its usage and application. This study analyzes the "Black Letter Rules" which was adopted by CISG Advisory Council in 2013 to provide an effective way of resolving the conflicting issues regarding the inclusion of standard terms in International Trade Contracts under the CISG. This study scrutinizes, the relevant rules and requirements for the inclusion of standard terms into a contract. It also deals with the offeror's duty of making clear reference to the standard terms, transmitting the contents of standard terms to the other party. As the other rules for the inclusion of standard terms, this study reviews the principle of denying the inclusion of standard terms after the formation of contracts, exclusion of surprising or unusual terms, preference of individually negotiated terms to the standard terms, contra preferentum rule and preference of the "knock-out rule" to "last-shot rule" in resolving the issue of so called, "Battle of Forms." Lastly, on the basis of analyzed opinion, this study suggests the practical implications for the people working at International Trade-related business sector to facilitate International Trade.

• Proceedings of the KSR Conference
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• 2007.11a
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• pp.816-823
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• 2007

As the South Korean rolling stock industry is developing designs for full compliance with the European Standards, it is fitting to take a look at these two core standards. The paper presents an overview of the load cases and structural requirements developed in Europe for the design of safe and compatible rolling stock vehicles. These load cases and structural requirements have been compiled into two standards namely EN12663 and EN15227. Standard EN12663 was developed as a reference design requirements standard. The work was mandated and sponsored by the European Committee for Standardization and Standard issuing National Institutions. EN12663 specifies a series of proof and fatigue load cases for European rolling stock regulations compliant vehicle designs. As EN12663 does not address the crashworthiness issue, a dedicated crashworthiness standard, EN15227, was therefore developed in a similar manner through industry wide consultations managed by a Trans-European working group of experienced engineers and specialists. In both standards, the vehicle and/or trains are grouped into categories reflecting the vehicle types and/or their indented operational function. EN15227, developed to complement EN12663, addresses the "passive" crashworthiness capability of the vehicles and trains. EN15227 specifies reference crash scenarios similar to those found in the Technical Specification for Interoperability (TSI) of high speed trains operating in Europe. The overview also touches on a general comparison with the corresponding British Group Standard (GM/RT2100) and also the UIC leaflet based load cases. The exercise is extended to pertinent design load cases specified by the Federal Railroad Administration (FRA) in the US.

• Proceedings of the Korean Society of Medical Physics Conference
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• 2002.09a
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• pp.241-243
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• 2002

New types of protocols have been recently in development, all based on an absorbed dose-to-water with the aim of improving the accuracy of measurements of absorbed dose to water. IAEA TRS-277, the air-kerma standard-based present protocol, and IAEA TRS-398 and AAPM TG-51, the absorbed dose-to-water standard-based new one, were studied and compared theoretically and experimentally for photon beams of 6, 10, and 15 MV. NE 2571 and 3 Farmer types of ionization chambers in widely commercial use were used to determine an absorbed dose to water at the reference depth in water. Two different kinds of calibration factors were given respectively for every chamber calibrated in $\^$60/CO gamma ray beams from a Korean Secondary Standard Dosimetry Laboratory (KFDA). This work shows that there is around 1 % of difference of absorbed doses measured between two different types of calibration systems owing to different physical parameters and reference conditions used. We hope this work to help form the basis on development of new type of protocol in Korea.

• The Korean Journal of Nuclear Medicine Technology
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• v.18 no.1
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• pp.158-162
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• 2014

Purpose: Reference material (RM) is defined as material that is safe and homogeneous enough about specified characteristic that is made with a purpose of using test of measurement or nominal characteristic. Certified reference material (CRM), which is issued by authorized organization, is defined as reference material that provides characteristic value, link uncertainty and retroactivity. The purpose of this paper was to evaluate recovery of radioimmunoassay by Certified Reference Material enclosed with a certificate and therefore to enhance reliability of test. Materials and Methods: WHO certified reference material is purchased from NIBSC (National Institute for Biological Standard and Control, United Kingdom) and made of 3 levels that are C-1 (low concentration), C-2 (medium concentration) and C-3 (high concentration) and measured for kit at the Seoul National University Hospital. Recovery rate is evaluated after measurement at four different days. Results: Recovery rate results using WHO certified reference material are T4 90%, Ferritin 88%, PSA 94%, Prolactin 99%, AFP 94% and TSH 93%. Conclusion: A procedure that appropriate accuracy, precision, specificity, sensitivity, reproducibility, and validate on the subject of kit for radioimmunoassay is essential. Recovery rate assay as extraction efficiency of analysis process is percent about already measuring results of analysis result after all measuring process. This is very important assessment standards of performance evaluation of immunoassay kit. Recovery rate results of 6 type used WHO CRM are satisfactory to 88~99%. This demonstrates that the radioimmunoassay is a very accurate measurement, which is very effectively utilized in clinical practice.

• Journal of Ginseng Research
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• v.37 no.1
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• pp.124-134
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• 2013

The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.

• Korean Journal of Health Education and Promotion
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• v.31 no.4
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• pp.1-10
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• 2014

Objectives: The effectiveness of Blood ${\beta}$-ketone testing by using self-monitoring strip on diabetic patients. Methods: Clinical effectiveness of blood ${\beta}$-ketone testing was assessed through correlation with reference test that measured blood ${\beta}$-ketone value through gas chromatography or enzyme method, diagnostic accuracy, time taken for the test and time taken for confirmative diagnosis of diabetic ketosis by selecting literatures on researches that conducted this test on ketosis(suspected) patients or diabetic ketosis(suspected) patients. Each of the stages from literature search to application of selection standards and extraction of data were carried out independently by the Subcommittee along with 2 researchers. Results: 7 reports were selected. ${\beta}$-ketone testing displayed high level of correlation in the range of r=0.92~0.99 with test using enzyme method as the reference standard. Regarding the diagnostic accuracy, sensitivity of 0.82, specificity of 0.74. The time taken for the test was 30seconds for the index test, which is shorter than reference standard test. Conclusion: Blood ${\beta}$-ketone testing was assessed to be a safe and effective test to monitor ketosis and assess the level of risk of ketosis by measuring the blood ${\beta}$-ketone on ketosis patients and diabetic ketosis patients since it has high level of correlation with reference test and short period of testing.

• YAKHAK HOEJI
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• v.49 no.3
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• pp.212-216
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• 2005

A rapid, sensitive and selective electrospray tandem mass spectrometric (ESI-LC/MS/MS) method for the quantitation of gliquidone in human plasma was developed. A bioavailability study of gliquidone tablet (30 mg gliquidone, Boehringer Ingelheim Korea Co.) was performed using the validated ESI-LC/MS/MS method. The dose of 30 mg of gliquidone (1 tablet) was orally administered to 9 healthy Korean subjects. After administration, blood was taken at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24, and 33 hour. The validation data were as follows; the standard curve was linear ($r^2$=0.999) over the concentration range of $10\~1000 ng/ml$. The coefficient of variation for intra- and inter-day assay were $8.30\~18.86$, and $2.19\~12.92\%$, respectively. The lower limit of quantification for gliquidone was 10 ng/ml. The pharmacokinetic parameters obtained were as follows; $AUC_t$ was 3861.17$\pm$1328.61 ng-hr/ml, $C_{max}$ was 831.02$\pm$227.99 ng/ml, $T_{max}$ was $2.94{\pm}0.77 hr,\;K_e$, was 0.19$\pm$0.06 1/hr, and $t_{l/2}$ was 4.47$\pm$3.52 hr. Based on the validated analytical method and pharmacokinetic parameters, a standard guideline of the bioavailability test of gliquidone dosage forms was prepared successfully and could be used for the bioequivalence test of gliquidone preparation.

• YAKHAK HOEJI
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• v.49 no.3
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• pp.225-229
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• 2005

A rapid, sensitive and selective tandem mass spectrometric method (LC-MS/MS) for the quantitation of nicorandil in human plasma was developed. A bioavailability study of Sigmat tablet (5 mg nicorandil, Choongwae Co.) was per-formed using the validated LC-MS/MS method. The dose of 5 fig of nicorandil (1 tablet) was orally administered to 9 healthy Korean subjects. After administration, blood was taken at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, and 24 hour. The validation data were as follows; the standard curve was linear ($r^2$=0.999) over the concentration range of $0.5\~200.0 ng/ml$. The coefficient of variation for intra- and inter-day assay were $3.55\~7.44$, and $2.17\~9.102\%$, respectively. The lower limit of quantification for nicorandil was 0.5 ng/ml. The pharmacokinetic parameters obtained were as follows; $AUC_t$ was 145.9$\pm$83.0 ng-hr/ml, Cmax was 83.8$\pm$32.2 ng/ml, $C_{max}$ was 0.42$\pm$0.13 hr, $K_e$ was 0.56$\pm$0.23 l/hr, and $t_{l/2}$ was 1.42$\pm$0.52 hr. Based on the validated analytical method and pharmacokinetic parameters, a standard guideline of the bioavailability test of nicorandil dos-age forms was prepared successfully and could be used for the bioequivalence test of nicorandil preparation.