• Toxicological Research
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• v.34 no.2
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• pp.111-125
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• 2018

Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.

• Agribusiness and Information Management
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• v.4 no.1
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• pp.24-31
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• 2012

This case study investigates the KIKO currency option that has been a social issue in recent years among developing countries, especially Korea, where the financial derivatives market is in a state of rapid growth. The forward transaction which becomes a basis of derivatives is intended to hedge risks that may be caused by a future change in asset prices. Although it originates from a simple form of agricultural transactions, there currently exists a variety of derivatives in more sophisticated forms. In the Korean agricultural industry, the need to use such derivatives is great, as there is a huge risk of price fluctuation in agricultural products due to frequent adverse weather. In addition, many developing countries with export-led industrial structures similar to Korea's, of necessity must resort to currency hedging as a method of reducing relevant risk. However, in most cases, the lack of understanding about financial derivatives results in an inappropriate application of these derivatives. The KIKO in this study represents such cases. Since 2007, KIKO has been sold in Korea to many small- and medium-sized export companies for the purpose of currency hedging when the exchange rate between the Korean won and the U.S. dollar was in a downward spiral. The main focus of this study is a case which is most representative of KIKO. As inflation rapidly increased during the financial crisis in the U.S. at the end of 2007, derivatives became a hot issue in the courts rather than in the financial markets. This case study investigates what KIKO and the fierce legal debates over it imply, from the perspective of the option of value evaluation in order to suggest not only a direction in which companies can utilize financial derivatives, but also a roadmap for the future derivatives market.

• Journal of The Korean Institute of Defense Technology
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• v.5 no.2
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• pp.23-30
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• 2023

TRA(Technology Readiness Assessment) quantitatively assesses the current level of domestic technology and is used as a key tool for determining the possibility of domestic R&D and risk management. However, since the current TRA utilizes hardware-oriented TRL(Technology Readiness Level), it is suitable for independent assessment of each technologies, but has limitations in evaluation from a system integration perspective. In addition, the checklist-based assessment is highly likely to involve subjective evaluation. This study proposes an enhanced TRA framework by redefining TRA procedures and criteria from the systems integration perspective of system engineering. We focused on developing a framework that overcomes the limitations of the current TRL/TRA and enables easier and more intuitive assessment. The proposed framework distinguishes between TE(Technology Element) and CTE(Critical Technology Element) in terms of HW, SW and interface and redefines TRL. TRA is performed according to the TRL redefined from the above three points of view, and the lowest evaluation value is used as system maturity level in consideration of risk management. The proposed CTE selection method minimizes the intervention of the evaluator by utilizing the quantitative goal of the key ROC(Required Operational Capability), development difficulty, and application of COTS(Common Off The Shelf) technology. The effectiveness of this framework was confirmed through a case study of the TSS(Target Surveillance System). It is hoped that starting with this study, research at the framework level will be activated and contribute to the improvement of the TRA system.

• Korean Journal of Clinical Pharmacy
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• v.26 no.3
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• pp.201-206
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• 2016

Objective: Direct current cardioversion for atrial fibrillation could be associated with the risk of thromboembolic events. Anticoagulation therapy with warfarin (INR 2.0-3.0) is recommended 3 weeks before and 4 weeks after cardioversion to reduce the risk of thromboembolism. This study evaluated warfarin therapy in pharmacist-managed anticoagulant services (ACS). Methods: This retrospective study was performed in 106 patients with atrial fibrillation from 2012 to 2013. The primary efficacy endpoint was the composite of stroke, transient ischemic attack, myocardial infarction, and cardiovascular death. The primary safety measure was major bleeding. To evaluate the peri-procedural effects of warfarin treatment, we studied whether target INR was maintained, as well as the maintenance period of the therapeutic range. Quality of treatment was measured by time in therapeutic range (TTR) by using the Rosendaal method. Results: There were no thromboembolic events, but TEE examination at time of cardioversion showed a left atrial thrombus in three patients (2.8%). Bleeding complications after cardioversion occurred in 2 patients (1.9%). The average INR value at the time of cardioversion was $2.59{\pm}0.8$, and was within the therapeutic range in 83 patients (78%). Analysis of the patients in whom the value was within the therapeutic range twice consecutively showed that the ratio of TTR was 80% and the therapeutic range was maintained in 67 patients (63%) for an average of 4.90 weeks prior to cardioversion. Similarly, 76 patients (72%) had a stable INR within the therapeutic range for an average of 5.70 weeks and a mean TTR of 83%. Conclusion: Pharmacists significantly contributed to appropriate warfarin treatment with close monitoring during cardioversion. Likewise, active pharmacist monitoring and systemic management should be considered to reduce thromboembolism and bleeding complications in the peri-cardioversion period.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.14
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• pp.5721-5727
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• 2014

Objectives: To evaluate the performance of clustering methods used in the prognostic assessment of categorical clinical data for hepatocellular carcinoma (HCC) patients in China, and establish a predictable prognostic nomogram for clinical decisions. Materials and Methods: A total of 332 newly diagnosed HCC patients treated with hepatic resection during 2006-2009 were enrolled. Patients were regularly followed up at outpatient clinics. Clustering methods including the Average linkage, k-modes, fuzzy k-modes, PAM, CLARA, protocluster, and ROCK were compared by Monte Carlo simulation, and the optimal method was applied to investigate the clustering pattern of the indices including platelet count, platelet/lymphocyte ratio (PLR) and serum aspartate aminotransferase activity/platelet count ratio index (APRI). Then the clustering variable, age group, tumor size, number of tumor and vascular invasion were studied in a multivariable Cox regression model. A prognostic nomogram was constructed for clinical decisions. Results: The ROCK was best in both the overlapping and non-overlapping cases performed to assess the prognostic value of platelet-based indices. Patients with categorical platelet-based indices significantly split across two clusters, and those with high values, had a high risk of HCC recurrence (hazard ratio [HR] 1.42, 95% CI 1.09-1.86; p<0.01). Tumor size, number of tumor and blood vessel invasion were also associated with high risk of HCC recurrence (all p< 0.01). The nomogram well predicted HCC patient survival at 3 and 5 years. Conclusions: A cluster of platelet-based indices combined with other clinical covariates could be used for prognosis evaluation in HCC.

• Journal of the Korean Society of Marine Environment & Safety
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• v.24 no.6
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• pp.785-795
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• 2018

The International Maritime Organization (IMO) has recognized the risk of hull fouling and announced '2011 Guidelines for the control and management of ship's biofouling to minimize the transfer of invasive aquatic species'and is planning international regulations to enforce them in the future. In this study, to effectively respond to future international regulation, we introduce the case of leading countries related to management of hull fouling and also investigate environmental risk assessment techniques for in-water cleaning. Australia and New Zealand, the leading countries in hull fouling management, have established hull fouling regulations through biological and chemical risk assessment based on in-water cleaning scenarios. Most European countries without their government regulation have been found to perform in-water cleaning in accordance with the IMO's hull fouling regulations. In the Republic of Korea, there is no domestic law for hull fouling organisms, and only approximately 17 species of marine ecological disturbance organisms, are designated and managed under the Marine Ecosystem Law. Since in-water cleaning is accompanied by diffusion of alien species and release of chemical substances into aquatic environments, results from biological as well as chemical risk assessment are performed separately, and then evaluation of in-water cleaning permission is judged by combining these two results. Biological risk assessment created 40 codes of in-water cleaning scenarios, and calculated Risk Priority Number (RPN) scores based on key factors that affect intrusion of alien species during in-water cleaning. Chemical risk assessment was performed using the MAMPEC (Marine Antifoulant Model to Predict Environmental Concentrations), to determine PEC and PNEC values based on copper concentration released during in-water cleaning. Finally, if the PEC/PNEC ratio is >1, it means that chemical risk is high. Based on the assumption that the R/V EARDO ship performs in-water cleaning at Busan's Gamcheon Port, biological risk was estimated to be low due to the RPN value was <10,000, but the PEC/PNEC ratio was higher than 1, it was evaluated as impossible for in-water cleaning. Therefore, it will be necessary for the Republic of Korea to develop the in-water cleaning technology by referring to the case of leading countries and to establish domestic law of ship's hull fouling management, suitable for domestic harbors.

• The Journal of Economics, Marketing and Management
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• v.7 no.1
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• pp.1-14
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• 2019

Purpose - Currently, the economic globalization has become a common channel for China's enterprise to perform the international economic activities. Due to this background, this paper tries to analyze the influence of internationalization level on operation performance of enterprises. Research design, data, and Methodology - This paper aims at 296 companies going listed in Shanghai Stock Exchange and Shenzhen Stock Exchange. The data about the listed companies during the 12 years from 2005 to 2016 have been collected. Relevant theories, including the theory of comparative advantage, monopolistic advantage and product life cycle in developed countries as well as the small scale technology and state on localized technological capacities in developing countries, have been summarized to provide theoretical basis for the influence of international operation on operation performance of the enterprises. Moreover, the current status of international operation of China's enterprises, including the dynamic cause of the internationalization of China's enterprises, its competitive advantage and disadvantage as well as the interest and potential risk of the internationalization, have been also analyzed. Results - Via adopting the panel data to conduct an empirical analysis, It can be found that the relationship between international operation level and operation performance of China's enterprises can be expressed as the S-curve of declining, rising and declining again. Conclusions - This paper has taken the lead in using Ohlson corporate value model to fill the gap in the relevant researches in China. It can also provide guidance for the international operation of China's enterprises. Meanwhile, the two systems for international operation and performance evaluation index have been put forward. The performance of international operation can be classified as financial performance or corporate value so that the operation effect of those China's enterprises going abroad can be better evaluated.

• Journal of Korean Neurosurgical Society
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• v.64 no.1
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• pp.13-22
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• 2021

Objective : High precision and accuracy are expected in gamma knife radiosurgery treatment. Because of the requirement of clinically applying complex radiation and dose gradients together with a rapid radiation decline, a dedicated quality assurance program is required to maintain the radiation dosimetry and geometric accuracy and to reduce all associated risk factors. This study investigates the validity of Leksell Gamma plan (LGP)10.1.1 system of 5th generation Gamma Knife Perfexion as modified variable ellipsoid modeling technique (VEMT) method. Methods : To verify LGP10.1.1 system, we compare the treatment plan program system of the Gamma Knife Perfexion, that is, the LGP, with the calculated value of the proposed modified VEMT program. To verify a modified VEMT method, we compare the distributions of the dose of Gamma Knife Perfexion measured by Gafchromic EBT3 and EBT-XD films. For verification, the center of an 80 mm radius solid water phantom is placed in the center of all sectors positioned at 16 mm, 4 mm and 8 mm; that is, the dose distribution is similar to the method used in the x, y, and z directions by the VEMT. The dose distribution in the axial direction is compared and analyzed based on Full-Width-of-Half-Maximum (FWHM) evaluation. Results : The dose profile distribution was evaluated by FWHM, and it showed an average difference of 0.104 mm for the LGP value and 0.130 mm for the EBT-XD film. Conclusion : The modified VEMT yielded consistent results in the two processes. The use of the modified VEMT as a verification tool can enable the system to stably test and operate the Gamma Knife Perfexion treatment planning system.

• Journal of the Society of Disaster Information
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• v.19 no.3
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• pp.532-544
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• 2023

Purpose: To identify and evaluate the risk of chemical fire causative substances by using thermal analysis methods (DSC, TGA) for the hazards and physical property changes that occur when newly used biofuels are mixed with existing fuels It is to use it for identification and evaluation of the cause of fire by securing data related to the method and the hazards of the material according to it. Method: The research method used in this experiment is the differential scanning calorimeter (DSC: Difference in heat flux) through quantitative information on the caloric change from the location, shape, number, and area of peaks. flux) was measured, and the weight change caused by decomposition heat at a specific temperature was continuously measured by performing thermogravimetric analyzer (TGA: Thermo- gravimetric Analyzer). Result: First, in the heat flux graph, the boiling point of the material and the intrinsic characteristic value of the material or the energy required for decomposition can be checked. Second, as the content of biodiesel increased, many peaks were identified. Third, it was confirmed through analysis that substances with low expected boiling points were contained. Conclusion: It was shown that the physical risk of the material can be evaluated by using the risk of biodiesel, which is currently used as a new energy source, through various physical and chemical analysis techniques (DSC + TGA).In addition, it is expected that the comparison of differences between test methods and the accumulation and utilization of know-how on experiments in this study will be helpful in future studies on physical properties of hazardous materials and risk assessment of materials.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.28 no.1
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• pp.15-21
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• 2022

The purpose of our study was to investigate the migration level of lead (Pb), cadmium (Cd), and barium (Ba) from glassware into a food simulant and to evaluate the exposure of each element. The test articles were glassware, including tableware, pots, and other containers. Pb, Cd, and Ba were analysed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). The analytical performance of the method was validated in terms of its linearity, limit of detection (LOD), limit of quantification (LOQ), recovery, precision, and uncertainty. The monitoring was performed for 110 samples such as glass cups, containers, pots, and bottles. a food simulant. Migration test was conducted at 25? for 24 hours in a dark place using 4% acetic acid as a food simulant. Based on the data; exposure assessment was carried out to compare the estimated daily intake (EDI) to the human safety criteria. The risk levels of Pb and Ba determined in this study were approximately 1.9% and 0.3% of the provisional tolerable weekly intake (PTWI) and tolerable daily intake (TDI) value, respectively, thereby indicating a low exposure to the population.