• Journal of Pharmaceutical Investigation
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• 제39권4호
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• pp.299-307
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• 2009

Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

• The Korean Journal of Emergency Medical Services
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• 제7권1호
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• pp.235-246
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• 2003

Due to major disasters Korea has been damaged, and they caused lots of casualties: for last ten years natural disasters caused 1288 deaths including missing people; human disasters including industrial disasters brought as many as 4,512.148 casual ties (126,372 deaths with 4,385,400 injuries); and they cost 44.1 trillion property damage. However, even though major disasters have brought about tremendous human loss and property damage, Koreas National Disaster Medical System to rescue casualties is insufficient, and it has not been activated. Fortunately, through major disaster management process, the National Disaster Management System has been developed, increasing its own efficiency, and resulting in to organize an Office of Firefighting and Prevention of Disasters under the central government. Considering the value of human lives, the disaster medical part, in the U.S.A. as well as in Korea, must have an independent organization in the government, not as one sector of the government department. It will have its own organizational structure, such as disaster planning, operation, and logistics, and interact with central and local government or between local government agencies. So each agency will cooperate and supply resources interchangeably. Also, with the system of disaster management and restoration, the disaster medical system must be advanced in keeping step. Its role must be extended due to the possibility of biological terror or SARS around the world, resulting in severe casualties. Korea has the Emergency Medical Service System based on the regulation of emergency medical care, yet it is a part of the National Disaster Management System. It must be managed independently apart from it. As we see the emergency medical technicians playing as the backbone in disaster medical care in the US, we should have legal foundations for Koreas emergency medical technicians, emergency medical providers, to participate in rescue operation actively. At the same time, we need to have a national register system to classify disaster medical resources, and a total plan to place resources according to the impact of disaster, and how to organize teams. We also need to draw up a scheme to activate civil disaster medical resources, as integrating public and private or voluntary organizations.

• Journal of Korean Physical Therapy Science
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• 제9권4호
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• pp.7-14
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• 2002

The drug therapy for rheumatoid arthritis must be maintained constantly or for the whole life but is apt to induce the adverse effects in gastrointestinal or renal system. Therefor, newer methods are paid attention to reduce adverse effects. The thirty-two rat female separated into seven groups depending on the therapy or Freund's adjuvant applied: Normal group(n=8) not received anything, Positive control group(n=8) only received adjuvant, USC group(n=8) received continuous US, USP group(n=8) received pulsed US. The physical and radiological findings by thermal and non-thermal effects of ultrasound were evaluated in groups with continuous mode at 1 MHz, $0.5\;W/cm^2$ for 6 minutes and with pulsed mode (duty cycle 1:9) at 1 MHz, $0.5\;W/cm^2$ for 6 minutes. The result summarized followings. 1. Swelling of forepaw and hindpaw was significantly reduced in USP. 2. Arthritis indices in USP group were significantly reduced than those in PCG. 3. In naked eye and radiologic findings, swelling was significantly prevented in USP group but not in PCG. The change of swelling, arthritis index, gross feature in naked eye, radiologic finding were significantly improved in all groups except for USC group, taking care for using its continuous mode.

• Journal of Navigation and Port Research
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• 제36권10호
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• pp.857-864
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• 2012

Reviewing the statistics of harbor shipment of hazardous and noxious substance and the past spill accidents of HNS enabled us to assess the potential risks of transportation of HNS through the major harbors in Korea. Ulsan, Yeosu, Daesan port are relatively evaluated high risk in fire, health and environment disaster. Through the analysis of domestic preparedness to HNS accidents, the supplement of expertise resource to respond the vulnerability of the explosion, the fire and the physiological hazard, is required. Based on this risk assessment and review of the advanced case of Japan in building up HNS response system, a resource model at a national level was proposed which differentiates the sea areas for the proper allocation of resources to respond effectively to HNS accidents in the future.

• Journal of Environmental Science International
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• 제22권12호
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• pp.1579-1587
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• 2013

This study was performed to evaluate the asbestos exposure levels and to calculate excess lifetime cancer risk (ELCR) for the risk assessment of the asbestos fibers released from asbestos-cement slate roofing (ASR) building. Total number of ASR buildings was into 21,267 in Busan, and 82.03 percent of the buildings was residential houses, and 43.61 percent of the buildings was constructed in 1970s. For this study, ten buildings were selected randomly among the ASR buildings. The range of airborne asbestos concentration in the selected ten ASR buildings was from 0.0016 to 0.0067 f/mL, and the concentration around no-admitted ASR buildings was higher than that around admitted buildings. The ELCR based on US EPA IRIS (integrated risk information system) model is within 3.5E-05 ~ 1.5E-04 levels, and the ELCR of no-admitted ASR buildings was higher than 1.0E-04 (one person per million) level that is considered a more aggressive approach to mitigate risk. These results indicate that the cancer risk from ASR buildings is higher than other buildings, and systematic public management is required for control of no-admitted ASR buildings within near future.

• Quality Improvement in Health Care
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• 제7권2호
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• pp.204-216
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• 2000

Background : There has been a concern that the quality of care provided to end-stage renal disease (ESRD) patients in the United States may not be as good as recommended. This paper illustrates a composite measure to assess, the quality of care received by ESRD patients undergoing in-center hemodialysis by incorporating outcomes for 4 major treatment areas. The 4 treatment areas are: dialysis treatments, anemia control, nutritional management, and blood pressure control. Methods : The major data source for the study was the United States Renal Data System (USRDS) Dialysis Morbidity and Mortality Study Wave 1 (DMMS-1) d Sixteen categories of a composite quality indicator were constructed by combining 4 dichotomous variables (16=2*2*2*2). representing the optimal vs. less than optimal level of outcome for each of the 4 treatment outcome measure respectively. Optimal outcome level for each treatment area was defined based on the recommendation from the National Kidney Foundation: (a) delivered dialysis doses (Kt/V) ${\geq}$ 1.2; (b) hematocrit level ${\geq}$ 30%; (c) serum albumin concentration ${\geq}$ 3.8g/dl ; and (d) blood pressure of <140 / <90mmHg. The 16 quality indicator were ranked according to their relative quality weights, which were estimated from its association with the relative risk of survival, adjusting for patient's baseline severity and dialysis facility characteristics. Results : Out of the entire sample of 2,179 patients, only 229 (10%) meet th recommended outcome levels for all 4 treatment areas. Overall, the study patients were distributed evenly over the 16 quality indicators, indicating a great variation in the quality of ESRD care. It appears that the rank of the 16 quality-indicators is driven by serum albumin concentration, suggesting that serum albumin concentration may be the most powerful predictor of ESRD patient survival among the 4 outcome measures. Conclusion : The developed quality indicator has the advantage of describin a range of care for dialysis patients and thus providing a more complete picture of care as compared to previous studies that have focused on only single or few components of the ESRD care.

• Korean Journal of Clinical Pharmacy
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• 제28권2호
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• Smart Structures and Systems
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• 제6권5_6호
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• pp.675-687
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• 2010

Structural Health Monitoring (SHM) is the science and technology of monitoring and assessing the condition of aerospace, civil and mechanical infrastructures using a sensing system integrated into the structure. Impedance-based SHM measures impedance of a structure using a PZT (Lead Zirconate Titanate) patch. This paper presents a low-power wireless autonomous and active SHM node called Autonomous SHM Sensor 2 (ASN-2), which is based on the impedance method. In this study, we incorporated three methods to save power. First, entire data processing is performed on-board, which minimizes radio transmission time. Considering that the radio of a wireless sensor node consumes the highest power among all modules, reduction of the transmission time saves substantial power. Second, a rectangular pulse train is used to excite a PZT patch instead of a sinusoidal wave. This eliminates a digital-to-analog converter and reduces the memory space. Third, ASN-2 senses the phase of the response signal instead of the magnitude. Sensing the phase of the signal eliminates an analog-to-digital converter and Fast Fourier Transform operation, which not only saves power, but also enables us to use a low-end low-power processor. Our SHM sensor node ASN-2 is implemented using a TI MSP430 microcontroller evaluation board. A cluster of ASN-2 nodes forms a wireless network. Each node wakes up at a predetermined interval, such as once in four hours, performs an SHM operation, reports the result to the central node wirelessly, and returns to sleep. The power consumption of our ASN-2 is 0.15 mW during the inactive mode and 18 mW during the active mode. Each SHM operation takes about 13 seconds to consume 236 mJ. When our ASN-2 operates once in every four hours, it is estimated to run for about 2.5 years with two AAA-size batteries ignoring the internal battery leakage.

• International Journal of Advanced Culture Technology
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• 제7권2호
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• pp.28-33
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• 2019

Electronic health records (EHRs) enable us to use and re-use electronic data for various multiple purposes, such as public reporting, quality improvement, and patient outcomes research. Current hospital-acquired pressure injury (HAPI) risk assessment instruments have not been specifically developed for intensive care unit (ICU) patients and showed false positive rates in this specific populations. Previous research studies report a number of risk factors; however, it is still not clear what factors influence ICU HAPI in this population. As part of a larger research study, we performed an exploratory analysis by using a large electronic health record data. The aims of this study were to compare characteristics of patients who developed HAPIs during their ICU stay with those who did not, and to determine whether the two groups were different in the aspects of length of ICU stay, discharge disposition, and discharge destinations. We conducted chi-square test and t-test for group comparison. Association was examined by using bivariate analyses. Pearson correlation coefficients were used to examine correlation between LOS and number of medications. Our findings suggest a number of consistent and potentially modifiable risk factors, such as sedation, feeding tubes, and the number of medications administered. The mortality of the HAPI group was significantly higher than the non-HAPI group in our data. Discharge disposition was significantly different between the groups. 67% of the HAPI group transferred to intermediate or long-term care hospitals whereas 57.7% of the non-HAPI group went home after discharge. Awareness of these risk factors can lead to clinical interventions that can be preventative in the ICU setting.

• Environmental Analysis Health and Toxicology
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• 제10권1_2호
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• pp.1-14
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• 1995

The purpose of this research is to assess the health risk of pollutants in drinking water and recommend the guidelines and management plans for maintaining good quality of drinking water. This study has been funded as a national project for three years from 1992 to 1995. This study(the second year, 1993-1994) was conducted to monitor 32 species of carcinogenic chemicals such as volatile organic compounds(VOCs), polynuclear aromatic hydrocarbons(PAHs), pesticides and heavy metals of drinking water at some area in six cities of Korea, and evaluate health risk due to these chemicals through four main steps of risk assessment in drinking water. In hazard identification, 32 species of carcinogenic chemicals were identified by the US EPA classification system. In the step of exposure assessment, sampling of raw, treated and tap water from the public water supply system had been conducted from 1993 to 1994, and 32 chemicals were analyzed. In dose-response assessment, cancer potencies, unit risk estimates and virtually safe doses of carcinogens were obtained by TOX-RISK (Version 3.1). In risk characterization of detected chemicals, health risk due to carcinogens such as vinyl chloride, carbon tetrachloride, dichloromethane, 1, 2-dichloromethane, chloroform, benzene and arsenic of tap water in several cities exceeded 10$^{-5}$ level. We suggest that non-regulated chemicals which exceed 10$^{-5}$ excess cancer risk level, such as vinyl chloride, carbon tetrachloride and 1, 2-dichloroethane, should be monitored periodically and be regulated by the Drinking Water Management Act, and database for exposure parameter of our own situation should be established.