• Title/Summary/Keyword: Long-term safety assessment

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Safety and efficacy of fimasartan with essential hypertension patients in real world clinical practice: data from a post marketing surveillance in Korea

  • Han, Su-Eun;Jeong, Seung Hee;Kang, Hye Jeong;Hong, Myung Sook;Paek, Eunah;Cho, Hijung;Choe, Seong Choon
    • Translational and Clinical Pharmacology
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    • v.26 no.3
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    • pp.118-127
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    • 2018
  • The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as 'patients with long-term follow-up', and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ${\leq}140mmHg$ or decreased SBP differences ${\geq}20mmHg$ after treatment or diastolic blood pressure (DBP) controlled to ${\leq}90mmHg$ or decreased DBP differences ${\geq}10mmHg$ after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.

Long-Term Performance Evaluation of a GFRP Slab Bridge (GFRP 슬래브 교량의 장기성능 평가)

  • Ji, Hyo-Seon
    • Journal of Korean Society of Steel Construction
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    • v.24 no.3
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    • pp.349-360
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    • 2012
  • This paper describes a detailed assessment of the structural safety, serviceability, capacity rating and long-term performance of a glass fiber-reinforced polymer (GFRP) slab bridge superstructure. This first all-GFRP slab bridge was installed in Korea on May 2002. The GFRP slab bridge is a simply supported, its length is 10.0 m, and is designed to carry two-lane traffic and has an overall width of 8.0m. The GFRP slab bridge is a sandwich structure with a corrugated core, fabricated by hand lay-up process with E-glass fibers and vinyl ester resins. The assessment of long-term performance for the GFRP slab bridge in 2004, 2011 includes a field load testing identical to that performed in 2002. The assessment indicates that the GFRP slab bridge has no structural problems and is structurally performing well in-service as expected. The assessment may provide a baseline data for the capacity ratings assessment of the GFRP slab bridge and also serve as part of a long-term performance of all-GFRP bridge superstructure.

Preliminary Post-closure Safety Assessment of Disposal System for Disused Sealed Radioactive Source (폐밀봉선원 처분시스템 예비 폐쇄후 안전성평가)

  • Lee, Seunghee;Kim, Juyoul
    • Journal of Soil and Groundwater Environment
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    • v.22 no.4
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    • pp.33-48
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    • 2017
  • An optimum disposal plan of disused sealed radioactive sources (DSRSs) should be established to ensure long-term disposal safety at the low- and intermediate-level radioactive waste (LILW) disposal facility in Gyeongju. In this study, an optimum disposal system was suggested and preliminary post-closure safety assessment was performed. The DSRSs disposal system was composed of a rock cavern and near surface disposal facilities at the Gyeongju LILW disposal facility. The assessment was conducted using GoldSim program, and probabilistic assessment and sensitivity analysis were implemented to evaluate the uncertainties in the input parameters of natural barriers. Deterministic and probabilistic calculations indicated that the maximum dose was below the regulatory limits ($0.1mSvyr^{-1}$ for the normal scenario, $1mSvyr^{-1}$ for the well scenario). It was concluded that the DSRSs disposal system would maintain environmental safety over a long-time. Moreover, the partition coefficient of Np in host rock, Darcy velocity in host rock, and density of the host rock were the most sensitive parameters in predicting exposure dose in the safety assessment.

EXTENSION OF OPERATIONAL LIFE-TIME OF WWER-440/213 TYPE UNITS AT PAKS NUCLEAR POWER PLANT

  • Katona, Tamas Janos;Ratkai, Sandor
    • Nuclear Engineering and Technology
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    • v.40 no.4
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    • pp.269-276
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    • 2008
  • Operational license of WWER-440/213 units at Paks NPP, Hungary is limited to the design lifetime of 30 years. Prolongation by additional 20 years of the operational lifetime is feasible. Moreover, enhancement of the reactor thermal power by 8% will increase both the net power output and the competitiveness of the plant. Paks NPP is a pioneer considering the power up-rate and preparation of long-term operation of WWER-440/213 design. Systematic preparatory work for long-term operation of Paks NPP has been started in 2000. A regulatory framework and a comprehensive engineering practice have been developed. According to the authors view, creation of a gapless engineering system via consequent application of best practices, and feed-back of experiences together with proper consideration of WWER-440/V213 features are the decisive elements of ensuring the safety of long-term operation. That systematic engineering approach is in the focus of recent paper. Key elements of justification and measures for ensuring the safety of long-term operation of Paks NPP WWER-440/213 units are identified and discussed. These are the assessment of plant condition and review of adequacy of ageing management programmes, also the review, validation and reconstitution of time limited ageing analyses as core tasks of licence renewal.

Assessment of Radionuclide Deposition on Korean Urban Residential Area

  • Lee, Joeun;Han, Moon Hee;Kim, Eun Han;Lee, Cheol Woo;Jeong, Hae Sun
    • Journal of Radiation Protection and Research
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    • v.45 no.3
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    • pp.101-107
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    • 2020
  • Background: An important lesson learned from the Fukushima accident is that the transition to the mid- and long-term phases from the emergency-response phase requires less than a year, which is not very long. It is necessary to know how much radioactive material has been deposited in an urban area to establish mid- and long-term countermeasures after a radioactive accident. Therefore, an urban deposition model that can indicate the site-specific characteristics must be developed. Materials and Methods: In this study, the generalized urban deposition velocity and the subsequent variation in radionuclide contamination were estimated based on the characteristics of the Korean urban environment. Furthermore, the application of the obtained generalized deposition velocity in a hypothetical scenario was investigated. Results and Discussion: The generalized deposition velocities of 137Cs, 106Ru, and 131I for each residence type were obtained using three-dimensional (3D) modeling. For all residence types, the deposition velocities of 131I are greater than those of 106Ru and 137Cs. In addition, we calculated the generalized deposition velocities for each residential types. Iodine was the most deposited nuclide during initial deposition. However, the concentration of iodine in urban environment drastically decreases owing to its relatively shorter half-life than 106Ru and 137Cs. Furthermore, the amount of radioactive material deposited in nonresidential areas, especially in parks and schools, is more than that deposited in residential areas. Conclusion: In this study, the generalized urban deposition velocities and the subsequent deposition changes were estimated for the Korean urban environment. The 3D modeling was performed for each type of urban residential area, and the average deposition velocity was obtained and applied to a hypothetical accident. Based on the estimated deposition velocities, the decision-making systems can be improved for responding to radioactive contamination in urban areas. Furthermore, this study can be useful to predict the radiological dose in case of large-scale urban contamination and can support decision-making for long-term measurement after nuclear accident.

Health Risk Assessment for Residents after Exposure to Chemical Accidents: Formaldehyde (화학사고물질 노출에 따른 피해지역 주민 건강위해성평가: 폼알데하이드 사례를 중심으로)

  • Park, Sihyun;Cho, Yong-Sung;Lim, Huibeen;Park, Jihoon;Lee, Cheolmin;Hwang, Seung-Ryul;Lee, Chungsoo
    • Journal of Environmental Health Sciences
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    • v.47 no.2
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    • pp.155-165
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    • 2021
  • Objectives: Acute exposure to high concentrations of chemicals can occur when a chemical accident takes place. As such exposure can cause ongoing environmental pollution, such as in the soil and groundwater, there is a need for a tool that can assess health effects in the long term. The purpose of this study was assessing the health risks of residents living near a chemical accident site due to long-term exposure while considering the temporal concentration changes of the toxic chemicals leaked during the accident until their extinction in the environment using a multimedia environmental dynamics model. Methods: A health risk assessment was conducted on three cases of formaldehyde chemical accidents. In this study, health risk assessment was performed using a multimedia environmental dynamics model that considers the behavior of the atmosphere, soil, and water. In addition, the extinction period of formaldehyde in the environment was regarded as extinction in the environment when the concentration in the air and soil fell below the background concentration prior to the accident. The subjects of health risk assessment were classified into four groups according to age: 0-9 years old, 10-18 years old, 19-64 years old, and over 65 years old. Carcinogenic risk assessment by respiratory exposure and non-carcinogenic risk assessment by soil intake were conducted as well. Results: In the assessment of carcinogenic risk due to respiratory exposure, the excess carcinogenic risk did not exceed 1.0×10-6 in all three chemical accidents, so there was no health effect due to the formaldehyde chemical accident. As a result of the evaluation of non-carcinogenic risk due to soil intake, none of the three chemical accidents had a risk index of 1, so there was no health effect. For all three chemical accidents, the excess cancer risk and hazard index were the highest in the age group 0-9. Next, 10-18 years old, 65 years old or older, and 19-64 years old showed the highest risk. Conclusion: This study considers environmental changes after a chemical accident occurs and until the substance disappears from the environment. It also conducts a health risk assessment by reflecting the characteristics of the long-term persistence and concentration change over time. It is thought that it is of significance as a health risk assessment study reflecting the exposure characteristics of the accident substance for an actual chemical accident.

The vibration impact assessment for long-term damage mechanism of a pump (펌프 장기손상 메커니즘 규명을 위한 진동영향 평가)

  • Kim, T.H.;Kim, H.S.;Kim, D.K.;Kim, W.T.;Han, B.S.
    • Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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    • 2009.10a
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    • pp.441-445
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    • 2009
  • The most of the goals of pump designers and users are efficient operation and productivity. But the safety-grade pumps in nuclear power plants are needed to operate continuously for an essential condition of system operation. Also, most of the rules and regulatory standards that have been prepared for nuclear pumps are dedicated to achieve public safety. The study examined pump vibration in a pump outlet flow and distinguished the regions of pump vibration frequency cause by cavitation and recirculation. The study made a counterproposal in determination of pump outlet flow so that the discharge flow will be able to minimize the long-term damage of the pump.

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Advanced Structural Monitoring System Using Fiber Optic Sensors (광섬유 센서를 이용한 첨단 구조계측)

  • 김기수;김종우
    • Proceedings of the Korea Concrete Institute Conference
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    • 2002.10a
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    • pp.717-723
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    • 2002
  • Recently, the interest in safety assessment of civil infrastructures is increasing in Korea. Especially, as bridge structures become large-scale, it is necessary to monitor and maintain the safety state of bridges, which requires the monitoring system that can make a long-term measurement during the service time of bridge. In this paper, advanced fiber optic sensors for long-term measurement, setup techniques of bridge monitoring system and the assessment of measured data are introduced. Attached or embedded optical fiber sensors to structural members of small and big structures including Sung San Bridge are surveyed. For the Sung San Bridge, the responses of the fiber optic sensors by 30 ton weigh truck loads with various speeds ate measured. Monitoring system is also applied to the mock-up of bridges. The monitoring capability of the advanced fiber optic sensor system was confirmed.

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Smart Concrete Structures with Optical Fiber Sensors

  • Kim, Ki-Soo
    • KCI Concrete Journal
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    • v.11 no.3
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    • pp.109-114
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    • 1999
  • Recently the interest in the safety assessment of civil infrastructures has increased. As bridge structures become large-scale, it is necessary to monitor and maintain the safety of large bridges, which requires smart systems that can make long-term monitoring a reality . Civil engineers have applied monitoring systems to several bridges, such as the New Haeng-Ju Bridge and Riverside Urban Highway Bridge, but these applications have some problems with the sensors for long-term measurement, setup techniques for the bridge monitoring system and the assessment of measured data. In the present study, an optical fiber sensor smart system was tested and confirmed in laboratory tests on the concrete members. By Attaching optical fiber sensors to the structural parts of the Sung-San Bridge, the bridge load test was measured. These smart concrete structure systems can be applied to bridges and the load capacity of the bridge can assessed.

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INTERNATIONAL COLLABORATION IN ASSESSMENT OF RADIOLOGICAL IMPACTS ARISING FROM RELEASES TO THE BIOSPHERE AFTER DISPOSAL OF RADIOACTIVE WASTE INTO GEOLOGICAL REPOSITORIES

  • Smith, Graham;Kato, Tomoko
    • Nuclear Engineering and Technology
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    • v.42 no.1
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    • pp.1-8
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    • 2010
  • Geological disposal is designed to provide safe containment of radioactive waste for very long times, with the containment provided by a combination of engineered and geological barriers. In the extreme long term, after many thousands of years or longer, residual amounts of long-lived radionulides such as Cl-36, but also radionuclides in the natural decay chains, may be released into the environment normally accessed and used by humans, termed here, the biosphere. It is necessary to ensure that any such releases meet radiation protection objectives through the development of a safety case, which will include assessment of radiation doses to humans. The design of such dose calculations over such long timeframes is not straightforward, because of the range of potentially relevant assumptions which could be made, concerning environmental change and changes in human behavior. These conceptual uncertainties are additional to those that more typically arise, for example, in the assessment of present day situations, but which also have to be addressed. The issue has therefore been subject to international cooperation for many years. This paper summarizes the evolution and results of that collaboration leading up to the present day, taking account of developments in international recommendations on radiation protection objectives and the more recent greater focus on preparation of site specific safety cases.