• Journal of Pharmaceutical Investigation
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• v.39 no.4
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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.

• Journal of the Korean Geosynthetics Society
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• v.18 no.3
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• pp.11-22
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• 2019

This study was conducted to identify the causes of the unusually high number of rock slope failures during an expressway construction in Yangsan fault system. The shear strength (cohesion and internal friction angle) of 128 slopes of discontinuities including bedding, joint, and fault planes were re-evaluated through the examination of face mapping and back analysis. The re-evaluated values were analyzed and then compared with the existing data and values used in the design. As a result, the re-evaluated cohesion and friction angles were very low compared to the existing data and the values applied in the design. This incongruity was pointed as the primary reason for the rock slopes failures during the construction. This may be related to the inherent features of clastic sedimentary rocks in the study area, and the discontinuities in the sedimentary rocks in this region played a significant role. Especially, bedding discontinuity showed a big difference compared to the existing data. The shear strength depended on the type of discontinuity in case of clay filled in discontinuity. However, shear strength was independent on the type of discontinuity in case of shattered materials filled in discontinuity.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.14
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• pp.5967-5970
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• 2015

Background: The prevalence of prostate cancer is considered high in many countries, and screening tests are very important in order to detect prostate cancer in its early stages; however false positivity with these screening tests means that a lot of patients undergo unnecessary biopsy, which is an invasive procedure, for the confirmatory test. The purpose of this study was to estimate the frequency of unnecessary biopsy cases in patients referred for prostate biopsy in one of the most important and overload cancer centers in Syria. Materials and Methods: Retrospective data for a period of four years between January 2009 and December 2012 were collected in Al-Bayrouni University Medical hospital in Damascus, Syria. The patients from whom data were collected were referred to our histopathological department because of elevated prostate specific antigen (PSA) serum or an abnormal digital rectal examination (DRE). All patients underwent prostatic TRUS-guided biopsies. Diagnosis of prostate cancer (PCa) or benign prostatic hyperplasia (BPH) was based on histopathological examination and prostate cancers cases were graded and scored according to the Gleason score system. Results: For the 406 patients referred to biopsy, the $mean{\pm}SD$ age was $58.4{\pm}23.3$ years. The $mean{\pm}SD$ PSA level was $49.2{\pm}21.5ng/ml$. Of the total we found 237 patients diagnosed with PCa (58. 4%), 166 patients with BPH (40.9%) and 3 cases were unable to be diagnosed (0.7%) because of biopsy collection errors. Conclusions: Our study shows that a high percentage of patients are undergoing unnecessary biopsy, which suggests that the performed screening tests had a high level of false positive and may need re-evaluation.

• Korean Journal of Veterinary Research
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• v.55 no.2
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• Journal of the Korean Society of Radiology
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• v.6 no.1
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• pp.39-45
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• 2012

Conventional periphery radiography system has a various problem such as patient dose and the pain of X-ray examination. In this paper, to solve these problems, we suggested insertional miniature x-ray system and we verified the feasibility of this system. First, we performed the Geant4 x-ray simulation to design x-ray collimator and filter to use miniature x-ray tube and we decided optimized thickness of filter and collimator. Also, we measured x-ray spectrum using CdTe detector and PX4 module to verify simulation results. Also, we acquired teeth image of fabricated phantom using conventional dental x-ray and prosed miniature x-ray system. As a results, our system has good image quality as compared to those of conventional systems. Our evaluation of the proposed system indicates that it can be potentially very useful for dental imaging.

• Archives of Pharmacal Research
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• v.26 no.11
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• pp.906-911
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• 2003

We previously reported that the butanol (BuOH) fraction of the head of Panax ginseng exhibited gastroprotective activity in peptic and chronic ulcer models. In order to identify the active constituent, an activity-guided isolation of the BuOH faction was conducted with a HCI$.$ethanol-induced gastric lesion model. The BuOH fraction was passed through a silica-gel column using a chloroform-methanol gradient solvent system, and six fractions (frs. 1-6) were obtained. The active fr. 5 was further separated by silica-gel column, to yield 6 subfractions (subfrs. a-f). Subfr. d was composed of ginsenosides Re, Rc and $Rb_1$. The most active constituent was ginsenoside $Rb_1$ ($GRb_1$), a protopanaxadiol glycoside, which was investigated for its anti-ulcer effect. Gastric injury induced by HCI$.$ethanol, indomethacin and pyloric ligation (Shay ulcer) was apparently reduced with oral $GRb_1$ doses of 150 and 300 mg/kg. $GRb_1$ at these dosage significantly increased the amount of mucus secretion in an ethanol-induced model. The anti-ulcer effects were consistent with the result of histological examination. These results suggest that the major active constituent in the head of Panax ginseng is $GRb_1$ and that anti-ulcer effect is produced through an increase in mucus secretion.

• KSCE Journal of Civil and Environmental Engineering Research
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• v.31 no.5D
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• pp.649-656
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• 2011

The increase in the traffic demand and behavioral pattern of its use reached the limit for the only means of road construction to bear; thus the multilateral efforts to find a solution to this problem together with the examination and research on this issue, among which the most representative strategy is Ramp Metering System controlling access traffic volume to connection roads. The operation standard and running time was re-established in consideration of geographical conditions and traffic circumstances by considering the standard of operation and running time of the currently operated Jangsu- Jungdong section of the outer ring expressway of Seoul. For this purpose, this research analyzed the operative standard of RMS home and abroad and suggested a new operative standard of ramp metering through the analysis of break points.

• Korean Journal of Clinical Laboratory Science
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• v.41 no.4
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• pp.158-166
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• 2009

On the basis of morphological characteristics, of total 128 strains of from sputum of tuberculos inpatient were identified as A. fumigatus (61 strains), A. niger (37), A. flavus (26), A. versicolor (1), A. nidulans (1), A. clavatus (1) and Neosartorya fennelliae (1). These strains were re-identified according to recent Aspergillus classification system which is mainly based on molecular characteristics. The strains were grouped by randomly amplified polymorphic DNA (RAPD) techniques. The representative strains from each group were sequenced with partial ${\beta}$-tubulin gene and compared with those of reference strains in the Aspergillus and were identified by the sequence. The identification was confirmed by morphology examination. As the results, they are reidentified as A. fumigatus (58), A. niger (11), A. tubingensis (26), A. flavus (27), A. sydowii (3), A. nidulans (1), A. clavatus (1) and Neosatorya fennelliae (1). This is the first report of A. tubuingensis in clinical field in Korea.

• Interdisciplinary Bio Central
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• v.3 no.2
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• pp.7.1-7.6
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• 2011

Background: Published manuscripts are the main source of biological knowledge. Since the manual examination is almost impossible due to the huge volume of literature data (approximately 19 million abstracts in PubMed), intelligent text mining systems are of great utility for knowledge discovery. However, most of current text mining tools have limited applicability because of i) providing abstract-based search rather than sentence-based search, ii) improper use or lack of ontology terms, iii) the design to be used for specific subjects, or iv) slow response time that hampers web services and real time applications. Results: We introduce an advanced text mining system called PubMine that supports intelligent knowledge discovery based on diverse bio-ontologies. PubMine improves query accuracy and flexibility with advanced search capabilities of fuzzy search, wildcard search, proximity search, range search, and the Boolean combinations. Furthermore, PubMine allows users to extract multi-dimensional relationships between genes, diseases, and chemical compounds by using OLAP (On-Line Analytical Processing) techniques. The HUGO gene symbols and the MeSH ontology for diseases, chemical compounds, and anatomy have been included in the current version of PubMine, which is freely available at http://pubmine.kobic.re.kr. Conclusions: PubMine is a unique bio-text mining system that provides flexible searches and analysis of biological entity relationships. We believe that PubMine would serve as a key bioinformatics utility due to its rapid response to enable web services for community and to the flexibility to accommodate general ontology.

• Proceedings of the KSR Conference
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• 2011.10a
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• pp.374-374
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• 2011

Recently the construction of railway sections passing the central area of cities and stations under railway lines are increasing, and then it is urgently required to take the countermeasures against the railway vibration and the second-phase noise radiated from it. The most efficient countermeasure, out of technologies developed up to now, is the floating slab track which is the track system isolated from the sub-structure by springs. In other countries, the source technologies for anti-vibration design and vibration isolator - one of key components - have been developed and many installation experiences have been accumulated. However, in Korea, since the system design technology and technologies for key components are not yet developed, the foreign system are being introduced without any adjustment, and the key component, vibration isolator, depends on imports. In this study, based on the results of previous studies of the dust-control device installation using the slab and go through time after lifting impressive when stepped on power generated by the cross-section of the slab and shear connection re-examined the structural stability.