• Title/Summary/Keyword: Over-G Protection

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Bioequivalence Test of Rebamipide 100 mg Tablets (레바미피드 100 mg 정제의 새울학적동등성)

  • Kim, Se-Mi;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.1
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    • pp.38-44
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    • 2008
  • Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.84$\sim$log 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

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Cancer Registration in Korea: The Present and Furtherance (암 등록사업의 현황과 추진방향)

  • Ahn, Yoon-Ok
    • Journal of Preventive Medicine and Public Health
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    • v.40 no.4
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    • pp.265-272
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    • 2007
  • It was not until 1975 that cancer registration was initiated in Korea; voluntary registration of cancer patients of training hospitals throughout the country began under the auspices of the Korean Cancer Society(KCS). However, an official cancer registration, the Korea Central Cancer Registry(KCCR), began on July 1st, 1980. Forty-five training and two non-training hospitals throughout the country initiated registration of patients in whom neoplasms had been found. Data related to case information specified are to be sent to the KCCR at the National Medical Center(it moved at National Cancer Center in 2000). The initial cancer registration of KCS was merged to the KCCR in 1980. Although the KCCR covers most all the large training hospitals in Korea, it cannot provide incidence data. It is, however, the only of its kind in the world, being neither hospital nor population based. The first population based cancer registry(PBCR) was launched in a small county, Kangwha(it has around 80,000 inhabitants), by Yonsei University Medical College in 1983. All data were collected by active methods, and incidence statistics for 1986-1992 appeared in Vol VII of the CI5. Another PBCR, Seoul Cancer Registry(SCR), started in 1991. It was supported by a civilian foundation, the Korean Foundation for Cancer Research. The basic idea of case registration of SCR was the incorporation of KCCR data to PBCR, e. g. dual sources of case registration, i.e., from the KCCR and also including cases diagnosed in small hospitals and other medical facilities. Assessing completeness and validity of case registration of SCR, the program and methodology used by the SCR was later extended to other large cities and areas in Korea, and the PBCR in each area was established. Cancer incidence statistics of Seoul for 1993-1997, Busan for 1996-1997, and Daegu for 1997-1998, as well as Kangwha for 1993-1997, appeared eventually in Vol VIII of the CI5. The Korean or 'pillar' model for a PBCR is a new one. The KCCR data file is a reliable basis, as a pillar, for a PBCR in each area. The main framework of the model for such a registry is the incorporation of a KCCR data file with data from additionally surveyed cases; the data related to cancer deaths, medical insurance claims, and visit-and surveillance of non-KCCR medical facilities. Cancer registration has been adopted as a national cancer control program by Korean government in 2004 as the Anti-Cancer Act was enacted. Since then, some officers have tried to launch a nation-wide PBCR covering whole country. In the meantime, however, cancer registration was interrupted and discontinued for years due to the Privacy Protection Law, which was solved by an amendment of the Anti-Cancer Act in 2006. It would be premature to establish the nation-wide PBCR in Korea. Instead, continuous efforts to improve the completeness of registration of the KCCR, to progress existing PBCRs, and to expand PBCRs over other areas are still to be devoted. The nation-wide PBCR in Korea will be established eventually with summation of the PBCRs of the Korean model.

Effects of Posttraumatic Hypothermia in an Animal Model of Traumatic Brain Injury(TBI) - Immunohistochemical Stain by TUNEL & β-APP - (실험적 외상성 뇌손상모델에서 외상 후 저체온법의 효과 - TUNEL과 β-APP Immunohistochemical Stain -)

  • An, Byeong Kil;Ha, Young Soo;Hyun, Dong Keun;Park, Chong Oon;Kim, Joon Mee
    • Journal of Korean Neurosurgical Society
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    • v.29 no.4
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    • pp.461-470
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    • 2000
  • Objective : Many investigators have demonstrated the protective effects of hypothermia following traumatic brain injury(TBI) in both animals and humans. It has long been recognized that mild to moderate hypothermia improves neurologic outcomes as well as reduces histologic and biochemical sequelae after TBI. In this study, two immunohistochemical staining using terminal deoxynucleotidyl-transferase-mediated biotin dUTP nick end labeling(TUNEL), staining of apoptosis, and ${\beta}$-amyloid precursor protein(${\beta}$-APP), a marker of axonal injury, were done and the authors evaluated the protective effects of hypothermia on axonal and neuronal injury after TBI in rats. Material and Method : The animals were prepared for the delivery of impact-acceleration brain injury as described by Marmarou and colleagues. TBI is achieved by allowing of a weight drop of 450gm, 1 m height to fall onto a metallic disc fixed on the intact skull of the rats. Fourty Sprague-Dawley rats weighing 400 to 450g were subjected to experimental TBI induced by an impact-acceleration device. Twenty rats were subjected to hypothermia after injury, with their rectal temperatures maintained at $32^{\circ}C$ for 1 hour. After this 1-hour period of hypothermia, rewarming to normothermic levels was accomplished over 30-minute period. Following 12 hours, 24 hours, 1 week and 2 weeks later the animals were killed and semiserial sagittal sections of the brain were reacted for visualization of the apoptosis and ${\beta}$-APP. Results : The density of ${\beta}$-APP marked damaged axons within the corticospinal tract at the pontomedullary junction and apoptotic cells at the contused cerebral cortex were calculated for each animal. In comparison with the untreated controls, a significant reduction in ${\beta}$-APP marked damaged axonal density and apoptotic cells were found in all hypothermic animals(p<0.05). Conclusion : This study shows that the posttraumatic hypothermia result in substantial protection in TBI, at least in terms of the injured axons and neurons.

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Guidelines for dental clinic infection prevention during COVID-19 pandemic (코로나 바이러스 대유행에 따른 치과 의료 관리 가이드라인)

  • Kim, Jin
    • Journal of Korean Academy of Dental Administration
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    • v.8 no.1
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    • pp.1-7
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    • 2020
  • Dental settings have unique characteristics that warrant specific infection control considerations, including (1) prioritizing the most critical dental services and provide care in a way that minimizes harm to patients due to delayed care, or harm to personnel from potential exposure to persons infected with the COVID-19 disease, and (2) proactively communicate to both personnel and patients the need for them to stay at home if sick. For health care, an interim infection prevention and control recommendation (COVID-19) is recommended for patients suspected of having coronavirus or those whose status has been confirmed. SARS-CoV-2, which is the virus that causes COVID-19, is thought to be spread primarily between people who are in close contact with one another (within 6 feet) through respiratory droplets that are produced when an infected person coughs, sneezes, or talks. Airborne transmission from person-to-person over long distances is unlikely. However, COVID-19 is a new disease, and there remain uncertainties about its mode of spreads and the severity of illness it causes. The virus has been shown to persist in aerosols for several hours, and on some surfaces for days under laboratory conditions. COVID-19 may also be spread by people who are asymptomatic. The practice of dentistry involves the use of rotary dental and surgical instruments, such as handpieces or ultrasonic scalers, and air-water syringes. These instruments create a visible spray that can contain particle droplets of water, saliva, blood, microorganisms, and other debris. While KF 94 masks protect the mucous membranes of the mouth and nose from droplet spatter, they do not provide complete protection against the inhalation of airborne infectious agents. If the patient is afebrile (temperature <100.4°F)* and otherwise without symptoms consistent with COVID-19, then dental care may be provided using appropriate engineering and administrative controls, work practices, and infection control considerations. It is necessary to provide supplies for respiratory hygiene and cough etiquette, including alcohol-based hand rub (ABHR) with 60%~95% alcohol, tissues, and no-touch receptacles for disposal, at healthcare facility entrances, waiting rooms, and patient check-ins. There is also the need to install physical barriers (e.g., glass or plastic windows) in reception areas to limit close contact between triage personnel and potentially infectious patients. Ideally, dental treatment should be provided in individual rooms whenever possible, with a spacing of at least 6 feet between the patient chairs. Further, the use of easy-to-clean floor-to-ceiling barriers will enhance the effectiveness of portable HEPA air filtration systems. Before and after all patient contact, contact with potentially infectious material, and before putting on and after removing personal protective equipment, including gloves, hand hygiene after removal is particularly important to remove any pathogens that may have been transferred to the bare hands during the removal process. ABHR with 60~95% alcohol is to be used, or hands should be washed with soap and water for at least 20 s.

Recent Developments in Law of International Electronic Information Transactions (국제전자정보거래(國際電子情報去來)에 관한 입법동향(立法動向))

  • Hur, Hai-Kwan
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.23
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    • pp.155-219
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    • 2004
  • This paper focuses on two recent legislative developments in electronic commerce: the "Uniform Computer Information Transactions Act" ("UCITA") of USA and the "preliminary draft convention on the use of data message in [international trade] [the context of international contracts]" ("preliminary draft Convention") of UNCITRAL. UCITA provides rules contracts for computer information transactions. UCITA supplies modified contract formation rules adapted to permit and to facilitate electronic contracting. UCITA also adjusts commonly recognized warranties as appropriate for computer information transactions; for example, to recognize the international context in connection with protection against infringement and misappropriation, and First Amendment considerations involved with informational content. Furthermore, UCITA adapts traditional rules as to what is acceptable performance to the context of computer information transactions, including providing rules for the protection of the parties concerning the electronic regulation of performance to clarify that the appropriate general rule is one of material breach with respect to cancellation (rather than so-called perfect tender). UCITA also supplies guidance in the case of certain specialized types of contracts, e.g., access contracts and for termination of contracts. While for the most part carrying over the familiar rules of Article 2 concerning breach when appropriate in the context of the tangible medium on which the information is fixed, but also adapting common law rules and rules from Article 2 on waiver, cure, assurance and anticipatory breach to the context of computer information transactions, UCITA provides a remedy structure somewhat modeled on that of Article 2 but adapted in significant respects to the different context of a computer information transaction. For example, UCITA contains very important limitations on the generally recognized common law right of self-help as applicable in the electronic context. The UNCITRAL's preliminary draft Convention applies to the use of data messages in connection with an existing or contemplated contract between parties whose places of business are in different States. Nothing in the Convention affects the application of any rule of law that may require the parties to disclose their identities, places of business or other information, or relieves a party from the legal consequences of making inaccurate or false statements in that regard. Likewise, nothing in the Convention requires a contract or any other communication, declaration, demand, notice or request that the parties are required to make or choose to make in connection with an existing or contemplated contract to be made or evidenced in any particular form. Under the Convention, a communication, declaration, demand, notice or request that the parties are required to make or choose to make in connection with an existing or contemplated contract, including an offer and the acceptance of an offer, is conveyed by means of data messages. Also, the Convention provides for use of automated information systems for contract formation: a contract formed by the interaction of an automated information system and a person, or by the interaction of automated information systems, shall not be denied on the sole ground that no person reviewed each of the individual actions carried out by such systems or the resulting agreement. Further, the Convention provides that, unless otherwise agreed by the parties, a contract concluded by a person that accesses an automated information system of another party has no legal effect and is not enforceable if the person made an error in a data message and (a) the automated information system did not provide the person with an opportunity to prevent or correct the error; (b) the person notifies the other party of the error as soon as practicable when the person making the error learns of it and indicates that he or she made an error in the data message; (c) The person takes reasonable steps, including steps that conform to the other party's instructions, to return the goods or services received, if any, as a result of the error or, if instructed to do so, to destroy such goods or services.

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Trend in Research and Application of Hard Carbon-based Thin Films (탄소계 경질 박막의 연구 및 산업 적용 동향)

  • Lee, Gyeong-Hwang;Park, Jong-Won;Yang, Ji-Hun;Jeong, Jae-In
    • Proceedings of the Korean Institute of Surface Engineering Conference
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    • 2009.05a
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    • pp.111-112
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    • 2009
  • Diamond-like carbon (DLC) is a convenient term to indicate the compositions of the various forms of amorphous carbon (a-C), tetrahedral amorphous carbon (ta-C), hydrogenated amorphous carbon and tetrahedral amorphous carbon (a-C:H and ta-C:H). The a-C film with disordered graphitic ordering, such as soot, chars, glassy carbon, and evaporated a-C, is shown in the lower left hand corner. If the fraction of sp3 bonding reaches a high degree, such an a-C is denoted as tetrahedral amorphous carbon (ta-C), in order to distinguish it from sp2 a-C [2]. Two hydrocarbon polymers, that is, polyethylene (CH2)n and polyacetylene (CH)n, define the limits of the triangle in the right hand corner beyond which interconnecting C-C networks do not form, and only strait-chain molecules are formed. The DLC films, i.e. a-C, ta-C, a-C:H and ta-C:H, have some extreme properties similar to diamond, such as hardness, elastic modulus and chemical inertness. These films are great advantages for many applications. One of the most important applications of the carbon-based films is the coating for magnetic hard disk recording. The second successful application is wear protective and antireflective films for IR windows. The third application is wear protection of bearings and sliding friction parts. The fourth is precision gages for the automotive industry. Recently, exciting ongoing study [1] tries to deposit a carbon-based protective film on engine parts (e.g. engine cylinders and pistons) taking into account not only low friction and wear, but also self lubricating properties. Reduction of the oil consumption is expected. Currently, for an additional application field, the carbon-based films are extensively studied as excellent candidates for biocompatible films on biomedical implants. The carbon-based films consist of carbon, hydrogen and nitrogen, which are biologically harmless as well as the main elements of human body. Some in vitro and limited in vivo studies on the biological effects of carbon-based films have been studied [$2{\sim}5$].The carbon-based films have great potentials in many fields. However, a few technological issues for carbon-based film are still needed to be studied to improve the applicability. Aisenberg and Chabot [3] firstly prepared an amorphous carbon film on substrates remained at room temperature using a beam of carbon ions produced using argon plasma. Spencer et al. [4] had subsequently developed this field. Many deposition techniques for DLC films have been developed to increase the fraction of sp3 bonding in the films. The a-C films have been prepared by a variety of deposition methods such as ion plating, DC or RF sputtering, RF or DC plasma enhanced chemical vapor deposition (PECVD), electron cyclotron resonance chemical vapor deposition (ECR-CVD), ion implantation, ablation, pulsed laser deposition and cathodic arc deposition, from a variety of carbon target or gaseous sources materials [5]. Sputtering is the most common deposition method for a-C film. Deposited films by these plasma methods, such as plasma enhanced chemical vapor deposition (PECVD) [6], are ranged into the interior of the triangle. Application fields of DLC films investigated from papers. Many papers purposed to apply for tribology due to the carbon-based films of low friction and wear resistance. Figure 1 shows the percentage of DLC research interest for application field. The biggest portion is tribology field. It is occupied 57%. Second, biomedical field hold 14%. Nowadays, biomedical field is took notice in many countries and significantly increased the research papers. DLC films actually applied to many industries in 2005 as shown figure 2. The most applied fields are mold and machinery industries. It took over 50%. The automobile industry is more and more increase application parts. In the near future, automobile industry is expected a big market for DLC coating. Figure 1 Research interests of carbon-based filmsFigure 2 Demand ratio of DLC coating for industry in 2005. In this presentation, I will introduce a trend of carbon-based coating research and applications.

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