• Title/Summary/Keyword: Procedure Quality

Search Result 1,880, Processing Time 0.03 seconds

Development and Validation of an HPLC Method for the Pharmacokinetic Study of Fexofenadine in Human (테르페나딘 체내동태 연구를 위한 혈청 중 펙소페나딘의 HPLC 정량법 개발 및 검증)

  • Cho, Hye-Young;Kang, Hyun-Ah;Kim, Yoon-Gyoon;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.35 no.6
    • /
    • pp.437-443
    • /
    • 2005
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of a major metabolite of terfenadine, fexofenadine, in human serum was developed, validated, and applied to the pharmacokinetic study of terfenadine. Fexofenadine and internal standard, haloperidol were extracted from human serum by liquid-liquid extraction with acetonitrile and analyzed on a $Symmetry^{TM}$ C8 column with the mobile phase of 1% triethylamine phosphate (pH 3.7)-acetonitrile (67:33, v/v, adjusted to pH 5.6 with triethylamine). Detection wavelength of 230 nm for excitation, 280 nm for emission and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed fexofenadine concentration (50 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 10-500 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 10 ng/mL, which was sensitive enough for the pharmacokinetic studies of terfenadine. The overall accuracy of the quality control samples ranged from 95.70 to 114.58% for fexofenadine with overall precision (% C.V.) being 3.53-14.39%. The relative mean recovery of fexofenadine for human serum was 90.17%. Stability studies (freeze-thaw, short-term, extracted serum sample and stock solution) showed that fexofenadine was stable during storage, or during the assay procedure in human serum. However, the storage at $-70^{\circ}C$ for 4 weeks showed that fexofenadine was not stable. The peak area and retention time of fexofenadine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of fexofenadine in human serum samples for the pharmacokinetic studies of orally administered Tafedine tablet (60 mg as terfenadine) at three different laboratories, demonstrating the suitability of the method.

Development and Validation of an HPLC Method for the Pharmacokinetic Study of Etodolac in Human (에토돌락 체내동태 연구를 위한 혈청 중 에토돌락의 HPLC 정량법 개발 및 검증)

  • Cho, Hea-Young;Kang, Hyun-Ah;Moon, Jai-Dong;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.35 no.4
    • /
    • pp.265-271
    • /
    • 2005
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of etodolac in human serum was developed, validated, and applied to the pharmacokinetic study of etodolac. Etodolac and internal standard, ibuprofen were extracted from human serum by liquid-liquid extraction with hexane/isopropanol (95:5, v/v) and analyzed on a Luna C18(2) column with the mobile phase of 1% aqueous acetic acid-acetonitrile (4:6, v/v). Detection wavelength of 227 nm and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^3$ factorial design using a fixed etodolac concentration $(1\;{\mu}g/mL)$ with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of $0.05-40\;{\mu}g/mL$ with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 0.05 ${\mu}g/mL$, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 92.00 to 110.00% for etodolac with overall precision (% C.V.) being 1.08-10.11%. The percent recovery for human serum was in the range of 76.73-115.30%. Stability studies showed that etodolac was stable during storage, or during the assay procedure in human serum. The peak area and retention time of etodolac were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of etodolac in human serum samples for the pharmacokinetic studies of orally administered Lodin XL tablet (400 mg as etodolac) at three different laboratories, demonstrating the suitability of the method.

An Implementation of Bandwidth Broker Based on COPS for Resource Management in Diffserv Network (차별화 서비스 망에서 COPS 기반 대역 브로커 설계 및 구현)

  • 한태만;김동원;정유현;이준화;김상하
    • Journal of Korea Multimedia Society
    • /
    • v.7 no.4
    • /
    • pp.518-531
    • /
    • 2004
  • This paper discusses a testbed architecture for implementing scalable service differentiation in the Internet. The differentiated services (DiffServ) testbed architecture is based on a model in which a bandwidth broker (BB) can control network resources, and the ALTQ can reserve resources in a router to guarantee a Quality of Service (QoS) for incoming traffic to the testbed. The reservation and releasemessage for the ALTQ is contingent upon a decision message in the BE. The BB has all the information in advance, which is required for a decision message, in the form of PIB. A signaling protocol between the BB and the routers is the COPS protocol proposed at the IETF. In terms of service differentiation, a user should make an SLA in advance, and reserve required bandwidth through an RAR procedure. The SLA and RAR message between a user and the BB has implemented with the COPS extension which was used between a router and the BB. We evaluates the service differentiation for the video streaming in that the EF class traffic shows superb performance than the BE class traffic where is a network congestion. We also present the differentiated service showing a better packet receiving rate, low packet loss, and low delay for the EF class video service.

  • PDF

Surgical Treatment of Gastric Cancer

  • Kim, Sang-Woon
    • Journal of Yeungnam Medical Science
    • /
    • v.20 no.2
    • /
    • pp.105-116
    • /
    • 2003
  • Definitely, treatment for gastric cancer is primarily surgical. Detection in early stage of disease and complete surgical resection is the best way to cure gastric cancer. If surgery is planned, careful preoperative evaluation and corrections of physiologic and psychologic abnormalities are essential to reduce perioperative morbidity or mortality. Basic principle of gastrectomy for gastric cancer is an en bloc resection of tumor with adequate margins of normal tissue and with regional lymph nodes and omental tissues. To complete these principles, regional lymph nodes and all omental tissues should be removed altogether during performing various types of gastric resection. The lymph node dissection is one of the most effective procedures for gastric cancer to achieve curative resection. The basic types of gastric resection are distal subtotal gastrectomy and total gastrectomy according to the condition of primary lesions and the status of lymph node metastases. When the primary lesion is located near the esophagogastric junction, it is sometimes hard for a surgeon to select adequate surgical method. Postoperative quality of life in a patient has become a very important factor to be considered in every step of surgical therapy. With increasing incidence of early gastric cancer, a number of surgical trials for limited surgery or endoscopic procedures have been performed, but the long-term clinical results should be carefully analyzed to define the clinical relevance of these new techniques. For patients with disseminated gastric cancer, a palliative procedure can be performed to improve quality of life of patients and to avoid immediate death due to the cancer-related complications.

  • PDF

Study on the Manufacturing of Chitosan Using Krill(Euphausia superba Dana) and Quality Characteristics (크릴을 이용한 키토산 제조 및 품질 특성)

  • Do, Jeong-Ryong;Park, In-Sung;Rhee, Seong-Kap;Kim, Dong-Soo
    • Applied Biological Chemistry
    • /
    • v.43 no.4
    • /
    • pp.309-313
    • /
    • 2000
  • For the use of Antartic krill(Euphausia superba Dana) as food resource, general composition, extracting condition of chitin and quality characteristics of chitosan were investigated. General composition of frozen krill(Euphausia superba Dana) was consisted of moisture 79.0%, protein 13.1%, lipid 4.0%, VBN 7.7mg%, ash 2.7%, others 1.2% and that of dried krill powder was moisture 5.6%, protein 56.1%, lipid 18.8%, ash 11.4%, others 8.1%. The condition of chitin extraction from krill powder was treated with 1N NaOH at $40^{\circ}C$ for removing protein, 1N HCl for excepting mineral substances and methanol for decoloring. The yield of chitin by new procedure developed was 3.7%. The composition of extracted chitin contents was moisture 7.1%, ash 0.4%, protein 3.5%, lipid 3.1%. The results of degree of deacetylation in chitosan at 50% NaOH, $121^{\circ}C$, for 2 hrs was showed 82%. At the same alkali concentration and reaction concentration, a longer reaction time gave a decreased degree of deacetylation. The apparant viscosity was 0.09241 Pa in 1% chitosan from krill and 0.13826 Pa in standard chitosan.

  • PDF

Construction and Validation of Infection Control Practice Scale for Dental Hygienist (치과위생사의 감염관리 실천도 측정도구의 개발과 타당화)

  • Cho, Young-Sik;Jun, Bo-Hye;Choi, Young-Suk
    • Journal of dental hygiene science
    • /
    • v.9 no.1
    • /
    • pp.53-59
    • /
    • 2009
  • Infection control is now recognized as an important quality indicator in dental health service setting. The purpose of this study was to develop and validate Dental Hygienist's Infection Control Practice Scale for quality management of dental health service in Korea. The data of 254 dental hygienists was subjected to exploratory factor analysis using SPSS 16.0 and confirmatory factor analysis using AMOS 16.0. The total items of preliminary scale were 21 items and 5 subscale. Principal component analysis was completed with Varimax rotation. The results show a change in factor structure from 5 factor solution to 4 factor solution. The confirmatory factor analysis confirmed the four subscales(Immunization and periodic tests, Clinical procedure, Handwashing, Personal protection) which have a total of 12 items. After the item deleted because factor loading was low, measured model was tested. The results of the measurement model indicated fit indices: $x^2$= 79.593(df = 38, 0 = 0.000), RMR = 0.045, GFI = 0.940, CFI = 0.904, AGFI = 0.896, NFI = 0.837, TLI = 0.861, RMSEA = 0.67. The squared correlation between four constructs were less than the average variance extracted(AVE) of four constructs. Multiple regression analysis was completed. Dependent variable was the perceived infection control practice by dental hygienist. Independent variables were four summated subscales(R = 0.552, $R^2$= 0.304, Adjusted $R^2$= 0.431, F = 25.813, p = 0.000). Unstandardized coefficients of three independent variables were statistically significant.

  • PDF

A Study on the Issues and Improvement of the Existing Environmental Impact Assessment System - Evaluation in an operator Viewpoint - (현행 환경영향평가 제도의 문제점과 개선방안 - 실무자적 관점에서 검토 -)

  • Lee, Seung-Won;Kim, Jung-gun;Seo, Jung-Kuk
    • Journal of Environmental Science International
    • /
    • v.27 no.5
    • /
    • pp.281-289
    • /
    • 2018
  • The Korean environmental impact assessment(EIA) system, and explored ways to improve it as a more efficient and viable institution relevant to the demand of our time and conditions in study. The first problem this study identified is found in the fact that the party to write up the assessment report is itself the business operator or the one who is planning to work out the business plan. This structure translates into placing an order with an agent for EIA report. The reporting job may br subcontracted to the agent at a cost far below the rate specified in the 'Standard for Estimate of Agency Fee for Environmental Impact Assessment.' This practice also causes the vicious circle of producing a report that is written to justify the project or business in question or it leads to rough-and ready and poor documentation to minimize the time required. Second, in order to achieve the goal of the plan or business, which is the target of EIA, the local residents tend to ve regarded as an obstacle. This means elimination of the local people from participating in the EIA or their opinion being frequently ignored. This is the seed of distrust and hostility that sometimes provoke disagreements or fierce conflicts. The first proposal to improve these problem is to improve the factors that cause poor documentation of the assessment report as well as improve the understanding of the EIA system. This study proposes the following measures for improvement. The agency cost for EIA should be paid by the business operator or a third party that can ensure faithful implementation of the payment. A system should be established to verify transparent estimation of the agency cost. In order to enhance the professional quality of EIA agents, there should be implementation of qualification test for industrial engineer of related engineers in addition to the current EIA Qualification Test. The second proposal for improvement is to improve the citizen participation process by instituting a legal framework to make clear the purpose of the briefing session for local residents, which is held as a procedure of EIA, and to ensure more positive publicity during the stage of listening to the opinion of the local community. For a smooth and rational communication process, a moderator and a communicator of opinion, as is the case in a public hearing, could be instituted to clearly get the purpose of the briefing session across to the residents and to help to carry out the explanation and Q & A sessions according to the categories of the opinion of the residents. At present, the notification of the public inspection of the draft of the assessment report and briefing session for the residents is made on the newspaper and internet network. But some people have difficulty with access to this method of announcement. A higher participation rate could be secured if a legal provision is added to specify putting up placards in specific places such as the entrance to the place for the briefing session for residents or the building of administrative agencies of the area concerned.

Quality and Sensory Characteristics of Bechamel Sauce with Various Amounts of Chungkukjang Powder (청국장파우더를 첨가한 베샤멜소스의 품질 및 관능적 특성)

  • Park, Ki-Bong;Choi, Soo-Keun
    • Culinary science and hospitality research
    • /
    • v.18 no.3
    • /
    • pp.252-265
    • /
    • 2012
  • This study was intended to develop a value-added and functional sauce with addition of Chungkukjang powder. This study was conducted as the following procedure. 10%, 20%, 30%, and 40% of Chungkukjang powder was respectively added to make different Bechamel sauces. And then, physical testing (moisture, color value, viscosity, salinity, spreadability and pH) and sensory testing (a quantitative descriptive analysis and an acceptance test) were performed. After that, the correlation between the physical testing and the sensory testing was investigated to choose an optimal mixture ratio. The study results are presented as follows. As the addition percentage of Chungkukjang powder increased, a-value, b-value, salinity, spreadability, and pH significantly increased (p<0.001), but moisture content, L-value and viscosity decreased. The QDA result indicated that, regarding color intensity(5.89), Chungkukjang flavor(5.32) and Chungkukjang taste(6.26), the 40% addition group had the highest value, and that, regarding thickness(6.42), milk flavor(5.00), oily taste(5.21), mouth feel(5.32), the control group had the highest value. As a result, as the addition percentage of Chungkukjang powder increased, color intensity, Chungkukjang flavor, and Chungkukjang taste increased, but thickness, milk flavor, oily taste, and mouth feel decreased. According to the result of acceptance test, the 20% addition group had the highest value in terms of appearance, flavor, taste, glossy and overall acceptance. As shown earlier, it is considered that proper addition of Chungkukjang powder positively affects the overall acceptance, and that the 20% addition of Chungkukjang powder is most suitable to improve the sensory and physical quality-characteristics of Bechamel sauce.

  • PDF

Issues on User Participation in Korean Disability Services : Implications from UK Community Care (영국 커뮤니티케어의 이용자 참여 기제와 한국 장애인복지서비스에 대한 함의)

  • Kim, Yong-Deug
    • Korean Journal of Social Welfare
    • /
    • v.57 no.3
    • /
    • pp.363-387
    • /
    • 2005
  • The purpose of this study is to find out implications which can be useful for enhancement of user participation in Korean disability services from UK community care experience. In Korea, until recently dominant issue on social services always has been the shortage of service provision. But during the recent 20 years, we experienced great expansion in quantity, as though it may be not yet enough. And more recently, disabled people and organizations began to actively argue for appropriate service in quantity and quality. Now, Korean disability policy and practice are confronted to the difficult and embarrassing task how to meet the need of disabled people with limited resources, and how to response to the disabled people's voice arguing on independence and choice. This task would require somewhat deliberate reform which might be quite different from previous one. UK's experience of implementation and development of community care system would give meaningful implications to Korean disability service policy and practice related to user participation. The results of the review on user participation issues in the UK community care give several implications to Korean disability services. Above all, consumerist approach which is the key strategy adopted by UK community care change is not appropriate for Korean disability service because of largely different service environment. The second implication is about decentralization. To enable decentralization of social service leads to enhancement of user involvement avoiding a lowering of service quality, prerequisite conditions should be secured. A third is securing and making declaration on the disabled person's right to assessment and constructing public service system operated by case management process. Fourth, formalized complaints procedure should be established. Fifth, professional education which enables professionals to encourage participation of disabled people should be developed, and the role of disability movement leading disabled users to participate on their services also should be highlighted.

  • PDF

Effects of Seed Treatments for Promoting Seedling Emergence of Codonopsis lanceolata Trautv. (입묘율 향상을 위한 더덕 종자의 처리 효과)

  • Kang, Jin-Ho;Shim, Young-Do;Jeong, Jong-Il
    • Korean Journal of Medicinal Crop Science
    • /
    • v.9 no.1
    • /
    • pp.68-75
    • /
    • 2001
  • Reasonable seedling emergence is a prerequisite for successful crop cultivation especially in medicinal crops. The study was carried out to model the pretreatment or seed treatment of Codonopsis lanceolata seeds by evaluating the treatment effects of priming, $GA_3$, drying and water imbibition after drying on their germination and then their successive seed treatment on the basis of its seedling emergence. The priming using $Ca(NO_3)_2$ and $GA_3$ treatment under their different concentrations and light quality illuminated for 12 hours a day were separately done and the two best results from priming and $GA_3$ treatments were compared to determine the better one. The drying of imbibed seeds using the above best result and water imbibition of the dried seeds were successively done to measure the rates of germination and emergence. On the greatest germination rate of the first two individual treatments, priming was obtained at $Ca(NO_3)_2$ 150 mM under blue, red light or darkness for 2 days but $GA_3$ was done at 0.1 mM under blue light imposed for 3 days. However, the result of the latter $GA_3$ treatment was better than that of priming. $GA_3$ treated seeds were best desiccated under $35^{\circ}C$ and 4 hour red light illumination. A day water imbibition immediately before sowing increased the germination rate of seeds dried after $GA_3$ treatment. Seedling emergence tested after all 3 successive treatments, $GA_3$, drying and water imbibition before sowing was greater than the two others, only $GA_3$ treatment and the combination of $GA_3$ and drying, meaning that its pretreatment of seeds or seed treatment must follow the successive procedure of the above 3 ones.

  • PDF