• 제목/요약/키워드: Acceptable limits

검색결과 234건 처리시간 0.028초

Bioequivalence Assessment of Two Brands (Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ vs. Wyeth Korea $\textrm{Ledercoat}^{(R)}$ 4 mg Tablets) of Triamcinolone in Healthy Male Human Volunteers

  • Kwon, Oh-Seung;Heesoo Pyoa;Jang, Moon-Sun;Chung, Youn-Bok
    • 한국응용약물학회:학술대회논문집
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    • 한국응용약물학회 2002년도 창립10주년기념 및 국립독성연구원 의약품동등성평가부서 신설기념 국재학술대회:생물학적 동등성과 의약품 개발 전략을 위한 국제심포지움
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    • pp.206-206
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    • 2002
  • The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ vs. Wyeth Korea $\textrm{Ledercoat}^{(R)}$) was assesed in healthy male Korean volunteers after oral administration of 16 mh triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0{\longrightarrow}last}$. $AUC_{0{\longrightarrow}imf}$, and $T_{1/2,\beta}$ were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to the United State or Korea Food and Drug Administration Guidelines. The analysis of variance did not show any signigicant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ tablet is bioequivalent to the $\textrm{Ledercoat}^{(R)}$ tablet produced by Wyeth Korea.

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튜브와 지지대 사이의 동적상호 충격력 측정장치 특성규명에 관한 연구 (A Study on the Characteristics of the Tube-to-Support Dynamic Impact Force Measurement Facility)

  • 김일곤;박진무
    • 소음진동
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    • 제5권1호
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    • pp.95-106
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    • 1995
  • Flow-induced vibration in heat exchanger (or fuel rod) in nuclar power plant can cause dynamic interactions between tubes and tube supports resulting in fretting-wear. To increase the reliability and design life of heat exchanger components, design criteria that establish acceptable limits of vibration and minimize fretting wear are necessary. The fretting-wear rate is dependent upon material combination, contact configuration, environmental conditions and tube-to tube support dynamic interaction. It is demostrated that the fretting -wear rate correlates well with tube-to-support contact force or work rate. The tube-to-support dynamic interaction, which consists of dynamic contact forces and tube motion, is used to relate single-span wear data to real heat exchanger configurations consisting of multi-span tube bundles. This paper describes the test facility to measure tube-to-support dynamic impact force and reports its dynamic characteristics through the four impact tests - a force transduces independent and external impact tests, central ring inside impact test and additional cylinder impact test. Through the tests the impact parameter change dependent upon the material difference of impacting ball is studied, and the impact parameters of Force Transducer Assembly components are measured. And also the dynamic behavior of Force Transducer Assembly is analyzed. The force measurement technique herein is shown to provide a reasonable measure of dynamic contact forces.

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Dental Implant 금속재료의 성분차이에 따른 세포독성에 관한 연구 (A STUDY ON CYTOTOXICITY OF THE NEW TITANIUM ALLOYS FOR DENTAL IMPLANT MATERIAL)

  • 김태인;한준현;이인석;이규환;신명철;최부병
    • 대한치과보철학회지
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    • 제34권4호
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    • pp.675-686
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    • 1996
  • Today, dental implants are an acceptable alternative, capable of providing bone-anchored fixed prostheses for improved quality of life and self esteem for many patients. Research advances in dental implantology have led to the development of several different types of materials, and it is anticipated that continued research will likewise lead to advanced dental implant materials. Currently used pure titanium has relatively low hardness and strength which possibly limits its ability to resist the functional loads as a dental implant. Ti-6Al-4V also has potential problems such as corrosion resistance, bone biocompatibility etc. The carefully selected Zr, Nb, Ta, Pd, In constituents could improve mechanical strength, corrosion resistance, and biocompatibility compared to that of currently used implant metals. On the basis of the totality of the data from our study, it can be concluded that new titanium alloys containing Zr, Nb, Ta, Pd, In are able to provide improved mechanical properties, corrosion resistance and biocompatibility to warrant further investigation of it's potential as new biomaterials for dental implants.

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Comprehensive Vibration Assessment Program for Yonggwang Nuclear Power Plant Unit 4

  • Huinam Rhee;Hwang, Jong-Keun;Kim, Tae-Hyung;Kim, Jung-Kyu;Song, Heuy-Gap;Kim, Beom-Shig
    • 한국원자력학회:학술대회논문집
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    • 한국원자력학회 1995년도 추계학술발표회논문집(2)
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    • pp.1001-1007
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    • 1995
  • A Comprehensive Vibration Assessment Program (CVAP) has been performed for Yonggwang Nuclear Power Plant Unit 4 (YGN 4) in order to verify the structural integrity of the reactor internals for flow induced vibrations prior to commercial operation. The theoretical evidence for the structural integrity of the reactor internals and the basis for measurement and inspection are provided by the analysis. Flow induced hydraulic loads and reactor internals vibration response data were measured during pre-core hot functional testing in YGN 4 site. Also, the critical areas in the reactor internals were inspected visually to check any existence of structural abnormality before and after the pre-core hot functional testing. Then, the measured data have been analyzed and compared with the predicted data by analysis. The measured stresses are less than the predicted values and the allowable limits. It is concluded that the vibration response of the reactor internals due to the flow induced vibration under normal operation is acceptable for long term operation.

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Fabrication of In-needle Microextraction Device Using Nichrome Wire Coated with Poly(ethylene glycol) and Poly(dimethylsiloxane) for Determination of Volatile Compounds in Lavender Oils

  • Lee, Eun Ji;Lee, Dong-Sun
    • Bulletin of the Korean Chemical Society
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    • 제35권1호
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    • pp.211-217
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    • 2014
  • A new needle-based device for headspace wire coated in-needle microextraction (HS-WC-INME) was fabricated using a nichrome wire coated with poly(ethylene glycol) (PEG) and poly(dimethylsiloxane) (PDMS) mixture. The proposed needle device was applied for the determination of volatile compounds in lavender and lavandin essential oils by gas chromatography. Fundamental parameters such as needle design, conditions of extraction and desorption were optimized along with the validation of the extraction and desorption efficiency. The optimal conditions were 30 min extraction at $50^{\circ}C$ and 2 min desorption at $240^{\circ}C$. The calibration curves showed good linearity with the suitable values of the coefficients of determination ($r^2$) greater than 0.99. The limits of detection for linalyl acetate, ${\beta}$-caryophyllene, linalool and (+)-limonene were 7.15, 9.04, 10.79 and 22.26 ng, respectively. Analytical recoveries were acceptable in the test samples, varying from 86.7% to 108.0%. The values of relative standard deviations for run to run showed range less than 0.9% while 3.9% through 7.2% for needle to needle. The proposed PEG-PDMS coating could be more suitable than PDMS coating to extract particular polar groups such as alcohols.

Robust feedback-linearization control for axial power distribution in pressurized water reactors during load-following operation

  • Zaidabadi nejad, M.;Ansarifar, G.R.
    • Nuclear Engineering and Technology
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    • 제50권1호
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    • pp.97-106
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    • 2018
  • Improved load-following capability is one of the most important technical tasks of a pressurized water reactor. Controlling the nuclear reactor core during load-following operation leads to some difficulties. These difficulties mainly arise from nuclear reactor core limitations in local power peaking: the core is subjected to sharp and large variation of local power density during transients. Axial offset (AO) is the parameter usually used to represent the core power peaking. One of the important local power peaking components in nuclear reactors is axial power peaking, which continuously changes. The main challenge of nuclear reactor control during load-following operation is to maintain the AO within acceptable limits, at a certain reference target value. This article proposes a new robust approach to AO control of pressurized water reactors during load-following operation. This method uses robust feedback-linearization control based on the multipoint kinetics reactor model (neutronic and thermal-hydraulic). In this model, the reactor core is divided into four nodes along the reactor axis. Simulation results show that this method improves the reactor load-following capability in the presence of parameter uncertainty and disturbances and can use optimum control rod groups to maneuver with variable overlapping.

ICSID 중재판정의 취소에 관한 연구 - 우리 중재법과의 비교를 중심으로 - (A Study on the "Annulment" of ICSID Arbitration Award - Focused on Comparison with the Arbitration Act of Korea -)

  • 김용일
    • 무역상무연구
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    • 제37권
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    • pp.133-158
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    • 2008
  • The purpose of this article is to examine the "Annulment" of ICSID Arbitration Award. Most of the international conventions provide for arbitration as the preferred method of dispute settlement. In general they either provide for ad hoc arbitration under the UNCITRAL Rules or under the rules of an acceptable arbitration institution, e.g. ICC, AAA, LCIA and in particular ICSID. The most distinctive feature of ICSID arbitration is the self-contained and exhaustive nature of its review procedures. Unlike other arbitration regimes, control is exercised by internal procedures rather than by the courts. Remedies against the award are limited to those provided for in the Convention and do not include court involvement. Especially, the annulment of the ICSID award by an ad hoc committee must be considered as jeopardizing ICSID Arbitration because it clearly depart from the current trends of international commercial arbitration which limits any kinds of judicial review and excludes any kinds of review on the merits. I wish that the future decisions of the ad hoc committees will restore a narrow scope to the ICSID procedure of annulment in order not to endanger the ICSID Arbitration mechanism.

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한국인에 의한 농약의 이론적 최대섭취량 및 안전지표의 산정 (Computation of Theoretical Maximum Daily Intake and Safety Index of Pesticides by Korean Population)

  • 이서래;이미경;김남형
    • 한국식품과학회지
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    • 제27권4호
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    • pp.618-624
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    • 1995
  • 우리나라에서 식품중 농약잔류 허용기준의 적합성을 평가하고 Codex 기준의 수용 가능성을 검토하기 위하여 허용기준치와 한국인의 식품계수 만을 적용한 농약성분의 이론적 최대섭취량을 계산한 다음 ADI 값과 비교하였다. 국내에서 허용기준이 설정된 105개 농약성분의 ADI 대비율은 대부분이 80% 이하 수준을 유지하고 있으나 ADI를 초과하는 농약은 13개 성분이었다. 한편 Codex 기준이 있는 82개 농약성분에서 ADI를 초과하는 농약은 20개 성분에 이르고 있다. 한국기준 또는 Codex 기준에서 ADI를 초과하는 22개 성분에 대해서는 그 원인을 지적하였으며 안전마진 확보를 위한 대책이 마련되어야 할 것이다.

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단일 임플란트지지 보철물의 후유증에 관한 체계적 연구 (A systematic review of the complications of single implant-supported restorations)

  • 장문택
    • Journal of Periodontal and Implant Science
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    • 제36권4호
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    • pp.925-938
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    • 2006
  • The aim of this study was to systematically investigate the complications of single implant-supported restorations followed more than 5-year. Thirty-five studies were selected for the systematic review. A total of 3932 single implants were included at the beginning of studies. Thirty-one implants were removed before loading and 91 implants after loading. The overall implant loss rate was 3.1 %. Implant losses were concentrated on the period between loading and 2-year follow-up, and, after a stable period, increased after 5-year follow-up. The mean marginal bone loss at single-tooth implants was well within 0.2 mm/year, i.e., acceptable annual bone loss by the implant success criteria. However, considerable amounts of single implants suffered a marginal bone loss at implant more than 0.2 mm/year. Fistula was a frequent biological complication in the early studies. The most frequent technical problem was a screw loosening, but its frequency was reduced after the use of a gold screw and torque controller. Within the limits of this study, the complications of single implants might be underestimated due to the lack of information about the biological and technical complications available in the relevant literature.

Assessment of non-prismatic beams having symmetrical parabolic haunches with constant haunch length ratio of 0.5

  • Yuksel, S. Bahadir
    • Structural Engineering and Mechanics
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    • 제42권6호
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    • pp.849-866
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    • 2012
  • Single span historic bridges often contain non-prismatic members identified with a varying depth along their span lengths. Commonly, the symmetric parabolic height variations having the constant haunch length ratio of 0.5 have been selected to lower the stresses at the high bending moment points and to maintain the deflections within the acceptable limits. Due to their non-prismatic geometrical configuration, their assessment, particularly the computation of fixed-end horizontal forces (FEFs) and fixed-end moments (FEMs) becomes a complex problem. Therefore, this study aimed to investigate the behavior of non-prismatic beams with symmetrical parabolic haunches (NBSPH) having the constant haunch length ratio of 0.5 using finite element analyses (FEA). FEFs and FEMs due to vertical loadings as well as the stiffness coefficients and the carry-over factors were computed through a comprehensive parametric study using FEA. It was demonstrated that the conventional methods using frame elements can lead to significant errors, and the deviations can reach to unacceptable levels for these types of structures. Despite the robustness of FEA, the generation of FEFs and FEMs using the nodal outputs of the detailed finite element mesh still remains an intricate task. Therefore, this study advances to propose effective formulas and dimensionless estimation coefficients to predict the FEFs, FEMs, stiffness coefficients and carry-over factors with reasonable accuracy for the analysis and re-evaluation of the NBSPH. Using the proposed approach, the fixed-end reactions due to vertical loads, and also the stiffness coefficients and the carry-over factors of the NBSPH can be determined without necessitating the detailed FEA.