• Title/Summary/Keyword: Test & Evaluation (T&E)

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Bioavailability Evaluation of Two Ceftriaxone Formulations Using Two Way Crossover Design in Voluteers

  • Kwon, Kwang-Il;Bok, Soo-Jin;Kim, Moo-Heon;Lee, Chang-Hyun
    • Archives of Pharmacal Research
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    • v.18 no.4
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    • pp.237-242
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    • 1995
  • For the vioequivalence study of two ceftriaxone injection formulations ($Rocephin{\circledR}$ ; Roche, and Triaxone ; Hanmi0, the HPLC analytical method for the analysis of ceftriaxone in plasma was used. Fourteen healthy volunteers completed the study and each subject were IM in jected signle doses (1 g) of the test and the reference formulations in a two-way crossover design with an one week drug free interval between doses. Following each administration, plasma concentrations of ceftrixone were monitored over a period of 24 h. Bioequivalence parameters $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT determined from the data obtained for the two formulations were examined by analyses of variance (ANOVA) and other criteria and tests for bioequivalence. Results of ANOVA and confidence limits of test/reference ratios of $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within $100{\pm}20%$) except for $T_{max}$ The mean of $T_{max}$ showed only 6. 9% difference from the reference but the detection limit was 22.5% which is slightly over the 20% criteria. No pharmacokinetic parameters including Ka, Kel, Vd and Cl indicated significant difference in between the two fomulations. It was concluded that the data yielded fro the two cefriaxone formulations demonstrated that they were bioequivalent.

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Model-Based Architecture Design of the Range Safety Process for Live Fire Test with Enhanced Safety (실사격 시험 프로세스의 안전성 강화를 위한 MBSE 기반 아키텍처 연구)

  • Ye, Sung Hyuck;Lee, Jae-Chon
    • Journal of the Korea Safety Management & Science
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    • v.16 no.2
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    • pp.43-52
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    • 2014
  • In weapon systems development, live fire tests have been frequently adopted to evaluate the performance of the systems under development. Therefore, it is necessary to ensure safety in the test ranges where the live fire tests can cause serious hazards. During the tests, a special care must be taken to protect the test and evaluation (T&E) personnel and also test assets from potential danger and hazards. Thus, the development and management of the range safety process is quite important in the tests of guided missiles and artillery considering the explosive power of the destruction. Note also that with a newly evolving era of weapon systems such as laser, EMP and non-lethal weapons, the test procedure for such systems is very complex. Therefore, keeping the safety level in the test ranges is getting more difficult due to the increased unpredictability for unknown hazards. The objective of this paper is to study on how to enhance the safety in the test ranges. To do so, an approach is proposed based on model-based systems engineering (MBSE). Specifically, a functional architecture is derived utilizing the MBSE method for the design of the range safety process under the condition that the derived architecture must satisfy both the complex test situation and the safety requirements. The architecture developed in the paper has also been investigated by simulation using a computer-aided systems engineering tool. The systematic application of this study in weapon live tests is expected to reduce unexpected hazards and test design time. Our approach is intended to be a trial to get closer to the recent theme in T&E community, "Testing at the speed of stakeholder's need and rapid requirement for rapid acquisition."

A Comparision on Structure Analysis and Load Test of Driving Bogie for Electrical Multiple Unit (전동차 구동대차의 구조해석 및 하중시험 비교 고찰)

  • Kim W.K.;Yoon S.C;Kwon S.T.;Park O.J.
    • Proceedings of the Korean Society of Precision Engineering Conference
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    • 2005.06a
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    • pp.404-409
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    • 2005
  • This paper describes the result of structure analysis and load test for bogie frame. The purpose of the analysis and test is to evaluate an safety which body structure shall be considered fully sufficient rigidity so as to satisfy proper system function under maximum load. Bogie system consists of bogie frame, suspensions, wheel-sets, braking system and transmission system. Among these component, the bogie frame is most significant component subjected to the vehicle and passenger loads. The evaluation method is used the JIS E 4207 specification throughout the FEM analysis and static load test. The analysis and test results have been very safety and stable for design load conditions.

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A Study on Load Test of Bogie for High Speed Electrical Multiple Unit (고속용 전동차 대차의 하중시험에 관한 연구)

  • Kim W.K.;Yoon S.C.;Jun C.S.;Kwon S.T.
    • Proceedings of the Korean Society of Precision Engineering Conference
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    • 2005.10a
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    • pp.34-38
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    • 2005
  • This paper describes the result of load test of a bogie frame. The purpose of test is to evaluate the safety which bogie frame shall be considered fully sufficient rigidity so as to satisfy proper system function under maximum load. Bogie system consist of the bogie frame, suspensions, wheel-sets, a brake system and a transmission system. Among these component, the bogie frame is most significant component subjected to the vehicle and passenger loads. The evaluation method is used the JIS E 4207 specifications throughout the static load test. The test results have shown the bogie frame to be safe and stable under design load conditions.

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Research on Interoperability Level Assessment Regard of Tactical Data-Link Characteristics (전술데이터링크의 특성을 고려한 상호운용성 수준평가 연구)

  • Na, Hyeng-Doo;Cheon, Jae-Young;Lee, Nam-Yong
    • Journal of the Korea Institute of Military Science and Technology
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    • v.14 no.1
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    • pp.84-91
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    • 2011
  • The Systems Interoperability Test and Evaluation System(SITES) is an T&E support tool for both information system and weapon system. The SITES was developed by reference to the Level of Information Systems Interoperability(LISI) in US. We use the tool via MND Broad convergence Network(BCN) in order to assess information system's interoperability. Nowadays, there are many ongoing researches on expanding assessment capability into weapon systems. As part of those research topics, this paper analyze the characteristics of tactical data-link messages which is the way to exchange the information among the weapon systems, and reflect that characteristics in interoperability level assessment.

SE Model-Based Test & Evaluation System - Application Case for Smart UAV (SE 모델기반 시험평가 체계 - 스마트 무인기 적용사례)

  • Oh, Soo Hun;Kim, Yuen Tae;Lee, Joong Yoon
    • Journal of the Korean Society of Systems Engineering
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    • v.3 no.1
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    • pp.1-7
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    • 2007
  • For the systems engineering process-based development, all requirements of 'Smart UAV Development Program' have been constructed as the database of CORE(R), computer aided systems engineering tool. In this paper, the construction and application of model-based test & evaluation system using those database is described, which prevents omitting essential tests and performing unnecessary rests and enables automatic reflection of database changes and standardization of document formats.

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Statistical evaluation of the monotonic models for FRP confined concrete prisms

  • Hosseinpour, Farid;Abdelnaby, Adel E.
    • Advances in concrete construction
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    • v.3 no.3
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    • pp.161-185
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    • 2015
  • FRP confining is a widely used method for seismic retrofitting of concrete columns. Several studies investigated the stress-strain behavior of FRP confined concrete prisms with square and rectangular sections both experimentally and analytically. In some studies, the monotonic stress-strain behavior of confined concrete was investigated and compressive strength models were developed. To study the reliability of these models, thorough statistical tests are required. This paper aims to investigate the reliability of the presented models using statistical tests including t-test, wilcoxon rank sum test, wilcoxon signed rank test and sign test with a level of significance of 5%. Wilk Shapiro test was also employed to evaluate the normality of the data distribution. The results were compared for different cross section and confinement types. To see the accuracy of the models when there were no significant differences between the results, the coefficient of confidence was used.

Bioequivalence Evaluation of Two Brands of Cefixime 100 mg Capsule (Suprax and Alpha-Cefixime) in Korean Healthy Volunteers

  • Choi, Dong-Hyun;Burm, Jin-Pil
    • Biomolecules & Therapeutics
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    • v.15 no.3
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    • pp.182-186
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    • 2007
  • Cefixime is an orally absorbed cephalosporin with a broad spectrum of activity against Gram-negative bacteria and is highly resistant to beta-lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cefixime capsules, Suprax capsule (Dong-A Pharmaceutical Co., reference drug) and Alpha-Cefixime capsule (Alpha Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal subjects, $23.5{\pm}3.72$ years in age and $68.3{\pm}8.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. There was one week washout period between the doses. After one capsule containing 100 mg of cefixime was orally administered, plasma was taken at predetermined time intervals and the concentrations of cefixime in plasma were determined using HPLC with UV detector. 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. The results showed that the differences in $AUC_{t}$, $C_{max}$ and $T_{max}$ between two products were -3.91%, -2.23% and -3.18%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of $log0.8{\leq}{\delta}{\leq}log1.25$ (e.g., $log0.8786{\leq}{\delta}{\leq}log1.0523$ and $log0.8889{\leq}{\delta}{\leq}log1.0512$ for $AUC_{t}$ and $C_{max}$, respectively). The 90% confidence intervals using untransformed data was within ${\pm}20%$(e.g., $-10.37%{\leq}{\delta}{\leq}6.73%$ for $T_{max}$). All parameters met the criteria of KFDA for bioequivalence, indicating that Alpha-Cefixime capsule (Alpha Pharmaceutical Co.) is bioequivalent to Suprax capsule (Dong-A Pharmaceutical Co.).

Study on Performance and Meat Characteristics in Korean Native Commercial Chicken II. Study on Meat Characteristics in Korean Native Commercial Chicken by Feeding System (한국재래닭의 육용실용계의 발육 및 육질특성 구명 연구 2. 사료 급여체계에 따른 한국재래닭 육용실용계 계육의 특성)

  • 강보석;이상진;김상호;서옥석;나재천;장병귀;박범영;이종문;오봉국
    • Korean Journal of Poultry Science
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    • v.25 no.3
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    • pp.137-145
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    • 1998
  • This study was conducted to compare the meat characteristics Korean Native Commercial Chicken(KNCC) by feeding system Feeding system of T$_1$ and T$_2$were same types from hatch to 8 weeks, starter diets( 0~4 weeks, mash, ME 3,l00kcal, CP 22.94%), grower diets(4~8 weeks, crumble, ME 3,l00kcal, CP 19.31%). Nutrient contents of finisher diets of T$_1$(pellet, M.E 3, 200kcal, CP 20.44%) was higher than T$_2$(mash, ME 3,l00kcal, CP 14.88%). Breast and legs meat of KNCC were used to analyze chemical composition, physicochemical characteristics, textural traits and sensory evaluation test. Live weight(L.W) /abdominal fat accumulation(A.F.A) was significantly different(P<0.05), but live weight(L.W) /dressed weight(D.W), percentage of cutted meat, chemical composition(moisture, CF, EE, CA), meat color(CIE), physicochemical properties, sensory evaluation score were not significantly by feeding systerns, at 12 ar'd 16 weeks of age.

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On Multiple ETA-based Test Framework to Enhance Safety Maturity of Live Fire Tests for Weapon Systems (무기체계 실사격 시험의 안전성 강화를 위한 다중 사건나무분석 기반의 시험구조에 관한 연구)

  • Ye, Sung Hyuck;Lee, Jae-Chon
    • Journal of the Korea Safety Management & Science
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    • v.17 no.1
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    • pp.75-84
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    • 2015
  • Successful development of weapon systems requires a stringent verification and validation (V&V) process due to the nature of the weapons in which continual increase of operational capability makes the system requirements more complicated to meet. Thus, test and evaluation (T&E) of weapon systems is becoming more difficult. In such a situation, live fire tests appear to be effective and useful methods in not only carrying out V&V of the weapon systems under development, but also increasing the maturity of the end users operability of the system. However, during the process for live fire tests, a variety of accidents or mishaps can happen due to explosion, pyro, separation, and so on. As such, appropriate means to mitigate mishap possibilities should be provided and applied during the live fire tests. To study a way of how to accomplish it is the objective of this paper. To do so, top-level sources of hazard are first identified. A framework for T&E is also described. Then, to enhance the test range safety, it is discussed how test scenarios can be generated. The proposed method is based on the use of the anticipatory failure determination (AFD) and multiple event tree analysis (ETA) in analyzing range safety. It is intended to identify unexpected hazard components even in the environment with constraints. It is therefore expected to reduce accident possibilities as an alternative to the traditional root-cause analysis.