• Title/Summary/Keyword: Validation Rate

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Full validation of high-throughput bioanalytical method for the new drug in plasma by LC-MS/MS and its applicability to toxicokinetic analysis

  • Han, Sang-Beom
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2006년도 추계학술대회
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    • pp.65-74
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    • 2006
  • Modem drug discovery requires rapid pharmacokinetic evaluation of chemically diverse compounds for early candidate selection. This demands the development of analytical methods that offer high-throughput of samples. Naturally, liquid chromatography / tandem mass spectrometry (LC-MS/MS) is choice of the analytical method because of its superior sensitivity and selectivity. As a result of the short analysis time(typically 3-5min) by LC-MS/MS, sample preparation has become the rate- determining step in the whole analytical cycle. Consequently tremendous efforts are being made to speed up and automate this step. In a typical automated 96-well SPE(solid-phase extraction) procedure, plasma samples are transferred to the 96-well SPE plate, internal standard and aqueous buffer solutions are added and then vacuum is applied using the robotic liquid handling system. It takes only 20-90 min to process 96 samples by automated SPE and the analyst is physically occupied for only approximately 10 min. Recently, the ultra-high flow rate liquid chromatography (turbulent-flow chromatography)has sparked a huge interest for rapid and direct quantitation of drugs in plasma. There is no sample preparation except for sample aliquotting, internal standard addition and centrifugation. This type of analysis is achieved by using a small diameter column with a large particle size(30-5O ${\mu}$m) and a high flow rate, typically between 3-5 ml/min. Silica-based monolithic HPLC columns contain a novel chromatographic support in which the traditional particulate packing has been replaced with a single, continuous network (monolith) of pcrous silica. The main advantage of such a network is decreased backpressure due to macropores (2 ${\mu}$m) throughout the network. This allows high flow rates, and hence fast analyses that are unattainable with traditional particulate columns. The reduction of particle diameter in HPLC results in increased column efficiency. use of small particles (<2 urn), however, requires p.essu.es beyond the traditional 6,000 psi of conventional pumping devices. Instrumental development in recent years has resulted in pumping devices capable of handling the requirements of columns packed with small particles. The staggered parallel HPLC system consists of four fully independent binary HPLC pumps, a modified auto sampler, and a series of switching and selector valves all controlled by a single computer program. The system improves sample throughput without sacrificing chromatographic separation or data quality. Sample throughput can be increased nearly four-fold without requiring significant changes in current analytical procedures. The process of Bioanalytical Method Validation is required by the FDA to assess and verify the performance of a chronlatographic method prior to its application in sample analysis. The validation should address the selectivity, linearity, accuracy, precision and stability of the method. This presentation will provide all overview of the work required to accomplish a full validation and show how a chromatographic method is suitable for toxirokinetic sample analysis. A liquid chromatography/tandem mass spectrometry (LC-MS/MS) method developed to quantitate drug levels in dog plasma will be used as an example of tile process.

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소형 챔버법에 의한 건축자재의 휘발성유기화합물 방출량 측정 및 CFD해석 (Validating of small chamber method by CFD simulation and VOCs emission rate of construction materials.)

  • 김윤덕
    • 한국태양에너지학회 논문집
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    • 제26권3호
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    • pp.99-110
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    • 2006
  • This study focused on the emission rate of the construction materials. The method of study is as follows. First, validation of small chamber method to determine emission rate of construction material was performed by CFD simulation. For the result of this study, uniform air velocity in small chamber was founded, and small chamber as a test material for emission rate was validated. Second, the construction materials were categorized by their feature and the emission rate of volatile organic compound was determined. Totally, VOCs emission rate of 49 materials were determined.

유압 저하시험 모델과 자동차 연료필터의 토설율 측정 실험 연구 (A Study on Hydraulic Drawdown Test Model and Experimental Estimation of Desorption Rate Ratios of Fuel Filters)

  • 이재천;계중읍
    • 한국정밀공학회지
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    • 제20권9호
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    • pp.205-213
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    • 2003
  • This study describes the mathematical equation of drawdown test model and introduces the experimental test apparatus and procedure to estimate the desorption rate ratio of a filter. The characteristics of a hydraulic filtration system of drawdown test were demonstrated by numerical simulation for various properties of filters and operation conditions. Experiments for three kinds of fuel filters were conducted according to the proposed test method. And the test results of desorption rate ratio were compared with those values anticipated in precedent multipass filtration tests. Experimental results revealed the validation of drawdown test method proposed in this study. Domestic fuel filter yielded high desorption rate ratio comparing with other foreign products, which means that the Beta ratio decreases a lot during the test. The results also showed that filtration system model could be developed including desorption rate ratio to estimate the variable Beta ratio in service life.

Iodine Quantification on Spectral Detector-Based Dual-Energy CT Enterography: Correlation with Crohn's Disease Activity Index and External Validation

  • Kim, Yeon Soo;Kim, Se Hyung;Ryu, Hwa Sung;Han, Joon Koo
    • Korean Journal of Radiology
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    • 제19권6호
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    • pp.1077-1088
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    • 2018
  • Objective: To correlate CT parameters on detector-based dual-energy CT enterography (DECTE) with Crohn's disease activity index (CDAI) and externally validate quantitative CT parameters. Materials and Methods: Thirty-nine patients with CD were retrospectively enrolled. Two radiologists reviewed DECTE images by consensus for qualitative and quantitative CT features. CT attenuation and iodine concentration for the diseased bowel were also measured. Univariate statistical tests were used to evaluate whether there was a significant difference in CTE features between remission and active groups, on the basis of the CDAI score. Pearson's correlation test and multiple linear regression analyses were used to assess the correlation between quantitative CT parameters and CDAI. For external validation, an additional 33 consecutive patients were recruited. The correlation and concordance rate were calculated between real and estimated CDAI. Results: There were significant differences between remission and active groups in the bowel enhancement pattern, subjective degree of enhancement, mesenteric fat infiltration, comb sign, and obstruction (p < 0.05). Significant correlations were found between CDAI and quantitative CT parameters, including number of lesions (correlation coefficient, r = 0.573), bowel wall thickness (r = 0.477), iodine concentration (r = 0.744), and relative degree of enhancement (r = 0.541; p < 0.05). Iodine concentration remained the sole independent variable associated with CDAI in multivariate analysis (p = 0.001). The linear regression equation for CDAI (y) and iodine concentration (x) was y = 53.549x + 55.111. For validation patients, a significant correlation (r = 0.925; p < 0.001) and high concordance rate (87.9%, 29/33) were observed between real and estimated CDAIs. Conclusion: Iodine concentration, measured on detector-based DECTE, represents a convenient and reproducible biomarker to monitor disease activity in CD.

충돌사고 재구성 해석을 위한 차량 블랙박스의 개발 (Development of an Automobile Black Box for Reconstruction Analysis of Collision Accidents)

  • 이원희;한인환
    • 한국자동차공학회논문집
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    • 제12권2호
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    • pp.205-214
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    • 2004
  • This paper presents design concepts, specifications and performances of a newly developed Black Box, the reconstruction analysis tool with the records, and results of validation tests. The Black Box can detect crash accidents automatically, and record the vehicle's motion and driver's maneuvers during a pre-defined time period before and after the accident. The items of the Black Box included the acceleration, yaw-rate, vehicle speed, engine RPM, braking application, steering and several digital inputs for recording driver's maneuvers. To detect the accident-related-crash, it is important to understand characteristics of the crash signal, which are much different from those of normal driving. Therefore, analytical considerations should be taken in designing pre-filtering circuits and selecting appropriate parameters for identifying crash accidents. And, it is necessary to select proper combination of motion sensors and design proper pre-filtering circuits in order to describe the vehicle's motion. The analysis algorithms were developed and implemented which can perform accurate detection of crash accidents, simulating pre-crash trajectories, and calculating parameters for reconstruction analysis of crash accidents. The developed Black Box was installed on passenger cars and several types of validation tests were conducted. Through the tests, the accuracy of the recorded data and usefulness of the analysis tool for reconstruction have been validated.

Validation of RELAP5 MOD3.3 code for Hybrid-SIT against SET and IET experimental data

  • Yoon, Ho Joon;Al Naqbi, Waleed;Al-Yahia, Omar S.;Jo, Daeseong
    • Nuclear Engineering and Technology
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    • 제52권9호
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    • pp.1926-1938
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    • 2020
  • We validated the performance of RELAP MOD3.3 code regarding the hybrid SIT with available experimental data. The concept of the hybrid SIT is to connect the pressurizer to SIT to utilize the water inside SIT in the case of SBO or SB-LOCA combined with TLOFW. We investigated how well RELAP5 code predicts the physical phenomena in terms of the equilibrium time, stratification, condensation against Separate Effect Test (SET) data. We also conducted the validation of RELAP5 code against Integrated Effect Test (IET) experimental data produced by the ATLAS facility. We followed conventional approach for code validation of IET data, which are pre-test and post-test calculation. RELAP5 code shows substantial difference with changing number of nodes. The increase of the number of nodes tends to reduce the condensation rate at the interface between liquid and vapor inside the hybrid SIT. The environmental heat loss also contributes to the large discrepancy between the simulation results of RELAP5 and the experimental data.

Effective Validation Model and Use of Mobile-Health Applications for the Elderly

  • Lopez, Leonardo Juan Ramirez;Pinto, Edward Paul Guillen;Linares, Carlos Omar Ramos
    • Healthcare Informatics Research
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    • 제24권4호
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    • pp.276-282
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    • 2018
  • Objectives: Due to the uncontrolled increase of the mobile health applications and their scarce use by elderly for reason of absence credibility of measurements by lack scientific support, the aim of this study was to evaluate the differences between the biophysical measurements based on standard instrument against a mobile application using controlled experiments with elderly to propose an effective validation model of the developed apps. Methods: The subjects of the study (50 people) were elderly people who wanted to check their weight and cardiac status. For this purpose, two mobile applications were used to measure energy expenditure based on physical activity (Activ) and heart rate (SMCa) during controlled walking at specific speeds. Minute-by-minute measurements were recorded to evaluate the average error and the accuracy of the data acquired through confidence intervals by means of statistical analysis of the data. Results: The experimental results obtained by the Activ/SMCa apps showed a consistent statistical similarity with those obtained by specialized equipment with confidence intervals of 95%. All the subjects were advised and trained on the use of the applications, and the initial registration of data to characterize them served to significantly affect the perceived ease of use. Conclusions: This is the first model to validate a health-app with elderly people allowed to demonstrate the anthropometric and body movement differences of subjects with equal body mass index (BMI) but younger. Future studies should consider not only BMI data but also other variables, such as age and usability perception factors.

LC-MS/MS를 이용한 반려동물 사료에서 곰팡이독소 동시분석법 유효성 확인 (Validation of simultaneous mycotoxin analysis method in pet food using LC-MS/MS)

  • 최윤화;안우석;김지은;김두환
    • 한국동물위생학회지
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    • 제45권3호
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    • pp.237-242
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    • 2022
  • The simultaneous analysis of mycotoxins using LC-MS/MS, a food official analysis method, was applied with compound feed for pets with high consumer preferences. In this study, the linearity of all calibration curves showed good linearity of 0.99 or more. and both the accuracy (recovery rate) and precision (repeatability) criteria of the concentration range for each mycotoxin in the National Agricultural Products Quality Management Service's Validation and Verification Guidelines were met. And as a result of analyzing FAPAS QCM in the same way, it was assesed that the z-scores of Aflatoxin B1, Ochratoxin A, Zearalenone, and Fumonisin B1, were within ±2 range. This study showed that the application of the food official analysis method to compound feed for pets is suitable.

기술력평가 자료를 이용한 중소벤처기업 파산예측 판별모형에 관한 연구 (A Study on Predicting Bankruptcy Discriminant Model for Small-Sized Venture Firms using Technology Evaluation Data)

  • 성웅현
    • 기술혁신학회지
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    • 제9권2호
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    • pp.304-324
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    • 2006
  • 재무분석가들은 기업의 파산에 양향을 미치는 예측변수를 탐색하기 위해서 상당한 연구가 수행되어 왔다. 그러나 기술지향적 중소벤처기업은 일반적으로 역사적 재무자료가 부족하고, 기술경쟁력 수준에 따라 잠재적인 고성장과 고위험이 존재한다. 본 논문에서는 재무자료 대신에 기술력평가 자료를 이용하여 파산을 예측하기 위해서 파산예측 판별모형을 제안하였고, 모형의 정분류율을 통해서 예측력을 검증하기 위해서 교차타당성방법, 최대사후확률방법 등을 사용하였다. 분석결과 중소 벤처기업의 파산예측모형으로 선형판별모형이 로지스틱판별모형보다 적합한 모형이고, 표본자료에 대한 정분류율 추정은 약 69% 이고 정분류율 예측은 약 67% 가 될 것으로 기대된다.

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Uncertainty Analysis and Improvement of an Altitude TestFacility for Small Jet Engines

  • Jun, Yong-Min;Yang, In-Young;Kim, Chun-Taek;Yang, Soo-Seok;Lee, Dae-Sung
    • International Journal of Aeronautical and Space Sciences
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    • 제5권1호
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    • pp.46-56
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    • 2004
  • The verification and improvement of the measurement uncertainty have beenperformed in the altitude test facility for small gas turbine engines, which was built atthe Korea Aerospace Research Institute (KARI) in October 1999. This test is performedwith a single spool turbojet engine at several flight conditions. This paper discussesthe evaluation and validation process for the measurement uncertainty improvements usedin the altitude test facility. The evaluation process, defined as tests before the facilitymodification, shows that the major contnbutors to the measurement uncertainty are theflow meter discharge coefficient, the inlet static and total pressures, the cell pressureand the fuel flow rate. The measurement uncertainty is focused on the primary parametersof the engine performance such as airflow rate, thrust and specific fuel consumption (SFC).The validation process, defined as tests after the facility modification, shows that themeasurement uncertainty, in seal level condition, is tmproved to the acceptable level throughthe facility modification. In altitude test conditions, the measurement uncertainties arenot improved as much as the uncertainty in sea level condition.