• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.17 no.4
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• pp.363-373
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• 2019

Waste characterisation associated with nuclear site decommissioning relies on radiochemical analysis of a diverse range of sample types, requiring extensive validation of analytical techniques using matrix-matched materials. The absence of relevant reference materials has hindered robust method development and validation. The paper discusses how method validation in support of nuclear waste characterisation can be achieved without using reference materials. The key stages in an analytical procedure are evaluated and a multi-stage approach is proposed with the ultimate aim of determining an operational envelope for an analytical procedure.

• YAKHAK HOEJI
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• v.50 no.3
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• pp.154-159
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• 2006

For the increasing demand for the validation of analytical results, one of the important concerns of the analyst is to be assured that the instrumentation is working to qualified conditions. In this study, we have investigated and compared several validation guidelines of the performance verification of UV-VIS spectrophotometer used in pharmacopoeias of major countries and UV-VIS instrument analytical companies, and we proposed the practically useful validation guidelines of UV-VIS spectrophotometer. Based on our proposed validation guidelines of UV-VIS spectrophotometer, several UV-VIS spectrophotometers used in drug manufacturing laboratories were validated for their performances.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.19 no.2
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• pp.96-101
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• 2009

The purpose of this study was to conduct the field validation of alternative method(ETM method) by using non-carcinogenic, and less toxic solvents than NIOSH (National Institute for Occupational Safety and Health) analytical method 5524 for measuring the airborne metalworking fluids in workplaces. We carried out the field validation test by using the exposure chamber, guaranteeing the air sampling homogeneously in a machining environment. The ETM mixed solvent presented the complete solubility of MWFs used in test field. Based on the field test data, the bias of the ETM method from reference method, NIOSH analytical method 5524, was from -7.0% to 5.1%. The overall uncertainty of the ETM nethod was 21.6%, which satisfied the NIOSH criteria for the sampling and analytical criteria.

• Korean Journal of Pharmacognosy
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• v.38 no.1
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• pp.19-21
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• 2007

Myristica fragrans has been used for the treatment of stomachache in East Asia. It is very important to determine the amount of myristicin in Myristica fragrans, because excess myristicin causes side effects. In this study, we developed and validated the method for determination contents of myristicin in Myristica fragrans which was purchased from various regions of Korea. The average content of myristicin in Myristica fragrans was 2.10% with the validated HPLC analysis method.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.19 no.3
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• pp.288-296
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• 2009

We conducted validation for asbestos quality control (QC) samples made by the developed method which was presented in our published paper. The main results of the validation study are as follows. The pooled coefficient variations of analytical results in three different concentrations (low, medium, and high concentration) for amosite and chrysotile were less than 20 %, which met the sample homogenicity criteria of NIOSH. Also we confirmed the homogenicity of asbestos samples by using the relocatable field slide. To evaluate the field applicability of the developed asbestos QC samples, the field validation was performed with four proficient asbestos analysts by using the statistical methods of AIHA asbestos PAT program. All analytical results from four asbestos analysts were located in the acceptable range.

• YAKHAK HOEJI
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• v.57 no.5
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• pp.362-368
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• 2013

High performance liquid chromatograph (HPLC) is the most frequently used analytical instrument in analytical laboratories for pharmaceutical analysis. In order to provide a high level of assurance for reliable data generated from the HPLC analysis, the performance qualification of the HPLC system is required. For this purpose, the performance of HPLC system should be regularly monitored by examining the key functions of the typical HPLC system (solvent delivery system, injector system, column oven, UV-VIS detector system). We have investigated the validation guidelines of the performance verification of these key modules for HPLC system. And we proposed and evaluated its validation guidelines and the related verification methods for pharmaceutical analysis that could be practically applied in Korea.

• The Transactions of the Korea Information Processing Society
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• v.7 no.4
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• pp.1112-1121
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• 2000

Design metrics that quantify the design phase play an important role in reducing system development cost because the problems in early phases of software development seriously affected the quality of the late products. Real-time systems such as telecommunication systems are so large that design quantification is more important in real-time system design. Although many metrics have been proposed, few of them are correctly validated. This paper revises the SDL metrics set proposed in earlier study [9] and perform an analytical validation o the metrics set. Axiomatic approach and dimensional analysis are used for metrics validation and the old metrics are revised ot satisfy the validation criteria.

• Geomechanics and Engineering
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• v.28 no.5
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• pp.437-454
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• 2022

The hydro-mechanical (HM) two-way sequential coupling in the TOUGH2-FLAC3D linking algorithm is validated completely and successfully in both M to H and H to M directions, which are initiated by mechanical surface loading for geomechanical validation and hydrological groundwater pumping for hydrogeological validation, respectively. For such complete and successful validation, a TOUGH2-FLAC3D linked numerical model is developed first by adopting the TOUGH2-FLAC3D linking algorithm, which uses the two-way (fixed-stress split) sequential coupling scheme and the implicit backward time stepping method. Two geomechanical and two hydrogeological validation problems are then simulated using the linked numerical model together with basic validation strategies and prerequisites. The second geomechanical and second hydrogeological validation problems are also associated with the Mandel effect and the Noordbergum and Rhade effects, respectively, which are three phenomenally well-known but numerically challenging HM effects. Finally, sequentially coupled numerical solutions are compared with either analytical solutions (verification) or fully coupled numerical solutions (benchmarking). In all the four validation problems, they show almost perfect to extremely or very good agreement. In addition, the second geomechanical validation problem clearly displays the Mandel effect and suggests a proper or minimum geometrical ratio of the height to the width for the rectangular domain to maximize agreement between the numerical and analytical solutions. In the meantime, the second hydrogeological validation problem clearly displays the Noordbergum and Rhade effects and implies that the HM two-way sequential coupling scheme used in the linked numerical model is as rigorous as the HM two-way full coupling scheme used in a fully coupled numerical model.

• Journal of Korean Society for Quality Management
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• v.50 no.4
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• pp.831-842
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• 2022

Purpose: This study carried out the Quality by Design (QbD)6σ process to verify the effectiveness and equivalence of the finished D-antigen quantitative test method, and compared the OFAT-based method validation and test result acceptance criteria with the Analytical Quality by Design (AQbD)-based method validation and test method. This is a study on how to reduce the risk of delay in permit change by increasing the reliability of permit data in the existing method by statistically analyzing the results. Methods: With the QbD6σ process, the effectiveness and equivalence of the D-antigen quantitative test method were verified with the data of the existing test method and the new test method. Results: Method validation tests are performed based on AQbD. Critical Method Parameters are identified through risk assessment, and single/combined actions are verified by designing and performing tests for Critical Method Parameters (analysis of variance, full factorial design method). Method validation can be effectively accomplished with the QbD6σ process. Conclusion: The use of QbD6σ can be used to achieve satisfactory results for both pharmaceutical companies and regulators by using appropriate statistical analytical methods for method validation as required by regulatory agencies.

• Spatial Information Research
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• v.21 no.2
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• pp.45-54
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• 2013

Analytical and simulation error models have the ability to describe (or realize) error-corrupted versions of spatial data. But the different approaches for modeling positional errors require an internal validation that ascertains whether the analytical and simulation error models predict correct positional errors in a defined set of conditions. This paper presents stochastic simulation models of a point and a line segm ent to be validated w ith analytical error models, which are an error ellipse and an error band model, respectively. The simulation error models populate positional errors by the Monte Carlo simulation, according to an assumed error distribution prescribed by given parameters of a variance-covariance matrix. In the validation process, a set of positional errors by the simulation models is compared to a theoretical description by the analytical error models. Results show that the proposed simulation models realize positional uncertainties of the same spatial data according to a defined level of positional quality.