시험 · 검사방법의 유효성 검증 방법 비교

황종연,이신우,김금희,허유정,유은진,김보경,김희중,이혜리,고상호,김지혜,전수아,이진주,이경로,홍석영,정현미,최종우 한국환경분석학회 2019 환경분석과 독성보건 Vol.22 No.3

One of the most important purposes of a validation method is to verify whether a test method is suitable for the purpose of the test. In this study, validation parameters that are used by national and international institutes for test and inspection bodies are classified. As a result of classifying these general factors, method validation parameters were performed, including the following cases: ① the confirmation of a new test method, ② comparison between a non-standardized test method and standardized method, ③confirmation of a test method needing such extensions as a test method verification, verification of the test method applied between other test institutes or analysts, ④ verification of the required similarity between test methods, and ⑤ revalidation of the previously verified test methods. The general parameters applied in the validation processes were classified as follows; specificity, selectivity, linearity, sensitivity, accuracy, precision, detection limit uncertainty, quantitative limit, and range. By a comparison of the validation guidelines or guideline parameters applied by the test and inspection bodies, the survey results were considered to be useful in preparing validation guidelines for environmental testing and inspection methods.

QbD6시그마 프로세스를 통한 D-항원 정량 시험법의 유효성과 동등성에 관한 연구

김강희,김현정 한국품질경영학회 2022 품질경영학회지 Vol.50 No.4

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.

인지진단모형 Q행렬 타당화 방법 간의 회복률 비교

김성은(Sung Eun Kim) 한국교육평가학회 2015 교육평가연구 Vol.28 No.3

인지진단모형에서의 Q행렬 불확정성을 보완하기 위한 다양한 통계적 Q행렬 타당화 방법들이 제안되고 있다. 이들 중 자료에 알맞은 방법을 선택하기 위해 Q행렬 타당화 방법들의 특징을 파악할 필요가 있으며, 정확성을 비교할 수 있다면 여러 Q행렬 타당화 방법을 이해하고 활용하는데 의미 있는 정보가 될 것이다. 따라서 본 연구는 현재까지 제안된 Q행렬 타당화 방법들을 종합하여 소개하고 각각의 특성에 대하여 논하였다. 또, 가장널리 사용되고 있는 ‘경험적 δ방법’과 비교적 최근에 개발된 ‘RSS방법’은 다양한 조건 하에서 모의실험을 진행하였다. 실험결과 RSS방법은 수정한 요소들 대부분이 실제로 오지 정된 요소인 경우가 많았으나 오지정 요소 가운데 일부만을 수정하였고, δ방법은 오지정된 요소 대부분을 수정하였으나 수정이 불필요한 요소도 함께 수정하는 경우가 많았다.또한 두 방법 모두 여러 번 반복 추정 과정에서 특정 문항 및 요소를 집중적으로 수정하는 경향을 보였다. Several static Q-matrix validation methods are suggested in order to implement the uncertainty of Q-matrix. The characteristics of these Q-matrix validation methods are required to be understood for selecting adequate methodologies for data, which can be significant information to comprehend and utilize several Q-matrix validation methods to compare the accuracy of each method. Therefore, this study comprehensively introduced the Q-matrix validation methods which have been proposed up to date and discussed each feature of these methods. In addition, the simulation study was conducted under a variety of conditions regarding empirical δ method which have been most widely utilized and RSS method which was developed somewhat recently. The experimental results were as follows. In the case of RSS method, the majority of revised elements were actually misspecified elements, however, only part of misspicified elements were revised. In case of δ method, the majority of misspecified elements were revised, however, the elements which did not require revision tended to be revised altogether. Also, there was a tendency that certain questions or elements were concentrated to be revised in the process of several iterations in both methods.

검사법 평가: 검사법 비교와 신뢰도 평가

공경애 이화여자대학교 의과학연구소 2017 EMJ (Ewha medical journal) Vol.40 No.1

The reliability of clinical measurements is critical to medical research and clinical practice. Newly proposed methods are assessed in terms of their reliability, which includes their repeatability, intra- and interobserver reproducibility. In general, new methods that provide repeatable and reproducible results are compared with established methods used clinically. This paper describes common statistical methods for assessing reliability and agreement between methods, including the intraclass correlation coefficient, coefficient of variation, Bland-Altman plot, limits of agreement, percent agreement, and the kappa statistic. These methods are more appropriate for estimating reliability than hypothesis testing or simple correlation methods. However, some methods of reliability, especially unscaled ones, do not clearly define the acceptable level of error in real size and unit. The Bland-Altman plot is more useful for method comparison studies as it assesses the relationship between the differences and the magnitude of paired measurements, bias (as mean difference), and degree of agreement (as limits of agreement) between two methods or conditions (e.g., observers). Caution should be used when handling heteroscedasticity of difference between two measurements, employing the means of repeated measurements by method in methods comparison studies, and comparing reliability between different studies. Additionally, independence in the measuring processes, the combined use of different forms of estimating, clear descriptions of the calculations used to produce indices, and clinical acceptability should be emphasized when assessing reliability and method comparison studies.

왕수분해와 결합한 자동분석법의 토양 중 불소시험 유효성 연구

나경호,윤인철,이정복,Na, Kyung-Ho,Yun, In-Chul,Lee, Jung-Bok 한국지하수토양환경학회 2010 지하수토양환경 Vol.15 No.5

The purpose of this research is to check the validation of an auto-analysis method combined with aqua regia digestion apparatus for improvement of water distillation method used as a fluorine test of soil. Fluorine contents of CaO used in the pretreatment course of water distillation method were 120 mg/kg ~ 5,064 mg/kg at the blank test, which was exceeded up to maximum 12.5 times of the soil standard, so it was estimated due to a effect of fluorine existing as impurities of CaO. The recovery test of the same samples indicated that water distillation method and auto-analysis method were 134.5mg/kg and 161.7mg/kg respectively, the recovery ratio of the latter was 16.8% higher than the formal. The validation test of two methods satisfied the standard, but auto analysis method was excellent more than distillation method. Also, auto analysis method could save a analysis time up to maximum 4.7 times by comparison with water distillation method.

병동 병원감염 환례수집 담당간호사에 의해 조사된 병원감염 감시기록의 정확도

조윤숙,김정순 대한감염학회 2000 감염 Vol.32 No.4

Validation Method for Autonomous Vehicles Using Scenario Analysis and Risk Assessment (SARA)

문병준,하성재 한국산업기술융합학회 2023 산업기술연구논문지 (JITR) Vol.28 No.3

In this study, we propose an autonomous vehicle safety validation method to address the limitations of existing vehicle safety validation methods. Using scenario analysis and risk assessment of the autonomous vehicle safety validation scenario, the proposed method determines the significance of scenario validation, difficulty of scenario implementation, and critical nature of accidents that occur during validation testing. Then, it calculates the autonomous vehicle test level based on these results. Various safety validation tests, such as audits, simulation tests, proving ground tests, and real road tests, were performed according to the calculated level. Based on the validation results, the proposed method enables authorities to request improvement in the original equipment manufacturer address areas and is expected to contribute to providing safe autonomous vehicles to consumers.

New Method for Simultaneous Quantification of 12 Ginsenosides in Red Ginseng Powder and Extract: In-house Method Validation

In, Gyo,Ahn, Nam-Geun,Bae, Bong-Seok,Han, Sung-Tai,Noh, Kil-Bong,Kim, Cheon-Suk The Korean Society of Ginseng 2012 Journal of Ginseng Research Vol.36 No.2

For quality control of components in Korean red ginseng powder and extract, a new method for simultaneous quantification of 12 ginsenosides ($Rg_1$, Re, Rf, $Rh_1$, $Rg_2$[S], $Rg_2$[R], $Rb_1$, Rc, $Rb_2$, Rd, $Rg_3$[S], and $Rg_3$[R]) was studied. Compared to the official method for quantification of marker substances (ginsenosides $Rg_1$ and $Rb_1$), the proposed methods were guaranteed by in-house method validation. Several criteria such as linearity, specificity, precision and accuracy were evaluated. For red ginseng powder, recovery (averaging 95% to 105%) was calculated, and analysis of variance was carried out to estimate the relative standard deviation (0.20% to 2.12%). For red ginseng extract, the average recovery rate was 90% to 99% and the relative standard deviation was 0.39% to 2.40%. These results indicate that the proposed method could be used in the laboratory for determination of 12 ginsenosides in red ginseng powder and extract. In addition, this method was found to be suitable for quality control of ginseng products and potentially offer time and cost benefits.

The Relationship between Internal and External Validity in the Experimental Research Method

정윤철 한국교육학회 2011 敎育學硏究 Vol.49 No.2

The research problem is concerned with the relationship between internal and external validity. Generally it is said that there is an inverse relationship between internal and external validity. Criticizing the inverse relationship, the study supports that generally there is a direct relationship between internal and external validity. The main research method is literature review. The main materials are books and journal articles which are related with research method and research validity especially. First of all the study brings out the problems which are incurred from the perspective of an inverse relationship. Then the author makes 2 arguments against the inverse relationship. That is, first there is no empirical data for the inverse relationship and the inverse relationship comes from the background of clinical research which is very different with educational research. Second, according to the logic of inverse relationship lab research is apt to have high internal validity and low external validity and field research is apt to have low internal validity and high external validity. However, Dipvoye et al. verified that there is no relationship between lab and field research, that is, internal and external validity. Also the author makes 2 arguments for the direct relationship. That is, first there are very similar threats to internal and external validity. So internal and external validity can be increased or decreased by controlling the same threats at the same time. Second, there is high probability that the representativeness of sample could be sustained or increased through the control of critical factors. That is, the lab research could have high internal and external validity through even controls.

New Method for Simultaneous Quantifi cation of 12 Ginsenosides in Red Ginseng Powder and Extract

Gyo In,Nam-Geun Ahn,Bong-Seok Bae,Sung-Tai Han,Kil-Bong Noh,Cheon-Suk Kim 고려인삼학회 2012 Journal of Ginseng Research Vol.36 No.2

For quality control of components in Korean red ginseng powder and extract, a new method for simultaneous quantifi cation of 12 ginsenosides (Rg₁, Re, Rf, Rh₁, Rg₂[S], Rg₂[R], Rb₁, Rc, Rb₂, Rd, Rg₃[S], and Rg₃[R]) was studied. Compared to the offi cial method for quantifi cation of marker substances (ginsenosides Rg1 and Rb₁), the proposed methods were guaranteed by in-house method validation. Several criteria such as linearity, specifi city, precision and accuracy were evaluated. For red ginseng powder, recovery (averaging 95% to 105%) was calculated, and analysis of variance was carried out to estimate the relative standard deviation (0.20% to 2.12%). For red ginseng extract, the average recovery rate was 90% to 99% and the relative standard deviation was 0.39% to 2.40%. These results indicate that the proposed method could be used in the laboratory for determination of 12 ginsenosides in red ginseng powder and extract. In addition, this method was found to be suitable for quality control of ginseng products and potentially offer time and cost benefi ts.