• 생약학회지
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• 제51권1호
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• pp.78-85
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• 2020

In this study, we shortly introduced the HPLC method validation guideline for the analysis of functional food which was released from the Ministry of Food and Drug Safety of Korea in Dec 2018. The HPLC method validation was performed through the aforementioned HPLC method validation guideline in order to quantitate scopoletin content from the hot-water extract powder of Artemisia annua Linné. The HPLC method was validated by evaluating specificity, accuracy, precision, limit of quantitation and linearity. All parameters were in the suitable ranges which are designated in the guideline, which indicated the current HPLC method is reliable to quantitate the scopoletin content from the hot-water extract of A. annua.

• 한국군사과학기술학회지
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• 제13권3호
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• pp.478-485
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• 2010

The vaccine is biological pretreatment that improves immunity to a particular disease. We can get immunity from producing antibody with injection antigen which has ability to defense against the disease. The ELISA is the most widely used method to measure antibody titer. We have developed and performed validation of ELISA according to the guideline of KFDA and ICH. In this paper, we have verified ELISA method is an excellent method to measure the titer of anti-PA antibody. We have constructed recombinant protective antigen among anthrax toxins and used as antigen of ELISA. In this validation, we have evaluated precision (repeatability, interlaboratory precision), specificity, linearity(range) and LOD, which are validation articles suggested by guideline. Inter-person precision was replaced with inter-laboratory precision. From the results, we have confirmed high precision in all experiments with CV under 20%.

• 한국원자력학회:학술대회논문집
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• 한국원자력학회 2004년도 요약집 춘계학술발표대회
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• pp.171.1-171.1
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• 2004

• 약학회지
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• 제50권3호
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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.

• 한국지진공학회:학술대회논문집
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• 한국지진공학회 2003년도 추계 학술발표회논문집
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• pp.49-57
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• 2003

Lately, a guideline for seismic design of electric substation facilities has been newly prepared and issued. The guideline adopts a new simplified dynamic analysis technique called "pseudo-resonance method" from the design code of Japan. The method can effectively consider resonance effect of structural system during earthquake motion. However, reliability and practical applicability of the method have not been fully guaranteed under the different seismic and engineering situations in Korea. This paper presents a validation study of the pseudo-resonance method for practical seismic analysis. For this purpose, various parametric studies have been performed using recorded earthquake motions and idealized substation equipment models. The results showed that the pseudo-resonance method can be effectively used for the practical seismic design of substation facilities in Korea.

• Toxicological Research
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• 제25권1호
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• pp.1-8
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• 2009

Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

• 자동차안전학회지
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• 제13권3호
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• pp.86-94
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• 2021

Since automated driving system (ADS) has great potential to innovate various fields of automobile and mobility industries, major countries are establishing safety standards for autonomous vehicles to support technology development. However, in order to prevent technology development from being hampered by the safety standards for technologies still under development, safety guidelines are applied until the technologies are mature. For example, the safety 'guideline' for level 4 ADS was published in December 2020 by the Ministry of Land, Infrastructure and Transport of Korea, while the safety 'standards' for level 3 ADS was promulgated in December 2019. In this study, the domestic safety guideline for level 4 ADS is analyzed with the guidelines of major advanced countries in terms of safety elements. As it takes a lot of time before the safety standards of level 4 ADS is introduced, it is expected that the safety guideline will be updated several times. As necessary considerations when updating the safety guideline, industry acceptance, harmonization between safety elements, validation methods of system performance, and the user options are discussed.

• 한국소음진동공학회:학술대회논문집
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• 한국소음진동공학회 2014년도 추계학술대회 논문집
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• pp.347-349
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• 2014

Model verification and validation (V&V) is a current research topic to build computational models with high predictive capability by addressing the general concepts, processes and statistical techniques. The hypothesis test for validity check is one of the model validation techniques and gives a guideline to evaluate the validity of a computational model when limited experimental data only exist due to restricted test resources (e.g., time and budget). The hypothesis test for validity check mainly employ Type I error, the risk of rejecting the valid computational model, for the validity evaluation since quantification of Type II error is not feasible for model validation. However, Type II error, the risk of accepting invalid computational model, should be importantly considered for an engineered products having high risk on predicted results. This paper proposes a technique named as the response-adaptive experimental design to reduce Type II error by adaptively designing experimental conditions for the validation experiment. A tire tread block problem and a numerical example are employed to show the effectiveness of the response-adaptive experimental design for the validity evaluation.

• 임상간호연구
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• 제17권2호
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• pp.176-191
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• 2011

Purpose: This methodological study translated, adapted, and validated the evidence based guideline of RNAO (Registered Nurses Association of Ontario) in Canada, for acute stroke care to domestic circumstances. Methods: Quality of the RNAO guideline was evaluated using AGREE tool. Then the guideline was translated into Korean and a preliminary guideline was established After checking content validation by an expert group, the Korean version of the guideline was applied to clinical settings to see its applicability. Results: The RNAO guideline in Korea was deemed appropriate. The Korean version of the guideline was drawn up with 56 items in 3 areas in stroke system related nursing, nursing of acute stroke inpatients, and stroke nursing assessment. A questionnaire survey was performed on appropriateness, enforceability, and applicability of those recommendations. A total of 54 recommendations were finalized after deleting 2 items below CVI 0.7 and correcting 3 items by taking professional advices. After trial application of the guideline to 40 stroke patients hospitalized at a ward of a hospital in Seoul, its performance was improved but was not statistically significant. Conclusion: This guideline is expected to contribute to improving nursing quality by offering it as a guide to evidence based practices for acute stroke care in Korea.

• 약학회지
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• 제57권5호
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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.