• Title/Summary/Keyword: method validation

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Improvement of Performance for Online Certificate Status Validation (실시간 인증서 상태검증의 성능개선)

  • Jung, Jai-Dong;Oh, Hae-Seok
    • The KIPS Transactions:PartC
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    • v.10C no.4
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    • pp.433-440
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    • 2003
  • According as the real economic activities are carried out in the cyber world and the identity problem of a trade counterpart emerges, digital signature has been diffused. Due to the weakness for real-time validation using the validation method of digital signature, Certificate Revocation List, On-line Certificate Status Protocol was introduced. In this case, every transaction workload requested to verify digital signature is concentrated of a validation server node. Currently this method has been utilized on domestic financial transactions, but sooner or later the limitation will be revealed. In this paper, the validation method will be introduced which not only it can guarantee real-time validation but also the requesting node of certificate validation can maintain real-time certificate status information. This method makes the revocation management node update the certificate status information in real-time to the validation node while revoking certificate. The characteristic of this method is that the revocation management node should memorize the validation nodes which a certificate holder uses. If a certificate holder connects a validation node for the first time, the validation node should request its certificate status information to the above revocation management node and the revocation management node memorizes the validation node at the time. After that, the revocation management node inform the revocation information in real-time to all the validation node registered when a request of revocation happens. The benefits of this method are the fact that we can reduce the validation time because the certificate validation can be completed at the validation node and that we can avoid the concentration of requesting certificate status information to a revocation node.

Validation Process of HPLC Assay Methods of Drugs in Biological Samples (생체시료내 약물의 HPLC 분석법에 대한 유효성 검토방법)

  • Chi, Sang-Cheol;Jun, H.-Won
    • Journal of Pharmaceutical Investigation
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    • v.21 no.3
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    • pp.179-188
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    • 1991
  • An HPLC assay method of a drug to be applied to the pharmacokinetic studies of the drug should be completely validated. The validation process for an HPLC assay method in a biological sample was discussed using the data obtained from the development of HPLC method for the simultaneous quantitation of verapamil and norverapamil in human serum. The validation criteria included were specificity, linearity, accuracy, precision, sensitivity, recovery, drug stability, and ruggedness of an assay method.

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HPLC Method Validation for Quantitative Analysis of Scopoletin from Hot-Water Extract Powder of Artemisia annua Linné (기능성 원료 인정을 위한 제출자료 작성 가이드[민원인 안내서]에 따른 개똥숙 열수추출분말의 Scopoletin 분석을 위한 HPLC 분석법 밸리데이션)

  • Kim, Seon-Hee;Yoon, Kee Dong
    • Korean Journal of Pharmacognosy
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    • v.51 no.1
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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.

Validation of Radioanalytical Techniques for Nuclear Waste Characterisation

  • Warwick, Phillip E.
    • 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.

Validation Test of DEVS Models using SPN (SPN을 이용한 DEVS 모델의 타당성 검사)

  • 정영식
    • Journal of the Korea Society for Simulation
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    • v.1 no.1
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    • pp.77-86
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    • 1992
  • In this paper, we study validation test methods of DEVSA(Descrete Event system Specification) models using SPN(Stochastic Petri Net) models. We discuss conventional validation test methods, by which DEVS models can be transformed to SPN models, by reviewing the features of DEVS model. Based on the model transformation method, we define a new homogeneous function for validation test and suggest a new validation test method of DEVS models using the property of SPN models and the new homogeneous function.

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A VALIDATION METHOD FOR EMERGENCY OPERATING PROCEDURES OF NUCLEAR POWER PLANTS BASED ON DYNAMIC MULTI-LEVEL FLOW MODELING

  • QIN WEI;SEONG POONG HYUN
    • Nuclear Engineering and Technology
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    • v.37 no.1
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    • pp.118-126
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    • 2005
  • While emergency operating procedures (EOPs) occupy an important role in the management of various abnormal situations in nuclear power plants (NPPs), current technology for the validation of EOPs still largely depends on manual review. A validation method for EOPs of NPPs is thus proposed based on dynamic multi-level flow modeling (MFM). The MFM modeling procedure and the EOP validation procedure are developed and provided in the paper. Application of the proposed method to EOPs of an actual NPP shows that the proposed method provides an efficient means of validating EOPs. It is also found that the information on state transitions in MFM models during the management of abnormal situations is also useful for further analysis on EOPs including their optimization.

A Study on the Efficacy and Equivalence of D-antigen Quantitative Analysis through QbD6sigma Process (QbD6시그마 프로세스를 통한 D-항원 정량 시험법의 유효성과 동등성에 관한 연구)

  • Kim, Kang Hee;Hyun-jung, Kim
    • 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.

Validation Technique using variance and confidence interval of metamodel (근사모델의 분산과 신뢰구간을 이용한 모델의 정확도 평가법)

  • Han, In-Sik;Lee, Yong-Bin;Choi, Dong-Hoon
    • Proceedings of the KSME Conference
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    • 2008.11a
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    • pp.1169-1175
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    • 2008
  • The validation technique is classified with two methods whether to demand of additional experimental points. The method which requires additional experimental points such as RSME is actually impossible in engineering field. Therefore, the method which only use experimented points such as the cross validation technique is only available. But the cross validation not only requires considerable computational costs for generating metamodel each iterations, but also cannot measure quantitatively the fidelity of metamodel. In this research we propose a new validation technique for representative metamodels using an variance of metamodel and confidence interval information. The proposed validation technique computes confidence intervals using a variance information from the metamodel. This technique will have influence on choosing the accurate metamodel, constructing ensemble of each metamodels and advancing effectively sequential sampling technique.

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A Study on the Realtime Cert-Validation of Certification based on DARC (DARC 기반에서의 실시간 인증서 유효성 검증에 관한 연구)

  • 장홍종;이정현
    • Proceedings of the CALSEC Conference
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    • 2001.08a
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    • pp.155-163
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    • 2001
  • There are cases that revoke the certification because of disclosure of private key, deprivation of qualification and the expiration of a term of validity based on PKI. So, a user have to confirm the public key whether valid or invalid in the certification. There are many method such as CRL, Delta-CRL, OCSP for the cert-validation of certification. But these method many problems which are overload traffic on network and the CRL server because of processing for cert-validation of certification. In this paper we proposed the realtime cert-validation of certification method which solved problems that are data integrity by different time between transmission and receiving for CRL, and overload traffic on network and the CRL server based on DARC.

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A study on the Preconditions of Space Program Validation of Healthcare Architecture for Application of BIM Technology (병원건축의 BIM적용을 위한 공간프로그램유효성평가의 전제조건에 관한 연구)

  • Seong, Joonho;Kim, Khilchae
    • Journal of The Korea Institute of Healthcare Architecture
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    • v.19 no.2
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    • pp.19-30
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    • 2013
  • Purpose: The planning and design of hospital generally requires the participation and consultation of skilled experts since it has more complex space program than any other buildings. Therefore, the BIM systems for the planning of hospital have been tried continuously. The purpose of this study is to identify the precondition for space Program validation of healthcare architecture based on BIM, which is recently receiving wide attention. Method: For this study, United States, Australia and Finland's guidelines were analyzed among the description space program validation system in 14 overseas BIM Guidelines. And the propose precondition that can be applied to healthcare architecture from among these description of space program validation items, target, process etc for General building. Result: 1) spatial program validation is the following four evaluation phase. Step 1: Standard setting phase Step 2: BIM model accuracy assessment phase Step 3: space validation phase Step 4: Performance evaluation phase 2) The standards for the building elements at Standards Setting stage is considered to the standards for the architectural elements of General building. 3) Healthcare Architecture Area calculation method is considered to be reasonable that borrowing the area calculation standard of general architecture according to the UIA of international standards. However, Be proposed of measuring method that reflect the efficiency of the design process step-by-step area calculation method. The performance assessment indicators of reflect the Hospital uniqueness have to developed. And the research needs to be carried out continuously according to the purpose for healthcare architecture of feature-oriented. Implications: In this paper like to understanding that precondition of space program validation considering the BIM. As a result, understanding to condition about step of the evaluation, the evaluation standards. Is expected to keep the focus on the development of performance indicators that reflect the uniqueness of the hospital for the efficient evaluation of the Hospital building.