Search results for: validation studies

Authors: Neli P. Zlatareva

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Ontology validation is an important part of web applications’ development, where knowledge integration and ontological reasoning play a fundamental role. It aims to ensure the consistency and correctness of ontological knowledge and to guarantee that ontological reasoning is carried out in a meaningful way. Existing approaches to ontology validation address more or less specific validation issues, but the overall process of validating web ontologies has not been formally established yet. As the size and the number of web ontologies continue to grow, the necessity to validate and ensure their consistency and interoperability is becoming increasingly important. This paper presents a validation technique intended to test the consistency of independent ontologies utilized by a common application.

Keywords: knowledge engineering, ontological reasoning, ontology validation, semantic web

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Authors: Shashank Tiwari, S. P. Mahapatra

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The aim of this technique is to reduce the steps of process scales up, save time & cost of the industries. This technique will minimise the steps of process scale up. The new steps are, Novel Lab Scale, Novel Lab Scale Trials, Novel Trial Batches, Novel Exhibit Batches, Novel Validation Batches. In these steps, it is not divided to validation batches in three parts but the data of trials batches, Exhibit Batches and Validation batches are use and compile for production and used for validation. It also increases the batch size of the trial, exhibit batches. The new size of trials batches is not less than fifty Thousand, the exhibit batches increase up to two lack and the validation batches up to five lack. After preparing the batches all their data & drugs use for stability & maintain the validation record and compile data for the technology transfer in production department for preparing the marketed size batches.

Keywords: batches, technique, preparation, scale up, validation

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Authors: Shahadut Hossain

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Measurement errors in continuous covariates and/or misclassifications in categorical covariates are common in epidemiological studies. Regression analysis ignoring such mismeasurements seriously biases the estimated main and interaction effects of covariates on the outcome of interest. Thus, adjustments for such mismeasurements are necessary. In this research, we propose a Bayesian parametric framework for eliminating deleterious impacts of covariate mismeasurements in logistic regression. The proposed adjustment method is unified and thus can be applied to any generalized linear and non-linear regression models. Furthermore, adjustment for covariate mismeasurements requires validation data usually in the form of either gold standard measurements or replicates of the mismeasured covariates on a subset of the study population. Initial investigation shows that adequacy of such adjustment depends on the sizes of main and validation samples, especially when prevalences of the categorical covariates are low. Thus, we investigate the impact of main and validation sample sizes on the adjusted estimates, and provide a general guideline about these sample sizes based on simulation studies.

Keywords: measurement errors, misclassification, mismeasurement, validation sample, Bayesian adjustment

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Authors: Adriano Bessa Albuquerque, Francisco Jose Barreto Nunes

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Software vulnerabilities are increasing and not only impact services and processes availability as well as information confidentiality, integrity and privacy, but also cause changes that interfere in the development process. Security test could be a solution to reduce vulnerabilities. However, the variety of test techniques with the lack of real case studies of applying tests focusing on software development life cycle compromise its effective use. This paper offers an overview of how a Systematic Mapping Study (MS) about security verification, validation and test (VVT) was performed, besides presenting general results about this study.

Keywords: software test, software security verification validation and test, security test institutionalization, systematic mapping study

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Authors: Yoonsuh Jung, Steven N. MacEachern

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Check loss function is used to define quantile regression. In the prospect of cross validation, it is also employed as a validation function when underlying truth is unknown. However, our empirical study indicates that the validation with check loss often leads to choosing an over estimated fits. In this work, we suggest a modified or L2-adjusted check loss which rounds the sharp corner in the middle of check loss. It has a large effect of guarding against over fitted model in some extent. Through various simulation settings of linear and non-linear regressions, the improvement of check loss by L2 adjustment is empirically examined. This adjustment is devised to shrink to zero as sample size grows.

Keywords: cross-validation, model selection, quantile regression, tuning parameter selection

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Authors: Mohammadreza Mohebbi, Masoumeh Sanagou

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The ability to predict clinical outcomes is of great importance to physicians and clinicians. A number of different methods have been used in an effort to accurately predict these outcomes. These methods include the development of scoring systems based on multivariate statistical modelling, and models involving the use of classification and regression trees. The process usually consists of two consecutive phases, namely model development and external validation. The model development phase consists of building a multivariate model and evaluating its predictive performance by examining calibration and discrimination, and internal validation. External validation tests the predictive performance of a model by assessing its calibration and discrimination in different but plausibly related patients. A motivate example focuses on prediction modeling using a sample of patients undergone coronary artery bypass graft (CABG) has been used for illustrative purpose and a set of primary considerations for evaluating prediction model studies using specific quality indicators as criteria to help stakeholders evaluate the quality of a prediction model study has been proposed.

Keywords: clinical prediction models, clinical decision rule, prognosis, external validation, model calibration, biostatistics

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Authors: Carl van Walraven, Meltem Tuna

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Background: Network meta-analysis (NMA) quantifies the relative efficacy of 3 or more interventions from studies containing a subgroup of interventions. This study applied the analytical approach of NMA to quantify the relative accuracy of prediction models with distinct inclusion criteria that are evaluated on a common population (‘concurrent external validation’). Methods: We simulated binary events in 5000 patients using a known risk function. We biased the risk function and modified its precision by pre-specified amounts to create 15 prediction models with varying accuracy and distinct patient applicability. Prediction model accuracy was measured using the Scaled Brier Score (SBS). Overall prediction model accuracy was measured using fixed-effects methods that accounted for model applicability patterns. Prediction model accuracy was summarized as the Network Relative Model Accuracy (NeRMA) Score which ranges from -∞ through 0 (accuracy of random guessing) to 1 (accuracy of most accurate model in concurrent external validation). Results: The unbiased prediction model had the highest SBS. The NeRMA score correctly ranked all simulated prediction models by the extent of bias from the known risk function. A SAS macro and R-function was created to implement the NeRMA Score. Conclusions: The NeRMA Score makes it possible to quantify the accuracy of binomial prediction models having distinct inclusion criteria in a concurrent external validation.

Keywords: prediction model accuracy, scaled brier score, fixed effects methods, concurrent external validation

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Authors: L. J. Díaz, M. A. Hernández, A. K. Molina, A. Bermúdez, C. Crane, V. M. Pabón

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One of the most important biological indicators that show the exposure to the radiation is the micronuclei (MN). This technique is using to determinate the radiation effects in blood cultures as a biological control and a complement to the physics dosimetry. In Colombia the necessity to apply this analysis has emerged due to the current biological indicator most used is the chromosomal aberrations (CA), that is why it is essential the MN technique’s standardization and validation to have enough tools to improve the radioprotection topic in the country. Besides, this technique will be applied on the construction of a dose-response curve, that allow measure an approximately dose to irradiated people according to MN frequency found. Inside the steps that carried out to accomplish the standardization and validation is the statistic analysis from the lectures of “in vitro” peripheral blood cultures with different analysts, also it was determinate the best culture medium and conditions for the MN can be detected easily.

Keywords: micronuclei, radioprotection, standardization, validation

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Authors: M. A. I Perera, C. R. Wijesinghe, A. R. Weerasinghe

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his study was conducted to review and identify the unsupervised techniques that can be employed to analyze gene expression data in order to identify better subtypes of tumors. Identifying subtypes of cancer help in improving the efficacy and reducing the toxicity of the treatments by identifying clues to find target therapeutics. Process of gene expression data analysis described under three steps as preprocessing, clustering, and cluster validation. Feature selection is important since the genomic data are high dimensional with a large number of features compared to samples. Hierarchical clustering and K Means are often used in the analysis of gene expression data. There are several cluster validation techniques used in validating the clusters. Heatmaps are an effective external validation method that allows comparing the identified classes with clinical variables and visual analysis of the classes.

Keywords: cancer subtypes, gene expression data analysis, clustering, cluster validation

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Authors: Bronwen Wade

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Over the last half-century, child welfare systems have increasingly relied on quantitative risk assessment tools, such as actuarial or predictive risk tools. These tools are developed by performing statistical analysis of how attributes captured in administrative data are related to future child maltreatment. Some scholars argue that attributes in administrative data can serve as proxies for race and that quantitative risk assessment tools reify racial bias in decision-making. Others argue that these tools provide more “objective” and “scientific” guides for decision-making instead of subjective social worker judgment. This study performs a systematic review of the literature on the impact of quantitative risk assessment tools on racial disproportionality; it examines methodological biases in work on this topic, summarizes key findings, and provides suggestions for further work. A search of CINAHL, PsychInfo, Proquest Social Science Premium Collection, and the ProQuest Dissertations and Theses Collection was performed. Academic and grey literature were included. The review includes studies that use quasi-experimental methods and development, validation, or re-validation studies of quantitative risk assessment tools. PROBAST (Prediction model Risk of Bias Assessment Tool) and CHARMS (CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies) were used to assess the risk of bias and guide data extraction for risk development, validation, or re-validation studies. ROBINS-I (Risk of Bias in Non-Randomized Studies of Interventions) was used to assess for bias and guide data extraction for the quasi-experimental studies identified. Due to heterogeneity among papers, a meta-analysis was not feasible, and a narrative synthesis was conducted. 11 papers met the eligibility criteria, and each has an overall high risk of bias based on the PROBAST and ROBINS-I assessments. This is deeply concerning, as major policy decisions have been made based on a limited number of studies with a high risk of bias. The findings on racial disproportionality have been mixed and depend on the tool and approach used. Authors use various definitions for racial equity, fairness, or disproportionality. These concepts of statistical fairness are connected to theories about the reason for racial disproportionality in child welfare or social definitions of fairness that are usually not stated explicitly. Most findings from these studies are unreliable, given the high degree of bias. However, some of the less biased measures within studies suggest that quantitative risk assessment tools may worsen racial disproportionality, depending on how disproportionality is mathematically defined. Authors vary widely in their approach to defining and addressing racial disproportionality within studies, making it difficult to generalize findings or approaches across studies. This review demonstrates the power of authors to shape policy or discourse around racial justice based on their choice of statistical methods; it also demonstrates the need for improved rigor and transparency in studies of quantitative risk assessment tools. Finally, this review raises concerns about the impact that these tools have on child welfare systems and racial disproportionality.

Keywords: actuarial risk, child welfare, predictive risk, racial disproportionality

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Authors: Gule Teri

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The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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Authors: Edward Holupka, John Rossman, Tye Morancy, Joseph Aronovitz, Irving Kaplan

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A common modality for the treatment of early stage prostate cancer is the implantation of radioactive seeds directly into the prostate. The radioactive seeds are positioned inside the prostate to achieve optimal radiation dose coverage to the prostate. These radioactive seeds are positioned inside the prostate using Transrectal ultrasound imaging. Once all of the planned seeds have been implanted, two dimensional transaxial transrectal ultrasound images separated by 2 mm are obtained through out the prostate, beginning at the base of the prostate up to and including the apex. A common deep neural network, called DetectNet was trained to automatically determine the position of the implanted radioactive seeds within the prostate under ultrasound imaging. The results of the training using 950 training ultrasound images and 90 validation ultrasound images. The commonly used metrics for successful training were used to evaluate the efficacy and accuracy of the trained deep neural network and resulted in an loss_bbox (train) = 0.00, loss_coverage (train) = 1.89e-8, loss_bbox (validation) = 11.84, loss_coverage (validation) = 9.70, mAP (validation) = 66.87%, precision (validation) = 81.07%, and a recall (validation) = 82.29%, where train and validation refers to the training image set and validation refers to the validation training set. On the hardware platform used, the training expended 12.8 seconds per epoch. The network was trained for over 10,000 epochs. In addition, the seed locations as determined by the Deep Neural Network were compared to the seed locations as determined by a commercial software based on a one to three months after implant CT. The Deep Learning approach was within \strikeout off\uuline off\uwave off2.29\uuline default\uwave default mm of the seed locations determined by the commercial software. The Deep Learning approach to the determination of radioactive seed locations is robust, accurate, and fast and well within spatial agreement with the gold standard of CT determined seed coordinates.

Keywords: prostate, deep neural network, seed implant, ultrasound

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Authors: T. Jayanthi, K. Velusamy, H. Seetha, S. A. V. Satya Murty

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Verification and Validation of Simulated Process Model is the most important phase of the simulator life cycle. Evaluation of simulated process models based on Verification and Validation techniques checks the closeness of each component model (in a simulated network) with the real system/process with respect to dynamic behaviour under steady state and transient conditions. The process of Verification and validation helps in qualifying the process simulator for the intended purpose whether it is for providing comprehensive training or design verification. In general, model verification is carried out by comparison of simulated component characteristics with the original requirement to ensure that each step in the model development process completely incorporates all the design requirements. Validation testing is performed by comparing the simulated process parameters to the actual plant process parameters either in standalone mode or integrated mode. A Full Scope Replica Operator Training Simulator for PFBR - Prototype Fast Breeder Reactor has been developed at IGCAR, Kalpakkam, INDIA named KALBR-SIM (Kalpakkam Breeder Reactor Simulator) wherein the main participants are engineers/experts belonging to Modeling Team, Process Design and Instrumentation and Control design team. This paper discusses the Verification and Validation process in general, the evaluation procedure adopted for PFBR operator training Simulator, the methodology followed for verifying the models, the reference documents and standards used etc. It details out the importance of internal validation by design experts, subsequent validation by external agency consisting of experts from various fields, model improvement by tuning based on expert’s comments, final qualification of the simulator for the intended purpose and the difficulties faced while co-coordinating various activities.

Keywords: Verification and Validation (V&V), Prototype Fast Breeder Reactor (PFBR), Kalpakkam Breeder Reactor Simulator (KALBR-SIM), steady state, transient state

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Authors: Sadiah Baharom, Che Nidzam Che Ahmad, Saipol Barin Ramli, Asmayati Yahaya, Sopia Md Yassin

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The early childhood care and education (ECCE) in Malaysia aspire to develop children who are intellectually, emotionally, physically and spiritually balanced. This aspiration can only materialise if the early childhood program developed comprehensive and is of high quality comparable to international standards. As such, there is a pressing need to assess the quality of the program in an all-encompassing manner. The overall research project aims at developing a comprehensive and integrated model of high-quality Malaysian ECCE. One of the major objectives of this project is to assess and evaluate the scope and quality of the existing ECCE programs in Malaysia. To this end, a specific aspect of this objective is to develop and validate an instrument to assess and evaluate the ECCE curriculum of the country. Thus this paper describes the development and validation of an instrument to explore the quality of early childhood care and education curriculum currently implemented in the country’s ECCE centres. The generation of the constructs and items were based on a set of criteria mapped against existing ECCE practice, document analyses, expert interviews and panel discussions. The items went through expert validation and were field tested on 597 ECCE teachers. The data obtained went through an exploratory factor analysis to validate the constructs of the instrument followed by reliability studies on internal consistency based on the Cronbach Alpha values. The final set of items for the ECCE curriculum instrument, earmarked for the main study, consists of four constructs namely philosophy and core values, curriculum content, curriculum review and unique features. Each construct consists of between 21 to 3 items with a total of 36 items in all. The reliability coefficients for each construct range from 0.65 to 0.961. These values are within the acceptable limits for a reliable instrument to be used in the main study.

Keywords: early childhood and care education, instrument development, reliability studies, validity studies

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Authors: Umit Duru

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The Soil and Water Assessment Tool (SWAT) was tested for prediction of water balance and sediment yield in the Ankara gauged basin, Turkey. The overall objective of this study was to evaluate the performance and applicability of the SWAT in this region of Turkey. Thirteen years of monthly stream flow, and suspended sediment, data were used for calibration and validation. This research assessed model performance based on differences between observed and predicted suspended sediment yield during calibration (1987-1996) and validation (1982-1984) periods. Statistical comparisons of suspended sediment produced values for NSE (Nash Sutcliffe efficiency), RE (relative error), and R² (coefficient of determination), of 0.81, -1.55, and 0.93, respectively, during the calibration period, and NSE, RE (%), and R² of 0.77, -2.61, and 0.87, respectively, during the validation period. Based on the analyses, SWAT satisfactorily simulated observed hydrology and sediment yields and can be used as a tool in decision making for water resources planning and management in the basin.

Keywords: calibration, GIS, sediment yield, SWAT, validation

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Authors: Amdouni Hamida, Gammoudi Mohamed Mohsen

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In order to help the expert to validate association rules extracted from data, some quality measures are proposed in the literature. We distinguish two categories: objective and subjective measures. The first one depends on a fixed threshold and on data quality from which the rules are extracted. The second one consists on providing to the expert some tools in the objective to explore and visualize rules during the evaluation step. However, the number of extracted rules to validate remains high. Thus, the manually mining rules task is very hard. To solve this problem, we propose, in this paper, a semi-automatic method to assist the expert during the association rule's validation. Our method uses rule-based classification as follow: (i) We transform association rules into classification rules (classifiers), (ii) We use the generated classifiers for data classification. (iii) We visualize association rules with their quality classification to give an idea to the expert and to assist him during validation process.

Keywords: association rules, rule-based classification, classification quality, validation

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Authors: Zainab Magaji Musa, Nordin M. A. Rahman, Julaily Aida Jusoh

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The web services applications for digital reference service (WSDRS) of LIS model is an informal model that claims to reduce the problems of digital reference services in libraries. It uses web services technology to provide efficient way of satisfying users’ needs in the reference section of libraries. The formal WSDRS model consists of the Z specifications of all the informal specifications of the model. This paper discusses the formal validation of the Z specifications of WSDRS model. The authors formally verify and thus validate the properties of the model using Z/EVES theorem prover.

Keywords: validation, verification, formal, theorem prover

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Authors: Saowaluck Ukrisdawithid

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The thermal conductivity of thermal insulation materials are measured by Heat Flow Meter (HFM) apparatus. The components of uncertainty are complex and difficult on routine measurement by modelling approach. In this study, uncertainty of thermal conductivity measurement was estimated by single laboratory validation approach. The within-laboratory reproducibility was 1.1%. The standard uncertainty of method and laboratory bias by using SRM1453 expanded polystyrene board was dominant at 1.4%. However, it was assessed that there was no significant bias. For sample measurement, the sources of uncertainty were repeatability, density of sample and thermal conductivity resolution of HFM. From this approach to sample measurements, the combined uncertainty was calculated. In summary, the thermal conductivity of sample, polystyrene foam, was reported as 0.03367 W/m·K ± 3.5% (k = 2) at mean temperature 23.5 °C. The single laboratory validation approach is simple key of routine testing laboratory for estimation uncertainty of thermal conductivity measurement by using HFM, according to ISO/IEC 17025-2017 requirements. These are meaningful for laboratory competent improvement, quality control on products, and conformity assessment.

Keywords: single laboratory validation approach, within-laboratory reproducibility, method and laboratory bias, certified reference material

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Authors: Leonardo Ramirez Lopez, Edward Guillen Pinto, Carlos Ramos Linares

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The controversy brought about by the increasing use of mHealth apps and their effectiveness for disease prevention and diagnosis calls for immediate control. Although a critical topic in research areas such as medicine, engineering, economics, among others, this issue lacks reliable implementation models. However, projects such as Open Web Application Security Project (OWASP) and various studies have helped to create useful and reliable apps. This research is conducted under a quality model to optimize two mHealth apps for older adults. Results analysis on the use of two physical activity monitoring apps - AcTiv (physical activity) and SMCa (energy expenditure) - is positive and ideal. Through a theoretical and practical analysis, precision calculations and personal information control of older adults for disease prevention and diagnosis were performed. Finally, apps are validated by a physician and, as a result, they may be used as health monitoring tools in physical performance centers or any other physical activity. The results obtained provide an effective validation model for this type of mobile apps, which, in turn, may be applied by other software developers that along with medical staff would offer digital healthcare tools for elderly people.

Keywords: model, validation, effective, healthcare, elderly people, mobile app

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Authors: Bushra Nabi, Saleha Rehman, Sanjula Baboota, Javed Ali

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Aim: The objective of research undertaken is analytical method validation (HPLC method) of an anti-HIV drug Elvitegravir (EVG). Additionally carrying out the forced degradation studies of the drug under different stress conditions to determine its stability. It is envisaged in order to determine the suitable technique for drug estimation, which would be employed in further research. Furthermore, comparative pharmacokinetic profile of the drug from lipid architectonics and drug suspension would be obtained post oral administration. Method: Lipid Architectonics (LA) of EVR was formulated using probe sonication technique and optimized using QbD (Box-Behnken design). For the estimation of drug during further analysis HPLC method has been validation on the parameters (Linearity, Precision, Accuracy, Robustness) and Limit of Detection (LOD) and Limit of Quantification (LOQ) has been determined. Furthermore, HPLC quantification of forced degradation studies was carried out under different stress conditions (acid induced, base induced, oxidative, photolytic and thermal). For pharmacokinetic (PK) study, Albino Wistar rats were used weighing between 200-250g. Different formulations were given per oral route, and blood was collected at designated time intervals. A plasma concentration profile over time was plotted from which the following parameters were determined:

Keywords: AIDS, Elvitegravir, HPLC, nanostructured lipid carriers, pharmacokinetics

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Authors: Yoonsuh Jung

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As DNA microarray data contain relatively small sample size compared to the number of genes, high dimensional models are often employed. In high dimensional models, the selection of tuning parameter (or, penalty parameter) is often one of the crucial parts of the modeling. Cross-validation is one of the most common methods for the tuning parameter selection, which selects a parameter value with the smallest cross-validated score. However, selecting a single value as an "optimal" value for the parameter can be very unstable due to the sampling variation since the sample sizes of microarray data are often small. Our approach is to choose multiple candidates of tuning parameter first, then average the candidates with different weights depending on their performance. The additional step of estimating the weights and averaging the candidates rarely increase the computational cost, while it can considerably improve the traditional cross-validation. We show that the selected value from the suggested methods often lead to stable parameter selection as well as improved detection of significant genetic variables compared to the tradition cross-validation via real data and simulated data sets.

Keywords: cross validation, parameter averaging, parameter selection, regularization parameter search

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Authors: Karim Kootahi, Seyed Abolhasan Naeini

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The soil-water characteristic curve (SWCC), which represents the relationship between suction and water content (or degree of saturation), is an important property of unsaturated soils. The conventional method for determining SWCC is through specialized testing procedures. Since these procedures require specialized unsaturated soil testing apparatus and lengthy testing programs, several index properties-based correlations have been developed for estimating the SWCC of fine-grained soils. There are, however, considerable inconsistencies among the published correlations and there is no validation study on the predictive ability of existing correlations. In the present study, all existing index properties-based correlations are evaluated using a high quality worldwide database. The performances of existing correlations are assessed both graphically and quantitatively using statistical measures. The results of the validation indicate that most of the existing correlations provide unacceptable estimates of degree of saturation but the most recent model appears to be promising.

Keywords: SWCC, correlations, index properties, validation

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Authors: Emine Feyza Şükür, Mevlüt Türköz, Murat Dilmeç, Hüseyin Selçuk Halkacı

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In this study, a warm bulge test system was designed, built and experimentally validated to perform warm bulge tests with all necessary systems. In addition, performance of each sub-system is validated through repeated production and/or test runs as well as through part quality measurements. Validation and performance tests were performed to characterize the repeatability of the system. As a result of these tests, the desired temperature distribution on the sheet metal was obtained by the heating systems and the good repeatability of the bulge tests was obtained. Consequently, this study is expected to provide other researchers and manufacturer with a set of design and process guidelines to develop similar systems.

Keywords: design, test unit, warm bulge test unit, validation test

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Authors: Soon-Mi Park, Ihn Sook Jeong

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This retrospective study was aimed to identify risk factors of intravenous (IV) infiltration for hospitalized children. The participants were 1,174 children for test and 424 children for validation, who admitted to a general hospital, received peripheral intravenous injection therapy at least once and had complete records. Data were analyzed with frequency and percentage or mean and standard deviation were calculated, and decision tree analysis was used to screen for the most important risk factors for IV infiltration for hospitalized children. The decision tree analysis showed that the most important traditional risk factors for IV infiltration were the use of ampicillin/sulbactam, IV insertion site (lower extremities), and medical department (internal medicine) both in the test sample and validation sample. The correct classification was 92.2% in the test sample and 90.1% in the validation sample. More careful attention should be made to patients who are administered ampicillin/sulbactam, have IV site in lower extremities and have internal medical problems to prevent or detect infiltration occurrence.

Keywords: decision tree analysis, intravenous infiltration, child, validation

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Authors: Vijayalakshmi Marella, NageswaraRaoPilli

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This paper describes a simple, rapid and sensitive liquid chromatography / tandem mass spectrometry assay for the determination of montelukast in human plasma using montelukast d6 as an internal standard. Analyte and the internal standard were extracted from 50 µL of human plasma via solid phase extraction technique without evaporation, drying and reconstitution steps. The chromatographic separation was achieved on a C18 column by using a mixture of methanol and 5mM ammonium acetate (80:20, v/v) as the mobile phase at a flow rate of 0.8 mL/min. Good linearity results were obtained during the entire course of validation. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more number of samples in short time, thus increasing the productivity. The proposed method was found to be applicable to clinical studies.

Keywords: Montelukast, tandem mass spectrometry, montelukast d6, FDA guidelines

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Authors: E. E. Marschalko, K. Kalcza-Janosi, I. Kotta, B. Bibok

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Cultural moderation aspects have been highlighted in the literature on self-determination behavior in some cultures, including in the Hungarian population. There is a lack of validated instruments in Hungarian for the assessment of self-determination related behaviors. In order to fill in this gap, the aim of this study was the translation, cultural adaptation and validation of Self Determination Scale (Sheldon, 1995) for the Hungarian population. A total of 4335 adults participated in the study. The mean age of the participants was 27.97 (SD=9.60). The sample consisted mostly from females, less than 20% were males. Exploratory and confirmatory factor analyses were performed for adequacy checking. Cronbach’s alpha was used to examine the reliability of the factors. Our results revealed that the Hungarian version of SDS has good psychometric properties and it is a reliable tool for psychologist who would like to study or assess self-determination in their clients. The final, adapted and validated SDS items are presented in this paper.

Keywords: self-determination scale, Hungarian, adaptation, validation, reliability

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Authors: Ian Phil Canlas, Mageswary Karpudewan, Joyce Magtolis, Rosario Canlas

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This study reported the development and validation of the Awareness to Disaster Risk Reduction Questionnaire for Teachers (ADRRQT). The questionnaire is a combination of Likert scale and open-ended questions that were grouped into two parts. The first part included questions relating to the general awareness on disaster risk reduction. Whereas, the second part comprised questions regarding the integration of disaster risk reduction in the teaching process. The entire process of developing and validating of the ADRRQT was described in this study. Statistical and qualitative findings revealed that the ADRRQT is significantly valid and reliable and has the potential of measuring awareness to disaster risk reduction of stakeholders in the field of teaching. Moreover, it also shows the potential to be adopted in other fields.

Keywords: awareness, development, disaster risk reduction, questionnaire, validation

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Authors: Anil P. Dewani, Alok S. Tripathi, Anil V. Chandewar

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Present manuscript reports the development and validation of a quantitative high performance liquid chromatography method for the pharmacokinetic evaluation of Glimepiride (GLM) and Ilaprazole (ILA) in rat plasma. The plasma samples were involved with Solid phase extraction process (SPE). The analytes were resolved on a Phenomenex C18 column (4.6 mm× 250 mm; 5 µm particle size) using a isocratic elution mode comprising methanol:water (80:20 % v/v) with pH of water modified to 3 using Formic acid, the total run time was 10 min at 225 nm as common wavelength, the flow rate throughout was 1ml/min. The method was validated over the concentration range from 10 to 600 ng/mL for GLM and ILA, in rat plasma. Metformin (MET) was used as Internal Standard. Validation data demonstrated the method to be selective, sensitive, accurate and precise. The limit of detection was 1.54 and 4.08 and limit of quantification was 5.15 and 13.62 for GLM and ILA respectively, the method demonstrated excellent linearity with correlation coefficients (r2) 0.999. The intra and inter-day precision (RSD%) values were < 2.0% for both ILA and GLM. The method was successfully applied in pharmacokinetic studies followed by oral administration in rats.

Keywords: pharmacokinetics, glimepiride, ilaprazole, HPLC, SPE

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Authors: O. Behar, A. Khellaf, K. Mohammedi, S. Ait Kaci

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Up to now, most validation studies have been based on the MBE and RMSE, and therefore, focused only on long and short terms performance to test and classify solar radiation models. This traditional analysis does not take into account the quality of modeling and linearity. In our analysis we have tested 22 solar radiation models that are capable to provide instantaneous direct and global radiation at any given location Worldwide. We introduce a new indicator, which we named Global Accuracy Indicator (GAI) to examine the linear relationship between the measured and predicted values and the quality of modeling in addition to long and short terms performance. Note that the quality of model has been represented by the T-Statistical test, the model linearity has been given by the correlation coefficient and the long and short term performance have been respectively known by the MBE and RMSE. An important founding of this research is that the use GAI allows avoiding default validation when using traditional methodology that might results in erroneous prediction of solar power conversion systems performances.

Keywords: solar radiation model, parametric model, performance analysis, Global Accuracy Indicator (GAI)

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Authors: Pragathi Gurumurthy, Christina Hagen, Patricia Ulloa, Martin A. Koch, Thorsten M. Buzug

Abstract:

Obstructive sleep apnea (OSA) is a sleep disorder where the patient suffers a disturbed airflow during sleep due to partial or complete occlusion of the pharyngeal airway. Recently, numerical simulations have been used to better understand the mechanism of pharyngeal collapse. However, to gain confidence in the solutions so obtained, an experimental validation is required. Therefore, in this study an experimental validation of computational fluid dynamics (CFD) used for the study of human pharyngeal flow patterns during OSA is performed. A stationary incompressible Navier-Stokes equation solved using the finite element method was used to numerically study the flow patterns in a computed tomography-based human pharynx model. The inlet flow rate was set to 250 ml/s and such that a flat profile was maintained at the inlet. The outlet pressure was set to 0 Pa. The experimental technique used for the validation of CFD of fluid flow patterns is phase contrast-MRI (PC-MRI). Using the same computed tomography data of the human pharynx as in the simulations, a phantom for the experiment was 3 D printed. Glycerol (55.27% weight) in water was used as a test fluid at 25°C. Inflow conditions similar to the CFD study were simulated using an MRI compatible flow pump (CardioFlow-5000MR, Shelley Medical Imaging Technologies). The entire experiment was done on a 3 T MR system (Ingenia, Philips) with 108 channel body coil using an RF-spoiled, gradient echo sequence. A comparison of the axial velocity obtained in the pharynx from the numerical simulations and PC-MRI shows good agreement. The region of jet impingement and recirculation also coincide, therefore validating the numerical simulations. Hence, the experimental validation proves the reliability and correctness of the numerical simulations.

Keywords: computational fluid dynamics, experimental validation, phase contrast-MRI, obstructive sleep apnea

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