Search results for: analytical validation

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: Layla El Gaini, Majdouline Belaqziz, Meriem Outaki, Mariam Minhaj

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In this study, it introduce and validate a high-performance liquid chromatography method with diode-array detection (HPLC-DAD) specifically designed for the accurate quantification of caffeic acid in phenolic extracts obtained from olive mill wastewater. The separation process of caffeic acid was effectively achieved through the use of an Acclaim Polar Advantage column (5µm, 250x4.6mm). A meticulous multi-step gradient mobile phase was employed, comprising water acidified with phosphoric acid (pH 2.3) and acetonitrile, to ensure optimal separation. The diode-array detection was adeptly conducted within the UV–VIS spectrum, spanning a range of 200–800 nm, which facilitated precise analytical results. The method underwent comprehensive validation, addressing several essential analytical parameters, including specificity, repeatability, linearity, as well as the limits of detection and quantification, alongside measurement uncertainty. The generated linear standard curves displayed high correlation coefficients, underscoring the method's efficacy and consistency. This validated approach is not only robust but also demonstrates exceptional reliability for the focused analysis of caffeic acid within the intricate matrices of wastewater, thus offering significant potential for applications in environmental and analytical chemistry.

Keywords: high-performance liquid chromatography (HPLC-DAD), caffeic acid analysis, olive mill wastewater phenolics, analytical method validation

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Authors: Kamlesh Vishwakarma, Bipul Behari Saha, Sunilkumar Sing, Abhishek Mishra, Sreenivas Rao

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A rapid, sensitive and inexpensive method has been developed for complete analysis of Clodinafop Propargyl. Clodinafop Propargyl enantiomers were separated on chiral column, Chiral Pak AS-H (250 mm. 4.6mm x 5µm) with mobile phase n-hexane: IPA (96:4) at flow rate 1.5 ml/min. The effluent was monitored by UV detector at 230 nm. Clodinafop Propagyl content and impurity quantification was done with reverse phase HPLC. The present study describes a HPLC method using simple mobile phase for the quantification of Clodinafop Propargyl and its impurities. The method was validated and found to be accurate, precise, convenient and effective. Moreover, the lower solvent consumption along with short analytical run time led to a cost effective analytical method.

Keywords: Clodinafop Propargyl, method, validation, HPLC-UV

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Authors: Artemis Louppis, Michalis Constantinou, Ioanna Kosma, Federica Blando, Michael Kontominas, Anastasia Badeka

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The aim of the present study was to differentiate yellow prickly pear according to geographical origin based on the combination of mineral content, physicochemical parameters, vitamins and antioxidants. A total of 240 yellow prickly pear samples from Cyprus, Spain, Italy and Greece were analyzed for pH, titratable acidity, electrical conductivity, protein, moisture, ash, fat, antioxidant activity, individual antioxidants, sugars and vitamins by UPLC-MS/MS as well as minerals by ICP-MS. Statistical treatment of the data included multivariate analysis of variance followed by linear discriminant analysis. Based on results, a correct classification of 66.7% was achieved using the cross validation by mineral content while 86.1% was achieved using the cross validation method by combination of all analytical parameters.

Keywords: geographical differentiation, prickly pear, chemometrics, analytical techniques

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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: Alkaben Patel

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The proposed RP-HPLC method is easy, rapid, economical, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of Astorvastatin and Methylcobalamine in their combined dosage form has been developed.The separation was achieved by LC-20 AT C18(250mm*4.6mm*2.6mm)Colum and water (pH 3.5): methanol 70:30 as mobile phase, at a flow rate of 1ml/min. wavelength of this dosage form is 215nm.The drug is related to stress condition of hydrolysis, oxidation, photolysis and thermal degradation.

Keywords: RP- HPLC, atorvastatin, methylcobalamine, method, development, validation

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Authors: Mohammad Reza Shahnazari, Reza Kazemi, Ali Saberi

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Most of the engineering problems are in nonlinear forms. Nonlinear boundary layer problems defined in infinite intervals contain specific complexities, especially in boundary layer condition conformance. As an example of these nonlinear complex problems, the well-known Blasius equation can be mentioned, which itself is one of the classic boundary layer problems. No analytical solution has been proposed yet for the Blasius equation due to its complexity. In this paper, an analytical method, namely the Kourosh method, based on the singularity perturbation method and the Liao homotopy analysis is utilized to solve the Blasius problem. In this method, an inner solution is developed in the [0,1] interval to expedite the solution convergence. The magnitude of the f ˝(0), as an essential quantity for determining the physical parameters, is directly calculated from the solution of the boundary condition problem. The advantages of this solution are that it does not need any numerical solution, it has a closed form and that its validation is shown in the entire [0,∞] interval. Furthermore, all of the desirable parameters could be extracted through a series of simple analytical operations from the final solution. This solution also satisfies the continuity conditions, which is one of the main contributions of this paper in comparison with most of the other proposed analytical solutions available in the literature. Comparison with numerical solutions reveals that the proposed method is highly accurate and convenient for application.

Keywords: Blasius equation, boundary layer, Kourosh method, analytical solution

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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: Jinghua Zhang

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Shaft-tunnel junction is a typical case of the structural nonuniformity in underground structures. The shaft and the tunnel possess greatly different structural features. Even under uniform excitations, they tend to behave discrepantly. Studies on shaft-tunnel junctions are mainly performed numerically. Shaking table tests are also conducted. Although many numerical and experimental data are obtained, an analytical solution still has great merits of gaining more insights into the shaft-tunnel problem. This paper will try to remedy the situation. Since the seismic responses of shaft-tunnel junctions are very related to directions of the excitations, they are studied in two scenarios: the longitudinal-excitation scenario and the transverse-excitation scenario. The former scenario will be addressed in this paper. Given that responses of the tunnel are highly dependent on the shaft, the analytical solutions would be developed firstly for the vertical shaft. Then, the seismic responses of the tunnel would be discussed. Since vertical shafts bear a resemblance to rigid caissons, the solution proposed in this paper is derived by introducing terms of shaft-tunnel and soil-tunnel interactions into equations originally developed for rigid caissons. The validity of the solution is examined by a validation model computed by finite element method. The mutual influence between the shaft and the tunnel is introduced. The soil-structure interactions are discussed parametrically based on the proposed equations. The shaft-tunnel relative displacement and the soil-tunnel relative stiffness are found to be the most important parameters affecting the magnitudes and distributions of the internal forces of the tunnel. A hinge-joint at the shaft-tunnel junction could significantly reduce the degree of stress concentration compared with a rigid joint.

Keywords: analytical solution, longitudinal excitation, numerical validation , shaft-tunnel junction

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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: 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: Eliane G. Tótoli, Hérida Regina N. Salgado

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Daptomycin is an important antimicrobial agent used in clinical practice nowadays, since it is very active against some Gram-positive bacteria that are particularly challenges for the medicine, such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE). The importance of environmental preservation has receiving special attention since last years. Considering the evident need to protect the natural environment and the introduction of strict quality requirements regarding analytical procedures used in pharmaceutical analysis, the industries must seek environmentally friendly alternatives in relation to the analytical methods and other processes that they follow in their routine. In view of these factors, green analytical chemistry is prevalent and encouraged nowadays. In this context, infrared spectroscopy stands out. This is a method that does not use organic solvents and, although it is formally accepted for the identification of individual compounds, also allows the quantitation of substances. Considering that there are few green analytical methods described in literature for the analysis of daptomycin, the aim of this work was the development and validation of a green analytical method for the quantification of this drug in lyophilized powder for injectable solution, by Fourier-transform infrared spectroscopy (FT-IR). Method: Translucent potassium bromide pellets containing predetermined amounts of the drug were prepared and subjected to spectrophotometric analysis in the mid-infrared region. After obtaining the infrared spectrum and with the assistance of the IR Solution software, quantitative analysis was carried out in the spectral region between 1575 and 1700 cm-1, related to a carbonyl band of the daptomycin molecule, and this band had its height analyzed in terms of absorbance. The method was validated according to ICH guidelines regarding linearity, precision (repeatability and intermediate precision), accuracy and robustness. Results and discussion: The method showed to be linear (r = 0.9999), precise (RSD% < 2.0), accurate and robust, over a concentration range from 0.2 to 0.6 mg/pellet. In addition, this technique does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. Conclusion: The validated method proved to be adequate to quantify daptomycin in lyophilized powder for injectable solution and can be used for its routine analysis in quality control. In addition, the proposed method is environmentally friendly, which is in line with the global trend.

Keywords: daptomycin, Fourier-transform infrared spectroscopy, green analytical chemistry, quality control, spectrometry in IR region

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Authors: Marin Senila, Oana Cadar, Thorsten Janisch, Patrick Lacroix-Desmazes

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The study presents the analytical capability and validation of a method based on microwave-assisted acid digestion for quantitative determination of platinum and palladium in catalysts using inductively coupled plasma optical emission spectrometry (ICP-OES). In order to validate the method, the main figures of merit such as limit of detection and limit of quantification, precision and accuracy were considered and the measurement uncertainty was estimated based on the bottom-up approach according to the international guidelines of ISO/IEC 17025. Limit of detections, estimated from blank signal using 3 s criterion, were 3.0 mg/kg for Pt and respectively 3.6 mg/kg for Pd, while limits of quantification were 9.0 mg/kg for Pt and respectively 10.8 mg/kg for Pd. Precisions, evaluated as standard deviations of repeatability (n=5 parallel samples), were less than 10% for both precious metals. Accuracies of the method, verified by recovery estimation certified reference material NIST SRM 2557 - pulverized recycled monolith, were 99.4 % for Pt and 101% for Pd. The obtained limit of quantifications and accuracy were satisfactory for the intended purpose. The paper offers all the steps necessary to validate the determination method for Pt and Pd in catalysts using inductively coupled plasma optical emission spectrometry.

Keywords: catalyst analysis, ICP-OES, method validation, platinum, palladium

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Authors: Ashwani Kumar

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Abstract- This study presents an analytical modeling approach for analyzing the drain current behavior in Tunnel Field-Effect Transistor (TFET) biosensors used for the detection of DNA biomolecules. The proposed model focuses on elucidating the relationship between the drain current and the presence of DNA biomolecules, taking into account the impact of various device parameters and biomolecule characteristics. Through comprehensive analysis, the model offers insights into the underlying mechanisms governing the sensing performance of TFET biosensors, aiding in the optimization of device design and operation. A non-local tunneling model is incorporated with other essential models to accurately trace the simulation and modeled data. An experimental validation of the model is provided, demonstrating its efficacy in accurately predicting the drain current response to DNA biomolecule detection. The sensitivity attained from the analytical model is compared and contrasted with the ongoing research work in this area.

Keywords: biosensor, double-gate TFET, DNA detection, drain current modeling, sensitivity

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Authors: Hadi Farhadian, Homayoon Katibeh

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In this paper, groundwater seepage into Amirkabir tunnel has been estimated using analytical and numerical methods for 14 different sections of the tunnel. Site Groundwater Rating (SGR) method also has been performed for qualitative and quantitative classification of the tunnel sections. The obtained results of above-mentioned methods were compared together. The study shows reasonable accordance with results of the all methods unless for two sections of tunnel. In these two sections there are some significant discrepancies between numerical and analytical results mainly originated from model geometry and high overburden. SGR and the analytical and numerical calculations, confirm the high concentration of seepage inflow in fault zones. Maximum seepage flow into tunnel has been estimated 0.425 lit/sec/m using analytical method and 0.628 lit/sec/m using numerical method occurred in crashed zone. Based on SGR method, six sections of 14 sections in Amirkabir tunnel axis are found to be in "No Risk" class that is supported by the analytical and numerical seepage value of less than 0.04 lit/sec/m.

Keywords: water Seepage, Amirkabir Tunnel, analytical method, DEM, SGR

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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: Xiaoyun Li, Suoang Longzhou

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This paper derives the analytical solution of stellar distance according to its redshift based on the photon-dominated universe expansion model. Firstly, it calculates stellar separation speed and the farthest distance of observable stars via simulation. Then the analytical solution of stellar distance according to its redshift is derived. It shows that when the redshift is large, the stellar distance (and its separation speed) is not proportional to its redshift due to the relativity effect. It also reveals the relationship between stellar age and its redshift. The correctness of the analytical solution is verified by the latest astronomic observations of Ia supernovas in 2020.

Keywords: redshift, cosmic expansion model, analytical solution, stellar distance

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Authors: Mangana B. Rampheri, Timothy Dube, Farai Dondofema, Tatenda Dalu

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Identifying and delineating groundwater-dependent ecosystems (GDEs) is critical to the well understanding of the GDEs spatial distribution as well as groundwater allocation. However, this information is inadequately understood due to limited available data for the most area of concerns. Thus, this study aims to address this gap using remotely sensed, analytical hierarchy process (AHP) and in-situ data to identify and delineate GDEs in Khakea-Bray Transboundary Aquifer. Our study developed GDEs index, which integrates seven explanatory variables, namely, Normalized Difference Vegetation Index (NDVI), Modified Normalized Difference Water Index (MNDWI), Land-use and landcover (LULC), slope, Topographic Wetness Index (TWI), flow accumulation and curvature. The GDEs map was delineated using the weighted overlay tool in ArcGIS environments. The map was spatially classified into two classes, namely, GDEs and Non-GDEs. The results showed that only 1,34 % (721,91 km2) of the area is characterised by GDEs. Finally, groundwater level (GWL) data was used for validation through correlation analysis. Our results indicated that: 1) GDEs are concentrated at the northern, central, and south-western part of our study area, and 2) the validation results showed that GDEs classes do not overlap with GWL located in the 22 boreholes found in the given area. However, the results show a possible delineation of GDEs in the study area using remote sensing and GIS techniques along with AHP. The results of this study further contribute to identifying and delineating priority areas where appropriate water conservation programs, as well as strategies for sustainable groundwater development, can be implemented.

Keywords: analytical hierarchy process (AHP), explanatory variables, groundwater-dependent ecosystems (GDEs), khakea-bray transboundary aquifer, sentinel-2

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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: A. Seleem, M. Mortada, M. El-Morsi, M. Younan

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Diffusion stills have been effective in water desalination. The present work represents a model of the distillation process by using vertical single-effect diffusion stills. A semi-analytical model has been developed to model the process. A software computer code using Engineering Equation Solver EES software has been developed to solve the equations of the developed model. An experimental setup has been constructed, and used for the validation of the model. The model is also validated against former literature results. The results obtained from the present experimental test rig, and the data from the literature, have been compared with the results of the code to find its best range of validity. In addition, a parametric analysis of the system has been developed using the model to determine the effect of operating conditions on the system's performance. The dominant parameters that affect the productivity of the still are the hot plate temperature that ranges from (55-90 °C) and feed flow rate in range of (0.00694-0.0211 kg/m2-s).

Keywords: analytical model, solar distillation, sustainable water systems, vertical diffusion still

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Authors: Habtamu Abdisa

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Spring water is particularly valuable due to its high mineral content, which is beneficial for human health. However, anthropogenic activities usually imbalance the natural levels of its composition, which can cause adverse health effects. Regular monitoring of a naturally given environmental resource is of great concern in the world today. The spectrophotometric application is one of the best methods for qualifying and quantifying the mineral contents of environmental water samples. This research was conducted to evaluate the quality of spring water concerning its heavy metal composition. A grab sampling technique was employed to collect representative samples, including duplicates. The samples were then treated with concentrated HNO3 to a pH level below 2 and stored at 4oC. The samples were digested and analyzed for cadmium (Cd), chromium (Cr), manganese (Mn), copper (Cu), iron (Fe), and zinc (Zn) following method validation. Atomic Absorption Spectrometry (AAS) was utilized for the sample analysis. Quality control measures, including blanks, duplicates, and certified reference materials (CRMs), were implemented to ensure the accuracy and precision of the analytical results. Of the metals analyzed in the water samples, Cd and Cr were found to be below the detection limit. However, the concentrations of Mn, Cu, Fe, and Zn ranged from mean values of 0.119-0.227 mg/L, 0.142-0.166 mg/L, 0.183-0.267 mg/L, and 0.074-0.181 mg/L, respectively. Sediment analysis revealed mean concentration ranges of 348.31-429.21 mg/kg, 0.23-0.28 mg/kg, 18.73-22.84 mg/kg, 2.76-3.15 mg/kg, 941.84-1128.56 mg/kg, and 42.39-66.53 mg/kg for Mn, Cd, Cu, Cr, Fe, and Zn, respectively. The study results established that the evaluated spring water and its associated sediment met the regulatory standards and guidelines for heavy metal concentrations. Furthermore, this research can enhance the quality assurance and control processes for environmental sample analysis, ensuring the generation of reliable data.

Keywords: method validation, heavy metal, spring water, sediment, method detection limit

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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: Marie-Elise Beydon, Daniel Sacristan, Isabel Ruppen

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MB02 (Alymsys®) is a candidate biosimilar to bevacizumab, which was developed against the reference product (RP) Avastin® sourced from both the European Union (EU) and United States (US). MB02 has been extensively characterized comparatively to Avastin® at a physicochemical and biological level using sensitive orthogonal state-of-the-art analytical methods. MB02 has been demonstrated similar to the RP with regard to its primary and higher-order structure, post- and co-translational profiles such as glycosylation, charge, and size variants. Specific focus has been put on the characterization of Fab-related activities, such as binding to VEGF A 165, which directly reflect the bevacizumab mechanism of action. Fc-related functionality was also investigated, including binding to FcRn, which is indicative of antibodies' half-life. The data generated during the analytical similarity assessment demonstrate the high analytical similarity of MB02 to its RP.

Keywords: analytical similarity, bevacizumab, biosimilar, MB02

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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: Somya Ranjan Patro, Abhigna Bhatt, Arnab Banerjee

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Inertial amplifier has recently gained increasing attention as a new mechanism for vibration control of structures. Currently, theoretical investigations are undertaken by researchers to reveal its fundamentals and to understand its underline principles in altering the structural response of structures against dynamic loadings. This paper investigates experimental and analytical studies on the dynamic characteristics of hybrid beam inertial amplifier (HBIA). The analytical formulation of the HBIA has been derived by implementing the spectral element method and rigid body dynamics. This formulation gives the relation between dynamic force and the response of the structure in the frequency domain. Further, for validation of the proposed HBIA, the experiments have been performed. The experimental setup consists of a 3D printed HBIA of polylactic acid (PLA) material screwed at the base plate of the shaker system. Two numbers of accelerometers are used to study the response, one at the base plate of the shaker second one placed at the top of the inertial amplifier. A force transducer is also placed in between the base plate and the inertial amplifier to calculate the total amount of load transferred from the base plate to the inertial amplifier. The obtained time domain response from the accelerometers have been converted into the frequency domain using the Fast Fourier Transform (FFT) algorithm. The experimental transmittance values are successfully validated with the analytical results, providing us essential confidence in our proposed methodology.

Keywords: inertial amplifier, fast fourier transform, natural frequencies, polylactic acid, transmittance, vibration absorbers

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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: 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

Abstract:

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: V. Golubeva, O. Vakhnina, I. Konopkina, N. Gerasimova, N. Taturina, K. Zhogova

Abstract:

To improve chemical current sources, the ion-conducting electrolytes based on Li halides (LiCl-KCl, LiCl-LiBr-KBr, LiCl-LiBr-LiF) are developed. It is necessary to have chemical analytical methods for determination of halides to control the electrolytes technology. The methods of classical analytical chemistry are of interest, as they are characterized by high accuracy. Using these methods is a difficult task because halides have similar chemical properties. The objective of this work is to develop a titrimetric method for determining the content of bromides, chlorides, and fluorides in their joint presence in an ion-conducting electrolyte. In accordance with the developed method of analysis to determine fluorides, electrolyte sample is dissolved in diluted HCl acid; fluorides are titrated by La(NO₃)₃ solution with potentiometric indication of equivalence point, fluoride ion-selective electrode is used as sensor. Chlorides and bromides do not form a hardly soluble compound with La and do not interfere in result of analysis. To determine the bromides, the sample is dissolved in a diluted H₂SO₄ acid. The bromides are oxidized with a solution of KIO₃ to Br₂, which is removed from the reaction zone by boiling. Excess of KIO₃ is titrated by iodometric method. The content of bromides is calculated from the amount of KIO₃ spent on Br₂ oxidation. Chlorides and fluorides are not oxidized by KIO₃ and do not interfere in result of analysis. To determine the chlorides, the sample is dissolved in diluted HNO₃ acid and the total content of chlorides and bromides is determined by method of visual mercurometric titration with diphenylcarbazone indicator. Fluorides do not form a hardly soluble compound with mercury and do not interfere with determination. The content of chlorides is calculated taking into account the content of bromides in the sample of electrolyte. The validation of the developed analytical method was evaluated by analyzing internal reference material with known chlorides, bromides and fluorides content. The analytical method allows to determine chlorides, bromides and fluorides in case of their joint presence in ion-conducting electrolyte within the range and with relative total error (δ): for bromides from 60.0 to 65.0 %, δ = ± 2.1 %; for chlorides from 8.0 to 15.0 %, δ = ± 3.6 %; for fluorides from 5.0 to 8.0%, ± 1.5% . The analytical method allows to analyze electrolytes and mixtures that contain chlorides, bromides, fluorides of alkali metals and their mixtures (K, Na, Li).

Keywords: bromides, chlorides, fluorides, ion-conducting electrolyte

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Authors: Meesun Sun, Yongmin Kim

Abstract:

Estimating maintenance cost is crucial in defense management because it affects military budgets and availability of equipment. When it comes to estimating maintenance cost of the deployed equipment, time series forecasting can be applied with the actual historical cost data. It is more difficult issue to estimate maintenance cost of new equipment for which the actual costs are not provided. In this underlying context, this study proposes an analytical method for maintenance cost estimating relationships (CERs) development of helicopters using linear programming. The CERs can be applied to a new helicopter because they use non-cost independent variables such as the number of engines, the empty weight and so on. In the Republic of Korea, the maintenance cost of new equipment has been usually estimated by reflecting maintenance cost to unit price ratio of the legacy equipment. This study confirms that the CERs perform well for the 10 types of airmobile helicopters in terms of mean absolute percentage error by applying leave-one-out cross-validation. The suggested method is very useful to estimate the maintenance cost of new equipment and can help in the affordability assessment of acquisition program portfolios for total life cycle systems management.

Keywords: affordability analysis, cost estimating relationship, helicopter, linear programming, maintenance cost

Procedia PDF Downloads 139