Search results for: method validation

Authors: Navneet Singh Deora, Aastha Deswal, H. N. Mishra

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Pasta is one of the most widely consumed food products around the world. Rapid determination of the moisture content in pasta will assist food processors to provide online quality control of pasta during large scale production. Rapid Fourier transform near-infrared method (FT-NIR) was developed for determining moisture content in pasta. A calibration set of 150 samples, a validation set of 30 samples and a prediction set of 25 samples of pasta were used. The diffuse reflection spectra of different types of pastas were measured by FT-NIR analyzer in the 4,000-12,000 cm-1 spectral range. Calibration and validation sets were designed for the conception and evaluation of the method adequacy in the range of moisture content 10 to 15 percent (w.b) of the pasta. The prediction models based on partial least squares (PLS) regression, were developed in the near-infrared. Conventional criteria such as the R2, the root mean square errors of cross validation (RMSECV), root mean square errors of estimation (RMSEE) as well as the number of PLS factors were considered for the selection of three pre-processing (vector normalization, minimum-maximum normalization and multiplicative scatter correction) methods. Spectra of pasta sample were treated with different mathematic pre-treatments before being used to build models between the spectral information and moisture content. The moisture content in pasta predicted by FT-NIR methods had very good correlation with their values determined via traditional methods (R2 = 0.983), which clearly indicated that FT-NIR methods could be used as an effective tool for rapid determination of moisture content in pasta. The best calibration model was developed with min-max normalization (MMN) spectral pre-processing (R2 = 0.9775). The MMN pre-processing method was found most suitable and the maximum coefficient of determination (R2) value of 0.9875 was obtained for the calibration model developed.

Keywords: FT-NIR, pasta, moisture determination, food engineering

Procedia PDF Downloads 233

Authors: Tanwarat Kajsongkram, Saowalux Rotamporn, Sirinat Limbunruang, Sirinan Thubthimthed.

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High-Performance Liquid Chromatography (HPLC) method was developed and validated for simultaneous estimation of 6-Gingerol(6G) and 6-Shogaol(6S) in joint pain relief gel containing ginger extract. The chromatographic separation was achieved by using C18 column, 150 x 4.6mm i.d., 5μ Luna, mobile phase containing acetonitrile and water (gradient elution). The flow rate was 1.0 ml/min and the absorbance was monitored at 282 nm. The proposed method was validated in terms of the analytical parameters such as specificity, accuracy, precision, linearity, range, limit of detection (LOD), limit of quantification (LOQ), and determined based on the International Conference on Harmonization (ICH) guidelines. The linearity ranges of 6G and 6S were obtained over 20-60 and 6-18 µg/ml respectively. Good linearity was observed over the above-mentioned range with linear regression equation Y= 11016x- 23778 for 6G and Y = 19276x-19604 for 6S (x is concentration of analytes in μg/ml and Y is peak area). The value of correlation coefficient was found to be 0.9994 for both markers. The limit of detection (LOD) and limit of quantification (LOQ) for 6G were 0.8567 and 2.8555 µg/ml and for 6S were 0.3672 and 1.2238 µg/ml respectively. The recovery range for 6G and 6S were found to be 91.57 to 102.36 % and 84.73 to 92.85 % for all three spiked levels. The RSD values from repeated extractions for 6G and 6S were 3.43 and 3.09% respectively. The validation of developed method on precision, accuracy, specificity, linearity, and range were also performed with well-accepted results.

Keywords: ginger, 6-gingerol, HPLC, 6-shogaol

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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

Procedia PDF Downloads 114

Authors: Ulrich Wake, Eniman Syamsuddin

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The model for camera model identificaiton is trained using pretrained model ResNet43 and ResNet50. The dataset consists of 500 photos of each phone. Dataset is divided into 1280 photos for training, 320 photos for validation and 400 photos for testing. The model is trained using One Cycle Policy Method and tested using Test-Time Augmentation. Furthermore, the model is trained for 50 epoch using regularization such as drop out and early stopping. The result is 90% accuracy for validation set and above 85% for Test-Time Augmentation using ResNet50. Every model is also trained by slightly updating the pretrained model’s weights

Keywords: ​ One Cycle Policy, ResNet34, ResNet50, Test-Time Agumentation

Procedia PDF Downloads 171

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: Nurulnadwan Aziz, Ariffin Abdul Mutalib, Siti Mahfuzah Sarif

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This paper reports an ongoing project regarding the development of Conceptual Design Model of Assistive Courseware for Low Vision (AC4LV) learners. Having developed the intended model, it has to be validated prior to producing it as guidance for the developers to develop an AC4LV. This study requires two phases of validation process which are through expert review and prototyping method. This paper presents a part of the validation process which is findings from experts review on Conceptual Design Model of AC4LV which has been carried out through a questionnaire. Results from 12 international and local experts from various respectable fields in Human-Computer Interaction (HCI) were discussed and justified. In a nutshell, reviewed Conceptual Design Model of AC4LV was formed. Future works of this study are to validate the reviewed model through prototyping method prior to testing it to the targeted users.

Keywords: assistive courseware, conceptual design model, expert review, low vision learners

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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: Ana Vulic, Tina Lesic, Nina Kudumija, Maja Kis, Manuela Zadravec, Nada Vahcic, Tomaz Polak, Jelka Pleadin

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Mycotoxins are toxic secondary metabolites produced by numerous types of molds. They can contaminate both food and feed so that they represent a serious public health concern. Production of dry-fermented meat products involves ripening, during which molds can overgrow the product surface, produce mycotoxins, and consequently contaminate the final product. Citrinin is a mycotoxin produced mainly by the Penicillium citrinum. Data on citrinin occurrence in both food and feed are limited. Therefore, there is a need for research on citrinin occurrence in these types of meat products. The LC-MS/MS method for citrinin determination was developed and validated. Sample preparation was performed using immunoaffinity columns, which resulted in clean sample extracts. Method validation included the determination of the limit of detection (LOD), the limit of quantification (LOQ), recovery, linearity, and matrix effect in accordance to the latest validation guidance. The determined LOD and LOQ were 0.60 µg/kg and 1.98 µg/kg, respectively, showing a good method sensitivity. The method was tested for its linearity in the calibration range of 1 µg/L to 10 µg/L. The recovery was 100.9 %, while the matrix effect was 0.7 %. This method was employed in the analysis of 47 samples of dry-fermented sausages collected from local households. Citrinin wasn’t detected in any of these samples, probably because of the short ripening period of the tested sausages that takes three months tops. The developed method shall be used to test other types of traditional dry-cured products, such as prosciuttos, whose surface is usually more heavily overgrown by surface molds due to the longer ripening period.

Keywords: citrinin, dry-fermented meat products, LC-MS/MS, mycotoxins

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Authors: Mohd Hasni Chumiran

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The rapid growth of global industrialism over the past few decades has led to various environmental issues and ecological instability, all due to human activity. In order to solve this global issue, the manufacturers alike have begun to embrace the use of ecodesign products. However, when considering a specific field, multiple questions have been raised and industrial designers (the practising designer's R&D group) have been unable to define the ecological cycle methodology. In this paper, we investigate the validation of problematic in the creation of ecodesign products with the 'reduce, reuse and recycle' (3R’s) method, which is an untested product design theory. The aim of this research is to address the 3R’s method can be extracted in order to transmit an ecological form of ecodesign, specifically among Malaysian furniture manufacturers. By operating the Descriptive Study I (DS-I) phase: Design Research Methodology (DRM), the research has applied two research approaches by the methodological triangulation tradition. To achieve the result, this validation of descriptive structure (design theory) shall be matched with the research hypothesis along the use of research questions.

Keywords: design research methodology, ecodesign, ecological form, industrial design

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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

Procedia PDF Downloads 249

Authors: Endang Lukitaningsih, Fathul Jannah, Arief R. Hakim, Ratna D. Puspita, Zullies Ikawati

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Rifampicin is a semisynthetic antibiotic derivative of rifamycin B produced by Streptomyces mediterranei. RIF has been used worldwide as first line drug-prescribed throughout tuberculosis therapy. This study aims to develop and to validate an HPLC method couple with a UV detection for determination of rifampicin in spiked human plasma and its application for bioequivalence study. The chromatographic separation was achieved on an RP-C18 column (LachromHitachi, 250 x 4.6 mm., 5μm), utilizing a mobile phase of phosphate buffer/acetonitrile (55:45, v/v, pH 6.8 ± 0.1) at a flow of 1.5 mL/min. Detection was carried out at 337 nm by using spectrophotometer. The developed method was statistically validated for the linearity, accuracy, limit of detection, limit of quantitation, precise and specifity. The specifity of the method was ascertained by comparing chromatograms of blank plasma and plasma containing rifampicin; the matrix and rifampicin were well separated. The limit of detection and limit of quantification were 0.7 µg/mL and 2.3 µg/mL, respectively. The regression curve of standard was linear (r > 0.999) over a range concentration of 20.0 – 100.0 µg/mL. The mean recovery of the method was 96.68 ± 8.06 %. Both intraday and interday precision data showed reproducibility (R.S.D. 2.98% and 1.13 %, respectively). Therefore, the method can be used for routine analysis of rifampicin in human plasma and in bioequivalence study. The validated method was successfully applied in pharmacokinetic and bioequivalence study of rifampicin tablet in a limited number of subjects (under an Ethical Clearance No. KE/FK/6201/EC/2015). The mean values of Cmax, Tmax, AUC(0-24) and AUC(o-∞) for the test formulation of rifampicin were 5.81 ± 0.88 µg/mL, 1.25 hour, 29.16 ± 4.05 µg/mL. h. and 29.41 ± 4.07 µg/mL. h., respectively. Meanwhile for the reference formulation, the values were 5.04 ± 0.54 µg/mL, 1.31 hour, 27.20 ± 3.98 µg/mL.h. and 27.49 ± 4.01 µg/mL.h. From bioequivalence study, the 90% CIs for the test formulation/reference formulation ratio for the logarithmic transformations of Cmax and AUC(0-24) were 97.96-129.48% and 99.13-120.02%, respectively. According to the bioequivamence test guidelines of the European Commission-European Medicines Agency, it can be concluded that the test formulation of rifampicin is bioequivalence with the reference formulation.

Keywords: validation, HPLC, plasma, bioequivalence

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Authors: Jamerson Felipe Pereira Lima, Jeane Cecília Bezerra de Melo

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The difficulty and cost related to obtaining of protein tertiary structure information through experimental methods, such as X-ray crystallography or NMR spectroscopy, helped raising the development of computational methods to do so. An approach used in these last is prediction of tridimensional structure based in the residue chain, however, this has been proved an NP-hard problem, due to the complexity of this process, explained by the Levinthal paradox. An alternative solution is the prediction of intermediary structures, such as the secondary structure of the protein. Artificial Intelligence methods, such as Bayesian statistics, artificial neural networks (ANN), support vector machines (SVM), among others, were used to predict protein secondary structure. Due to its good results, artificial neural networks have been used as a standard method to predict protein secondary structure. Recent published methods that use this technique, in general, achieved a Q3 accuracy between 75% and 83%, whereas the theoretical accuracy limit for protein prediction is 88%. Alternatively, to achieve better results, support vector machines prediction methods have been developed. The statistical evaluation of methods that use different AI techniques, such as ANNs and SVMs, for example, is not a trivial problem, since different training sets, validation techniques, as well as other variables can influence the behavior of a prediction method. In this study, we propose a prediction method based on artificial neural networks, which is then compared with a selected SVM method. The chosen SVM protein secondary structure prediction method is the one proposed by Huang in his work Extracting Physico chemical Features to Predict Protein Secondary Structure (2013). The developed ANN method has the same training and testing process that was used by Huang to validate his method, which comprises the use of the CB513 protein data set and three-fold cross-validation, so that the comparative analysis of the results can be made comparing directly the statistical results of each method.

Keywords: artificial neural networks, protein secondary structure, protein structure prediction, support vector machines

Procedia PDF Downloads 583

Authors: Anton A. Larenkov, Alesya Ya Maruk

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In the present study, highly effective iTLC single strip method for the determination of radiochemical purity (RCP) of ⁶⁸Ga-BCA-peptides was developed (with no double-developing, changing of eluents or other additional manipulation). In this method iTLC-SG strips and commonly used eluent TFA_aq. (3-5 % (v/v)) are used. The method allows determining each of the key radiochemical forms of ⁶⁸Ga (colloidal, bound, ionic) separately with the peaks separation being no less than 4 σ. Rf = 0.0-0.1 for ⁶⁸Ga-colloid; Rf = 0.5-0.6 for ⁶⁸Ga-BCA-peptides; Rf = 0.9-1.0 for ionic ⁶⁸Ga. The method is simple and fast: For developing length of 75 mm only 4-6 min is required (versus 18-20 min for pharmacopoeial method). The method has been tested on various compounds (including ⁶⁸Ga-DOTA-TOC, ⁶⁸Ga-DOTA-TATE, ⁶⁸Ga-NODAGA-RGD₂ etc.). The cross-validation work for every specific form of ⁶⁸Ga showed good correlation between method developed and control (pharmacopoeial) methods. The method can become convenient and much more informative replacement for pharmacopoeial methods, including HPLC.

Keywords: DOTA-TATE, 68Ga, quality control, radiochemical purity, radiopharmaceuticals, TLC

Procedia PDF Downloads 268

Authors: Shaoying Guo, Yanyun Xu, Meng Zhang, Weiqing Huang

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The wireless communication network is developing rapidly, thus the wireless security becomes more and more important. Specific emitter identification (SEI) is an vital part of wireless communication security as a technique to identify the unique transmitters. In this paper, a SEI method based on multiscale dispersion entropy (MDE) and refined composite multiscale dispersion entropy (RCMDE) is proposed. The algorithms of MDE and RCMDE are used to extract features for identification of five wireless devices and cross-validation support vector machine (CV-SVM) is used as the classifier. The experimental results show that the total identification accuracy is 99.3%, even at low signal-to-noise ratio(SNR) of 5dB, which proves that MDE and RCMDE can describe the communication signal series well. In addition, compared with other methods, the proposed method is effective and provides better accuracy and stability for SEI.

Keywords: cross-validation support vector machine, refined com- posite multiscale dispersion entropy, specific emitter identification, transient signal, wireless communication device

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Authors: Muzaffar Iqbal, Essam Ezzeldin, Khalid A. Al-Rashood

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Pomalidomide is a second generation oral immunomodulatory agent, being used for the treatment of multiple myeloma in patients with disease refractory to lenalidomide and bortezomib. In this study, a sensitive UPLC-MS/MS assay was developed and validated for high-throughput determination of pomalidomide in rat plasma using celecoxib as an internal standard (IS). Liquid liquid extraction using dichloromethane as extracting agent was employed to extract pomalidomide and IS from 200 µL of plasma. Chromatographic separation was carried on Acquity BEHTM C18 column (50 × 2.1 mm, 1.7 µm) using an isocratic mobile phase of acetonitrile:10 mM ammonium acetate (80:20, v/v), at a flow rate of 0.250 mL/min. Both pomalidomide and IS were eluted at 0.66 ± 0.03 and 0.80 ± 0.03 min, respectively with a total run time of 1.5 min only. Detection was performed on a triple quadrupole tandem mass spectrometer using electrospray ionization in negative mode. The precursor to product ion transitions of m/z 272.01 → 160.89 for pomalidomide and m/z 380.08 → 316.01 for IS were used to quantify them respectively, using multiple reaction monitoring mode. The developed method was validated according to regulatory guideline for bioanalytical method validation. The linearity in plasma sample was achieved in the concentration range of 0.47–400 ng/mL (r2 ≥ 0.997). The intra and inter-day precision values were ≤ 11.1% (RSD, %) whereas accuracy values ranged from - 6.8 – 8.5% (RE, %). In addition, other validation results were within the acceptance criteria and the method was successfully applied in a pharmacokinetic study of pomalidomide in rats.

Keywords: pomalidomide, pharmacokinetics, LC-MS/MS, celecoxib

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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: Marcelo Hayashi, João Lima, Bruno Chieregatti, Ernani Volpe

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The adjoint method has been used as a successful tool to obtain sensitivity gradients in aerodynamic design and optimisation for many years. This work presents an alternative approach to the continuous adjoint formulation that enables one to compute gradients of a given measure of merit with respect to control parameters other than those pertaining to geometry. The procedure is then applied to the steady 2–D compressible Euler and incompressible Navier–Stokes flow equations. Finally, the results are compared with sensitivities obtained by finite differences and theoretical values for validation.

Keywords: adjoint method, aerodynamics, sensitivity theory, non-geometric sensitivities

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Authors: Pradeep A. G, Gorantla Giridhar, Vijay Turaga, Vinod Srinivasa

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The major problem in the flow control valve is of lower Cv, which will reduce the overall efficiency of the flow circuit. Designers are continuously working to improve the Cv of the valve, but they need to validate the design ideas they have regarding the improvement of Cv. The traditional method of prototyping and testing takes a lot of time. That is where CFD comes into the picture with very quick and accurate validation along with visualization, which is not possible with the traditional testing method. We have developed a method to predict Cv value using CFD analysis by iterating on various Boundary conditions, solver settings and by carrying out grid convergence studies to establish the correlation between the CFD model and Test data. The present study investigates 3 different ideas put forward by the designers for improving the flow capacity of the valves, like reducing the cage thickness, changing the port position, and using the parabolic plug to guide the flow. Using CFD, we analyzed all design changes using the established methodology that we developed. We were able to evaluate the effect of these design changes on the Valve Cv. We optimized the wetted surface of the valve further by suggesting the design modification to the lower part of the valve to make the flow more streamlined. We could find that changing cage thickness and port position has little impact on the valve Cv. The combination of optimized wetted surface and introduction of parabolic plug improved the Flow capacity (Cv) of the valve significantly.

Keywords: flow control valves, flow capacity (Cv), CFD simulations, design validation

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Authors: Danilo F. Rodrigues, Hérida Regina N. Salgado

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Introduction: The emergence of resistant microorganisms to a large number of clinically approved antimicrobials has been increasing, which restrict the options for the treatment of bacterial infections. As a strategy, drugs with high antimicrobial activities are in evidence. Stands out a class of antimicrobial, the cephalosporins, having as fourth generation cefepime (CEF) a semi-synthetic product which has activity against various Gram-positive bacteria (e.g. oxacillin resistant Staphylococcus aureus) and Gram-negative (e.g. Pseudomonas aeruginosa) aerobic. There are few studies in the literature regarding the development of microbiological methodologies for the analysis of this antimicrobial, so researches in this area are highly relevant to optimize the analysis of this drug in the industry and ensure the quality of the marketed product. The development of microbiological methods for the analysis of antimicrobials has gained strength in recent years and has been highlighted in relation to physicochemical methods, especially because they make possible to determine the bioactivity of the drug against a microorganism. In this context, the aim of this work was the development and validation of a microbiological method for quantitative analysis of CEF in powder lyophilized for injectable solution by turbidimetric assay. Method: For performing the method, Staphylococcus aureus ATCC 6538 IAL 2082 was used as the test microorganism and the culture medium chosen was the Casoy broth. The test was performed using temperature control (35.0 °C ± 2.0 °C) and incubated for 4 hours in shaker. The readings of the results were made at a wavelength of 530 nm through a spectrophotometer. The turbidimetric microbiological method was validated by determining the following parameters: linearity, precision (repeatability and intermediate precision), accuracy and robustness, according to ICH guidelines. Results and discussion: Among the parameters evaluated for method validation, the linearity showed results suitable for both statistical analyses as the correlation coefficients (r) that went 0.9990 for CEF reference standard and 0.9997 for CEF sample. The precision presented the following values 1.86% (intraday), 0.84% (interday) and 0.71% (between analyst). The accuracy of the method has been proven through the recovery test where the mean value obtained was 99.92%. The robustness was verified by the parameters changing volume of culture medium, brand of culture medium, incubation time in shaker and wavelength. The potency of CEF present in the samples of lyophilized powder for injectable solution was 102.46%. Conclusion: The turbidimetric microbiological method proposed for quantification of CEF in lyophilized powder for solution for injectable showed being fast, linear, precise, accurate and robust, being in accordance with all the requirements, which can be used in routine analysis of quality control in the pharmaceutical industry as an option for microbiological analysis.

Keywords: cefepime hydrochloride, quality control, turbidimetric assay, validation

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Authors: Nacer Eddine Chelbi, Ayet Bagane, Annie Saleh, Claude Sauvageau, Denis Gingras

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As recently stated by National Highway Traffic Safety Administration (NHTSA), to demonstrate the expected performance of a highly automated vehicles system, test approaches should include a combination of simulation, test track, and on-road testing. In this paper, we propose a new validation method for autonomous vehicles involving on-road tests (Field Operational Tests), test track (Test Matrix) and simulation (Worst Case Scenarios). We concentrate our discussion on the simulation aspects, in particular, we extend recent work based on Importance Sampling by using a Metropolis-Hasting algorithm (MHS) to sample collected data from the Safety Pilot Model Deployment (SPMD) in lane-change scenarios. Our proposed MH sampling method will be compared to the Importance Sampling method, which does not perform well in high-dimensional problems. The importance of this study is to obtain a sampler that could be applied to high dimensional simulation problems in order to reduce and optimize the number of test scenarios that are necessary for validation and certification of autonomous vehicles.

Keywords: automated driving, autonomous emergency braking (AEB), autonomous vehicles, certification, evaluation, importance sampling, metropolis-hastings sampling, tests

Procedia PDF Downloads 255

Authors: Renata L. C. Leão, João E. Nascimento, Natalia C. E. S. Nascimento, Elaine S. Vasconcelos, Mércia L. Oliveira

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The quality control procedures of a radiopharmaceutical include the assessment of its chemical purity. The method suggested by international pharmacopeias consists of a thin layer chromatographic run. In this paper, the method proposed by the United States Pharmacopeia (USP) is compared to a direct method to determine the final concentration of aminopolyether in Fludeoxyglucose (¹⁸F-FDG) preparations. The approach (no chromatographic run) was achieved by placing the thin-layer chromatography (TLC) plate directly on an iodine vapor chamber. Both methods were validated and they showed adequate results to determine the concentration of aminopolyether in ¹⁸F-FDG preparations. However, the direct method is more sensitive, faster and simpler when compared to the reference method (with chromatographic run), and it may be chosen for use in routine quality control of ¹⁸F-FDG.

Keywords: chemical purity, Kryptofix 222, thin layer chromatography, validation

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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: Aymen Laadhari

Abstract:

We present in this paper a fully implicit finite element method tailored for the numerical modeling of inextensible fluidic membranes in a surrounding Newtonian fluid. We consider a highly simplified version of the Canham-Helfrich model for phospholipid membranes, in which the bending force and spontaneous curvature are disregarded. The coupled problem is formulated in a fully Eulerian framework and the membrane motion is tracked using the level set method. The resulting nonlinear problem is solved by a Newton-Raphson strategy, featuring a quadratic convergence behavior. A monolithic solver is implemented, and we report several numerical experiments aimed at model validation and illustrating the accuracy of the proposed method. We show that stability is maintained for significantly larger time steps with respect to an explicit decoupling method.

Keywords: finite element method, level set, Newton, membrane

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Authors: Felix Baumann, Aleksandar Milutinovic, Dieter Roller

Abstract:

Up to this point business process management projects in general and business process modelling projects in particular could not rely on a practical and scientifically validated method to estimate cost and effort. Especially the model development phase is not covered by a cost estimation method or model. Further phases of business process modelling starting with implementation are covered by initial solutions which are discussed in the literature. This article proposes a method of filling this gap by deriving a cost estimation method from available methods in similar domains namely software development or software engineering. Software development is regarded as closely similar to process modelling as we show. After the proposition of this method different ideas for further analysis and validation of the method are proposed. We derive this method from COCOMO II and Function Point which are established methods of effort estimation in the domain of software development. For this we lay out similarities of the software development rocess and the process of process modelling which is a phase of the Business Process Management life-cycle.

Keywords: COCOMO II, busines process modeling, cost estimation method, BPM COCOMO

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

Abstract:

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

Abstract:

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: Aymen Laadhari, Gábor Székely

Abstract:

This paper is concerned with the development of a fully implicit and purely Eulerian fluid-structure interaction method tailored for the modeling of the large deformations of elastic membranes in a surrounding Newtonian fluid. We consider a simplified model for the mechanical properties of the membrane, in which the surface strain energy depends on the membrane stretching. The fully Eulerian description is based on the advection of a modified surface tension tensor, and the deformations of the membrane are tracked using a level set strategy. The resulting nonlinear problem is solved by a Newton-Raphson method, featuring a quadratic convergence behavior. A monolithic solver is implemented, and we report several numerical experiments aimed at model validation and illustrating the accuracy of the presented method. We show that stability is maintained for significantly larger time steps.

Keywords: finite element method, implicit, level set, membrane, Newton method

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Authors: Abid Fida Masih

Abstract:

Forced degradation study of Rifaximin was conducted to determine the stability indicating potential of HPLC testing method for detection of Rifaximin in formulated tablets to be employed for quality control and stability testing. The questioned method applied with mobile phase methanol: water (70:30), 5µm, 250 x 4.6mm, C18 column, wavelength 293nm and flow rate of 1.0 ml/min. Forced degradation study was performed under oxidative, acidic, basic, thermal and photolytic conditions. The applied method successfully determined the degradation products after acidic and basic degradation without interfering with Rifaximin detection. Therefore, the method was said to be stability indicating and can be applied for quality control and stability testing of Rifaxmin tablets during its shelf life.

Keywords: forced degradation, high-performance liquid chromatography, method validation, rifaximin, stability indicating method

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

Abstract:

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

Procedia PDF Downloads 223