Method Development and Validation of the Simultaneous Analysis of Methylisothiazolinone, Methylchloroisothiazolinone, Benzisothiazolinone and Bronopol in Washing-Up Liquid

A method of analysis for the simultaneous determination of methylisothiazolinone (MI), methylchloroisothiazolinone (CMI), benzisothiazolinone (BIT) and Bronopol (BNP) in washing-up liquid was established. The method consisted of a gradient HPLC analysis at three different wavelengths. The four compounds could be analyzed with good precision and accuracy.

Robustness Study and Superior Method Development and Validation for Analytical Assay Method of Atropine Sulfate in Pharmaceutical Ophthalmic Solution

Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation;flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. Method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD for the six sample assay of developed method was 0.4% where the % RSD of the compendial method was 1.2%. The reproducibility between two analysts was 100.4% for developed method on the contrary the compendial method was 98.4%.

Development and validation of a novel questionnaire regarding vision screening among preschool teachers in Malaysia

AIM:To develop and evaluate the validity and reliability of a knowledge,attitude,and practice questionnaire related to vision screening(KAP-VST)among preschool teachers in Malaysia.METHODS:The questionnaire was developed through a literature review and discussions with experts.Content and face validation were conducted by a panel of experts(n=10)and preschool teachers(n=10),respectively.A pilot study was conducted for construct validation(n=161)and test-retest reliability(n=60)of the newly developed questionnaire.RESULTS:Based on the content and face validation,71 items were generated,and 68 items were selected after exploratory factor analysis.The content validity index for items(I-CVI)score ranged from 0.8-1.0,and the content validity index for scale(S-CVI)/Ave was 0.99.Internal consistency was KR^(2)0=0.93 for knowledge,Cronbach’s alpha=0.758 for attitude,and Cronbach’s alpha=0.856 for practice.CONCLUSION:The KAP-VST is a valid and reliable instrument for assessing knowledge,attitude,and practice in relation to vision screening among preschool teachers in Malaysia.

Validation of a Method for Characterization of Ethanol in Water by HS-GC-FID to Serve the Traceability of Halal Measurements

The determination of the ethanol content in food products is of fundamental importance for HALAL certification. In this work, an analytical method for the determination of ethanol in water by headspace gas chromatography with flame ionization detector (HS-GC-FID) has been developed and validated for the use in characterization of ethanol reference materials. The validation study was carried out in the linear calibration range 100 - 1500 mg/kg using the NIST SRM 2900, nominal 95.6%. The studied performance characteristics of the method were the limit of detection, LOD, the limit of quantification LOQ, selectivity, linearity, precision, recovery and bias. The validation results showed that the method is selective, precise, accurate and free from any significant bias. The LOD and LOQ were 1.27 and 3.86 mg/kg respectively and the estimated expanded uncertainty was 2% indicating that the method is fit for the purpose of certification of ethanol in water reference materials.

An internal ballistic model of electromagnetic railgun based on PFN coupled with multi-physical field and experimental validation

To accelerate the practicality of electromagnetic railguns,it is necessary to use a combination of threedimensional numerical simulation and experiments to study the mechanism of bore damage.In this paper,a three-dimensional numerical model of the augmented railgun with four parallel unconventional rails is introduced to simulate the internal ballistic process and realize the multi-physics field coupling calculation of the rail gun,and a test experiment of a medium-caliber electromagnetic launcher powered by pulse formation network(PFN)is carried out.Various test methods such as spectrometer,fiber grating and high-speed camera are used to test several parameters such as muzzle initial velocity,transient magnetic field strength and stress-strain of rail.Combining the simulation results and experimental data,the damage condition of the contact surface is analyzed.

Adaptive Robust Servo Control for Vertical Electric Stabilization System of Tank and Experimental Validation

A tracking stability control problem for the vertical electric stabilization system of moving tank based on adaptive robust servo control is addressed.This paper mainly focuses on two types of possibly fast timevarying but bounded uncertainty within the vertical electric stabilization system:model parameter uncertainty and uncertain nonlinearity.First,the vertical electric stabilization system is constructed as an uncertain nonlinear dynamic system that can reflect the practical mechanics transfer process of the system.Second,the dynamical equation in the form of state space is established by designing the angular tracking error.Third,the comprehensive parameter of system uncertainty is designed to estimate the most conservative effects of uncertainty.Finally,an adaptive robust servo control which can effectively handle the combined effects of complex nonlinearity and uncertainty is proposed.The feasibility of the proposed control strategy under the practical physical condition is validated through the tests on the experimental platform.This paper pioneers the introduction of the internal nonlinearity and uncertainty of the vertical electric stabilization system into the settlement of the tracking stability control problem,and validates the advanced servo control strategy through experiment for the first time.

Development and validation of a circulating tumor DNA-based optimization-prediction model for short-term postoperative recurrence of endometrial cancer

BACKGROUND Endometrial cancer(EC)is a common gynecological malignancy that typically requires prompt surgical intervention;however,the advantage of surgical management is limited by the high postoperative recurrence rates and adverse outcomes.Previous studies have highlighted the prognostic potential of circulating tumor DNA(ctDNA)monitoring for minimal residual disease in patients with EC.AIM To develop and validate an optimized ctDNA-based model for predicting shortterm postoperative EC recurrence.METHODS We retrospectively analyzed 294 EC patients treated surgically from 2015-2019 to devise a short-term recurrence prediction model,which was validated on 143 EC patients operated between 2020 and 2021.Prognostic factors were identified using univariate Cox,Lasso,and multivariate Cox regressions.A nomogram was created to predict the 1,1.5,and 2-year recurrence-free survival(RFS).Model performance was assessed via receiver operating characteristic(ROC),calibration,and decision curve analyses(DCA),leading to a recurrence risk stratification system.RESULTS Based on the regression analysis and the nomogram created,patients with postoperative ctDNA-negativity,postoperative carcinoembryonic antigen 125(CA125)levels of<19 U/mL,and grade G1 tumors had improved RFS after surgery.The nomogram’s efficacy for recurrence prediction was confirmed through ROC analysis,calibration curves,and DCA methods,highlighting its high accuracy and clinical utility.Furthermore,using the nomogram,the patients were successfully classified into three risk subgroups.CONCLUSION The nomogram accurately predicted RFS after EC surgery at 1,1.5,and 2 years.This model will help clinicians personalize treatments,stratify risks,and enhance clinical outcomes for patients with EC.

Direct Pointwise Comparison of FE Predictions to StereoDIC Measurements:Developments and Validation Using Double Edge-Notched Tensile Specimen

To compare finite element analysis(FEA)predictions and stereovision digital image correlation(StereoDIC)strain measurements at the same spatial positions throughout a region of interest,a field comparison procedure is developed.The procedure includes(a)conversion of the finite element data into a triangular mesh,(b)selection of a common coordinate system,(c)determination of the rigid body transformation to place both measurements and FEA data in the same system and(d)interpolation of the FEA nodal information to the same spatial locations as the StereoDIC measurements using barycentric coordinates.For an aluminum Al-6061 double edge notched tensile specimen,FEA results are obtained using both the von Mises isotropic yield criterion and Hill’s quadratic anisotropic yield criterion,with the unknown Hill model parameters determined using full-field specimen strain measurements for the nominally plane stress specimen.Using Hill’s quadratic anisotropic yield criterion,the point-by-point comparison of experimentally based full-field strains and stresses to finite element predictions are shown to be in excellent agreement,confirming the effectiveness of the field comparison process.

Analytical Method Development and Validation of Some Biosimilar Drugs by High Performance Thin Layer Chromatography

A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.

Solriamfetol impurities:Synthesis,characterization,and analytical method(UPLC-UV)validation

Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications such as solriamfetol,which is used to treat excessive daytime sleepiness.Although the highperformance liquid chromatography analysis of commercial solriamfetol has revealed the presence of several impurities,their synthesis,structure elucidation,and chromatographic determination have not been reported yet.To bridge this gap,we herein identified,synthesized,and isolated eight processrelated solriamfetol impurities,characterized them using spectroscopic and chromatographic techniques,and proposed plausible mechanisms of their formation.Moreover,we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection,revealing that its selectivity,linearity,accuracy,precision,and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Thus,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.

Prediction of ground-borne vibration induced by impact pile driving:numerical approach and experimental validation

Deep foundations are currently used in engineering practice to solve problems caused by weak geotechnical characteristics of the ground.Impact pile driving is an interesting and viable solution from economic and technical points of view.However,it is necessary to ensure that the environmental drawbacks,namely ground-borne vibration,are adequately met.For this purpose,the authors propose an axisymmetric finite element method-perfectly matched layer(FEM-PML)approach,where the nonlinear behavior of the soil is addressed through an equivalent linear methodology.Given the complexity of the problem,an experimental test site was developed and fully characterized.The experimental work comprised in-situ and laboratory soil characterization,as well as the measurement of vibrations induced during pile driving.The comparison between experimental and numerical results demonstrated a very good agreement,from which it can be concluded that the proposed numerical approach is suitable for the prediction of vibrations induced by impact pile driving.The experimental database is available as supplemental data and may be used by other researchers in the validation of their prediction models.

Validation and accuracy analysis of wind products from scatterometer onboard the HY-2B satellite

The Chinese marine dynamic environment satellite HY-2B was launched in October 2018 and carries a Ku-band scatterometer.This paper focuses on the accuracies of HY-2B scatterometer wind data during the period from November 2018 to May 2021.The HY-2B wind data are validated against global moored buoys operated by the U.S.National Data Buoy Center and Tropical Atmosphere Ocean,numerical model data by the National Centers for Environmental Prediction,and the Advanced Scatterometer data issued by the Remote Sensing System.The results showed that the wind speeds and directions observed by the HY-2B scatterometer agree well with these buoy wind measurements.The root-mean-squared errors(RMSEs)of the HY-2B wind speed and direction are 0.74 m/s and 11.74°,respectively.For low wind speeds(less than 5 m/s),the standard deviation of the HY-2B-derived wind direction is higher than 20°,which implies that the HY-2B wind direction for low wind speeds is less accurate than that for moderate to high wind speed ranges.The RMSE of the HY-2B wind speed is slightly larger in high latitude oceans(60°–90°S and 60°–90°N)than in low latitude regions.Furthermore,the dependence of the residuals on the cross-track location of wind vector cells and the stability of the HY-2B scatterometer wind products are discussed.The wind stability assessment results indicate that a clear yearly oscillation is observed for the HY-2B wind speed bias which is due to seasonal weather variations.In general,the accuracy of HY-2B winds meets the operational precision requirement and is consistent with other wind data.

Validation of the index for the core competence of nurses leading discharge planning for older patients in China

Objective:With the continuous advancement of aging in China,the number of older inpatients has increased sharply.Older patients have a high demand for planning their discharge services.Nurses serve as the leader of discharge planning for patients;there is a lack of reliable evaluation tool to evaluate the core competitiveness of nurses who implement discharge planning for older patients in China.The purpose of this study was to validate the index for the core competence of nurses who lead discharge planning for older patients developed by a project team through the Delphi method in the early stage.Methods:A cross-sectional questionnaire survey with 3-stage stratified sampling was used to select 1075 nurses from 17 public general hospitals in Ningxia,China.Results:The index consists of 4 first-level indicators,13 second-level indicators,and 57 third-level indicators.The results show that 57 third-level indicators had good discrimination.With exploratory factor analysis(EFA),4 common factors that explained 72.79%of the total variance were extracted.The Cronbach's a was 0.98,and the retest reliability within a 14-d interval was 0.86.The confirmatory factor analysis(CFA)results show that the fit of the index structure was good.The criterion validity was 0.73.Conclusions:The index presented excellent psychometric proper ties and can be used to measure the core competence of nurses in implementing discharge planning for older patients in China.

Analysis and Optimization of Validation Procedure in Blockchain-Enhanced Wireless Resource Sharing and Transactions

To ensure the security of resource and intelligence sharing in 6G,blockchain has been widely adopted in wireless communications and applications.Although blockchain can ensure the traceability and non-tamperability of data in the concatenated blocks,it cannot guarantee the honest behaviors of users in the application before the generation of transactions.Thus,additional technologies are required to ensure that the source of blockchain data is reliable.In this paper,the detailed procedure is designed for the application-oriented task validation in the blockchainenhanced computing resource sharing and transactions in ultra dense networks(UDN).The corresponding queuing model is built and analyzed with the consideration of the wireless re-transmission and the probability of malicious deception by users.Based on the analysis results,the UDN deployment is optimized to save network cost while ensuring latency performance.Numerical results verify our analysis,and the optimized system deployment including the number and service capacities of both base stations and mobile edge computing(MEC)servers are also given with various system settings.

Validation of LPD Scale for the Assessment of Pressure Ulcer at Home

Objectives: This study was designed to test and validate the new LPD scale in a home care setting. The specific objectives are to validate the LPD scale for subjects cared for at home;and to compare LPD to the Braden scale for internal validity. Method: This multicenter, cross-sectional study was conducted in the domestic environment of subjects cared for Home Care services from North to South of Italy. Data collection lasted 8 months, between June 2018 and September 2020, and consisted of the simultaneous compilation of the new LPD, and the Braden scale. Home Care Expert nurses could interface with the recruited subjects and/or caregivers. The parameters considered to validate the new scale were sensitivity (Se), specificity (Sp), positive predictive values (PPV), odds ratio (OR), and the area under the receiver operating characteristic (ROC) curve. Results: Of the 679 recruited subjects, 63.2% were women, and more than 50% did not have a pressure ulcer. 48.2% of the sample aged over 85 years old;69% was affected by multiple disease, and 76.6% took a lot of drugs. 91.6% of the subjects were affected by a partial or total functional dependency. Around 50% of subjects presented double incontinence, and 43% were conscious and collaborated. 85.4% of subjects lived in a healthy environment. The predictive validity parameters showed: Se 77.25%, Sp 84.04%, PPV 91.37%, and the area under the curve (AUC) 0.88% with a confidence interval (CI) 95%. These values mean a moderately accuracy of the test. Conclusions: The new LPD scale has demonstrated a good capacity for identifying the subjects at risk of pressure ulcer and had a better discriminatory power rather than Braden scale.

Offshore Software Maintenance Outsourcing Process Model Validation:A Case Study Approach

The successful execution and management of Offshore Software Maintenance Outsourcing(OSMO)can be very beneficial for OSMO vendors and the OSMO client.Although a lot of research on software outsourcing is going on,most of the existing literature on offshore outsourcing deals with the outsourcing of software development only.Several frameworks have been developed focusing on guiding software systemmanagers concerning offshore software outsourcing.However,none of these studies delivered comprehensive guidelines for managing the whole process of OSMO.There is a considerable lack of research working on managing OSMO from a vendor’s perspective.Therefore,to find the best practices for managing an OSMO process,it is necessary to further investigate such complex and multifaceted phenomena from the vendor’s perspective.This study validated the preliminary OSMO process model via a case study research approach.The results showed that the OSMO process model is applicable in an industrial setting with few changes.The industrial data collected during the case study enabled this paper to extend the preliminary OSMO process model.The refined version of the OSMO processmodel has four major phases including(i)Project Assessment,(ii)SLA(iii)Execution,and(iv)Risk.

Prevention and Control of Postpartum Hemorrhage: Validation of Rangel’s Technology for Huambo, Angola

In the immediate postpartum period, women need to be observed by the obstetric nurse so that measures can be taken to prevent hemorrhages and reduce its complications. Most maternal deaths from hemorrhage are preventable with support measures for clinical practice, such as: guiding protocols, training of professionals, organization and management of health services and provision of adequate conditions for the parturition process. Objective: To validate Rangel’s instrument with its application in the Maternity Ward of the General Hospital of Huambo, Angola. Methodology: This is a descriptive study with a quantitative approach. This is the sixth stage, called pre-test, of the Translation and Cultural Adaptation process. This instrument was sent for evaluation by the validators using the electronic data collection form named Google forms, with a seven-point Likert-type scale (from 7—totally agree to 1—totally disagree). The analysis was performed with the Cronbach’s Alpha coefficient index (>0.91) and the Content Validity Index (CVI > 0.98). Results: Of the 10 items of evaluation criteria of the instrument analyzed by the 20 validators, 100% of them obtained a Cronbach’s Alpha index rating of 0.91: clarity;coherence;scientific writing;relevance;sequence;uniqueness and updating. Coverage, item criticality and objectivity reached a Cronbach’s Alpha of 0.95. The Content Validity Index was 0.95 for coverage, coherence, item criticality, scientific writing, relevance and updating. Conclusion: Rangel’s instrument for nursing care aimed at preventing and controlling hemorrhage in the third period of birth, translated into Angolan Portuguese and validated by nurses, through the statistical results obtained in the validation, was considered reliable and necessary for clinical nursing practice in Huambo, Angola. .

Validation of the Chinese Version of the Affective Exercise Experiences Questionnaire (AFFEXX-C)

Despite the well-established benefits of regular physical activity(PA)on health,a large proportion of the world population does not achieve the recommended level of regular PA.Although affective experiences toward PA may play a key role to foster a sustained engagement in PA,they have been largely overlooked and crudely measured in the existing studies.To address this shortcoming,the Affective Exercise Experiences(AFFEXX)questionnaire has been developed to measure such experiences.Specifically,this questionnaire was developped to assess the following three domains:antecedent appraisals(e.g.,liking vs.disliking exercise in groups),core affective exercise experiences(i.e.,pleasure vs.displeasure,energy vs.tiredness,and calmness vs.tension),and exercise motivation(i.e.,attraction vs.antipathy toward exercise).The current study aimed to validate a Chinese version of the AFFEXX questionnaire(AFFEXX-C).In study 1,722 Chinese college students provided data for analyses of factorial,convergent,discriminant,criterion validity,and test-retest reliability of the AFFEXX-C.In addition,1,300 college students were recruited in study 2 to further validate its structural model.Results showed that the AFFEXX-C demonstrates a goodfit and reliability.Additionally,results further supported the hypothesized model based on previous research:antecedent appraisals predicted core affective exercise experiences,which in turn predicted attraction-antipathy toward physical exercise.The AFFEXX-C was found to be a reliable and valid measure of affective exercise experiences in a population of Chinese college students.

Wheel-rail contact model for railway vehicle-structure interaction applications:development and validation

An enhancement in the wheel-rail contact model used in a nonlinear vehicle-structure interaction(VSI)methodology for railway applications is presented,in which the detection of the contact points between wheel and rail in the concave region of the thread-flange transition is implemented in a simplified way.After presenting the enhanced formulation,the model is validated with two numerical applications(namely,the Manchester Benchmarks and a hunting stability problem of a sus-pended wheelset),and one experimental test performed in a test rig from the Railway Technical Research Institute(RTRI)in Japan.Given its finite element(FE)nature,and contrary to most of the vehicle multibody dynamic commercial software that cannot account for the infrastructure flexibility,the proposed VSI model can be easily used in the study of train-bridge systems with any degree of complexity.The validation presented in this work proves the accuracy of the proposed model,making it a suitable tool for dealing with different railway dynamic applications,such as the study of bridge dynamics,train running safety under different scenarios(namely,earthquakes and crosswinds,among others),and passenger riding comfort.

Statistical Tests of the Validation of TCO Satellite Measurements, Recorded Simultaneously by TOMS-OMI (2005) and OMI-OMPS (2012-2018)

Two statistical validation methods were used to evaluate the confidence level of the Total Column Ozone (TCO) measurements recorded by satellite systems measuring simultaneously, one using the normal distribution and another using the Mann-Whitney test. First, the reliability of the TCO measurements was studied hemispherically. While similar coincidences and levels of significance > 0.05 were found with the two statistical tests, an enormous variability in the levels of significance throughout the year was also exposed. Then, using the same statistical comparison methods, a latitudinal study was carried out in order to elucidate the geographical distribution that gave rise to this variability. Our study reveals that between the TOMS and OMI measurements in 2005 there was only a coincidence in 50% of the latitudes, which explained the variability. This implies that for 2005, the TOMS measurements are not completely reliable, except between the -50° and -15° latitude band in the southern hemisphere and between +15° and +50° latitude band in the northern hemisphere. In the case of OMI-OMPS, we observe that between 2011 and 2016 the measurements of both satellite systems are reasonably similar with a confidence level higher than 95%. However, in 2017 a band with a width of 20° latitude centered on the equator appeared, in which the significance levels were much less than 0.05, indicating that one of the measurement systems had begun to fail. In 2018, the fault was not only located in the equator, but was also replicated in various bands in the Southern Hemisphere. We interpret this as evidence of irreversible failure in one of the measurement systems.