Development and Validation of a UPLC Method for the Determination of Docetaxel and Its Related Substances in Pharmaceutical Dosage Forms, an Antineoplastic Agent

A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. The stability-indicating capability of the method was demonstrated through forced degradation studies and a comprehensive mass balance evaluation. Chromatographic separation was achieved using an ACQUITY UPLC BEH C18 column (100 × 2.1 mm, 1.7 µm), with gradient elution. The mobile phase A comprised a mixture of water, methanol, and acetonitrile (500:300:200, v/v/v), while mobile phase B was acetonitrile and water (800:200, v/v). The flow rate was set at 0.4 mL/min, with detection at 232 nm using a photodiode array detector. The method exhibited excellent performance, with a tailing factor of 1.10 for Docetaxel. The method was rigorously validated for precision, accuracy, linearity, LOD, LOQ, ruggedness, specificity, and robustness. Forced degradation studies confirmed the method’s suitability for stability analysis. Stability testing on the drug substance was conducted following ICH guidelines.

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%.

Modeling and Validation of Diamagnetic Rotor Levitated by Permanent Magnetics

As an innovative,low-power consuming,and low-stiffness suspension approach,the diamagnetic levitation technique has attracted considerable interest because of its potential applicability in miniaturized mechanical systems.The foundation of a diamagnetic levitation system is mathematical modeling,which is essential for operating performance optimization and stability prediction.However,few studies on systematic mathematical modeling have been reported.In this study,a systematic mathematical model for a disc-shaped diamagnetically levitated rotor on a permanent magnet array is proposed.Based on the proposed model,the magnetic field distribution characteristics,diamagnetic levitation force characteristics(i.e.,levitation height and stiffness),and optimized theoretical conditions for realizing stable levitation are determined.Experiments are conducted to verify the feasibility of the proposed mathematical model.Theoretical predictions and experimental results indicate that increasing the levitation height enlarges the stable region.Moreover,with a further increase in the rotor radius,the stable regions of the rotor gradually diminish and even vanish.Thus,when the levitation height is fixed,a moderate rotor radius permits stable levitation.This study proposes a mathematical modeling method for a diamagnetic levitation system that has potential applications in miniaturized mechanical systems.

Surface and Content Validity of the Mentoring Function Scale for Novice Nurses

This study aimed to examine the surface and content validity of the Mentoring Function Scale for Novice Nurses, used to assess the mentoring of entry-level nurses, and to refine the scale items. In Study 1, six nurse education researchers, selected using convenience sampling, with five or more years of nursing experience and experience teaching novice nurses, were invited to an expert meeting in July 2015. A group interview was conducted that lasted approximately 120 minutes. Study 2 examined the content validity index. Between September and November 2015, we distributed a self-administered questionnaire survey to 11 participants selected by convenience sampling. The participants included five nurse education researchers with a minimum of five years of nursing experience and experience teaching novice nurses, as well as six clinical nurses with a master’s degree or higher. Finally, 81 questionnaire items were retained from the initial 125 items. The 81-item Mentoring Function Scale for Novice Nurses had higher content validity than the original scale. To further increase the scale’s applicability, future studies should assess its reliability, construct validity, and criterion-related validity.

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.

Scoring and Consequential Validity Evidence of Computer-and Paper-Based Writing Tests in Times of Change

Little is known about how the assessment modality,i.e.,computer-based(CB)and paper-based(PB)tests,affects language teachers’scorings,perceptions,and preferences and,therefore,the validity and fairness of classroom writing assessments.The present mixed-methods study used Shaw and Weir’s(2007)sociocognitive writing test validation framework to examine the scoring and consequential validity evidence of CB and PB writing tests in EFL classroom assessment in higher education.Original handwritten and word-processed texts of 38 EFL university students were transcribed to their opposite format and assessed by three language lecturers(N=456 texts,152 per teacher)to examine the scoring validity of CB and PB tests.The teachers’perceptions of text quality and preferences for assessment modality accounted for the consequential validity evidence of both tests.Findings revealed that the assessment modality impacted teachers’scorings,perceptions,and preferences.The teachers awarded higher scores to original and transcribed handwritten texts,particularly text organization and language use.The teachers’perceptions of text quality differed from their ratings,and physical,psychological,and experiential characteristics influenced their preferences for assessment modality.The results have implications for the validity and fairness of CB and PB writing tests and teachers’assessment practices.

Method Verification and Validation of Hydralazine Hydrochloride: Spectrophotometric Analysis in Pure and Pharmaceutical Formulations

The new method proposed is based on the formation of hydralazine-Bromophenol blue ion pair simply and without further extraction or heating. The ion pair was prepared in the presence of pH 3 citrate buffer forming a yellow-colored chromogen. A new maximum UV-visible band formed at 416 nm. The color was stable for more than 10 hours and obeyed Beer’s Law over the concentration range of 10 - 50 µg/mL. The calculated molar absorptivity and Sandell’s sensitivity were 1.01 × 104 L∙mol−1∙cm−1 and 0.0514 µg/mL, respectively. The elements of method validation stipulated by The International Conference on Harmonization [Q2 (R1)] were applied for hydralazine hydrochloride assay in pure and pharmaceutical tablet formulation. The average recoveries of the pure solution and the pharmaceutical formulation were 98.94% and 99.50%, respectively. The results were statistically compared by F-test, which indicates that the method can be precise and repeatable for both pure and pharmaceutical solutions. The method was found to be accurate, reproducible, and cost-effective, and validated for the assay of hydralazine in terms of the routine quality control.

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.

Establishing and clinically validating a machine learning model for predicting unplanned reoperation risk in colorectal cancer

BACKGROUND Colorectal cancer significantly impacts global health,with unplanned reoperations post-surgery being key determinants of patient outcomes.Existing predictive models for these reoperations lack precision in integrating complex clinical data.AIM To develop and validate a machine learning model for predicting unplanned reoperation risk in colorectal cancer patients.METHODS Data of patients treated for colorectal cancer(n=2044)at the First Affiliated Hospital of Wenzhou Medical University and Wenzhou Central Hospital from March 2020 to March 2022 were retrospectively collected.Patients were divided into an experimental group(n=60)and a control group(n=1984)according to unplanned reoperation occurrence.Patients were also divided into a training group and a validation group(7:3 ratio).We used three different machine learning methods to screen characteristic variables.A nomogram was created based on multifactor logistic regression,and the model performance was assessed using receiver operating characteristic curve,calibration curve,Hosmer-Lemeshow test,and decision curve analysis.The risk scores of the two groups were calculated and compared to validate the model.RESULTS More patients in the experimental group were≥60 years old,male,and had a history of hypertension,laparotomy,and hypoproteinemia,compared to the control group.Multiple logistic regression analysis confirmed the following as independent risk factors for unplanned reoperation(P<0.05):Prognostic Nutritional Index value,history of laparotomy,hypertension,or stroke,hypoproteinemia,age,tumor-node-metastasis staging,surgical time,gender,and American Society of Anesthesiologists classification.Receiver operating characteristic curve analysis showed that the model had good discrimination and clinical utility.CONCLUSION This study used a machine learning approach to build a model that accurately predicts the risk of postoperative unplanned reoperation in patients with colorectal cancer,which can improve treatment decisions and prognosis.

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.

Validity and Reliability of a Mental Health Recovery Checklist for Young Adults

The purpose of the present study is to evaluate the internal consistency and construct validity of a self-report checklist measuring clinical mental health recovery across six key domains:family and relationships,occupation and school,physical health,mental health,spirituality,and social support systems.The Mental Health Recovery Checklist(MHRC)was developed at The Dorm,an intensive outpatient mental health treatment program for young adults in New York,NY,and Washington DC that services individuals between the ages of 18 and 35 years old.The present study is cross-sectional,as data were pulled from clients’records who were discharged between January 2018 and May 2023.Pearson Correlations and Cronbach’s alpha were used to determine scale reliability.To establish validity,an Exploratory Factor Analysis(EFA)was conducted to assess a single-factor model using Principal Axis Factoring.Cronbach’s alpha was high(α=0.88),indicating good reliability.In the EFA,all items loaded strongly on a single factor.The unidimensional structure revealed in the EFA highlights the interconnected nature of various life domains as they pertain to mental health recovery in young adults.Future research is warranted to explore whether there are additional dimensions of mental health recovery that have not been assessed in the present scale.

A Framework for Cloud Validation in Pharma

The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.

Optimization and Validation of a Simple Spectrophotometric Based DPPH Method for Analysis of Antioxidant Activity in Aerated, Semi-Aerated and Non-Aerated Tea Products

In this study, the simple DPPH UV-spectrophotometric analytical procedures were optimized and validated for the estimation of antioxidant properties in aerated, semi-aerated and non-aerated tea products as per the AOAC guidelines. The method was found to be simple, rapid, accurate and economical in estimating antioxidant properties in the different tea products. A (0.0100 ± 0.0001) g well ground tea sample was extracted directly in 80% v/v methanol in distilled water. The precision of the method had an RSD% of 1.695 with a linear relation equation of Y = 200.7X + 5.25 (r2 = 0.997). The method proved to be a reliable and effective tool in analysis of anti-oxidant properties in varied tea cultivars and their processed products.

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.

Towards Lessening Learners’Aversive Emotions and Promoting Their Mental Health:Developing and Validating a Measurement of English Speaking Demotivation in the Chinese EFL Context

While a plethora of studies has been conducted to explore demotivation and its impact on mental health in second language(L2)education,scanty research focuses on demotivation in L2 speaking learning.Particularly,little research explores the measures to quantify L2 speaking demotivation.The present two-phase study attempts to develop and validate an English Speaking Demotivation Scale(ESDS).To this end,an independent sample of 207 Chinese tertiary learners of English as a Foreign Language(EFL)participated in the development phase,and another group of 188 Chinese EFL learners was recruited for the validation of the scale.Exploratory Factor Analysis(EFA)and Confirmatory Factor Analysis(CFA)were employed to determine the factor structure of the scale.The EFA results revealed a six-factor solution with Teacher-related Factors in Learning Spoken English(TFLSE),Interest and Valence in Learning Spoken English(IVLSE),Self-efficacy in Learning Spoken English(SELSE),Negative Peer Influence in Learning Spoken English(NPILSE),Undesirable Environment for Learning Spoken English(UELSE),and Negative Influence of Assessment and Learning Materials in speaking class(NIALM).In the validation phase,Confirmatory Factor Analysis(CFA)was performed to validate the internal structure of the scale.The CFA results showed that the model fits the data well.Overall,the ESDS is a robust and trustworthy psychometric tool that could be utilized to examine L2 speaking demotivation.Implications for diminishing EFL learners’demotivation,lessening their aversive emotions and promoting their mental health are also discussed.

Optimization of High-Concurrency Conflict Issues in Execute-Order-Validate Blockchain

With the maturation and advancement of blockchain technology,a novel execute-order-validate(EOV)architecture has been proposed,allowing transactions to be executed in parallel during the execution phase.However,parallel execution may lead to multi-version concurrency control(MVCC)conflicts during the validation phase,resulting in transaction invalidation.Based on different causes,we categorize conflicts in the EOV blockchain into two types:within-block conflicts and cross-block conflicts,and propose an optimization solution called FabricMan based on Fabric v2.4.For within-block conflicts,a reordering algorithm is designed to improve the transaction success rate and parallel validation is implemented based on the transaction conflict graph.We also merge transfer transactions to prevent triggering multiple version checks.For cross-block conflicts,a cache-based version validation mechanism is implemented to detect and terminate invalid transactions in advance.Experimental comparisons are conducted between FabricMan and two other systems,Fabric and Fabric++.The results show that FabricMan outperforms the other two systems in terms of throughput,transaction abort rate,algorithm execution time,and other experimental metrics.

Validity,Reliability,and Measurement Invariance of the Thai Smartphone Application-Based Addiction Scale and Bergen Social Media Addiction Scale

Background:In recent years,there has been increased research interest in both smartphone addiction and social media addiction as well as the development of psychometric instruments to assess these constructs.However,there is a lack of psychometric evaluation for instruments assessing smartphone addiction and social media addiction in Thailand.The present study evaluated the psychometric properties and gender measurement invariance of the Thai version of the Smartphone Application-Based Addiction Scale(SABAS)and Bergen Social Media Addiction Scale(BSMAS).Method:A total of 801 Thai university students participated in an online survey from January 2022 to July 2022 which included demographic information,SABAS,BSMAS,and the Internet Gaming Disorder Scale-Short Form(IGDS9-SF).Results:Confirmatory Factor Analyses(CFAs)found that both the SABAS and BSMAS had a one-factor structure.Findings demonstrated adequate psychometric properties of both instruments and also supported measurement invariance across genders.Moreover,scores on the SABAS and BSMAS were correlated with scores on the IGDS9-SF.Conclusion:The results indicated that the SABAS and BSMAS are useful psychometric instruments for assessing the risk of smartphone addiction and social media addiction among Thai young adults.