Validity Of Test Method Research Articles

Development and Validation of Reliability Testing Methods for Insulation Systems in High-Voltage Rotating Electrical Machinery on Ships

Lloyd’s Register became the first classification society to mandate reliability testing for insulation degradation in rotating electrical machinery. As the maritime industry shifts toward eco-friendly practices, high-voltage rotating electrical machinery on ships increasingly features higher voltages and larger capacities. However, incidents involving insulation systems have also become more frequent. Additionally, testing facilities with the necessary equipment to perform such reliability tests are lacking, and standardized testing methods are yet to be established. This study proposes test items, methods, and evaluation criteria for the reliability testing of high-voltage rotating electrical machinery. The testing methods are broadly categorized into four types: thermal, electrical, multifactor, and thermomechanical degradation reliability testing. The proposed methods were validated by conducting long-term testing over approximately one year. Key results showed a breakdown time of 7056 h in thermal evaluation, 5040 h in electrical evaluation, and 258.5 d in multifactor evaluation, as well as a 63rd percentile value of 245.7 h in thermomechanical evaluation, all of which fulfill the required criteria. The study offers practical guidelines for ensuring the durability and safety of high-voltage electrical machinery, aligning with the sustainability and safety goals of the maritime industry.

A New Era in Federal Quarantine and State Certification Diagnostics at Clean Plant Centers in the USA.

Quarantine and certification programs exist to prevent the entry or spread of harmful pests and pathogens into agricultural systems. Their common objective is to identify pathogen-free source material through the application of validated testing methods for subsequent release for propagation. Tests must be accurate, efficient and cost-effective. In recent decades, the best tests have been biological assays in conjunction with PCR testing. High throughput sequencing (HTS) has now become a reliable and cost-effective diagnostic method having greater accuracy and efficiency than biological assays. In this article, we review the role of clean plant centers in quarantine and certification programs, as well as the process by which HTS was evaluated as a testing method to replace biological assays for screening source material. The data from this evaluation included a side-by-side comparison of HTS and biological assays for cultivars of grapevine, Prunus and rose, and intra- and inter-laboratory validations of an HTS protocol. Based on the results of these evaluations, in 2021 USDA-APHIS and several state regulatory agencies accepted the use of HTS and quantitative polymerase chain reaction (qPCR) to test new introductions of source material, replacing biological indexing. This new protocol requires testing at two timepoints within at least a six-month interval and a dormancy separating the two tests. Under ideal conditions, testing can be completed in 18-24 months with subsequent release from quarantine of plant material that has tested negative for regulated pathogens. This new testing protocol has a profound impact on quarantine and certification programs, facilitating quicker access of stakeholders to clean materials for propagation and increasing the number of pathogens that are detected, and even discovered, with reduced cost, effort, and time.

Pengaruh Pelatihan dan Motivasi terhadap Kinerja Karyawan pada PT. Andalan Rantai Pasok Indonesia (Arpilog)

Human resource management has an important role as a driving force in the company, in improving employee performance, periodic training and motivating employees can be carried out. This study aims to determine the effect of training and motivation on employee performance at PT Andalan Rantai Pasok Indonesia. The type of research used is quantitative research. The population in this study was the entire sample size of 31 respondents. The analysis technique used in this study is the validity test method, reliability test, classical assumption test, multiple linear regression, and hypothesis testing using SPSS 26. The results showed that the Training Variable partially had a significant effect on Employee Performance with a t value of 2.244> 2.051 and a Sig value of 0.033 <0.05 and the Motivation Variable partially had a significant effect on Employee Performance with a t value of 3.137> 2.051 and a Sig value of 0.004<0.5. The F test shows that together, training and motivation have a significant effect on employee performance (F = 10,971, p = 0.000). So it can be concluded that Training and Motivation have a positive and significant effect on employee performance.

Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products.

Pharmacopeia monographs are not intended to establish biosimilarity. However, the US Food and Drug Administration (FDA) has stopped the US Pharmacopeia (USP) from creating monographs for biological drugs due to the need for side-by-side comparisons with the reference products. The USP can create Biological Product Specifications (BPS), not to be labeled as monographs, based on the analytical testing of reference products and validated test methods that will remove the need for side-by-side analytical testing of biosimilars with reference products. Scientific arguments confirm that this plan is logical and capable of creating global quality standards for biosimilars to allow their interchangeability with other biosimilars. While the regulatory agencies have waived many high-cost biosimilar tests, analytical assessment is the most sensitive test; reducing its cost will further enhance the entry of biosimilars with no clinically meaningful difference.

Addressing chemically-induced obesogenic metabolic disruption: selection of chemicals for in vitro human PPARα, PPARγ transactivation, and adipogenesis test methods.

Whilst western diet and sedentary lifestyles heavily contribute to the global obesity epidemic, it is likely that chemical exposure may also contribute. A substantial body of literature implicates a variety of suspected environmental chemicals in metabolic disruption and obesogenic mechanisms. Chemically induced obesogenic metabolic disruption is not yet considered in regulatory testing paradigms or regulations, but this is an internationally recognised human health regulatory development need. An early step in the development of relevant regulatory test methods is to derive appropriate minimum chemical selection lists for the target endpoint and its key mechanisms, such that the test method can be suitably optimised and validated. Independently collated and reviewed reference and proficiency chemicals relevant for the regulatory chemical universe that they are intended to serve, assist regulatory test method development and validation, particularly in relation to the OECD Test Guidelines Programme. To address obesogenic mechanisms and modes of action for chemical hazard assessment, key initiating mechanisms include molecular-level Peroxisome Proliferator-Activated Receptor (PPAR) α and γ agonism and the tissue/organ-level key event of perturbation of the adipogenesis process that may lead to excess white adipose tissue. Here we present a critical literature review, analysis and evaluation of chemicals suitable for the development, optimisation and validation of human PPARα and PPARγ agonism and human white adipose tissue adipogenesis test methods. The chemical lists have been derived with consideration of essential criteria needed for understanding the strengths and limitations of the test methods. With a weight of evidence approach, this has been combined with practical and applied aspects required for the integration and combination of relevant candidate test methods into test batteries, as part of an Integrated Approach to Testing and Assessment for metabolic disruption. The proposed proficiency and reference chemical list includes a long list of negatives and positives (20 chemicals for PPARα, 21 for PPARγ, and 11 for adipogenesis) from which a (pre-)validation proficiency chemicals list has been derived.

A modular strategy for the testing and assessment of non-genotoxic carcinogens

A modular strategy is described for the testing and assessment (MoSt) of non-genotoxic carcinogenicity (NGTxC) that is suitable for regulatory applications. It utilizes and builds upon work conducted by the OECD expert group on NGTxC. The approach integrates relevant test methods from the molecular- to cellular- and further to tissue level, many of which have been recently reviewed. Six progressive modules are included in the strategy. Advice is provided for the iterative selection of the next appropriate test method within each step of the strategy. Assessment is completed by a weight of evidence conclusion, which integrates the different streams of modular information. The assessment method gives higher weight to findings that are mechanistically linked with biological relevance to carcinogenesis. With a focus on EU-REACH, and pending upon successful test method validation and acceptance, this will also enable the MoSt for NGTxC to be applied for regulatory purposes across different regulatory jurisdictions.

Student's Gender Differences in Stress Management Through Communication

The aim of the article is to determine the specifics of optimizing the stress management of boys and girls during the student period through communicative training. The reliable data were obtained through valid and reliable test methods, and a formative experiment was planned and conducted. The results of the formative experiment indicate the moderate effectiveness of the developed communicative training programme for making stress management in student age more effective. Significant gender differences in stress management strategies and consequences of the impact of the training programme were identified. The girls are more focused on the strategy of actively overcoming the problem, planning a solution to the problem, and looking for social support. The boys are more focused on self-control, distancing, positive reassessment of the situation. Indicators of psychological well-being are higher among the boys compared to the girls. The training programme proved effective for the girls in building stress resistance, self-control, acceptance of responsibility, and psychological well-being. For boys, the most effective formative influence was based on self-control, search for social support, and the escape coping strategy. The study results can be used to optimize psychological assistance and the educational process at the student age.

Avoiding a reproducibility crisis in regulatory toxicology—on the fundamental role of ring trials

The ongoing transition from chemical hazard and risk assessment based on animal studies to assessment relying mostly on non-animal data, requires a multitude of novel experimental methods, and this means that guidance on the validation and standardisation of test methods intended for international applicability and acceptance, needs to be updated. These so-called new approach methodologies (NAMs) must be applicable to the chemical regulatory domain and provide reliable data which are relevant to hazard and risk assessment. Confidence in and use of NAMs will depend on their reliability and relevance, and both are thoroughly assessed by validation. Validation is, however, a time- and resource-demanding process. As updates on validation guidance are conducted, the valuable components must be kept: Reliable data are and will remain fundamental. In 2016, the scientific community was made aware of the general crisis in scientific reproducibility—validated methods must not fall into this. In this commentary, we emphasize the central importance of ring trials in the validation of experimental methods. Ring trials are sometimes considered to be a major hold-up with little value added to the validation. Here, we clarify that ring trials are indispensable to demonstrate the robustness and reproducibility of a new method. Further, that methods do fail in method transfer and ring trials due to different stumbling blocks, but these provide learnings to ensure the robustness of new methods. At the same time, we identify what it would take to perform ring trials more efficiently, and how ring trials fit into the much-needed update to the guidance on the validation of NAMs.

A novel test for hyposalivation using a sugar cube.

Hyposalivation is a highly prevalent condition in old persons. The aim of this study was to assess a novel tool for the diagnosis of hyposalivation using a sugar cube and to compare its reliability to other validated test methods. Five tests were performed: unstimulated salivary flow test by draining method (USFT), oral moisture device Mucus® (MCS), sugar cube test (SCT), stimulated salivary flow test by chewing gum (CG) and Saxon test (SX). The sugar cube test consisted in measuring the time needed to disintegrate a standard-sized sugar cube N°4 (5.6 g) placed beneath the tongue. Bivariate correlation analyses were performed. ROC curve analysis and the Youden Index were used to determine the cut-off value. Sensitivity and specificity were calculated according to the determined cut-off point. A total of 121 participants were recruited, with an average age of 49.8 ± 18.2 years. The USFT was best correlated with the SCT. No correlation was found between SCT and the stimulated saliva tests (CG, SX) as well as the MCS test. According to the Youden index, 140 s is appropriate to diagnose hyposalivation. Sensitivity of .64 and specificity of .91 were found for SCT using USFT as gold standard. The mean subjective evaluation score of the SCT was 3.1 ± 1, significantly higher than USFT 2.6 ± 1.1 (p < .05). The sugar cube test proved to be a useful method for assessing unstimulated salivation, reducing test execution time and causing less participant discomfort than the gold standard unstimulated salivary flow test.

The Accomplishments of KoCVAM in the Development and Implementation of Alternative Methods in Korea.

The Korean Center for the Validation of Alternative Methods (KoCVAM), which promotes the Three Rs principles and the use of alternative methods in Korea, has been operating within the Toxicological Screening and Testing Division of the Ministry of Food and Drug Safety (MFDS) since 2009. KoCVAM has exchanged opinions and information on the development and validation of non-animal alternative test methods as part of the International Cooperation on Alternative Test Methods (ICATM), and provided input into draft OECD Test Guidelines (TGs). Several Korean laws (e.g. the Cosmetics Act) encourage the use of alternative test methods for chemical testing and assessment. To promote and support the use of alternative test methods in the country, KoCVAM has published information and provided training on the national guidelines, which are based on the OECD TGs. In addition, KoCVAM has held annual training workshops on alternative test methods, to help Korean research institutions (including GLP test facilities) to implement them. In addition, by helping to develop and validate alternative test methods that were adopted in OECD TG 442B, TG 492 and TG 439, KoCVAM has contributed to the enhanced competitiveness of Korean industry on the worldwide stage.

Prediction and Verification of Groundwater Potential in Qingyang Area Based on Reliability Test, Validity Test and ROC Curve Method

The combination of remote sensing and GIS has become a common method to locate groundwater potential. Selecting reasonable and effective evaluation factors has become the most important thing in groundwater potential prediction. In this paper, reliability test and validity test are used to evaluate the rationality and validity of evaluation factors. The weight is determined by comprehensive weight method, and the groundwater potential map is obtained by visualization processing based on GIS.

Validation research of pressure decay test method for internal leakage detection of hydraulic cylinder

Leakage test is one of the acceptance tests to ensure hydraulic cylinder reliability. Under the consideration of economic and technical maturity conditions, the existing internal leakage detection methods may be difficult to achieve rapid screening. After research, the pressure decay test method is a common method of quickly testing hydraulic cylinders for internal leakage in the manufacturing industry. However, the validity of the pressure decay test method has not been theoretically verified, limiting the versatility of the method. This paper will theoretically validate the effectiveness of the pressure decay test method and provide important theoretical support for its use as a general rapid screening method for internal leakage, thereby improving the reliability and safety of hydraulic systems. Both simulation and experimental results show that there is a linear relationship between the pressure decay rate and the internal leakage rate. Especially for working pressures greater than 16 MPa, the pressure factor has an insignificant impact on the application of this method.

Technical evaluation and standardization of the human thyroid microtissue assay.

The success and sustainability of U.S. EPA efforts to reduce, refine, and replace in vivo animal testing depends on the ability to translate toxicokinetic and toxicodynamic data from in vitro and in silico new approach methods (NAMs) to human-relevant exposures and health outcomes. Organotypic culture models employing primary human cells enable consideration of human health effects and inter-individual variability but present significant challenges for test method standardization, transferability, and validation. Increasing confidence in the information provided by these in vitro NAMs requires setting appropriate performance standards and benchmarks, defined by the context of use, to consider human biology and mechanistic relevance without animal data. The human thyroid microtissue (hTMT) assay utilizes primary human thyrocytes to reproduce structural and functional features of the thyroid gland that enable testing for potential thyroid-disrupting chemicals. As a variable-donor assay platform, conventional principles for assay performance standardization need to be balanced with the ability to predict a range of human responses. The objectives of this study were to (1) define the technical parameters for optimal donor procurement, primary thyrocyte qualification, and performance in the hTMT assay, and (2) set benchmark ranges for reference chemical responses. Thyrocytes derived from a cohort of 32 demographically diverse euthyroid donors were characterized across a battery of endpoints to evaluate morphological and functional variability. Reference chemical responses were profiled to evaluate the range and chemical-specific variability of donor-dependent effects within the cohort. The data-informed minimum acceptance criteria for donor qualification and set benchmark parameters for method transfer proficiency testing and validation of assay performance.

HE EFFECT OF DIGITALIZATION FOR EMPLOYEES IN MANUFACTURING COMPANIES IN THE ERA OF INDUSTRIAL REVOLUTION 4.0 USING THE CFA (CONFIRMATORY FACTOR ANALYSIS) CALCULATION METHOD

Industrial digitalization 4.0 is a change in communication, function and interaction in industry to digital. So, this is an industrial transformation from a conventional concept to a virtual one. The purpose of this research is to examine the benefits of digitalization for employees in various manufacturing companies. This aim provides quite effective benefits in optimizing many things so that we don't need to spend a lot of time and effort to achieve the targets of our work. This research uses the Validity Test and Reliability Test method with a purposive sampling approach technique of 75 respondents from various employees in manufacturing companies. In this study, researchers used the JASP program version 0.17 with CFA (Confirmatory Factor Analysis) calculations. Of the 40 items that describe 3 components including the company's digitalization system, work productivity, job satisfaction. In the trial of the measuring instrument, it was reliable because the results were above 0.07, but the quality of the items was not good because there were still items whose benchmark was below 0.05. This measuring instrument was tested on 75 respondents. Based on the measuring instrument test, in the first stage 14 items were obtained that could be used and 26 items that could not be used with a validity value of 0 out of the 40 items that had been tested.

The benefits of validation of methods for toxicity testing outweigh its costs

The 4th Annual Forum on Endocrine Disrupters organized by the European Commission brought together the authors of this article around the topic: “From bench to validated test guidelines: (pre)val­idation of test methods”. Validation activities are meant to demonstrate the relevance and reliability of methods and approaches used in regulatory safety testing. These activities are essential to facil­itate regulatory use, still they are largely underfunded and unattractive to the scientific community. In the last decade, large amounts of funding have been invested in European research towards the development of approaches that can be used in regulatory decision-making, including for the identification of endocrine disrupters. There is a vast pool of candidate test methods for potential reg­ulatory applications, but most of them will not be used due to the absence of consideration of their relevance and reliability outside the method developer’s laboratory. This article explains the reasons why such a gap exists between the outputs of research projects and the uptake in a regulatory context. In parallel, there are also increasing expectations from the regulatory science community that validation becomes more efficient with respect to time and resources. This article shares some of the lessons learned and proposes paths forward for validation of new methods that are not intended as one-to-one replacements of animal studies. This includes submitting only mature methods for validation that were developed following good practices and good documentation, proposing a greater emphasis on well-documented transferability studies, and adopting a cost-sharing model among those who benefit from validated methods.

NEW ICT IMPLEMENTATION IN DEVELOPMENT COUNTRIES

In the modern world, the information and communication technologies (ICT) have become the basis for the confident development. All countries are on the way to the introduction of the new digital technologies in the following areas of activity: Smart Homes, Healthcare, Agriculture, Industrial Automation, Transportation and Logistics, Retail, Smart Cities, Energy Management, Digital Government. The key to implementing new ICTs is to integrate them into existing communication networks. However, it is necessary to verify that the new equipment will not damage the integrity of the Resilience and Security of the Communication Network. For these purposes, a system of mandatory confirmation of the conformity of means and services of communication is introduced and maintained in a working state. In the case of the introduction of new ICTs, there is a need to modify the current regulatory framework, Equipping testing laboratories with new equipment, Staff training and development activities, Validation and implementation of new test methods. In most developing countries the above-mentioned set of activities presents objective difficulties. The article provides a general approach to the organization of the introduction of new ICT.

The validation of regulatory test methods - Conceptual, ethical, and philosophical foundations.

Validation establishes the reproducibility and relevance of regulatory test methods, particularly for new approach methods (NAMs) as alternatives to animal testing. While validation concepts provide a framework to assess method suitability, they rarely undergo method-critical assessment. This paper explores the philosophical and ethical foundations of the validation process, drawing from various philosophical traditions and contemporary ethical frameworks. How validation intersects with utilitarian principles, ethics of responsibility, and post-modern critiques is examined, offering a multifaceted perspective on its role in scientific progress and societal values. The paper argues for a paradigm shift in validation, moving beyond traditional animal-based comparisons towards more flexible, fit-for-purpose approaches that embrace emerging technologies and ethical con-siderations. Key ethical principles guiding NAM validation are discussed, including beneficence, non-maleficence, justice, and respect for animal welfare. Integrating these principles with scientific rigor can create a more holistic validation framework that balances human safety, animal welfare, and technological innovation. By critically examining the philosophical underpinnings of validation, this paper aims to stimulate dialogue on reforming the process to better align with contemporary scientific knowledge, ethical standards, and societal expectations. It calls for a more adaptive, transparent, and ethically grounded approach to validation that can accelerate the adoption of innovative and human-relevant toxicological methods while maintaining scientific integrity and public trust.

FACTORS AFFECTING THE PERFORMANCE OF SHARIA BANK EMPLOYEES

This research is based on the background that employee performance is the main thing that companies must pay attention to when carrying out their work activities. For this reason, this problem requires company management to plan to increase competency, distribute knowledge (knowledge sharing) and carry out work supervision more strictly in order to improve the performance of its employees. This research aims to test the variables of Competency, Knowledge Sharing and Work Supervision on Employee Performance at Bank Sumsel Babel Syariah KC Palembang. This research uses quantitative methods. The population in this study was 62 employees using a purposive sampling technique. The sample in this study consisted of 33 respondents who were employees of Bank Sumsel Babel Syariah KC Palembang. Primary data was obtained from distributing questionnaires to employees and analyzed using the validity test method, reliability test, while data analysis techniques used the classic assumption test, multiple linear regression analysis, t test, f test and r test. The research results show that the competency variable has a positive and significant effect on employee performance at Bank Sumsel Babel Syariah KC Palembang. The results obtained were tcount &gt; t table (2.438 &gt; 1.699) with a significance of 0.021 &lt; 0.05. The knowledge sharing variable has a positive and significant effect on employee performance at Bank Sumsel Babel Syariah KC Palembang. The results obtained are t count &gt; ttable (2.160 &gt; 1.699) with a significance of 0.039 &lt; 0.05. The work supervision variable has a positive and significant effect on employee performance at Bank Sumsel Babel Syariah KC Palembang. The results obtained are tcount &gt; ttable (2.253 &gt; 1.699) with a significance of 0.032 &lt; 0.05. Simultaneously, the three variables have a positive and significant effect on employee performance at Bank Sumsel Babel Syariah KC Palembang. The results obtained are Fcount 12.925 &gt; Ftable 2.93 and a significance of 0.000 &lt; 0.05.

Validation studies of the spiral plating method to determine the potency of lactobacillus-containing probiotics

Scientific relevance. Viable cell counting is an important microbiological test for the quality assessment of medicinal products containing live microorganisms. To optimise labour and material costs and enhance testing precision and reproducibility, it is practical to use partially automated instrumental methods, such as the spiral plating method.Aim. The aim was to conduct a validation study of the spiral plating method for assessing the potency of biologicals containing live bacterial cells, using a lactobacillus-containing probiotic medicinal product as a case study.Materials and methods. This study used a culture of Lactiplantibacillus plantarum isolated from a probiotic medicinal product. Spiral plating on agar-based biological culture media was performed using an automatic Eddy Jet 2 plating system. The study used an IUL Flash &amp; Go colony counter for automatic reporting of the results. The validation study was conducted according to the general chapter on the validation of microbiological testing methods (OFS.1.1.0021.18) of the State Pharmacopoeia of the Russian Federation.Results. According to the validation results for the main parameters, the spiral plating method had the range of 104–105 CFU/mL; the limit of quantification of 102 CFU/mL; and the coefficient of linear determination, R2, of 0.99. The accuracy of the spiral plating method in determining the potency of the test sample was 93%; the repeatability was 4.9%.Conclusions. The study results confirm the similarity of the spiral plating method with an automatic colony counter to Koch’s plating method, which is currently used in accordance with the State Pharmacopoeia of the Russian Federation, in terms of the validated parameters. Therefore, spiral plating can be used to evaluate the potency of lactobacillus-containing probiotics. Spiral plating can help improve the cost-effectiveness and accuracy of testing.

Virtual‐ and Augmented Reality‐Assisted Screening for Early Detection of Cognitive Impairments

AbstractBackgroundA key element in providing future dementia patients with sufficient care is the early detection of cognitive impairment. Using augmented reality (AR) and virtual reality (VR), the project “Smart Cognition &amp; Behaviour Screening powered by Augmented Reality” (SCOBES‐AR) seeks to create a multimodal screening tool (MST) for the early and easy detection of cognitive impairment. The MST focusses on non‐pharmacological prevention by assessing behavioral and lifestyle‐associated risk factors and identifying personal resources.MethodsFirst, a validation study was carried out utilizing the established Cognitive Functions Dementia (CFD) test battery to evaluate a set of selected test procedures. The validated test procedures were implemented in an MST prototype based on AR/VR techniques. Using observational summative evaluation and the co‐discovery method, the usability and applicability of the validated test methods for therapists and subjects were further assessed in a subsequent cross‐over study with 98 healthy individuals (age 60‐75 years).Results310 people were involved in the validation study (age 60‐75 years). Among other things, the assessment of olfactory performance (r = 0.09, p = 0.003), reaction time (r = ‐0.47, p&lt;0.001), and activities of daily living (r = 0.29, p&lt;0.001) revealed a particularly high agreement with the CFD. Further, the MST prototype, that includes a tablet PC, AR head‐mounted display with smartphone, VR head‐mounted display, and Flic Buttons as input devices, was developed (see fig. 1). It allows the therapist to have control and direction over the screening process (see fig. 2).ConclusionThe focus of the MST is on non‐clinical cognitive and physical functionalities, as it integrates tests from multiple health professions and is low‐threshold viable. The development of the MST prototype enables the determination of ideal procedures for multimodal AR/VR‐based testing to measure cognitive impairment in older people. To bolster the findings and advance research, clinical trials involving people with cognitive decline and those who already have dementia would be required.