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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. [ABSTRACT FROM AUTHOR]

Background: When studying the association between treatment and a clinical outcome, a parametric multivariable model of the conditional outcome expectation is often used to adjust for covariates. The treatment coefficient of the outcome model targets a conditional treatment effect. Model-based standardization is typically applied to average the model predictions over the target covariate distribution, and generate a covariate-adjusted estimate of the marginal treatment effect. Methods: The standard approach to model-based standardization involves maximum-likelihood estimation and use of the non-parametric bootstrap. We introduce a novel, general-purpose, model-based standardization method based on multiple imputation that is easily applicable when the outcome model is a generalized linear model. We term our proposed approach multiple imputation marginalization (MIM). MIM consists of two main stages: the generation of synthetic datasets and their analysis. MIM accommodates a Bayesian statistical framework, which naturally allows for the principled propagation of uncertainty, integrates the analysis into a probabilistic framework, and allows for the incorporation of prior evidence. Results: We conduct a simulation study to benchmark the finite-sample performance of MIM in conjunction with a parametric outcome model. The simulations provide proof-of-principle in scenarios with binary outcomes, continuous-valued covariates, a logistic outcome model and the marginal log odds ratio as the target effect measure. When parametric modeling assumptions hold, MIM yields unbiased estimation in the target covariate distribution, valid coverage rates, and similar precision and efficiency than the standard approach to model-based standardization. Conclusion: We demonstrate that multiple imputation can be used to marginalize over a target covariate distribution, providing appropriate inference with a correctly specified parametric outcome model and offering statistical performance comparable to that of the standard approach to model-based standardization. [ABSTRACT FROM AUTHOR]

In 2020 several member states initiated at IMO forum (NCSR subcommittee) a process to create a single set of generic performance standards consolidating all existing performance standards for shipborne satellite navigation system receiver equipment without creating any new requirements. After over 4 years the resultant generic framework for GNSS/RNSS subsystems has not been adopted yet and awaits further amendments. Analysis of the proposed standards with stress on harmonization issues of the existing, IMO recognized, global and regional navigation satellite systems and the expected impact of these generic standards of satellite navigation receivers on the maritime user are presented in this paper. Additionally the strengths, weaknesses, opportunities, and threats awaiting maritime or shipborne GNSS/RNSS equipment standardization process are outlined in the paper. [ABSTRACT FROM AUTHOR]

In the second half of the nineteenth century, geologists created the International Geological Congress (IGC) to achieve the methodological and terminological uniformity that they thought their science lacked. Their desire to standardize their practice and their use of the conference to do so was neither new nor unique. Although late nineteenth-century international conferences have been recognized as important arenas of standardization, relatively little is known of the ways in which conferences organized standardization negotiations. This article aims to fill this gap by exploring how the IGC practically and socially organized standardization work. It appears that the session hall was not the sole and not even the main stage of geological standard-setting. The standardization process was also enacted through comparative study and informal exchanges that regular visits to purpose-built comparative geological exhibitions made possible. Relying on a sophisticated apparatus of commissions and subcommittees, the IGC also socially organized standards negotiation beyond the space and time of the triennial sessions. By tracing the material, spatial and social practices engineered through the IGC to serve geological standardization, this article unboxes the conference process and in so doing enriches our understanding of the period's wave of standardization. [ABSTRACT FROM AUTHOR]

The vision for fib MC2020 is to go beyond the point reached by fib MC2010, recent ISO codes, such as ISO 16311, and the current Eurocode activities to extend the application of Eurocodes to existing structures. The contents of fib MC2020 suit these forward‐looking objectives, dealing both with the design of new structures and all the activities associated with the life‐cycle management of existing concrete structures including matters, such as in‐service assessment and interventions upon them, including situations where new structural members are incorporated as parts of existing structures. With the fib MC2020 adaptations taking sustainability as a fundamental requirement, defining implications for subsidiary performance requirements critical to structural design and assessment procedures, it is logical that Model Code 2020 explicitly introduces and consequently seeks to make use of performance‐based concepts. A focus on performance provides a potential way to better align the interests of owners, users, technical consultants (such as structural engineers, material engineers, etc.), contractors, as well as material suppliers and manufacturers. It is envisaged that implementing the concept of the performance‐based approach in design and assessment will encourage rational design and technological progress which will facilitate the creation of superior structures for future generations, by removing constraints to the use of novel types of concrete and reinforcing materials and offering possibilities for optimization of solutions that better fit the needs of stakeholders. This paper addresses the principles of the performance‐based approach to design and assessment and discusses the manner in which it has been introduced in fib MC2020. The benefits and burdens associated with the performance‐based approach and the traditional prescriptive approach to engineering specification are discussed, both from a technical and process/commercial/contractual point of view, to describe the overall benefits of the performance‐based approach. Finally, the future outlook for a coherent integration of the performance‐based approach in design and assessment is addressed, paving the way for further work on standardization for sustainable concrete structures. [ABSTRACT FROM AUTHOR]

Free thyroxine (FT4) in serum is routinely measured in clinical practice to diagnose and monitor thyroid disease. Due to its concentration in picomolar range and the delicate equilibrium of free and protein-bound T4, accurate measurement is challenging. As a consequence, large inter-method differences in FT4 results exists. Optimal method design and standardization of the FT4 measurement is therefore necessary. The IFCC Working Group for Standardization of Thyroid Function Tests proposed a reference system with a conventional reference measurement procedure (cRMP) for FT4 in serum. In this study, we describe our FT4 candidate cRMP and its validation in clinical samples. This candidate cRMP is based on equilibrium dialysis (ED) combined with determination of T4 with an isotope-dilution liquid chromatography tandem mass-spectrometry (ID-LC-MS/MS) procedure and was developed according to the endorsed conventions. Its accuracy, reliability, and comparability was investigated using human sera. It was shown that the candidate cRMP adhered to the conventions and its accuracy, precision, and robustness were adequate in serum of healthy volunteers. Our candidate cRMP measures FT4 accurately and performs well in serum matrix. [ABSTRACT FROM AUTHOR]

The growing use of renewable energy sources and sustainable technologies has increased the attractiveness of low-voltage DC distribution grids. Despite initial research and standardization work, the definition of power quality (PQ) issues and their related compatibility levels in DC grids and the related measurement techniques remain in their infancy. The lack of available measurement results obtained in real-world situations is a major shortcoming. In this paper, the results of a measurement campaign obtained in a configurable bipolar 350 V/700 V DC microgrid in an urban environment are presented. Voltage and current signals were registered continuously at different positions in the microgrid with a sampling rate of 500 kSa/s while changing the configuration of the microgrid; the resulting data were analyzed afterwards, with a focus on DC voltage and current variation, ripple, and spectral analysis. The measurements were taken with custom-designed metrology-sound measurement equipment. The measurement results provide input to the development of DC PQ analysis tools and the standardization of DC PQ measurement methods. Furthermore, the experience obtained will be beneficial for utility companies and regulatory authorities for reliable planning-level and compatibility-level surveys. [ABSTRACT FROM AUTHOR]

Objective The applicability of current China's natural gas analysis and testing standards under hydrogen-blended conditions needs to be confirmed ed to promote the standardization of hydrogen-blended natural gas. Methods By analyzing China's natural gas analysis and testing standards, 10 standards related to hydrogen-blended natural gas have been selected and the applicability of natural gas composition analysis standards and physical property calculation standards under hydrogen-blended conditions has been studied. Results The results show that the maximum hydrogen concentration specified by the natural gas composition analysis standard represented by GB/T 13610-2020 Analysis of natural gas composition-Gas chromatography and the physical property calculation standard represented by GB/T 17747.2-2011 Natural gas-Calculation of compression factor- Part 2: Calculation using molar-composition analysis is 10%, and the relevant standards need to be revised under the condition of high hydrogen concentration. Besides, if the hydrogen is not separated downstream, the interchangeability of natural gas and its standardization need to be studied urgently. Conclusions The proposed formulation and revision framework has reference significance for the future standardization work of hydrogen-blended natural gas. [ABSTRACT FROM AUTHOR]

Although Jane Addams has long been recognized as a pioneer in North American pragmatism, efforts to develop her thought into a distinct research program have been limited. This article develops Addams's work as a method of sociological inquiry by focusing on her notions of "perplexity," "moral adjustment," and "sympathetic understanding." Emphasizing the essential role of language in moral conflicts and reconstruction, the article incorporates Charles Wright Mills's concept of "vocabularies of motives." Together, these notions offer a framework for exploring the moral dilemmas that care workers experience when responding to the imposition of standardization of their working practices. A case study demonstrates how care workers, while coping creatively with the effects of a service reform, develop motive vocabularies in defense of their professional ethics. Such situated creativity on "the shop floor" of social services remains relatively under-explored and under-theorized. [ABSTRACT FROM AUTHOR]

Radiomic approaches in precision medicine are promising, but variation associated with image acquisition factors can result in severe biases and low generalizability. Multicenter datasets used in these studies are often heterogeneous in multiple imaging parameters and/or have missing information, resulting in multimodal radiomic feature distributions. ComBat is a promising harmonization tool, but it only harmonizes by single/known variables and assumes standardized input data are normally distributed. We propose a procedure that sequentially harmonizes for multiple batch effects in an optimized order, called OPNested ComBat. Furthermore, we propose to address bimodality by employing a Gaussian Mixture Model (GMM) grouping considered as either a batch variable (OPNested + GMM) or as a protected clinical covariate (OPNested − GMM). Methods were evaluated on features extracted with CapTK and PyRadiomics from two public lung computed tomography (CT) datasets. We found that OPNested ComBat improved harmonization performance over standard ComBat. OPNested + GMM ComBat exhibited the best harmonization performance but the lowest predictive performance, while OPNested − GMM ComBat showed poorer harmonization performance, but the highest predictive performance. Our findings emphasize that improved harmonization performance is no guarantee of improved predictive performance, and that these methods show promise for superior standardization of datasets heterogeneous in multiple or unknown imaging parameters and greater generalizability. [ABSTRACT FROM AUTHOR]

The development of a hydrogen energy-based society is becoming the solution for more and more countries. Fuel cell electric vehicles are the best carriers for developing a hydrogen energy-based society. The current research on hydrogen leakage and the diffusion of fuel cell electric vehicles has been sufficient. However, the study of hydrogen safety has not reduced the safety concerns for society and government management departments, concerning the large-scale promotion of fuel cell electric vehicles. Hydrogen safety is both a technical and psychological issue. This paper aims to provide a comprehensive overview of fuel cell electric vehicles' hydrogen dispersion and the burning behavior and introduce the relevant work of international standardization and global technical regulations. The CFD simulations in tunnels, underground car parks, and multistory car parks show that the hydrogen escape performance is excellent. At the same time, the research verifies that the flow, the direction of leakage, and the vehicle itself are the most critical factors affecting hydrogen distribution. The impact of the leakage location and leakage pore size is much smaller. The relevant studies also show that the risk is still controllable even if the hydrogen leakage rate is increased ten times the limit of GTR 13 to 1000 NL/min and then ignited. Multi-vehicle combustion tests of fuel cell electric vehicles showed that adjacent vehicles were not ignited by the hydrogen. This shows that as long as the appropriate measures are taken, the risk of a hydrogen leak or the combustion of fuel cell electric vehicles is controllable. The introduction of relevant standards and regulations also indirectly proves this point. This paper will provide product design guidelines for R&D personnel, offer the latest knowledge and guidance to the regulatory agencies, and increase the public's acceptance of fuel cell electric vehicles. [ABSTRACT FROM AUTHOR]

By analyzing production with a continuum of tasks subject to common stochastic effects, the analysis shows that tension between business commonality and standardization is an important source of product cycles. The paper addresses the question of whether business commonality and standardization work in tandem or against each other in a general framework, when fragmentation of production is or is not possible due to contractual incompleteness or technology features. Unlike current literature, the analysis shows that a product cycle can be obtained even with complete contracts. This is so because retaining manufacturing within the firm enhances and exploits commonality in the early stages of production and, hence, reduces the moral hazard cost of providing incentives, which would be a hidden cost of outsourcing instead. Standardization later on can favor offshoring. [ABSTRACT FROM AUTHOR]

• A strong multidisciplinary organizational structure is necessary to drive consensus in selection and successfully implement point of care glucose meters across a large multi-hospital system. • Beyond the standard analytical laboratory evaluation, meter performance should be evaluated at the point of use, employing consensus error grids and defined acceptability criteria. • Structured end-user evaluation is as an essential element of the meter selection process which commonly includes the evaluation of cost, connectivity, indications for use, and ease of implementation. To select and standardize point-of-care (POC) glucose meters across a multi-hospital system. We formed a multidisciplinary POC glucose standardization working group including key stakeholders from each site. A set of selection criteria: usability, clinical and laboratory performance, indications for use, interface connectivity, ease of implementation and ongoing operational costs were used to develop a scoring schema to facilitate a consensus-driven selection process. Method comparison and consensus error grid evaluation against the clinically validated reference methods demonstrated that the analytical performance for all candidate meters was comparable for both the laboratory and clinical evaluation. However, Meter 1 ranked highest in usability evaluations, implementation and streamlined interface connectivity. The meter selection process and implementation were staggered across sites due to complexity of transitioning to a new manufacturer's meter and limitations in vendor support for training and ongoing troubleshooting of interface connectivity. Standardization of POC glucose meters in a large multi-hospital system is a complex undertaking requiring robust, multidisciplinary organizational structure both system-wide and locally, development of consensus-driven selection tools, usability evaluation by end-users, laboratory and clinical evaluation of the analytical performance, and a strong vendor-laboratory partnership during the implementation process. [ABSTRACT FROM AUTHOR]

With the development of 5G technology, Internet of Things (IoT) is proliferating and deeply integrated with our daily lives and industry productions. IoT applications in the 5G era generate massive connections, and this would bring about many security issues. In this paper, we first analyze security risks for massive IoT in the 5G era, then summarize related security policies and standards. Furthermore, we propose security requirements and measures for various layers, including sensor control equipment and IoT card, IoT network and transmission exchange, IoT business application and service, and IoT security management and operation. Next, we introduce the case of the cyber security monitoring platform, explain the security technology based on edge computing, and point out the related standards. Finally, we put forward suggestions on IoT security technology and standardization work, so as to promote the secure development of IoT in the 5G era. [ABSTRACT FROM AUTHOR]

The Wechsler Intelligence Scale for Children -- Fifth Edition is the most recent update to this scale, launched originally in 2014 in the United Stated. WISC-V includes several improvements from previous versions, such as an updated factorial structure that includes more indexes, new process scores and new procedures for norming. These improvements are particularly relevant in the Chilean context, since the previous version available in the country was the WISC-IIIv.ch, whose factorial structure dates from 1991, although it was standardized for Chilean population in 2007. This article presents the standardization process for the WISC-V, which includes the translation, adaptation and norming procedures for the Chilean population. It includes evidence for reliability and validity, and also results for various special groups samples, such as intellectual disability (24), attentional deficit disorder with hyperactivity (27), autism spectrum disorder (26), specific language disorder (56) and rural population (47). The Chilean data shows excellent reliability results and an excellent adjustment to the factorial model used in the North American version. This research provides evidence for convergent validity between WISC-V and other versions of these scales, such as the WAIS-IV and the WISC-IIIv.ch. Finally, we perform a comparison between private, voucher and public schools using this scale and a comparison between male and female performance in this scale. The main finding of this research is that the Chilean standardization of the WISC-V has excellent psychometric properties that allow recommending the use of this instrument in the country. [ABSTRACT FROM AUTHOR]

In December 1972, the Sub Department of Design of the Corporación de la Vivienda (CORVI) published a document with eighteen housing prototypes developed by its teams between 1966 and 1971. This document was the result of the previous experience of those teams in developing a large part of the social housing built in Chile, of the work of systematization and standardization of that set of works, and of the design indications given by the managers of these teams. Drawing on the document itself, secondary sources that report on CORVI's decisions, and interviews with Orlando Sepúlveda Mellado, an architect member of CORVI's design teams, this paper analyzes the practical meaning of "Tipología de viviendas racionalizadas 1966-1972" and suggests that it performs a non-canonical mode of the notion of typology, articulates a standardization of project ideas, and responds to the contingencies of the sociomaterial environment. This helps to conclude that the inaccuracies observed in the document are part of an objectual strategy of communication of the technical aspect that aims at its practicality, that is, to efficiently narrate the complexity of architectonic rationalization as a political and socio-technical program. [ABSTRACT FROM AUTHOR]

Global clinical trials depend on a range of standards in order for research results to be comparable. As standardization is more than a mere technical exercise, tensions can arise when things are not uniform. This paper uses empirical data from interviews with principal investigators as well as Clinical Research Organization and pharmaceutical industry representatives working in India's clinical trial industry to critically examine the ways Indian researchers navigate quests for standardization. It turns the analytical lens to the often obfuscated work of standardization aiming to transcend the biological and cultural specificity of research participants and research sites. Drawing on the concept of local biologies, it illustrates that the universal body presumed by clinical trial methodology is, in fact, a specifically Euro-American one: Indian participants not only need to be made globally comparable but also aligned with the drugs' future consumers. Focusing on the tensions between biomedicine's postulation of bodily universality and trial participants' local biologies, this paper advances recent interventions problematizing the structural violence undergirding global clinical trials. It also contributes to the literature on local biologies in its discussion of how these are negotiated in Indian for-profit clinical trials. [ABSTRACT FROM AUTHOR]

The use of conventional serum for supplementation of media in cell-based and single-cell functional assays has been a major challenge for assay performance, standardization, optimization, and reproducibility. It has been identified as the leading cause of variability and suboptimal performance in large, international Elispot proficiency panels (Janetzki et al., 2008; Rountree et al., 2016). Extensive pretesting and optimization activities are one approach to overcome these challenges, but they are time-consuming and resource-intensive because suitable lots of serum are difficult to identify and secure in sufficient quantities to provide stability in long-term studies. Advancements in manufacturing methods have resulted in a new class of serum with the potential to solve these challenges. An IFNɣ Elispot study was designed by the External Quality Assurance Program Oversight Laboratory (EQAPOL) at Duke Human Vaccine Institute's (DHVI) Immunology and Virology Quality Assessment Center (IVQAC) to test this new class of serum against their in-house, validated control serum, which is regarded as a global standard in performance for high functionality, recovery, and viability. Commonly used serum-free media were also included in the study. The results of this study compellingly demonstrate that this new class of serum produces high responses and low background reactivity comparable to the included serum standard, with excellent recovery and viability of cells. A protocol for ongoing testing has been developed to continuously validate new batches of this serum with the goal to make available to the field a pretested and validated serum that can be used with confidence in functional cell-based assays. [ABSTRACT FROM AUTHOR]

Agent-based models (ABMs) are an increasingly popular choice for simulating large systems of interacting components, and have been applied across a wide variety of natural and environmental systems. However, ABMs can be incredibly disparate and often opaque in their formulation, implementation, and analysis. This can impede critical assessment and re-implementation, and jeopardize the reproducibility and conclusions of ABM studies. In this review, we survey recent work towards standardization in ABM methodology in several aspects: model description and documentation, model implementation, and model analysis and inference. Based on a critical review of the literature, focused on ABMs of environmental and natural systems, we describe a recurrent trade-off between flexibility and standardization in ABM methodology. We find that standard protocols for model documentation are beginning to establish, although their uptake by the ABM community is inhibited by their sometimes excessive level of detail. We highlight how implementation options now exist at all points along a spectrum from ad hoc, 'from scratch' implementations, to specific software offering 'off-the-shelf' ABM implementations. We outline how the main focal points of ABM analysis (behavioural and inferential analysis) are facing similar issues with similar approaches. While this active development of ABM analysis techniques brings additional methods to our analysis toolbox, it does not contribute to the development of a standardized framework, since the performance and design of these methods tends to be highly problem-specific. We therefore recommend that agent-based modellers should consider multiple approaches simultaneously when analysing their model. Well-documented software packages, and critical comparative reviews of such, will be important facilitators in these advances. ABMs can additionally make better use of developments in other fields working with high-dimensional problems, such as Bayesian statistics and machine learning. • We review advances in ABM methodology, focusing on standardization. • A recurrent trade-off between flexibility and standardization is observed. • We describe similar developments in tools for behavioural and inferential analysis. • The future of ABM methodology depends on usable, well-documented software. [ABSTRACT FROM AUTHOR]

The paper presents ISO standardization work carried out to formulate guidelines for service robot modularity for assisting the development of open plug-n-play modules that can be easily assembled to create application specific robots and robot systems. Although robot modularity has been an active research field for many years, the developments have had little impact on advancing robot markets due to their individualist nature and the results not having sufficiently wide relevance or appeal. The paper initially provides an overview of the new ISO 22166-1 service robot modularity standard and aims to illustrate how to implement it with several use cases. Specific innovations produced in realizing robot modules under the guidance of ISO are introduced and two simple approaches based on block diagram approaches (the line and circle diagrams) are proposed for implementing and designing modular robots. Finally, the paper presents several use cases as examples where the new ISO robot modular approach can be used to good effect. • First ISO modularity standardization for service robots. • Line and circle diagrams for modular representation. • Real commercial modular robots as user case examples are demonstrated. [ABSTRACT FROM AUTHOR]