Search

Since the first approval of the anti-CD3 recombinant monoclonal antibody (mAb), muromonab-CD3, a mouse antibody for the prevention of transplant rejection, by the US Food and Drug Administration (FDA) in 1986, mAb therapeutics have become increasingly important to medical care. A wealth of information about mAbs regarding their structure, stability, post-translation modifications, and the relationship between modification and function has been reported. Yet, substantial resources are still required throughout development and commercialization to have appropriate control strategies to maintain consistent product quality, safety, and efficacy. A typical feature of mAbs is charge heterogeneity, which stems from a variety of modifications, including modifications that are common to many mAbs or unique to a specific molecule or process. Charge heterogeneity is highly sensitive to process changes and thus a good indicator of a robust process. It is a high-risk quality attribute that could potentially fail the specification and comparability required for batch disposition. Failure to meet product specifications or comparability can substantially affect clinical development timelines. To mitigate these risks, the general rule is to maintain a comparable charge profile when process changes are inevitably introduced during development and even after commercialization. Otherwise, new peaks or varied levels of acidic and basic species must be justified based on scientific knowledge and clinical experience for a specific molecule. Here, we summarize the current understanding of mAb charge variants and outline risk-based control strategies to support process development and ultimately commercialization.

Copyright of Financing is the property of Financing and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revista de Ciências da Administração is the property of Universidade Federal de Santa Catarina, Departamento de Ciencias da Administracao and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Enterprise resource planning (ERP) systems are indispensable for a majority of larger and midsize firms, and have changed the way accounting information is collected, stored, processed, and disseminated. Although most ERP systems integrate an eXtensible Business Reporting Language (XBRL) component in their core modules, little research has examined how ERP systems affect the quality of XBRL filings. Using unique data from branch-level ERP implementation, we find that the degree of ERP adoption among a firm's branches is negatively associated with the firm's XBRL filing errors and positively associated with XBRL reporting comparability, which in turn facilitates external users' access to the firm's XBRL filings in the SEC's EDGAR. These results suggest that ERP systems improve XBRL reporting quality. Moreover, our results indicate that ERP can mitigate the negative effect of extension taxonomies on XBRL reporting quality, which highlights the importance of the ERP system in a complicated XBRL reporting environment. [ABSTRACT FROM AUTHOR]

Background: Analytical performance should be evaluated before a new coagulation analyzer is adopted in a clinical laboratory. The objective of this study was to evaluate analytical performances of three new coagulation analyzers (STA-R Max3, CN-6000, and Cobas t511) and compare them based on the following four coagulation parameters: prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and D-dimer. Methods: A total of 427 plasma samples, including fresh and frozen/thawed plasma spanning wide ranges. Each of the manufacturers' quality control samples were used for the evaluation. Analytical performances were evaluated. Parameters considered were precision, carryover, verification of analytical measurement range, auto-dilution, and reference range according to the CLSI guidelines (H57-A). The results of each parameter were compared between STA-R compact (currently in use) and three new analyzers using fresh plasma. The results were compared among three new analyzers using fresh and frozen/thawed plasma, and samples with interferences of hemolysis/icterus/lipemia (H/I/L). Results: Analytical performances were excellent for all analyzers within each manufacturer's target based on results of precision, carryover, linearity, and verifications of auto-dilution, and reference range. Results for four parameters (PT/aPTT/fibrinogen/D-dimer) with the three new analyzers using fresh samples were well-correlated with those of STA-R Compact except for D-dimer tests (Pearson's r: 0.84 to 1.00). Good correlations were observed between the new analyzers with the total samples (fresh and frozen/thawed samples) (Pearson's r, 0.86 to 0.97). However, weaker correlation and/or higher mean bias% were observed for aPTT and D-dimer with total samples and for four parameters with normal samples rather than abnormal samples across the three analyzers. Differences were more prominent with H/I/L samples, especially between STA-R Max3 and CN-6000 or Cobas t511 for PT, aPTT, and D-dimers. Conclusions: With excellent analytical performances, the three new coagulation analyzers demonstrated good correlations, although high variabilities were seen for aPTT and D-dimers. High variability in comparison analysis might be mainly attributed to differences in reference and reportable ranges of each parameter across the three different analyzers. [ABSTRACT FROM AUTHOR]

Copyright of Zbornik Radova: Univerzitet 'Džemal Bijedić' u Mostaru, Ekonomski Fakultet is the property of Dzemal Bijedic University of Mostar, Faculty of Economics and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Publicly available summaries from Marketing Authorization Applications for gene and cell therapy products (advanced therapies) were evaluated to explore data expectations for product characteristics pre and post changes (comparability). Public assessment reports were used to analyze trends in information requests from regulators concerning comparability from current commercial advanced therapies. In the analysis, 12 products approved in the USA and EU were included. Inadequacies were highlighted for comparability data (six products); additional information requests (five products) and major objections were identified relating to comparability (two products, EU). Postapproval authorization obligations were imposed for six products. Comparability data are essential component for regulatory applications and public assessment reports provide a valuable source of insight into regulators' expectations. [ABSTRACT FROM AUTHOR]

Abstract This report summarizes the main themes and conclusions from the OECD-GESIS Seminar on Translating and Adapting Instruments in Large-Scale Assessments, which took place at the Organization for Economic Co-operation and Development (OECD), Paris, in June 2018. The five sessions covered the topics (1) etic (universal) vs. emic (culture-specific) measurement instruments, (2) language- and culture-sensitive development of measurement instruments, (3) international guidelines vs. implementation in countries and by translators, (4) tools and technological developments, and (5) quality control of translations. Key players in the field presented on best practice, lessons learned, and innovations and also made suggestions for moving the field forward.

Abstract Trauma is the leading cause of mortality in humans below the age of 40. Patients injured by accidents frequently suffer severe multiple trauma, which is life-threatening and leads to death in many cases. In multiply injured patients, thoracic trauma constitutes the third most common cause of mortality after abdominal injury and head trauma. Furthermore, 40–50% of all trauma-related deaths within the first 48 h after hospital admission result from uncontrolled hemorrhage. Physical trauma and hemorrhage are frequently associated with complex pathophysiological and immunological responses. To develop a greater understanding of the mechanisms of single and/or multiple trauma, reliable and reproducible animal models, fulfilling the ethical 3 R’s criteria (Replacement, Reduction and Refinement), established by Russell and Burch in ‘The Principles of Human Experimental Technique’ (published 1959), are required. These should reflect both the complex pathophysiological and the immunological alterations induced by trauma, with the objective to translate the findings to the human situation, providing new clinical treatment approaches for patients affected by severe trauma. Small animal models are the most frequently used in trauma research. Rattus norvegicus was the first mammalian species domesticated for scientific research, dating back to 1830. To date, there exist numerous well-established procedures to mimic different forms of injury patterns in rats, animals that are uncomplicated in handling and housing. Nevertheless, there are some physiological and genetic differences between humans and rats, which should be carefully considered when rats are chosen as a model organism. The aim of this review is to illustrate the advantages as well as the disadvantages of rat models, which should be considered in trauma research when selecting an appropriate in vivo model. Being the most common and important models in trauma research, this review focuses on hemorrhagic shock, blunt chest trauma, bone fracture, skin and soft-tissue trauma, burns, traumatic brain injury and polytrauma.

Nematodes are increasingly used as powerful bioindicators of soil food web composition and functioning in ecological studies. Todays’ ecological research aims to investigate not only local relationships but global patterns, which requires consistent methodology across locations. Thus, a common and easy extraction protocol of soil nematodes is needed. In this study, we present a detailed protocol of the Baermann-funnel method and highlight how different soil pre-treatments and equipment (soil type, soil height, sieving, and filter type) can affect extraction efficiency and community composition by using natural nematode communities. We found that highest nematode extraction efficiency was achieved using lowest soil height as indicated by the thickness of the soil sample in the extractor due to differences in soil weight (1, 2, or 4 cm soil height) in combination with soil sieving (instead of no sieving), and by using milk filters (instead of paper towels). PCA at the family level revealed that different pre-treatments significantly affected nematode community composition. Increasing the height of the soil sample by adding more soil increased the proportion of larger-sized nematodes likely because those are able to overcome long distances but selected against small nematodes. Sieving is suggested to break up soil aggregates and, therefore, facilitate moving in general. Interestingly, sieving did not negatively affect larger nematodes that are supposed to have a higher probability of getting bruised during sieving but, even if not significant, yielded more extracted nematodes than no sieving. We therefore recommend to use small heights of sieved soil with milk filter to extract free-living soil nematodes with the Baermann-funnel method. The present study shows that variations in the extraction protocol can alter the total density and community composition of extracted nematodes and provides recommendations for an efficient and standardized approach in future studies. Having a simple, cheap, and standardized extraction protocol can facilitate the assessment of soil biodiversity in global contexts.

Information comparability can be ensured by consistently applying the same financial reporting framework or similar financial reporting frameworks. The comparability of financial information can be measured both between firms and from one period to another. In the study there has been evaluated the comparability of accounting information over time, from one financial exercise to another, and in space, between firms, with panel data analysis using models with fixed-effects. The study was conducted on a sample of 63 BSE Romanian listed companies, during the period 2007-2016, and to obtain the research results, panel data analysis was performed. The main results have revealed that the move to IFRS has led to increased comparability of financial information, based on the estimates of time and cross fixed effects.

Objective: This study examines the impacts of management ability on financial statement comparability in 120 firms listed in the Tehran Stock Exchange, during 2005-2017. Method: In this study, the measure developed by Demerjian et al. (2012) was used to assess management ability, and the measure introduced by DeFranco et al. (2011) was used to specify accounting comparability. Panel data and multivariate regression models were taken to test the study hypothesis and analyze the results. Also, two alternative proxies for financial statement comparability were specified to re-test the hypothesis. Result: Findings from the above tests verified the findings of the study showing that the management ability has positively significant impact on financial statement comparability. Conclusion: This study suggests that firms can improve their financial statement comparability by employing higher quality managers.

This study investigates whether the value relevance of accounting information was changed after IFRS adoption in South Korea. Related prior studies have found mixed empirical evidence depending on research methodologies or research periods. Moreover, the effect of IFRS adoption on value relevance can be different between Korean stock markets (KSE and KOSDAQ) because they have different characteristics. Also, the main financial statements reported by Korean firms had changed from individual financial statements to consolidated financial statements after IFRS adoption. Thus, this study analyzes the effect of IFRS adoption on the value relevance of individual and consolidated accounting numbers expanding research periods (5 years before and after IFRS adoption) and comparing changes in explanatory powers of Ohlson (1995) model on each listing market. The empirical results indicate that the value relevance of Korean listed firms generally decreased after IFRS adoption. However, the value relevance of KSE listed firms decreased, while the value relevance of KOSDAQ listed firms increased after IFRS adoption. In addition, it was found that the effects of IFRS adoption on value relevance of individual and consolidated financial information were different depending on listed markets. This implies that different level of demand for information environment may induce differential effects of IFRS adoption on value relevance.

The primary objective of financial reporting in a modern market economy, which is based on the capital market, is to inform the investor about the financial position of a business entity. The unavoidable theme in modern accounting research is the valuation of balance sheet positions, regardless of the type and size of the business entity whose reports are the subject of this paper. The purpose of the research is to investigate whether there is a connection between the frequency of applying the accounting concept of fair value in valuing property positions and the quality of financial statements for businesses in Bosnia and Herzegovina. The target population comprises 34,515 small, medium and large enterprises registered as joint stock companies and limited liability companies in Bosnia and Herzegovina, and the questionnaire will be used as the empirical research instrument. The questionnaire is structured in parts to obtain knowledge about which technique or approach business entities use when using the fair value for the valuation of balance sheet items, and consequently how it affects the relevance, comprehensibility, comparability and credibility of the information presented in the financial statements.

Due to the growing significance of international studies, the need for tools to assess the equivalence of items is pressing. Web probing, which is implementing verbal probing techniques traditionally used in cognitive interviewing in online surveys, is a method to complement quantitative techniques to establish equivalence of items in crosscultural research. We illustrate this approach by assessing the question of 'how important it is that government authorities respect and protect the rights of minorities', which was originally used in the International Social Survey Program, for respondents in five countries (Germany, Britain, the U.S., Mexico, and Spain). First, participants answered this question using a 7-point Likert scale. Then they wrote freely what types of minorities they had thought of. Whether country differences in the response patterns can be interpreted substantially depends partially on how similarly the term 'minorities' is understood across these five contexts. Our results show that people in the participating countries have slightly different kinds of 'minorities' in mind.

Specifying accurate informative prior distributions is a question of carefully selecting studies that comprise the body of comparable background knowledge. Psychological research, however, consists of studies that are being conducted under different circumstances, with different samples and varying instruments. Thus, results of previous studies are heterogeneous, and not all available results can and should contribute equally to an informative prior distribution. This implies a necessary weighting of background information based on the similarity of the previous studies to the focal study at hand. Current approaches to account for heterogeneity by weighting informative prior distributions, such as the power prior and the meta-analytic predictive prior are either not easily accessible or incomplete. To complicate matters further, in the context of Bayesian multiple regression models there are no methods available for quantifying the similarity of a given body of background knowledge to the focal study at hand. Consequently, the purpose of this study is threefold. We first present a novel method to combine the aforementioned sources of heterogeneity in the similarity measure ω. This method is based on a combination of a propensity-score approach to assess the similarity of samples with random- and mixed-effects meta-analytic models to quantify the heterogeneity in outcomes and study characteristics. Second, we show how to use the similarity measure ωas a weight for informative prior distributions for the substantial parameters (regression coefficients) in Bayesian multiple regression models. Third, we investigate the performance and the behavior of the similarity-weighted informative prior distribution in a comprehensive simulation study, where it is compared to the normalized power prior and the meta-analytic predictive prior. The similarity measure ω and the similarity-weighted informative prior distribution as the primary results of this study provide applied researchers with means to specify accurate informative prior distributions.

Dual-task paradigms encompass a broad range of approaches to measure cognitive load in instructional settings. As a common characteristic, an additional task is implemented alongside a learning task to capture the individual’s unengaged cognitive capacities during the learning process. Measures to determine these capacities are, for instance, reaction times and interval errors on the additional task, while the performance on the learning task is to be maintained. Opposite to retrospectively applied subjective ratings, the continuous assessment within a dual-task paradigm allows to simultaneously monitor changes in the performance related to previously defined tasks. Following the Cognitive Load Theory, these changes in performance correspond to cognitive changes related to the establishment of permanently existing knowledge structures. Yet the current state of research indicates a clear lack of standardization of dual-task paradigms over study settings and task procedures. Typically, dual-task designs are adapted uniquely for each study, albeit with some similarities across different settings and task procedures. These similarities range from the type of modality to the frequency used for the additional task. This results in a lack of validity and comparability between studies due to arbitrarily chosen patterns of frequency without a sound scientific base, potentially confounding variables, or undecided adaptation potentials for future studies. In this paper, the lack of validity and comparability between dual-task settings will be presented, the current taxonomies compared and the future steps for a better standardization and implementation discussed.

Methodological studies usually gauge response quality in narrative open-ended questions with the proportion of nonresponse, response length, response time, and number of themes mentioned by respondents. However, not all of these indicators may be comparable and appropriate for evaluating open-ended questions in a cross-national context. This study assesses the cross-national appropriateness of these indicators and their potential bias. For the analysis, we use data from two web surveys conducted in May 2014 with 2,685 respondents and in June 2014 with 2,689 respondents and compare responses from Germany, Great Britain, the United States, Mexico, and Spain. We assess open-ended responses for a variety of topics (e.g., national identity, gender attitudes, and citizenship) with these indicators and evaluate whether they arrive at similar or contradictory conclusions about response quality. We find that all indicators are potentially biased in a cross-national context due to linguistic and cultural reasons and that the bias differs in prevalence across topics. Therefore, we recommend using multiple indicators as well as items covering a range of topics when evaluating response quality in open-ended questions across countries. [ABSTRACT FROM AUTHOR]

The running correlation coefficient (RCC) is useful for capturing temporal variations in correlations between two time series. The local running correlation coefficient (LRCC) is a widely used algorithm that directly applies the Pearson correlation to a time window. A new algorithm called synthetic running correlation coefficient (SRCC) was proposed in 2018 and proven to be reasonable and usable; however, this algorithm lacks a theoretical demonstration. In this paper, SRCC is proven theoretically. RCC is only meaningful when its values at different times can be compared. First, the global means are proven to be the unique standard quantities for comparison. SRCC is the only RCC that satisfies the comparability criterion. The relationship between LRCC and SRCC is derived using statistical methods, and SRCC is obtained by adding a constraint condition to the LRCC algorithm. Dividing the temporal fluctuations into high- and low-frequency signals reveals that LRCC only reflects the correlation of high-frequency signals; by contrast, SRCC reflects the correlations of high- and low-frequency signals simultaneously. Therefore, SRCC is the appropriate method for calculating RCCs. [ABSTRACT FROM AUTHOR]

Dual-task paradigms encompass a broad range of approaches to measure cognitive load in instructional settings. As a common characteristic, an additional task is implemented alongside a learning task to capture the individual's unengaged cognitive capacities during the learning process. Measures to determine these capacities are, for instance, reaction times and interval errors on the additional task, while the performance on the learning task is to be maintained. Opposite to retrospectively applied subjective ratings, the continuous assessment within a dual-task paradigm allows to simultaneously monitor changes in the performance related to previously defined tasks. Following the Cognitive Load Theory, these changes in performance correspond to cognitive changes related to the establishment of permanently existing knowledge structures. Yet the current state of research indicates a clear lack of standardization of dual-task paradigms over study settings and task procedures. Typically, dual-task designs are adapted uniquely for each study, albeit with some similarities across different settings and task procedures. These similarities range from the type of modality to the frequency used for the additional task. This results in a lack of validity and comparability between studies due to arbitrarily chosen patterns of frequency without a sound scientific base, potentially confounding variables, or undecided adaptation potentials for future studies. In this paper, the lack of validity and comparability between dual-task settings will be presented, the current taxonomies compared and the future steps for a better standardization and implementation discussed. [ABSTRACT FROM AUTHOR]

Specifying accurate informative prior distributions is a question of carefully selecting studies that comprise the body of comparable background knowledge. Psychological research, however, consists of studies that are being conducted under different circumstances, with different samples and varying instruments. Thus, results of previous studies are heterogeneous, and not all available results can and should contribute equally to an informative prior distribution. This implies a necessary weighting of background information based on the similarity of the previous studies to the focal study at hand. Current approaches to account for heterogeneity by weighting informative prior distributions, such as the power prior and the meta-analytic predictive prior are either not easily accessible or incomplete. To complicate matters further, in the context of Bayesian multiple regression models there are no methods available for quantifying the similarity of a given body of background knowledge to the focal study at hand. Consequently, the purpose of this study is threefold. We first present a novel method to combine the aforementioned sources of heterogeneity in the similarity measure ω. This method is based on a combination of a propensity-score approach to assess the similarity of samples with random- and mixed-effects meta-analytic models to quantify the heterogeneity in outcomes and study characteristics. Second, we show how to use the similarity measure ωas a weight for informative prior distributions for the substantial parameters (regression coefficients) in Bayesian multiple regression models. Third, we investigate the performance and the behavior of the similarity-weighted informative prior distribution in a comprehensive simulation study, where it is compared to the normalized power prior and the meta-analytic predictive prior. The similarity measure ω and the similarity-weighted informative prior distribution as the primary results of this study provide applied researchers with means to specify accurate informative prior distributions. [ABSTRACT FROM AUTHOR]

Introduction: Case reports are commonly used to report the health outcomes of mass gatherings (MGs), and many published reports of MGs demonstrate substantial heterogeneity of included descriptors. As such, it is challenging to perform rigorous comparisons of health services and outcomes between similar and dissimilar events. The degree of variation in published reports has not yet been investigated.Objective: Examine patterns of post-event medical reporting in the existing literature and identify inconsistencies in reporting.Methods: A systematic review of case reports was conducted. Included were English studies, published between January 2009 and December 2018, in Prehospital and Disaster Medicine (PDM) or Current Sports Medicine Reports (CSMR). Analysis of each paper was used to develop a list of 27 categories of data.Results: Seventy-five studies were initially reviewed with 54 publications meeting the inclusion criteria. Forty-two were full case reports (78%) and 12 were conference proceedings (22%). Of the 27 categories of data studied, only 13 were consistently reported in more than 50% of publications. Reporting patterns included inconsistent use of terminology/language and variable retrievability of reports. Reporting on event descriptors, hazard and risk analysis, and clinical outcomes were also inconsistent.Discussion: Case reports are essential tools for researchers and event team members such as medical directors and event producers. The authors found that current case reports, in addition to being inconsistent in content, were generally descriptive rather than explanatory; that is, focused on describing the outcomes as opposed to exploring possible connections between context and health outcomes.Conclusion: This paper quantifies and demonstrates the current state of heterogeneity in MG event reporting. This heterogeneity is a significant impediment to the functional use of published reports to further the science of MG planning and to improve health outcomes. Future work based on the insights gained from this analysis will aim to align and standardize reporting to improve the quality and value of event reporting. [ABSTRACT FROM AUTHOR]

Copyright of Revista Gestão & Tecnologia is the property of Revista Gestao & Tecnologia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In the vaccine industry, multiple physicochemical, immunological, in vitro and in vivo analytical methods are applied throughout the manufacturing process to characterize and monitor the quality of vaccines. Presented here is the Single Epitope Antigenicity Test (SEAT), an innovative, quantitative epitope profiling method which provides an extended immunochemical analysis for diphtheria toxoid (DTxd) to be used for consistency testing during manufacturing process changes. The method uses BioLayer Interferometry (BLI) and a panel of monoclonal antibodies (mAbs) to independently assess nine individual antigenic sites of DTxd. The panel includes mAbs which are functional, bind distinct sites on DTxd and are able to distinguish intact DTxd from that which has been exposed to heat treatment. The SEAT method was qualified for precision, accuracy, and linearity, and was used to define a preliminary comparability range for DTxd made using the current manufacturing process. DTxd lots manufactured using alternate processes were assessed in the context of this range to determine the impact on DTxd antigenicity. Epitope profiling by SEAT provides quantitative information on the integrity of multiple important antigenic regions of DTxd, and therefore represents a valuable tool in a comprehensive analytical test package which can be used to support manufacturing process changes for vaccines.

How to support the outreach and roll-out of standards in the developing statistical systems and what are the shortcomings in the outreach and roll-out systems? This paper aims to contribute to the debate by discussing the set of papers presented in the special Invited Paper Session of the ISI World Statistical Congress 2021 (The Hague) on the effectiveness of the outreach of official statistics standards and guidelines. I argue that the use of standards is essential to maximize the effectiveness of statistical outputs and the efficiency of the production process, however for the developing countries one should consider issues of capacity in implementation in line with the correct outreach and implementation of standards. [ABSTRACT FROM AUTHOR]

Objectives: We performed a verification study of the Sysmex XN-3100 hematology analyzer in comparison with the XE-2100 according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the International Council for Standardization in Hematology (ICSH). Materials and methods: Blood samples and quality control materials were used for precision. For comparison, we used the current XE-2100 as the comparative method and analyzed 540 blood samples. The Passing-Bablok and Bland-Altman tests were performed according to the CLSI EP09-A3 and a carryover study was performed according to the CLSI H26-A2 guidelines. The flagging performance of the two analyzers was compared, using two experienced laboratory technicians as the reference method. Results: The Sysmex XN-3100 demonstrated high levels of precision for most parameters. For the comparison analysis, all parameters, except for MCHC, monocytes and basophils were within the systematic error limits of desirable biological variability criterion (SeDBV). The carryover was less than 0.4% for all parameters. The flagging performance of the XN-3100 was satisfactory and the overall efficiency was high. Conclusions: The XN-3100 not only showed a strong correlation and agreement with the XE-2100 but also displayed a comparable analytical sensitivity, and increased specificity, which may result in an improved turnaround time and throughpu. [ABSTRACT FROM AUTHOR]

The German state of Hesse switched in 2015 from its own accounting practice, based on the country's private sector commercial code (the Handelsgesetzbuch), to the German public sector accounting standards (Standards Staatlicher Doppik: 'SsD'). Hesse was the earliest adopter of accrual accounting and the only state in Germany whose consolidated financial statements were audited by an external audit company. This article examines Hesse's critical areas of non-compliance with the SsD and the potential impact on comparability and transparency objectives and thus contributes to the literature on harmonization of accounting systems, extends the literature on areas of conflict between differing accounting rules in the public context and gives an exemplary case study of the situation in Germany. The article updates academics and practitioners on the state of accrual-based public sector accounting in Germany. The analysis reveals challenges in the implementation of new uniform standards (Standards Staatlicher Doppik: SsD), leading to a weakening of comparability and transparency objectives. The article provides standard-setters with insights into critical implementation aspects, such as choices between simplified rules and more realistic and useful accounting policies. The article demonstrates the importance of dialogue with early adopters of new standards. The findings will also be of significance for the European Public Sector Accounting Standards (EPSAS) project. [ABSTRACT FROM AUTHOR]

In the past decade, there has been increasing interest in mosquito microbiome research, leading to large amounts of data on different mosquito species, with various underlying physiological characteristics, and from diverse geographical locations. However, guidelines and standardized methods for conducting mosquito microbiome research are lacking. To streamline methods in mosquito microbiome research and optimize data quality, reproducibility, and comparability, as well as facilitate data curation in a centralized location, we are establishing the Mosquito Microbiome Consortium, a collaborative initiative for the advancement of mosquito microbiome research. Our overall goal is to collectively work on unraveling the role of the mosquito microbiome in mosquito biology, while critically evaluating its potential for mosquito-borne disease control. This perspective serves to introduce the consortium and invite broader participation. It highlights the issues we view as most pressing to the community and proposes guidelines for conducting mosquito microbiome research. We focus on four broad areas in this piece: (1) sampling/experimental design for field, semi-field, or laboratory studies; (2) metadata collection; (3) sample processing, sequencing, and use of appropriate controls; and (4) data handling and analysis. We finally summarize current challenges and highlight future directions in mosquito microbiome research. We hope that this piece will spark discussions around this area of disease vector biology, as well as encourage careful considerations in the design and implementation of mosquito microbiome research. 9AbpineHnudS4JNqJfbdjS Video Abstract [ABSTRACT FROM AUTHOR]

Biosimilar approval relies on the comparability of quality attributes (QAs), for which information can be derived from regulatory or scientific communities. Limited information is known about whether these sources are consistent with or complementary to each other. The consistency and complementarity of QA reporting in biosimilarity assessments for adalimumab biosimilars approved by the European Medicines Agency in European public assessment reports (EPARs) and scientific publications was assessed. A classification of 77 different QAs (53 structural and 24 functional attributes) was used to assess the types of and information on QAs reported. Six adalimumab biosimilars were analyzed, for which the number of QAs reported in EPARs and publications varied (range = 47 [61%]–60 [78%]). The proportion of QAs consistently reported in both sources varied (range = 28%–75%) among biosimilars; functional QAs (mean = 21 QAs [88%]; range = 19–23) were more consistently reported than structural QAs (mean = 33 QAs [62%]; range = 27–34). The EPARs frequently reported biosimilarity interpretation without providing test results (9–57 QAs in EPARs versus 0–8 QAs in publications), whereas publications frequently reported both test results and interpretations (13–40 QAs in publications versus 0–3 QAs in EPARs). Both sources provided information on the biosimilarity of QAs in a complementary manner and the same biosimilarity interpretation of test results for reported QAs (mean = 90%; range = 78%–100%), with a small discrepancy in biosimilarity interpretations of a few clinically relevant QAs related to post-translation modifications and biological activity. Comprehensive reporting of QAs can contribute to an improved understanding of the role of structural and functional attributes in establishing biosimilarity and the mechanism of action of biological substances in general. Proportional Venn diagrams presenting the number of quality attributes (QAs) described in the European public assessment reports (EPARs) and corresponding scientific publications for the adalimumab biosimilars approved in the EU. Image 1 • EPAR and scientific publication differ in aim but should provide consistent biosimilarity data on quality attributes (QAs). • Consistency and complementarity of 77 (53 structural, 24 functional) QAs were assessed in EPARs and scientific publications. • EPARs report biosimilarity interpretation and scientific publications strongly in present test results and interpretations. • Functional QAs are more frequently and consistently reported than structural QAs for adalimumab biosimilars. • Both sources should be systematically consulted to obtain a complete picture of biosimilarity assessment of QAs. [ABSTRACT FROM AUTHOR]

Copyright of Revista Contabilidade, Gestao E Governanca is the property of Revista Contabilidade, Gestao E Governanca and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

There has been a significant increase in cross-national and longitudinal data production in social science research in recent decades. Before drawing substantive conclusions based on cross-national and longitudinal survey data, researchers need to assess whether the constructs are measured in the same way across countries and time-points. If cross-national data are not tested for comparability, researchers risk confusing methodological artifacts as “real” substantive differences across countries. However, researchers often find it particularly difficult to establish the highest level of measurement invariance, that is, exact scalar invariance. When measurement invariance is rejected, it is crucial to understand why this was the case and to address its absence with approaches, such as alignment optimization or Bayesian structural equation modeling.

Orientation: The voluntary disclosure of non-Generally Accepted Accounting Principles (non-GAAP) earnings may lack decision-usefulness if not faithfully represented or comparable. Commonly accepted as being well defined, earnings before interest, tax, depreciation and amortisation (EBITDA) may be misleading if labelled, defined and calculated inconsistently. Research purpose: To assess the decision-usefulness of EBITDA disclosure by Johannesburg Stock Exchange (JSE)-listed companies. Motivation for the study: Prior research on voluntary disclosure largely excluded EBITDA from its focus, accepting it as standardised. Research approach/design and method: A quantitative content analysis was used to analyse the EBITDA disclosure in 220 Stock Exchange News Service (SENS) reports in which JSE-listed companies reported their annual results for the period 2014–2016. Main findings: Companies inconsistently labelled, defined and calculated EBITDA. Twenty-four per cent of the SENS reports labelled and defined EBITDA as earnings before interest, tax, depreciation and amortisation, but calculated it by adjusting for other items as well. Companies’ definitions of EBITDA also differed widely, with 27 different definitions identified in 52 SENS reports that disclosed an unmodified EBITDA label. Practical/managerial implications: Existing JSE reporting requirements appear lacking in ensuring that companies disclose EBITDA that is faithfully represented and comparable. The identified diversity of definitions has implications where EBITDA is used for valuation and contracting purposes. Contribution/value-add: The study contributes to the voluntary disclosure literature by focussing on a non-GAAP earnings measure that has largely been ignored by prior research, namely EBITDA. Empirical evidence is presented on the diversity that exists in EBITDA disclosure by JSE-listed companies.

Objective: Flow of information is a key parameter in an economic activity and acts as a crucial factor in the emergence, stability and efficiency of capital markets. The purpose of this paper is to investigate the effect of the comparability and ineffectiveness of the market on the value of information and changes in the distribution of accounting information. Methods: For this purpose, the data of the firms listed in Tehran Stock Exchange for the period of 2006 to 2016 were extracted and the regression model of the pooled data was used to test the research hypothesis. Results: The results of the research show that information asymmetry, comparability and market inefficiency have a significant effect on the expected returns (cost of capital) of investors. On the other hand, the interactive effects of comparability and imperfect market on the relationship between information asymmetry and cost of capital have been confirmed. Finally, the results of the research show that information asymmetry is a function of comparability and that the capital cost resulting from information asymmetry fluctuate and varies at different levels of comparability. Conclusion: Information asymmetry and market inefficiency can increase the firm's cost of capital, as less informed traders recognize that they are in a bad state of information and therefore maintain fewer assets within the market. The comparability along with creating high-quality information reduces the overall ambiguity and thus reduces the benefits that particular investors receive from private information about the company.

Background: Modern medicine requires use of effective antidiabetic drugs that can imitate the natural profile of insulin in the body of patients with diabetes mellitus. Examples of such preparations include biphasic insulin lispro, which is a mixture of insulin lispro ultra-short action and insulin lispro protamine suspension with prolonged effect. The clinical trials (CT) program for biosimilar insulins contains pharmacology studies: pharmacokinetics (PK), pharmacodynamics (PD) and clinical safety studies. Aims: To demonstrate Biphasic Insulin Lispro 25, suspension for subcutaneous administration, 100 U/ml (GEROPHARM-Bio, Russia) and Humalog® Mix 25, suspension for subcutaneous administration, 100 U/ml (Lilly France, France) have comparable pharmacokinetic profiles under conditions of hyperinsulinemic euglycemic clamp (HEC) in healthy volunteers. Materials and methods: The study was conducted on 48 healthy men aged between 18 to 50 years. This was a double-blind, randomized, crossover study of comparative pharmacokinetics of drugs. The investigational products (IP) were administered before the clamp in a single dose of 0.4 U/kg subcutaneously in the abdominal wall. Regular blood sampling was performed during the study. The insulin concentrations in the samples were determined using an ELISA method. The results of the determination were used to calculate the PK parameters and construct the concentration-time curves. Adjust glucose infusion rates were based on blood glucose measurements. These data were used to calculate the PD parameters. Results: Our results demonstrated that Biphasic Insulin Lispro 25 and Humalog® Mix 25 have comparable PK and PD profiles under conditions of HEC in healthy volunteers. The confidence intervals for the ratio of the geometric mean for Cins.max and AUCins.0–12 were 87.75–99.90% and 83.76–96.98% respectively, which were well within 80–125% limits for establishing comparability. Conclusions: Biphasic Insulin Lispro 25 and Humalog® Mix 25 are equivalent based on this CT applying the HEC technique in healthy volunteers.

This article, after briefly retracing the record of hearings to date and the previous verdicts in this area highlights how the Court’s reasoning with regard to the comparability of rainwater in contact with industrial waste water is, in the light of current legislation, debatable to say the least and, in the context of legal proceedings on this point, identifies as desirable a verdict from Sezioni Unite.

Public perception of “declining standards” in school-leaving examinations often accompanies increases in pass rates in school-leaving examinations. “Declining standards” to the public means easier examination papers. The present study evaluates a South African attempt to estimate the level of difficulty, as distinct from cognitive demand, to exit-level examination papers in Life Sciences. A team of four expert raters assigned a level of difficulty ranging from 1 (easy) to 4 (very difficult). Invalid items were assigned a difficulty level of 0. The reference point was “the ideal average South African learner.” Discussion and practice was conducted for 12 examination papers, followed by individual analysis of four examination papers. Inter-rater agreement for the final four papers was low. Raters assigned most items to difficulty levels 1 and 2, indicating that unreliability may be caused by the instrument having too many levels. Raters’ predictions of levels of difficulty supported the actual mark distribution for private school candidates, but not for public school candidates. The “ideal average South African learner” is an unsuitable reference point in the unequal educational landscape of the public school system. We recommend that the instrument be modified by reducing the number of levels of difficulty and removing the hypothetical reference point.