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The article explores the concept of crime prevention (criminal offenses) in the field of security activities, providing a characterization of the directions and measures of its prevention. Various approaches to understanding these definitions are examined, taking into account the experience of Ukrainian scholars in classifying crime prevention measures. Based on a general theoretical analysis of approaches to understanding the concept of «crime prevention» and defining its content, establishing the main crime prevention measures with their characteristics, as well as studying the system of crime prevention measures (criminal offenses) in the field of security activities and approaches to their classification, the author concludes that crime prevention is a multi-level socio-preventive activity aimed at eliminating and hindering the action of determinants or preventing the commission of acts at various stages of criminal manifestations that lead to the emergence of a certain type of crime, with the aim of ultimately ov ercoming it. The main goal and directions of crime prevention (criminal offenses) in the field of security activities in Ukraine are to create a positive, socially acceptable activity for individuals, introducing into their consciousness a correct, socially recognized understanding of criminal offenses and fostering intolerance towards their commission. General social crime prevention (criminal offenses) in the field of security activities includes a complex of measures conducted by state bodies, public organizations, and other entities aimed at reducing conflicts and stabilizing socio-economic, political, moral-psychological, and legal relations within the state and society. Special criminal crime prevention (criminal offenses) in the field of security activities includes a system of special government agencies that act to influence criminogenic factors, as well as identify the causes and conditions of committing criminal offenses in this sphere and take measures to eliminate them. Individual preventive work in the field of security activities includes early individual prevention, direct individual prevention, and post-criminal prevention. [ABSTRACT FROM AUTHOR]

The article approaches regulation of the wholesale energy market as a part of coordinated effort to establish single EU-27 energy market. We analyze the forms of the cooperation among the national regulators responsible for competition in the wholesale energy markets; such responsibility is split - between two, three or more regulators. The principle of cooperation dominates in the oversight of the wholesale energy market [over concurrency] and has been institutionalized in the form the memo, statute or code; it had also evolved in the EU acquis. Domestic legal system of a state remains a fundamental framework in the traditional nation-state world order as the domestic regulators (NCA, NRA or SMA), along with domestic authority, get also to vote in the EU authorities. Previous research concentrated on delegation of the sovereign powers to the EU level and, to a lesser extent, on coordination between national and state level in the federal EU Member States. This article, instead, looks at horizontal cooperation on the national level only using the comparative legal method. The national level appears to generate the ideas for the EU level and not vice versa, at least, in the analyzed settings of Belgium, France, Germany, the Netherlands, Spain and the United Kingdom. The working arrangements on the information exchange, pooling of resources in the form of task force, investigation crew, joint unit as well as consultations and mutual comments on the policy proposals are common cooperation formats in each of the countries analyzed, often as a formal legislative rule. At the same time, the EU level inter-agency cooperation for the wholesale energy market can boast only memoranda of understanding, quite short. The research also lay prospectives of how Ukrainian government could fit in with its oversight mandate split among the competition authority, financial market authority and energy regulating authority given decision by the European Council on 14-15 December 2023 to open accession negotiations with Ukraine. This publication is third in the planned series of four comparative legal research papers on the inter-action between the regulatory agencies, the first two papers deal with the characterization of the wholesale energy product and wholesale energy market, undertake a content-analysis of the EU-level agencies interactions; the closing fourth part will systematize regulatory policy proposals for the domestic inter-agency cooperation in Ukraine. [ABSTRACT FROM AUTHOR]

This perspective reflects on conservation efforts to increase the coverage of marine protected areas in Solomon Islands. We demonstrate that the current model in which international conservation NGOs provide technical and financial support to pilot projects, from which community‐based resource management will spontaneously spread, is misguided. These site‐based projects typically require substantial financial resources, ignore external threats to coastal ecosystems, and tend to bypass existing governance structures, which makes replication in other areas highly problematic. We argue that to effectively support indigenous peoples and local communities in the management of marine resources and, thereby, achieve biodiversity conservation outcomes at scale, it is necessary to move away from site‐based conservation projects and focus instead on strengthening the capability of government agencies. [ABSTRACT FROM AUTHOR]

Sensitivity analyses are important components of physiologically based pharmacokinetic (PBPK) model development and are required by regulatory agencies for PBPK submissions. They assess the impact of parametric uncertainty and variability on model estimates, aid model optimization by identifying parameters requiring calibration, and enable the testing of assumptions within PBPK models. One‐at‐a‐time (OAT) sensitivity analyses quantify the impact on a model output in response to changes in a single parameter while holding others fixed. Global sensitivity analysis (GSA) methods provide more comprehensive assessments by accounting for changes in all uncertain or variable parameters, though at a higher computational cost. This tutorial article presents a software package for conducting both OAT and GSA of PBPK models built in the Open Systems Pharmacology (OSP) Suite. The tool is accessible through either an R script or a graphical user interface, and the outputs consist of sensitivity metrics of pharmacokinetic (PK) parameters, such as Cmax and AUC, evaluated with respect to model input parameters. Results are formatted according to regulatory standards. The OAT analysis methods comprise two‐way local sensitivity analyses and probabilistic uncertainty analyses, whereas the GSA methods include the Morris, Sobol, and EFAST methods. These analyses can be conducted on single PBPK models or pairs of models for the evaluation of the sensitivity of PK parameter ratios in drug–drug interaction studies. The practical application of the package is demonstrated through three illustrative case studies. [ABSTRACT FROM AUTHOR]

How transparent are state governments in the United States? This Article explores the functioning of important, but often underappreciated, actors in the American constitutional system - state administrative agencies - and examines variation in the existence and implementation of transparency regimes across and within all 50 states. This Article first highlights differences that exist among state freedom of information ("FOI") laws, focusing on three components: who can submit requests; the requirements for and exemptions to public release; and the process for appeal of agency decisions not to disclose information. Because FOI laws require the public to request access to information and permit state agencies to refuse release of records, these laws constitute "passive" transparency and have little effect without a strong administrative apparatus to facilitate implementation. Simply, FOI laws rely on administrators to interpret statutory language in ways that provide access to government information. Because passive transparency regimes like state FOI laws require high-quality administration in order to be effective, this Article presents a novel exploratory field experiment of administrative performance across all 50 states. Specifically, this Article evaluates state implementation of FOI laws using an original empirical study of 248 state agencies' fulfillment of the same FOI request. This study illustrates that agency-level factors such as administrative function, policy mission, and leadership influence information disclosure. As a whole, this Article suggests the stringency of transparency law in the states only partially explains government provision of information to the public. Instead, how administrators react to internal and external pressures as they utilize their discretion to fill FOI requests constitutes a key aspect of open government. [ABSTRACT FROM AUTHOR]

To encourage small business inclusion in public procurement, the U.S. federal government has established the set-aside program that mandates government agencies to award a portion of their contracts to small businesses. We study whether and to what extent the performance of R&D contracts awarded through this program differs from those awarded through open competition. Analyzing a large dataset of federal R&D contracts, we find that despite restricting competition to small businesses, set-aside R&D contracts experience lower schedule and cost overrun than R&D contracts awarded through open competition. Furthermore, although set-aside R&D contracts experience lower schedule and cost overrun when they are awarded to more experienced contractor firms, this benefit arises primarily from a contractor firm's experience in executing R&D contracts across different agencies compared to the firm's experience with the same agency. Finally, set-aside R&D contracts awarded early in a fiscal year experience lower schedule and cost overrun than those awarded later. Post-hoc analysis examining the underlying dimensions of different-agency experience highlights the asymmetric effects of related-agency experience and unrelated-agency experience of contractor firms on the performance of set-aside R&D contracts awarded by the Department of Defense. While related-agency experience improves contract performance, unrelated-agency experience has a detrimental effect on contract performance. These findings demonstrate that small business inclusion policies may not necessarily compromise contract performance. Importantly, they emphasize the need for federal agencies and contracting officers to consider the underlying dimensions of contractor firm experience and contract award timing to improve contract performance and taxpayer money utilization. [ABSTRACT FROM AUTHOR]

Bangladesh's agriculture is highly rice-centric. Although economically rational, this is also risky, and arguably unsustainable. As a result, there is increasing interest in crop diversification (CD). This study examines the policy environment and the implementation of projects promoting CD in Bangladesh from 1971 to the present. An integrated analytical framework, developed by the International Wheat and Maize Improvement Center (CIMMYT) was used. Despite numerous policies and projects aimed at promoting CD, progress remains limited due to historical biases and various challenges. This research identifies a significant gap in existing approaches, which primarily focus on production aspects while neglecting market systems for new crops. Additionally, inadequate coordination among government agencies has impacted the effectiveness of projects implemented by development partners. The study highlights that CD efforts have been largely project-driven and short-lived, emphasizing the need for mainstreaming CD with dedicated annual funding to ensure long-term sustainability. Key challenges in funding, market development, and implementation are identified. The study recommends mainstreaming CD through annual budgets and enhancing market linkages. Furthermore, it provides actionable guidelines for policymakers and practitioners to effectively promote and sustain crop diversification in Bangladesh's agriculture. [ABSTRACT FROM AUTHOR]

The concept of frugal innovation has gained significant traction in low middle-income countries due to its potential to contribute to sustainable development goals (SDGs). This study examines the role of universities in promoting frugal innovation and their capacity to drive socio-economic development through entrepreneurial initiatives. The objective is to explore how universities can serve as both entrepreneurial and development-focused institutions and to develop a conceptual framework to guide their efforts. The study utilizes an exploratory single case study methodology, focusing on the American University of Nigeria (AUN), a leading institution in Nigeria known for its development and entrepreneurship programs. Drawing on data from the AUN THE global impact ranking 2024, the results of the study indicate that the ability of a university to effectively manage technology and skills transfer in frugal innovations is influenced by six university capabilities, and the generation of frugal innovations is moderated by policy and innovation ecosystems involving government agencies, regulatory bodies, and policymakers. This study contributes to the existing body of knowledge by initiating a discussion on how development and entrepreneurship can support frugal innovation, and offers practical insights to inspire other universities to develop their own models for societal and economic impact. The study underscores the necessity of integrating "development" into the vision of universities, particularly in low middle-income and developing economies, and emphasizes the significance of universities embracing both entrepreneurial and development-focused roles. The findings highlight the potential of universities in advancing sustainable development goals, particularly in low middle-income and developing economies, as they work towards meeting the global SDGs by 2030. [ABSTRACT FROM AUTHOR]

Canines are used by both government agencies and industries for their keen olfactory capability as well as selectivity, reliability, versatility, and speed. Within the last decade, canines have been used for the detection of on-shore crude oil. They were previously shown to find these deposits with high accuracy, providing increased confidence with little risk to oil spill response survey teams. In order to efficiently train canines, it is important to understand the odorants or groups of odorants that such canines use when locating subsurface crude oil deposits, as well as track how the odorant profile changes as the crude oil undergoes degradation. In this study, headspace solid phase microextraction (HS-SPME) was used in combination with gas chromatography-mass spectrometry (GC-MS) to extract and separate odorants from the headspace of various crude oils. After, eluent fractions of the crude oil odor profile were separated and collected onto sorbent materials, which were then used as canine testing probes in a series of trials. These probes, along with negative and positive controls were presented to three previously-trained and operational crude oil detection canines. Three eluent fractions of both fresh and weathered samples were presented, resulting in a 100% response rate from the canines on all three fractions from both the fresh and weathered samples. These results indicated that canines are capable of detecting crude oil from any fraction of the odor profile demonstrating the potential of the canines to generalize across a variety of crude oils and stages of weathering. [ABSTRACT FROM AUTHOR]

The use of immunophenotyping during immunotoxicity investigations was first popularized in the 1980 s and has since become more integrated into diagnostic and non-clinical assessments. The data provided from immunophenotyping can serve as an initial source of information to guide decisions for additional, more advanced, immunotoxicity testing as well as for human health safety and risk assessment of drugs and chemicals. However, comprehensive guidance describing applications of immunophenotyping data in immunotoxicity investigations is lacking, particularly among regulatory bodies. Therefore, a critical examination is needed for the appropriate interpretations and potential misinterpretations of such data during the assessment of drug safety and chemical risk. As such, the current uses and implications of immunophenotyping data in human health safety and risk assessments has been evaluated to provide additional context for the application of current methodologies and guidelines. In addition, case studies are presented to highlight the challenges of interpreting immunophenotyping results along with incorporating the findings into immunotoxicity investigations. Based on the analyses of current approaches and methodologies, a decision flow is presented for use of immunophenotyping data during risk informed decision making. [ABSTRACT FROM AUTHOR]

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients' quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a "medical device lag," where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA). [ABSTRACT FROM AUTHOR]

Background: In the last three decades, Electronic Health Records Systems (EHRSs) have become one of the top priorities of policymakers globally. Nowadays, EHRS reform is fast becoming a priority in developed countries. The introduction of EHRSs in Saudi healthcare organizations is considered one of the highest priorities of policymakers. Saudi Arabian e-health strategy pays reasonable attention to the EHRS implementation project. According to Saudi Vision 2030, the e-health transformation will be on top of IT projects in the country. However, an estimated 50% of EHRS implementations have failed. Project leadership and type of project management have been found to be crucial components of effective EHRS implementation. Aim of the study: To evaluate the role of centralized project management (CPM) in the implementation of large-scale EHRSs in Primary Healthcare Centers (PHCs) in Saudi Arabia (SA). Methods: A sequential explanatory mixed-methods approach involving a survey and semi-structured qualitative interview methods were utilized. Results: A total of 39 (75%) out of 53 policymakers at the Saudi Ministry of Health completed the survey, and 14 project team members were interviewed. Findings from both illustrated that adopting centralized project management approaches to implementation was beneficial in facilitating large-scale EHRS implementation and helped to overcome barriers that may have otherwise led to the failure of the project. EHRS interoperability and software selection were the factors that CPM influenced most positively. [ABSTRACT FROM AUTHOR]

The implementation of omics technologies and associated bioinformatics approaches hold significant promise for generating additional evidence for food and feed risk assessments thereby enhancing the European Food Safety Authority (EFSA) capacity to deliver scientific opinions and guidance documents in the future. To explore this possibility, EFSA launched a Call for the development of a roadmap to identify the main actions needed for a wider use of Omics in future risk assessments. To address this objective, this action roadmap outlines six project proposals. These proposals are based on a comprehensive mapping of the state‐of‐the‐art omics and associated bioinformatics technologies in research, EFSA's activities as well as current and planned activities from other relevant regulatory bodies and organisations. The outlined recommendations also address some of the identified main knowledge gaps and highlight the added value that further investments in the different food & feed safety scientific domains could bring. In addition, the work in this roadmap addresses some key challenges and blockers that might hinder a wider integration of omics in risk assessment and leverages on the opportunities for cooperation with external stakeholders. Finally, this roadmap provides suggestions on how EFSA may more broadly and effectively engage with relevant stakeholders in the use of omics technologies and associated bioinformatics approaches in regulatory science. [ABSTRACT FROM AUTHOR]

Background: The potency of inactivated and recombinant influenza vaccines is measured using the single‐radial immunodiffusion (SRID) assay. The strain‐specific antigen and antibody potency reagents required for the assay are prepared and distributed by regulatory agencies to ensure vaccine standardization, but timely reagent production is always challenging. This poses unique concerns for rapid pandemic responses. Alternative methods have been described for generating strain‐specific potency antibody reagents without the need for live influenza virus, but such methods are infrequently used, suggesting the need for additional antigen expression approaches. Methods: We describe a rapid process using a mammalian expression system to produce recombinant influenza hemagglutinin (rHA). This platform was used to generate rHA from two H5 clade 2.3.4.4 influenza viruses, in both soluble ectodomain or full‐length HA forms, and a soluble ectodomain rHA from an influenza H2 virus. Results: The purified rHAs were used as immunogens to produce HA antibody reagents that were tested for suitability in the SRID assay to accurately measure the potency of inactivated pandemic influenza vaccines. Antibody reagents generated to either ectodomain or full‐length rHA worked well in the SRID assay and resulted in vaccine potency values equivalent to those generated with standard reference antibodies. Conclusions: The results demonstrate that rHA produced from a simple mammalian cell transfection method can be used to generate HA antibody suitable for use in the influenza vaccine SRID potency assay and suggest a practical means by which an extensive library of pandemic reagents can easily be prepared in advance of and during an influenza emergency. [ABSTRACT FROM AUTHOR]

Regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognize pharmacogenetics as a key tool in their pharmacological guidelines for pharmaceutical counseling. In this context, community pharmacies play a crucial role in addressing this healthcare need, which could lead to a significant improvement in patients' quality of life by preventing ineffective or contraindicated treatments. In this work, we conducted a systematic review of the available scientific evidence regarding druggene interactions relevant to community pharmacy. We identified the main genes and polymorphisms associated with treatment response and adverse effects in primary care. Finally, we propose a model for implementing pharmacogenetic services in community pharmacies. [ABSTRACT FROM AUTHOR]

Introduction: The COVID‐19 pandemic was a public health emergency (PHE) of unprecedented magnitude and impact. It provided the possibility to investigate the Dutch citizens' understanding and perception of the actors involved in the Dutch pandemic response as a PHE unfolded. Methods: Three focus groups (FGs) were held with 16 Dutch citizens in June 2020. Citizens were recruited using the Dutch Health Care Consumer Panel. During the FGs, participants were asked to fill in a table with actors they thought were involved in the management of the COVID‐19 pandemic. They also received information on actors involved in Dutch outbreak responses. Then, the actors named and omitted by the participants were discussed. Results: An analysis of the FGs suggests that the Dutch citizens participating in the study were not fully aware of the scope of actors involved in the Dutch COVID‐19 pandemic response. Some participants would have appreciated more information on the actors involved. This would help them have an informed opinion of the actors involved in the decision‐making process, and accept non‐pharmaceutical interventions implemented. Lastly, most participants recognised that they played a role in limiting the spread of the COVID‐19 pandemic. Yet, very few spontaneously mentioned themselves as actors within the COVID‐19 pandemic response. Conclusion: This study suggests that early in the COVID‐19 pandemic, the Dutch citizens participating in this study's FG did not have a complete understanding of the scope of actors involved in the Dutch COVID‐19 pandemic response, or the potential role of the citizen. Future research can build on these results to explore the citizen's perception of their role during PHEs of another origin, as well as other geographical and historical contexts. Patient or Public Contribution: The public participated in the focus groups and received a non‐expert report summarising the outcomes of the focus groups. [ABSTRACT FROM AUTHOR]

Background/Objectives: For locally applied, locally acting generic drug products, comparison to an originator product based on systemic exposure is usually not feasible due to low plasma concentrations and inadequate reflection of local exposure at the site of action. Where a validated PD model exists, a comparative clinical study can be performed in healthy subjects; where no surrogate endpoint is available, patients with the relevant indication need to be enrolled, with all the associated factors which could result in lack of sensitivity. Even though the need for alternative in vitro approaches has been acknowledged by both industry and regulatory bodies, the complexity of in vivo drug delivery processes makes the development of guidance documents particularly difficult. Our objective was to present in vitro approaches less classically used and to address in vivo relevance of the selected tests. Methods: This article analyses current regulatory approaches in Europe and the U.S., and highlights the key advantages of in vitro tests in terms of their sensitivity, reliability, reproducibility and in vivo relevance using locally applied flurbiprofen in various formulations. Results: The in vitro esophageal retention (IVOR) model demonstrates that the first 6–10 min after application of different flurbiprofen formulations is important for their comparison and also offers the best correlation with in vivo data using the partial area under the concentration-time curves (pAUCs). Rheological evaluations further demonstrated that the mucoadhesive properties of the gel spray formulation are based on interaction with mucin. Conclusions: Designing a relevant in vitro test requires adequate evaluation of the complexity of the drug substance, drug product, dosing conditions and delivery processes. [ABSTRACT FROM AUTHOR]

Developing safe and effective drugs and other medical products is a complex and costly process. Drug development has been, historically, commonly competitive and uncollaborative, and this tendency toward a lack of interaction between stakeholders—the pharmaceutical industry, academia, regulatory agencies, healthcare providers, and communities, among others—can lead to missed opportunities to improve efficiency and, ultimately, public health. The Forum for Collaborative Research was established in 1997 to address current scientific, policy, and regulatory issues in global health through multistakeholder engagement and dialogue. By providing a neutral and safe space for discussion, the Forum's model has impacted how clinical trials in diverse health areas are conducted, supported broader and more equitable clinical trial participation, and accelerated delivery of new drugs. The Forum's focus and directions have shifted over time, and this responsiveness to the needs of the global health community will be critical to ensure that the Forum continues to support collaboration in global health. In this article, we present lessons learned from this innovative model of collaborative research and regulatory science, pioneered by the Forum for over 25 years, including the importance of collective ownership and governance by all stakeholders, and emphasis on common goals and advantages of collaboration. [ABSTRACT FROM AUTHOR]

Population pharmacokinetic (PK) models are widely used to inform drug development by pharmaceutical companies and facilitate drug evaluation by regulatory agencies. Developing a population PK model is a multi‐step, challenging, and time‐consuming process involving iterative manual model fitting and evaluation. A tool for fully automatic model development (AMD) of common population PK models is presented here. The AMD tool is implemented in Pharmpy, a versatile open‐source library for pharmacometrics. It consists of different modules responsible for developing the different components of population PK models, including the structural model, the inter‐individual variability (IIV) model, the inter‐occasional variability (IOV) model, the residual unexplained variability (RUV) model, the covariate model, and the allometry model. The AMD tool was evaluated using 10 real PK datasets involving the structural, IIV, and RUV modules in three sequences. The different sequences yielded generally consistent structural models; however, there were variations in the results of the IIV and RUV models. The final models of the AMD tool showed lower Bayesian Information Criterion (BIC) values and similar visual predictive check plots compared with the available published models, indicating reasonable quality, in addition to reasonable run time. A similar conclusion was also drawn in a simulation study. The developed AMD tool serves as a promising tool for fast and fully automatic population PK model building with the potential to facilitate the use of modeling and simulation in drug development. [ABSTRACT FROM AUTHOR]

Small communities in the Arequipa region of Peru are susceptible to rockfall hazards, which impact their lives and livelihoods. To mitigate rockfall hazards, it is first necessary to understand their locations and characteristics, which can be compiled into an inventory used in the creation of rockfall hazard rating maps. However, the only rockfall inventory available for Arequipa contains limited data of large, discrete events, which is insufficient for characterizing rockfall hazards at the community scale. A more comprehensive inventory would result in a more accurate rockfall hazard rating map—a significant resource for hazard mitigation and development planning. This study addresses this need through a remote method for rockfall hazard characterization at a community scale. Three communities located in geographically diverse areas of Arequipa were chosen for hazard inventory and characterization, with a fourth being used for validation of the method. Rockfall inventories of source zones and rockfall locations were developed using high-resolution aerial imagery, followed by field confirmation, and then predictions of runout distances using empirical models. These models closely matched the actual runout distance distribution, with all three sites having an R2 value of 0.98 or above. A semi-automated method using a GIS-based model was developed that characterizes the generation and transport of rockfall. The generation component criteria consisted of source zone height, slope angle, and rockmass structural condition. Transport was characterized by rockfall runout distance, estimated rockfall trajectory paths, and hazard ratings of corresponding source zones. The representative runout distance inventory model of the validation site matched that of a nearby site with an R2 of 0.98, despite inventorying less than a third of the number of rockfalls. This methodology improves upon current approaches and could be tested in other regions with similar climatic and geomorphic settings. These maps and methodology could be used by local and regional government agencies to warn residents of rockfall hazards, inform zoning regulations, and prioritize mitigation efforts. [ABSTRACT FROM AUTHOR]

As part of a program evaluation of the New York City Test & Trace program (T2)—one of the largest such programs in the USA—we conducted a study to assess how implementing organizations (NYC Health + Hospitals, government agencies, CBOs) communicated information about the T2 program on Twitter. Study aims were as follows: (1) quantify user engagement of posts ("tweets") about T2 by NYC organizations on Twitter and (2) examine the emotional tone of social media users' T2-related tweets in our sample of 1987 T2-related tweets. Celebrities and CBOs generated more user engagement (0.26% and 0.07%, respectively) compared to government agencies (e.g., Mayor's Office, 0.0019%), reinforcing the value of collaborating with celebrities and CBOs in social media public health campaigns. Sentiment analysis revealed that positive tweets (46.5%) had higher user engagement than negative tweets (number of likes: R2 =.095, p <.01), underscoring the importance of positively framing messages for effective public health campaigns. [ABSTRACT FROM AUTHOR]

The field of biodiversity conservation is in the midst of a cultural and practical transformation around evidence use, but the necessary institutional and technical support is still emerging. Over the past decade, the United States Agency for International Development (USAID) has invested in building institutional capacity for evidence use in its biodiversity conservation projects through technical assistance. We interviewed 34 technical assistance staff supporting biodiversity programming at USAID to explore how technical assistance is used to support evidence use and the extent to which technical assistance can fulfill the functions of "evidence bridges"—intermediaries who help practitioners access and use bodies of evidence for decision‐making. We found that the current technical assistance model supporting evidence employs varied strategies to support evidence use, some of which are more closely aligned with the functions of evidence bridges than others. We conclude that the current technical assistance model could strengthen support for evidence use through engagement with evidence bridges to promote uptake of synthesized evidence. We suggest that technical assistance and evidence bridges are needed to facilitate high‐quality evidence use at the scale necessary to achieve conservation impact, and more collaborative spaces at the boundary between research and practice are needed. [ABSTRACT FROM AUTHOR]

Background National action plans (NAPs) are key instruments for governing antimicrobial resistance (AMR). In Europe, we can now observe many countries updating their NAPs which raise two key research questions; what substantial modifications are states opting for, and how do they wish to address challenges related to AMR governance in a comparative perspective? Methods Building on a previous analytical classification, we address these two questions by examining data of updated versions of NAPs in 13 European Union member states covering seventeen elements related to AMR governance. Results Our results substantiate the large variation with regard to both substantive issues and governance-related matters. Most tellingly, they highlight the growing importance of the One Health approach in updated versions of NAPs. Our analysis also shows that while substantive issues remain important, One Health and the coordination and collaboration issues it entails are becoming more salient in the second or third generation of NAPs. Conclusions Updated NAPs suggest that EU member states are becoming increasingly knowledgeable on the causes and consequences of AMR and how it needs to be addressed. The enhanced level of knowledge also leads these countries to address the next set of issues and challenges; to improve domestic and international coordination and collaboration. Thus, the revised NAPs present a noticeable development from substantive issues towards governance issues. [ABSTRACT FROM AUTHOR]

Mesenchymal stromal cells (MSCs) have been used in multiple clinical trials for steroid-refractory moderate-severe (grade II–IV) acute graft-versus-host disease (aGVHD) across the world over the last two decades. Despite very promising results in a variety of trials, it failed to get widespread approval by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency. What lessons can we learn from this for future studies on MSCs and other cell therapy products? Broad heterogeneity among published trials using MSCs in aGVHD was likely the core problem. We propose a standardized approach in regards to donor-related factors, MSCs-related characteristics, as well as clinical trial design, to limit heterogeneity in trials for aGVHD and to fulfill the requirements of regulatory agencies. This approach may be expanded beyond MSCs to other Cell and Gene therapy products and trials in other diseases. [ABSTRACT FROM AUTHOR]

On June 30, 2022, judicial deference toward actions of administrative agencies took a significant hit. In West Virginia v. EPA, the Court formally recognized--for the first time--the major questions doctrine, which requires agencies to identify clear congressional authorization when claiming the authority to make decisions of vast economic and political significance. Since June 30, 2022, the Supreme Court has utilized the major questions doctrine in decisions of national importance, including topics ranging from environmental protection efforts to canceling student debt. This note offers a snapshot of how the major questions doctrine has been applied by federal courts across the country since West Virginia was decided. Beginning with the nondelegation doctrine, this note traces the rise and the beginning of the fall of congressional delegations of power to administrative agencies. This note then summarizes the major questions doctrine and shows how the doctrine has been applied by federal courts in forty-six cases since West Virginia was decided. [ABSTRACT FROM AUTHOR]

Copyright of Dados - Revista de Ciências Sociais is the property of DADOS 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.)

Aim: To analyze how the Police in Sweden perceives the drug problem and how it relates to changes in drug politics in the direction of liberalization. Method: The material analyzed consists of a content-analysis of the magazine of the Swedish Narcotic Police Association, covering 145 issues since the start in 1988, concentrating on lead articles, editorials and other articles on principles and politics. Results: The magazine demonstrate an alarmistic view of the drug problem, criticize government agencies and the media for liberal views, question the motives of proponents of decriminalization and legalization, leaves the costs of control of drug interventions aside, and sees the Police as guardian of status quo and as the defender of the goal of Swedish drug policy: "a drug-free society". [ABSTRACT FROM AUTHOR]

Aims: Voluntary self-exclusion (VSE) programmes are intended to minimise gambling-related harm. They are considered effective for the individual but several weaknesses have been reported that deter individuals from enrolment. The present paper summarises opinions about and experiences with VSE strategies and assesses gaps and needs with regard to the current self-exclusion regulations and programmes in seven jurisdictions. Methods: A total of 102 representatives from various sectors (research community; addiction help and care services; prevention; regulatory bodies; gambling providers) in Finland, Germany, Italy, Massachusetts (USA), Norway, Sweden, and Victoria (Australia) were surveyed about their experiences with and opinions about VSE strategies, as well as gaps and needs of the current VSE regulations in their jurisdiction. Results: The respondents agreed on the need for and importance of VSE programmes. However, in all participating jurisdictions, VSE regulations at the time of the survey were considered insufficient, and the respondents suggested potential improvements to facilitate the exclusion process, increase utilisation and reduce gamblers' breaching VSE. Representatives of the gambling industry also emphasised the individual's responsibility. Conclusions: Individuals with gambling disorder require effective VSE programmes to cope with their addictive behaviour. To effectively reduce breaches, technical and legal solutions are necessary. This includes access controls based on complete nationwide registries, strict enforcement and preventing excluded gamblers from accessing unlicensed online operators. [ABSTRACT FROM AUTHOR]

The implementation of rural entrepreneurship emerges as a pivotal pathway for fostering rural economic growth. However, unsustainable entrepreneurial endeavors have posed notable ecological threats and environmental degradation. Drawing upon the triple bottom line framework, this research devised a comprehensive evaluation system for sustainable rural entrepreneurship, spanning four dimensions: entrepreneurs, economic, social, and environmental aspects. Employing the fuzzy Decision-Making Trial and Evaluation Laboratory (DANP) approach, we delineated the intricate causal relationships among influencing factors and identified key determinants along with their respective weights. Our findings underscore the prominence of economic dimensions in fostering sustainable rural entrepreneurship. Specifically, entrepreneurial motivation, type of entrepreneurship, financial backing, economic value, favorable policy frameworks, and a conducive business environment emerged as pivotal indicators. Notably, the type of entrepreneurship, financial support, economic value, and favorable policies emerged as propelling factors driving sustainable rural entrepreneurial progress. Conversely, entrepreneurial motivation and the business environment manifested as dependent factors within this causal nexus. This study offers valuable managerial implications for entrepreneurial teams and pertinent government agencies, enabling decision-makers to formulate evidence-based strategies aimed at realizing sustainable rural entrepreneurship. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Modern Science is the property of Alcide De Gasperi University of Euroregional Economy 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.)

The migration of chemical compounds from packaging polymers to food presents a multifaceted challenge with implications for food safety and public health. This review explores the interaction between packaging materials and food products, focusing on permeation, migration, and sorption processes. The different migration mechanisms of contact migration, gas phase migration, penetration migration, set-off migration, and condensation/distillation migration have been discussed comprehensively. The major migrating compounds are plasticizers, nanoparticles, antioxidants, light stabilizers, thermal stabilizers, monomers, oligomers, printing inks, and adhesives, posing potential health risks due to their association with endocrine disruption and carcinogenic effects. Advanced analytical methods help in the monitoring of migrated compounds, facilitating compliance with regulatory standards. Regulatory agencies enforce guidelines to limit migration, prompting the development of barrier coatings and safer packaging alternatives. Furthermore, there is a need to decipher the migration mechanism for mitigating it along with advancements in analytical techniques for monitoring the migration of compounds. [ABSTRACT FROM AUTHOR]

Copyright of Retos: Nuevas Perspectivas de Educación Física, Deporte y Recreación is the property of Federacion Espanola de Asociaciones de Docentes de Educacion Fisica 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.)

Voluntary sustainability standards emerged in the 1980s with the promise of making agrifood systems sustainable, and have developed over time into rather sophisticated systems of rules and sanctions. With this promise of change, has also come an interest in understanding whether or not change has come about. This is particularly pertinent as public agencies and governments are increasingly seeking to use sustainability standards as proxies for progress towards sustainability. In this short commentary, I share some of the recent knowledge about the impact of sustainability standards and Fairtrade standards in particular. I explore the impact of the use of the Fairtrade Premium and the impact of engagement with the Fairtrade system on business practices. I conclude with some reflections on the importance of standards in current debates in Europe. [ABSTRACT FROM AUTHOR]

A new discipline, implementation science, has emerged in recent years. This has resulted in confusion between what ‘implementation science’ is and how it differs from real-world scale-up of health interventions. While there is considerable overlap, in this perspective, we seek to highlight some of the differences between these two concepts in relation to their origin, drivers, research methods and implications for population impact and practice. We recognise that implementation science generates new information on optimal methods and strategies to facilitate the uptake of evidence-based practices. This new knowledge can be used as part of any scaling-up endeavour. However, real-world scale-up is influenced to a much greater extent by political and strategic needs and key actors and generally requires the support of governments or large agencies that can fund population-level scale-up. Furthermore, scale-up often occurs in the absence of any evidence of effectiveness. Therefore, while implementation science and scale-up both ultimately aim to facilitate the uptake of interventions to improve population health, their immediate intentions differ, and these distinctions are worth highlighting for policymakers and researchers. [ABSTRACT FROM AUTHOR]

Objectives and importance of study: In the public service context, codesign is novel and ever-expanding. Co-design brings together decisionmakers and people impacted by a problem to unpack the problem and design solutions together. Government agencies are increasingly adopting co-design to understand and meet the unique needs of priority populations. While the literature illustrates a progressive uptake of co-design in service delivery, there is little evidence of co-design in policy development. We propose a qualitative study protocol to explore and synthesise the evidence (literary, experiential and theoretical) of co-design in public policy. This can inform a framework to guide policymakers who co-design health policy with Aboriginal and Torres Strait Islander people. Methods: The study design is informed by a critical qualitative approach that comprises five successive stages. The study commences with the set-up of a co-design brains trust (CBT), comprising people with lived experience of being Aboriginal and Torres Strait Islander who have either co-designed with public agencies and/or have health policymaking expertise (stage 1) The brains trust will play a key role in guiding the protocol’s methodology, data collection, reporting and co-designing a ‘Version 1’ framework to guide policymakers in co-designing health policy with Aboriginal and Torres Strait Islander people (the framework). Two realist evaluations will explore codesign in health policy settings to understand how co-design works for whom, under what circumstances, and how (stages 2 and 3) The findings of the realist evaluations will guide the CBT in developing the framework (stage 4). A process evaluation of the CBT setup and framework development will assess the degree to which the CBT achieved its intended objectives (stage 5). Conclusion: The proposed study will produce much-needed evidence to guide policymakers to share decision-making power and privilege the voices of Aboriginal and Torres Strait Islander people when co-designing health policy. Learnings from this translational research will be shared via the CBT, academic papers, conference presentations and policy briefings. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion This study aimed to examine the cardiac and overall safety and pharmacokinetic (PK) profiles of soticlestat (TAK‐935), an oral, first‐in‐class selective cholesterol 24‐hydroxylase inhibitor.Data came from a randomised, phase 1 study of soticlestat in 33 healthy Japanese adults (NCT04461483); 24 adults in Part 1 (single‐dose soticlestat 200‐1200 mg or placebo) and 9 in Part 2 (soticlestat 100‐300 mg twice daily or placebo for 21 days). PK sample collection was paired with 12‐lead electrocardiogram data from continuous Holter recordings. The concentration‐QTc relationship was analysed using a linear mixed‐effects model. QTc prolongation safety margins were determined for two scenarios of calculated high clinical exposures: scenario 1 (NCT05064449) involved coadministration of single‐dose soticlestat 300 mg with itraconazole or mefenamic acid and scenario 2 (NCT05098054) involved single‐dose soticlestat 300 mg administration in participants with mild/moderate hepatic impairment (implementing a 3‐fold dose reduction for moderate severity).Based on concentration‐QTc analysis, placebo‐corrected change‐from‐baseline QT values (90% confidence intervals), corrected for heart rate (Fridericia's method), were 0.94 ms (−2.35, 4.23) for soticlestat and 0.63 ms (−3.15, 4.41) for its N‐oxide metabolite plasma concentrations at therapeutic doses (soticlestat 300 mg twice daily); safety margins were >2‐fold for scenarios of calculated high clinical exposures. No (Part 1) and five (83.3%; Part 2) participants experienced treatment‐emergent adverse events (all mild).There was no evidence for QT prolongation with soticlestat at therapeutic doses or in two scenarios of high clinical exposures, which resulted in regulatory agencies waiving requirements of a thorough QT study. Safety/PK findings aligned with previous soticlestat clinical studies. [ABSTRACT FROM AUTHOR]

This article examines the regulatory framework related to human trafficking in Hong Kong and identifies its deficiencies as the lack of an accepted internationally compliant definition of trafficking and the absence of any specific criminal offence of trafficking as a result. The article compares the approach taken in Hong Kong to efforts undertaken in Europe by the Council of Europe, the UK, and the European Union and identifies several lessons from the European experience that could help rectify failures observed in Hong Kong. In particular, effective combatting of human trafficking requires not only a definition of the offence that recognises the essential elements--an "act," a "means," and a "purpose" of exploitation--but also the establishment of sufficient state institutions and agencies dedicated to identifying and protecting trafficking victims. Without the detection of trafficking victims, criminals engaged in the act of trafficking perceive their chances of being caught and prosecuted as low and operate with impunity. This necessitates the adoption of a consistent and readily identifiable criminal offence of "trafficking" aligned with the approach taken by the Palermo Protocol, just as the EU and UK have done. [ABSTRACT FROM AUTHOR]

Immunotherapy with checkpoint inhibitors including atezolizumab, pembrolizumab and nivolumab has become an essential pillar in the management of muscle invasive and metastatic urothelial carcinoma. The field has evolved quickly in the past few years and several early beliefs have recently been upended. One such belief relates to the predictive value of PD-L1 expression based on immunohistochemistry. Nevertheless, requirements for PD-L1 expression from regulatory bodies still restrict the use of checkpoint inhibitors in urothelial carcinoma. This article provides a critical review of the available data from the registration trials on which the current regulations have been based with the conclusion that a review of the current approval status incorporating PD-1 expression is warranted. [ABSTRACT FROM AUTHOR]

Background: On 6 February 2023, an Mw 7.8 earthquake struck southern and central Türkiye and north-western Syria, affecting the lives of 4.6 and 2.5 million children, respectively. In such crises, infants who are dependent on commercial milk formula (CMF) face increased vulnerability to diseases and malnutrition as safe preparation of CMF becomes difficult and sometimes impossible. The Operational Guidance on Infant and Young Child Feeding in Emergencies (OG-IFE) provides guidance on protecting and supporting recommended infant and young child feeding and minimizing the risks that come with CMF feeding. In addition, the International Code of Marketing of Breastmilk Substitutes (the Code) ensures adequate nutrition for infants by protecting and promoting breastfeeding and ensuring the proper usage of CMF. This study aims to document violations of the Code and the OG-IFE during the earthquake relief efforts to help strengthen infant and young child feeding emergency responses and inform future disaster relief policies. Methods: Data was collected from 6 February to 10 March 2023 through Internet sources. Social media, news websites, and the Emergency Nutrition Network forum were used for data collection. Turkish content was translated into English for analysis, with a focus on donation-related information and Code violations related to baby food and infant feeding. Results: A total of 40 reports on CMF, complementary food, and feeding equipment donations were collected. Three main types of violations of the OG-IFE and the Code were identified, with the majority of them being incidences of individuals, humanitarian organizations, and government agencies seeking or accepting donations. Infant formula companies continued to violate the Code by donating large quantities of CMF and feeding equipment to the Turkish Red Crescent, government agencies, and disaster relief infant and young child feeding (IYCF) coordination authorities. Conclusions: These incidents reflected a systematic violation of the Code and non-compliance with the OG-IFE. Globally accepted IYCF standards and recommendations were not consistently followed due to fragmented early responses. There is a critical need to step up efforts to ensure appropriate and safe IYCF practice protecting and supporting breastfed and non-breastfed infants in emergencies. [ABSTRACT FROM AUTHOR]

Tagalag, an urban barangay in Valenzuela, has been providing fish supplies to its city since the 1980s. The barangay was established after a massive flood, and in 2016, it was declared a city eco-tourism zone. The Sustainable Development Goals (SDGs) prioritize economic growth, social inclusion, and sustainable development, encompassing objectives pertaining to the tourism sector. The application of the Sustainable Development Goals (SDGs) to the tourism sector has been undertaken by the World Tourism Organization (UNWTO), with the aim of advocating for the implementation of sustainable, equitable, and environmentally friendly practices within the tourism industry. Sustainable tourism encompasses the comprehensive evaluation of its societal, ecological, and economic consequences while simultaneously addressing the requirements of both tourists and local communities, safeguarding natural resources, and mitigating adverse environmental effects. Under the SDG #6 Clean Water and Sanitation this goal is making sure about the Tagalag fishing village has an availability of clean water and good sanitation by all and how this can be sustained in the Tagalag community which the researchers do some recommended plan for the community Tagalag Fishing Village is dedicated to sustainable fishing practices and marine life habitat restoration, implementing scientifically based management programs and regulatory agencies. The village prioritizes water resource conservation and surface runoff reduction but could benefit from enhancing infrastructure and promoting sustainable development. The village's economic growth is exemplary, with policies promoting economic growth, job opportunities, entrepreneurial endeavors, and indigenous culture preservation. However, there is room for improvement in sanitation and clean water. [ABSTRACT FROM AUTHOR]

The designation of Komodo National Park as one of the New 7 Wonders in 2012 sparked increased tourism, resulting in growth in Labuan Bajo's hospitality sector, with low entry fees and stakeholders advocating for Komodo dragon conservation. Determining an appropriate entrance fee is crucial for park maintenance and Komodo dragon conservation. This study aims to analyze tourism trends, willingness to pay (WTP) for entrance fees, and willingness to contribute (WTC) to conservation funds. The analysis reveals a consistent rise in visitor numbers from 2015 to 2019, along with significant growth in non-tax revenue, hotel accommodation, and bed capacity from 2010 to 2019. Tourists exhibit strong support for Komodo conservation with a notable USD 25.573 in WTP for domestic visitors and 39.4 for foreign tourists. Respondents express readiness to contribute to conservation funds. Government agencies, local communities, and non-governmental organizations (NGOs) are favored to manage the conservation fund. The preservation of Komodo dragons has a positive impact on ecosystem balance and economic improvement from tourism. [ABSTRACT FROM AUTHOR]

Medicines are an essential element for all health systems. This makes them an indispensable social good of quality and effectiveness for health problems. From a public health perspective, it is important to have health regulations as a fundamental instrument of health protection. This paper aims to characterize the role of health regulation of medicines from four historical, political and socioeconomic determinants of Mexico, and present the strategies implemented by Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris, in Spanish) to close gaps in universal access to medicines. Discussion. In the 21st century, the constant increase of population without access to health care entails a great challenge for the State to reduce gaps between supply and demand and to focus such policies on the functions of regulating, providing and reporting. For Mexico, the last two centuries have reflected a national drug policy model that permeated a health regulation that prioritizes efficiency, quality, and pre-market with little attention to universal access to medicines and other health supplies. Faced with this, the current administration of the Cofepris promotes a paradigm shift, orienting its action strategies to regulatory optimization and reduction of asymmetry of direct information to the population which also takes into account access to health supplies. Conclusions. In the Region of the Americas, the actions of National Regulatory Agencies such as Cofepris are crucial for the solidification of a public policy model focused not only on the efficacy and quality of medicines, but also regulatory optimization that supports the objectives and goals of universal access to essential medicines and other health supplies. [ABSTRACT FROM AUTHOR]

With the continuous emergence and steady development of new technologies the way for Maritime Autonomous Surface Ship (MASS) is being paved. However, this manifold of available and imminent technologies challenges regulatory bodies and auditing authorities. Technologies which make use of Artificial Intelligence (AI), in particular Machine Learning (ML), play a special role. On one hand, they are not covered by current regulations or audit processes and, on the other hand, they may represent black boxes whose behaviours are not readily explainable and thus impede audit processes even further. In an upcoming study titled VerifAI the authors focus on this gap within European and German regulatory bodies and auditing authorities. The technological scope lies on MASS-related products which rely on partially or fully AI-based systems. In the present article the original authors summarize the outlined study. The authors review the current regulatory status concerning audit processes and the market situation concerning available and imminent (partially) AI-based systems of MASS-related products. To close the gap a conceptual, integrated framework consisting of a Safety Guideline for the manufacturers and a Verification Guideline for the auditing authorities is presented. The framework aims to give regulatory bodies and auditing authorities an overview of necessary steps for robust verification of safe products without hindering innovation or requiring in-depth knowledge about the (black box-like) systems. The results are condensed into recommendations for actions, listing the most important results, and proposing entry points as well as future research in the field of verifying (partially) AI-based MASS-related products. [ABSTRACT FROM AUTHOR]

Food safety encompasses the supply and assurance of safe, high‐quality food for consumers. It is a crucial aspect of food security, gaining greater global attention due to the increasing number of widespread foodborne incidents. International trade is expanding as countries increasingly rely on each other to secure a sufficient and diverse food supply. Beyond this, concerns about food safety have become more prevalent due to various factors. Therefore, this review aims to investigate the effects of food safety–associated risks on the international trade of food and related products. A total of 37 published studies retrieved using different search engines were included in this review. This review revealed that because of rapid population growth and rising food demand in developing nations, agricultural intensification is growing. It has been found that foodborne illnesses and associated discrepancies can impede the international trade of food commodities. Trade bans due to the fear of foodborne illnesses are growing. The consequences of foodborne diseases are multifaceted and include financial losses from trade restrictions, medical costs for prevention or control, resource depletion and a decline in food production. The overall effects are increased international trade tensions and livelihood vulnerability to poverty, notably for small‐scale livestock producers. Potential food contaminants include microbes, pesticides, pharmaceutical residues, heavy metals and fraudulent such as improper food processing, mislabelling, poor packaging, adulteration and substitution. Hence, countries are encouraged to harmonize the rights and duties set by the World Trade Organization under sanitary and phytosanitarys to maximize their advantages in global markets. Based on this evidence, we recommend that each country develop and integrate regulations that would ensure the safety of both domestic and international food production systems. Furthermore, the global community should either revise the current functioning food regulatory and monitoring body or establish a more genuine collaborative network. [ABSTRACT FROM AUTHOR]

MicroRNAs (miRNAs) are crucial regulators of gene expression involved in various pathophysiological processes. Their ability to modulate multiple pathways simultaneously and their involvement in numerous diseases make miRNAs attractive tools and targets in therapeutic development. Significant efforts have been made to advance miRNA research in the preclinical stage, attracting considerable investment from biopharmaceutical companies. Consequently, an increasing number of miRNA-based therapies have entered clinical trials for both diagnostic and therapeutic applications across a wide range of diseases. While individual miRNAs can regulate a broad array of mRNA targets, this also complicates the management of adverse effects seen in clinical trials. Several candidates have been discontinued due to toxicity concerns, underscoring the need for comprehensive risk assessments of miRNA therapeutics. Despite no miRNA-based strategies have yet received approval from regulatory agencies, prominent progress in the miRNA modulation approaches and in the nano-delivery systems have been made in the last decade, leading to the development of novel safe and well-tolerated miRNA drug candidates. In this review, we present recent advances in the development of miRNA therapeutics currently in preclinical or clinical stages for treating both rare genetic disorders and multifactorial common conditions. We also address the challenges related to the safety and targeted delivery of miRNA therapies, as well as the identification of the most effective therapeutic candidates in preclinical and clinical trials. [ABSTRACT FROM AUTHOR]

Industrial policy is a critical element that determines the development of economic sectors, including the defence industry. In today's context of growing geopolitical tensions, technological progress and globalisation, effective functioning and development of the defence industry is highly relevant. The purpose of the work is to investigate the role of industrial policy in the formation of the most effective strategies and approaches to the development of the defence-industrial complex and the possibility of their adaptation in Ukraine. The study was conducted using comparative, systemic and SWOT analyses. The results showed that each country under consideration – the United States, France and China – has unique opportunities for developing the defence industry but also faces specific threats. The defence industry of these countries is a complex system that encompasses big corporations, research institutions, and government agencies. All of them receive considerable funding from the state budget, invest in research and development, and collaborate with international partners, which allows their products to be of high quality and innovativeness. The USA has the largest defence budget and significant technological capabilities but depends on political decisions and high costs. France has a solid technical base but faces limited budgetary resources and dependence on European politics. China is showing a significant increase in its defence budget, but limited international cooperation is hindering the stable development of its defence industry. The findings show that a balanced industrial policy that combines economic and international legal aspects is the key to creating a sustainable and competitive defence industry. Further research in this area will help find more effective strategies for developing the defence industry and enhancing national security and economic stability. [ABSTRACT FROM AUTHOR]

This study analyzed the relevance of governance structure for efficient revenue collection by Brazilian water utilities (WUs). Data were collected from the National Information System on Sanitation (SNIS) for 127 Brazilian WUs, covering a balanced longitudinal panel from 2018 to 2022. The governance structures evaluated included ownership (public or private) and corporatization (publicly traded or not). We searched scientific databases and did not find any studies on the efficiency of specific WUs in collecting customer bills for services rendered and its relationship with this type of governance; thus, this is the main innovative contribution of this study to the literature. In the first stage, this study utilized the dynamic slack-based model (DSBM) to assess revenue collection efficiency. In the second stage, an econometric model with generalized estimating equation (GEE) was used to explain the efficiency. The findings revealed a global average inefficiency in revenue collection of 50.47%. Corporatization was linked to higher collection efficiencies, while ownership type was significantly linked with lower collection efficiency. Factors such as tariff accessibility, urbanization, and the COVID-19 pandemic also influenced efficiency. This study suggests that regulatory bodies should consider these insights to implement policies that prevent inefficiencies from affecting the tariff system for services. [ABSTRACT FROM AUTHOR]

Copyright of Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal 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 Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal 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.)