Search results for: regulatory compliance

Authors: Mohammaad Afzal Khan, Ghazi Abdulmalik Ashoor , Fatimah Alanazi, Talal Shamma, Abdullah Altuhami, Hala Abdalrahman Ahmed, Abdullah Mohammed Assiri, Dieter Clemens Broering

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Microvascular injuries during inflammation are key causes of transplant malfunctioning and permanent failure, which play a major role in the development of chronic rejection of the transplanted organ. Inflammation-induced microvascular loss is a promising area to investigate the decisive roles of regulatory and effector responses. The present study was designed to investigate the impact of IL-10 on immunotolerance, in particular, the microenvironment of the allograft during rejection. Here, we investigated the effects of IL-10 blockade/ reconstitution and serially monitored regulatory T cells (Tregs), graft microvasculature, and airway epithelium in rejecting airway transplants. We demonstrated that the blocking/reconstitution of IL-10 significantly modulates CD4+FOXP3+ Tregs, microvasculature, and airway epithelium during rejection. Our findings further highlighted that blockade of IL-10 upregulated proinflammatory cytokines, IL-2, IL-1β, IFN-γ, IL-15, and IL-23, but suppressed IL-5 secretion during rejection; however, reconstitution of IL-10 significantly upregulated CD4+FOXP3+ Tregs, tissue oxygenation/blood flow and airway repair. Collectively, these findings demonstrate a potential reparative modulation of IL-10 during microvascular and epithelial repair, which could provide a vital therapeutic window to rejecting transplants in clinical practice.

Keywords: interleukin -10, regulatory T cells, allograft rejection, immunotolerance

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Authors: P. Asiabi, M. Shahhoseini, R. Favaedi, F. Hassani, N. Nassiri, B. Movaghar, L. Karimian, P. Eftekhariyazdi

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Introduction: Polycystic Ovary Syndrome is a common gynecologic disorder. Many factors including environment, metabolism, hormones and genetics are involved in etiopathogenesis of PCOS. Of genes that have altered expression in human reproductive system disorders are HOX family genes which act as transcription factors in regulation of cell proliferation, differentiation, adhesion and migration. Since recent evidences consider epigenetic factors as causative mechanisms of PCOS, evaluation of association between known epigenetic marks of acetylation/methylation of histone 3 (H3K9ac/me) with regulatory regions of these genes can represent better insight about PCOS. In the current study, cumulus cells (CCs) which have critical roles during folliculogenesis, oocyte maturation, ovulation and fertilization were aimed to monitor epigenetic alterations of HOX genes. Material and methods: CCs were collected from 20 PCOS patients and 20 fertile women (18-36 year) with male infertility problems referred to the Royan Institute to have ICSI under GnRH antagonist protocol. Informed consents were obtained from the participants. Thirty six hours after hCG injection, ovaries were punctured and cumulus oocyte complexes were dissected. Soluble chromatin were extracted from CCs and Chromatin Immune precipitation (ChIP) coupled with Real Time PCR was performed to quantify the epigenetic marks of histone H3K9 acetylation/methylation (H3K9ac/me) on regulatory regions of 15 members of HOX genes from A-D subfamily. Results: Obtained data showed significant increase of H3K9ac epigenetic mark on regulatory regions of HOXA1, HOXB2, HOXC4, HOXD1, HOXD3 and HOXD4 (P < 0.01) and HOXC5 (P < 0.05) and also significant decrease of H3K9ac into regulatory regions of HOXA2, HOXA4, HOXA5, HOXB1 and HOXB5 (P < 0.01) and HOXB3 (P<0.05) in PCOS patients vs. control group. On the other side, there was a significant decrease in incorporation of H3K9me level on regulatory region of HOXA2, HOXA3, HOXA4, HOXA5, HOXB3 and HOXC4 (P≤0.01) and HOXB5 (P < 0.05) in PCOS patients vs. control group. This epigenetic mark (H3K9me2) has significant increase on regulatory region of HOXB1, HOXB2, HOXC5, HOXD1, HOXD3 and HOXD4 (P ≤ 0.01) and HOXB4 (P < 0.05) in patients vs. control group. There were no significant changes in acetylation/methylation levels of H3K9 on regulatory regions of the other studied genes. Conclusion: Current study suggests that epigenetic alterations of HOX genes can be correlated with PCOS and consequently female infertility. This finding might offer additional definitions of PCOS, and eventually provides insight for novel treatments with epidrugs for this disease.

Keywords: epigenetic, HOX genes, PCOS, female infertility

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Authors: Sophie Lemoussu, Jean-Charles Chaudemar, Robertus A. Vingerhoeds

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Many innovative projects exist in the field of aeronautics, each addressing specific areas so to reduce weight, increase autonomy, reduction of CO2, etc. In many cases, such innovative developments are being carried out by very small enterprises (VSE’s) or small and medium sized-enterprises (SME’s). A good example concerns airships that are being studied as a real alternative to passenger and cargo transportation. Today, no international regulations propose a precise and sufficiently detailed framework for the development and certification of airships. The absence of such a regulatory framework requires a very close contact with regulatory instances. However, VSE’s/SME’s do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses an additional challenge for those VSE’s/SME’s, in particular those that have system integration responsibilities and that must provide all the necessary evidence to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The main objective of this research is to provide a methodological framework enabling VSE’s/SME’s with limited resources to organize the development of airships while taking into account the constraints of safety, cost, time and performance. This paper proposes to provide a contribution to this problematic by proposing a Model-Based Systems Engineering approach. Through a comprehensive process modeling approach applied to the development processes, the regulatory constraints, existing best practices, etc., a good image can be obtained as to the process landscape that may influence the development of airships. To this effect, not only the necessary regulatory information is taken on board, also other international standards and norms on systems engineering and project management are being modeled and taken into account. In a next step, the model can be used for analysis of the specific situation for given developments, derive critical paths for the development, identify eventual conflicting aspects between the norms, standards, and regulatory expectations, or also identify those areas where not enough information is available. Once critical paths are known, optimization approaches can be used and decision support techniques can be applied so to better support VSE’s/SME’s in their innovative developments. This paper reports on the adopted modeling approach, the retained modeling languages, and how they all fit together.

Keywords: aeronautics, certification, process modeling, project management, regulation, SME, systems engineering, VSE

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Authors: Ivan Poza Martínez

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The international energy landscape has been significantly affected by the Covid-19 pandemic and te conflict in Ukraine. The Vaca Muerta sedimentary formation in Argentina´s Neuquén province has become a crucial area for energy production, specifically in the shale gas ad shale oil sectors. The massive investment required for theexploitation of this reserve make it essential to understand te determinants of the investment in the upstream sector at both local ad international levels. The aim of this study is to identify the qualitative and quantitative determinants of investment in Vaca Muerta. The research methodolody employs both quantiative ( econometrics ) and qualitative approaches. A linear regression model is used to analyze the impact in non-conventional hydrocarbons. The study highlights that, in addition to quantitative factors, qualitative variables, particularly the design of a regulatory framework, significantly influence the level of the investment in Vaca Muerta. The analysis reveals the importance of attracting both domestic and foreign capital investment. This research contributes to understanding the factors influencing investment inthe Vaca Muerta regioncomapred to other published studies. It emphasizes to role of qualitative varibles, such as regulatory frameworks, in the development of the shale gas and oil sectors. The study uses a combination ofquantitative data , such a investment figures, and qualitative data, such a regulatory frameworks. The data is collected from various rpeorts and industry publications. The linear regression model is used to analyze the relationship between the variables and the investment in Vaca Muerta. The research addresses the question of what factors drive investment in the Vaca Muerta region, both from a quantitative and qualitative perspective. The study concludes that a combination of quantitative and qualitative factors, including the design of a regulatory framework, plays a significant role in attracting investment in Vaca Muerta. It highlights the importance of these determinants in the developmentof the local energy sector and the potential economic benefits for Argentina and the Southern Cone region.

Keywords: vaca muerta, FDI, shale gas, shale oil, YPF

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Authors: Ramazan I. Kadiev, Arcady Ponosov

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Mathematical models of gene regulatory networks can in many cases be described by ordinary differential equations with switching nonlinearities, where the initial value problem is ill-posed. Several regularization methods are known in the case of deterministic networks, but the presence of stochastic noise leads to several technical difficulties. In the presentation, it is proposed to apply the methods of the stochastic singular perturbation theory going back to Yu. Kabanov and Yu. Pergamentshchikov. This approach is used to regularize the above ill-posed problem, which, e.g., makes it possible to design stable numerical schemes. Several examples are provided in the presentation, which support the efficiency of the suggested analysis. The method can also be of interest in other fields of biomathematics, where differential equations contain switchings, e.g., in neural field models.

Keywords: ill-posed problems, singular perturbation analysis, stochastic differential equations, switching nonlinearities

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Authors: Muna Mohamed Omer Mirghani

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This paper responds to one of the key national development strategies and a typical challenge in the Gash Basin as well as in different parts of Sudan, namely managing water scarcity in view of climate change impacts in minor water systems sustaining over 50% of the Sudan population. While now focusing on the Gash river basin, the ultimate aim is to replicate the same approach in similar water systems in central and west Sudan. The key objective of the paper is the identification of outcome-based water governance interventions in Gash Basin, guided by the global Sustainable Development Goal six (SDG 6 on water and sanitation) and the Sudan water resource policy framework. The paper concluded that improved water resources management of the Gash Basin is a prerequisite for ensuring desired policy outcomes of groundwater use and flood risk management purposes. Analysis of various water governance dimensions in the Gash indicated that the operationalization of a Basin-level institutional reform is critically focused on informed actors and adapted practices through knowledge and technologies along with the technical data and capacity needed to make that. Adapting the devolved Institutional structure at state level is recommended to strengthen the Gash basin regulatory function and improve compliance of groundwater users.

Keywords: water governance, Gash Basin, integrated groundwater management, Sudan

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Authors: M. A. Okezue, K. L. Clase, S. R. Byrn

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The requirement for maintaining data integrity in laboratory operations is critical for regulatory compliance. Automation of procedures reduces incidence of human errors. Quality control laboratories located in low-income economies may face some barriers in attempts to automate their processes. Since data from quality control tests on pharmaceutical products are used in making regulatory decisions, it is important that laboratory reports are accurate and reliable. Zinc Sulphate (ZnSO₄) tablets is used in treatment of diarrhea in pediatric population, and as an adjunct therapy for COVID-19 regimen. Unfortunately, zinc content in these formulations is determined titrimetrically; a manual analytical procedure. The assay for ZnSO4 tablets involves time-consuming steps that contain mathematical formulae prone to calculation errors. To achieve consistency, save costs, and improve data integrity, validated spreadsheets were developed to simplify the two critical steps in the analysis of ZnSO4 tablets: standardization of 0.1M Sodium Edetate (EDTA) solution, and the complexometric titration assay procedure. The assay method in the United States Pharmacopoeia was used to create a process flow for ZnSO₄ tablets. For each step in the process, different formulae were input into two spreadsheets to automate calculations. Further checks were created within the automated system to ensure validity of replicate analysis in titrimetric procedures. Validations were conducted using five data sets of manually computed assay results. The acceptance criteria set for the protocol were met. Significant p-values (p < 0.05, α = 0.05, at 95% Confidence Interval) were obtained from students’ t-test evaluation of the mean values for manual-calculated and spreadsheet results at all levels of the analysis flow. Right-first-time analysis and principles of data integrity were enhanced by use of the validated spreadsheet calculators in titrimetric evaluations of ZnSO₄ tablets. Human errors were minimized in calculations when procedures were automated in quality control laboratories. The assay procedure for the formulation was achieved in a time-efficient manner with greater level of accuracy. This project is expected to promote cost savings for laboratory business models.

Keywords: data integrity, spreadsheets, titrimetry, validation, zinc sulphate tablets

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Authors: Thelma Maria Melo Pinheiro, Guilherme Raposo Diniz Vieira, Sidney Matos da Silva, Leonardo Mendonça de Oliveira Queiroz, Mateus Sousa Pinheiro, Danyllo Wenceslau de Oliveira Lopes

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The present article has the objective to describe the regulatory impact analysis (RIA) of the contracting efficiency of the Brazilian transmission system usage. This contracting is made by users connected to the main transmission network and is used to guide necessary investments to supply the electrical energy demand. Therefore, an inefficient contracting of this energy amount distorts the real need for grid capacity, affecting the sector planning accuracy and resources optimization. In order to provide this efficiency, the Brazilian Electricity Regulatory Agency (ANEEL) homologated the Normative Resolution (NR) No. 666, from July 23th of 2015, which consolidated the procedures for the contracting of transmission system usage and the contracting efficiency verification. Aiming for a more efficient and rational transmission system contracting, the resolution established economic incentives denominated as Inefficiency installment for excess (IIE) and inefficiency installment for over-contracting (IIOC). The first one, IIE, is verified when the contracted demand exceeds the established regulatory limit; it is applied to consumer units, generators, and distribution companies. The second one, IIOC, is verified when the distributors over-contract their demand. Thus, the establishment of the inefficiency installments IIE and IIOC intends to avoid the agent contract less energy than necessary or more than it is needed. Knowing that RIA evaluates a regulatory intervention to verify if its goals were achieved, the results from the application of the above-mentioned normative resolution to the Brazilian transmission sector were analyzed through indicators that were created for this RIA to evaluate the contracting efficiency transmission system usage, using real data from before and after the homologation of the normative resolution in 2015. For this, indicators were used as the efficiency contracting indicator (ECI), excess of demand indicator (EDI), and over-contracting of demand indicator (ODI). The results demonstrated, through the ECI analysis, a decrease of the contracting efficiency, a behaviour that was happening even before the normative resolution of 2015. On the other side, the EDI showed a considerable decrease in the amount of excess for the distributors and a small reduction for the generators; moreover, the ODI notable decreased, which optimizes the usage of the transmission installations. Hence, with the complete evaluation from the data and indicators, it was possible to conclude that IIE is a relevant incentive for a more efficient contracting, indicating to the agents that their contracting values are not adequate to keep their service provisions for their users. The IIOC also has its relevance, to the point that it shows to the distributors that their contracting values are overestimated.

Keywords: contracting, electricity regulation, evaluation, regulatory impact analysis, transmission power system

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Authors: Sean Hall

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Nanosystems for drug delivery are not new; as medicines evolve, so too does the desire to deliver a more targeted, patient-compliant medicine. Though, historically the widespread use of nanosystems for drug delivery has been fouled by non-replicability, scalability, toxicity issues, and economics. Examples include steps of manufacture and thus cost to manufacture, toxicity for nanoparticle scaffolding, autoimmune response, and considerable technical expertise for small non-commercial yields. This, unfortunately, demonstrates the not-so-obvious chasm between science and drug formulation for regulatory approval. Regardless there is a general and global desire to improve the delivery of medicines, reduce potential side effect profiles, promote increased patient compliance, and increase and/or speed public access to medicine availability. In this paper, the author will discuss NanoCelle®, a nano-delivery platform that specifically addresses degradation and solubility issues that expands from fundamental micellar preparations. NanoCelle® has been deployed in several Australian listed medicines and is in use of several drug candidates across small molecules, with research endeavors now extending into large molecules. The author will discuss several research initiatives as they relate to NanoCelle® to demonstrate similarities seen in various drug substances; these examples will include both in vitro and in vivo work.

Keywords: NanoCelle®, micellar, degradation, solubility, toxicity

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Authors: Jian-Jun Shu

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The statistical properties of CRMs are explored by estimating similar-word set occurrence distribution. It is observed that CRMs tend to have a fat-tail distribution for similar-word set occurrence. Thus, the fat-tail test with two fatness coefficients is proposed to distinguish CRMs from non-CRMs, especially from exons. For the first fatness coefficient, the separation accuracy between CRMs and exons is increased as compared with the existing content-based CRM prediction method – fluffy-tail test. For the second fatness coefficient, the computing time is reduced as compared with fluffy-tail test, making it very suitable for long sequences and large data-base analysis in the post-genome time. Moreover, these indexes may be used to predict the CRMs which have not yet been observed experimentally. This can serve as a valuable filtering process for experiment.

Keywords: statistical approach, transcription factor binding sites, cis-regulatory modules, DNA sequences

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Authors: Samuel Faboyede, Obiamaka Nwobu, Samuel Fakile, Dickson Mukoro

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In the present dynamic business environment of corporate governance and regulations, financial reporting is an inevitable and extremely significant process for every business enterprise. Several financial elements such as Annual Reports, Quarterly Reports, ad-hoc filing, and other statutory/regulatory reports provide vital information to the investors and regulators, and establish trust and rapport between the internal and external stakeholders of an organization. Investors today are very demanding, and emphasize greatly on authenticity, accuracy, and reliability of financial data. For many companies, the Internet plays a key role in communicating business information, internally to management and externally to stakeholders. Despite high prominence being attached to external reporting, it is disconnected in most companies, who generate their external financial documents manually, resulting in high degree of errors and prolonged cycle times. Chief Executive Officers and Chief Financial Officers are increasingly susceptible to endorsing error-laden reports, late filing of reports, and non-compliance with regulatory acts. There is a lack of common platform to manage the sensitive information – internally and externally – in financial reports. The Internet financial reporting language known as eXtensible Business Reporting Language (XBRL) continues to develop in the face of challenges and has now reached the point where much of its promised benefits are available. This paper looks at the emergence of this revolutionary twenty-first century language of digital reporting. It posits that today, the world is on the brink of an Internet revolution that will redefine the ‘business reporting’ paradigm. The new Internet technology, eXtensible Business Reporting Language (XBRL), is already being deployed and used across the world. It finds that XBRL is an eXtensible Markup Language (XML) based information format that places self-describing tags around discrete pieces of business information. Once tags are assigned, it is possible to extract only desired information, rather than having to download or print an entire document. XBRL is platform-independent and it will work on any current or recent-year operating system, or any computer and interface with virtually any software. The paper concludes that corporate stakeholders and the government cannot afford to ignore the XBRL. It therefore recommends that all must act locally and think globally now via the adoption of XBRL that is changing the face of worldwide business reporting.

Keywords: XBRL, financial reporting, internet, internal and external reports

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Authors: Kalbende Krunal Ramesh

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The Carbon Capture and Storage Technology (CCS) provides a veritable platform to bridge the gap between the seemingly irreconcilable twin global challenges of ensuring a secure, reliable and diversified energy supply and mitigating climate change by reducing atmospheric emissions of carbon dioxide. Making its proper regulatory policy and making it flexible for the government and private company by law to regulate, also exploring the opportunity in this sector is the main aim of this paper. India's total annual emissions was 1725 Mt CO2 in 2011, which comprises of 6% of total global emission. It is very important to control the greenhouse gas emission for the environment protection. This paper discusses the various regulatory policy and technology adopted by some of the countries for successful using CCS technology. The brief geology of sedimentary basins in India is studied, ranging from the category I to category IV and deep water and potential for mature technology in CCS is reviewed. Areas not suitable for CO2 storage using presently mature technologies were over viewed. CSS and Clean development mechanism was developed for India, considering the various aspects from research and development, project appraisal, approval and validation, implementation, monitoring and verification, carbon credit issued, cap and trade system and its storage potential. The opportunities in oil and gas operations, power sector, transport sector is discussed briefly.

Keywords: carbon credit issued, cap and trade system, carbon capture and storage technology, greenhouse gas

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Authors: Matt Fullmer, Carol Wilkinson, Keven Prusak, Dennis Eggett, Todd Pennington

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Obesity and chronic health issues are linked to physical inactivity. Physical education (PE) programs in school can play a major role in combating these health-related issues. This study focused on supporting competence through keeping a leisure-time physical activity (LTPA) record as part of PE. Keeping a daily LTPA record may be an effective intervention helping students feel more competent toward exercise, and thus, self-determined (within the context of self-determination theory) to exercise. Little is known about the relationship between daily LTPA records and perceived competence, motivational profiles, and LTPA levels of students enrolled in PE. This study examined the relationship between keeping a daily, online LTPA record and adolescent (a) motivational profiles toward LTPA, (b) perceived competence toward LTPA, and (c) LTPA behaviors. Secondary students (N = 124) in physical education classes completed a baseline questionnaire which consisted of the Behavioural Regulation in Exercise Questionnaire–2, the Perceived Competence Scale, and the Godin Leisure-Time Exercise Questionnaire. For three weeks, the students were assigned to keep the Presidential Active Lifestyle Award Challenge (PALAC) as their online LTPA record. They completed the questionnaire after each week. A 2 (gender) x 4 (trials) repeated measures ANCOVA examined the relationships between recording compliance and motivation, perceived competence, and physical activity. Results showed that recording compliance was not a significant predictor of perceived competence to participate in LTPA. Examining motivational factors, a significant interaction between recording compliance and introjected regulation was found. The more students recorded the less motivated they were by guilt or obligation to exercise in their leisure-time. Also, a significant interaction was found between recording compliance and intrinsic regulation, indicating that the more students recorded the more intrinsically motivated they were to exercise in their leisure-time. Lastly, there was a significant interaction between recording compliance and LTPA. As students kept the LTPA record, girls’ LTPA levels significantly decreased and boys’ LTPA levels significantly increased. The key findings are that, as implemented in this study: a) the lack of PALAC compliance suggests that daily LTPA records may NOT be the most effective intervention for this population, b) keeping a daily LTPA record did NOT help students feel more competent to exercise in their leisure-time, c) a daily LTPA record may help students move towards being more self-determined in their feelings towards LTPA, and d) the outcome of keeping a LTPA record on LTPA behavior is statistically significant, although actual differences may not be practically important.

Keywords: behavioural regulation in exercise questionnaire–2, Godin leisure–time exercise questionnaire, online physical activity log, perceived competence scale, self-determination theory

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Authors: Karisma Karisma, Pardis Moslemzadeh Tehrani

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This study aims to conduct a high-level strategic dialogue on the lack of consensus, consistency, and legal certainty regarding blockchain-based energy prosumerism so that appropriate institutional and governance structures can be put in place to address the inadequacies and gaps in the legal and regulatory framework. The drive to achieve national and global decarbonization targets is a driving force behind climate goals and policies under the Paris Agreement. In recent years, efforts to ‘demonopolize’ and ‘decentralize’ energy generation and distribution have driven the energy transition toward decentralized systems, invoking concepts such as ownership, sovereignty, and autonomy of RE sources. The emergence of individual and collective forms of prosumerism and the rapid diffusion of blockchain is expected to play a critical role in the decarbonization and democratization of energy systems. However, there is a ‘regulatory void’ relating to individual and collective forms of prosumerism that could prevent the rapid deployment of blockchain systems and potentially stagnate the operationalization of blockchain-enabled energy sharing and trading activities. The application of broad and facile regulatory fixes may be insufficient to address the major regulatory gaps. First, to the authors’ best knowledge, the concepts and elements circumjacent to individual and collective forms of prosumerism have not been adequately described in the legal frameworks of many countries. Second, there is a lack of legal certainty regarding the creation and adaptation of business models in a highly regulated and centralized energy system, which inhibits the emergence of prosumer-driven niche markets. There are also current and prospective challenges relating to the legal status of blockchain-based platforms for facilitating energy transactions, anticipated with the diffusion of blockchain technology. With the rise of prosumerism in the energy sector, the areas of (a) network charges, (b) energy market access, (c) incentive schemes, (d) taxes and levies, and (e) licensing requirements are still uncharted territories in many countries. The uncertainties emanating from this area pose a significant hurdle to the widespread adoption of blockchain technology, a complementary technology that offers added value and competitive advantages for energy systems. The authors undertake a conceptual and theoretical investigation to elucidate the lack of consensus, consistency, and legal certainty in the study of blockchain-based prosumerism. In addition, the authors set an exploratory tone to the discussion by taking an analytically eclectic approach that builds on multiple sources and theories to delve deeper into this topic. As an interdisciplinary study, this research accounts for the convergence of regulation, technology, and the energy sector. The study primarily adopts desk research, which examines regulatory frameworks and conceptual models for crucial policies at the international level to foster an all-inclusive discussion. With their reflections and insights into the interaction of blockchain and prosumerism in the energy sector, the authors do not aim to develop definitive regulatory models or instrument designs, but to contribute to the theoretical dialogue to navigate seminal issues and explore different nuances and pathways. Given the emergence of blockchain-based energy prosumerism, identifying the challenges, gaps and fragmentation of governance regimes is key to facilitating global regulatory transitions.

Keywords: blockchain technology, energy sector, prosumer, legal and regulatory.

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Authors: Ilya B. Tsyrlov, Dmitry Y. Oshchepkov

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A computational search for dioxin response elements (DREs) in genes of proteins comprising the Ah receptor (AhR) cytosolic core complex was performed by highly efficient tool SITECON. Eventually, the following number of new DREs in 5’flanking region was detected by SITECON: one in AHR gene, five in XAP2, eight in HSP90AA1, and three in HSP90AB1 genes. Numerous DREs found in genes of AhR and AhR cytosolic complex members would shed a light on potential mechanisms of expression, the stoichiometry of unliganded AhR core complex, and its degradation vs biosynthesis dynamics resulted from treatment of target cells with the AhR most potent ligand, 2,3,7,8-TCDD. With human viruses, reduced susceptibility to TCDD of geneencoding HIV-1 P247 was justified by the only potential DRE determined in gag gene encoding HIV-1 P24 protein, whereas the regulatory region of CMV genes encoding IE gp/UL37 has five potent DRE, 1.65 kb/UL36 – six DRE, pp65 and pp71 – each has seven DRE, and pp150 – ten DRE. Also, from six to eight DRE were determined with SITECON in the regulatory region of HSV-1 IE genes encoding tegument proteins, UL36 and UL37, and of UL19 gene encoding bindingglycoprotein C (gC). So, TCDD in the low picomolar range may activate in human cells AhR: Arnt transcription pathway that triggers CMV and HSV-1 reactivation by binding to numerous promoter DRE within immediate-early (IE) genes UL37 and UL36, thus committing virus to the lytic cycle.

Keywords: dioxin response elements, Ah receptor, AhR: Arnt transcription pathway, human and viral genes

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Authors: Paulina Pietrzak

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The understanding of the role of the contemporary translator is fraught with contradictions and idealistic visions of individuals who, by definition, should be fully competent and versatile. In spite of the fact that lots of translation researchers have probed into the identification and exploration of the concept of translator competence, little study has been devoted to its metacognitive aspects. Due to the dynamic nature of the translator’s occupation, it is difficult to predict what specific skills will prove useful for novice translators in their professional career. Thus, it is crucial that the translator is self-regulated enough to adapt to changing job demands and effectively function in the contemporary, highly dynamic, translation market. The objective of the presentation is to investigate the role and nature of the translator’s self-regulation. It will also demonstrate the results of a pilot study into translation trainees’ self-regulatory skills and explore implications of these findings for translator training in relation to theories of student empowerment.

Keywords: cognitive translation research, translator competence, self-regulatory skills, translator training

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Authors: Isa Raquel Alves Soeiro, Cristina Isabel Branco de Sá

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In Portugal, since 2008, there has been a requirement to export the Standard Audit File for Tax Purposes (SAF-T) standard file (in XML format). This file thus gathers tax-relevant information from a company relating to a specific period of taxation. There are two types of SAF-T files that serve different purposes: the SAF-T of revenues and the SAF-T of accounting, which requires taxpayers and accounting firms to invest in order to adapt the accounting programs to the legal requirements. The implementation of the SAF-T accounting file aims to facilitate the collection of relevant tax data by tax inspectors as support of taxpayers' tax returns for the analysis of accounting records or other information with tax relevance (Portaria No. 321-A/2007 of March 26 and Portaria No. 302/2016 of December 2). The main objective of this research project is to verify, through quantitative analysis, what is the cost of compliance of Small and Medium Enterprises (SME) in the district of Leiria in the introduction and implementation of the tax obligation of SAF-T - Standard Audit File for Tax Purposes of accounting. The information was collected through a questionnaire sent to a population of companies selected through the SABI Bureau Van Dijk database in 2020. Based on the responses obtained to the questionnaire, the companies were divided into two groups: Group 1 -companies who are self-employed and whose main activity is accounting services; and Group 2 -companies that do not belong to the accounting sector. In general terms, the conclusion is that there are no statistically significant differences in the costs of complying with the accounting SAF-T between the companies in Group 1 and Group 2 and that, on average, the internal costs of both groups represent the largest component of the total cost of compliance with the accounting SAF-T. The results obtained show that, in both groups, the total costs of complying with the SAF-T of accounting are regressive, which appears to be similar to international studies, although these are related to different tax obligations. Additionally, we verified that the variables volume of business, software used, number of employees, and legal form explain the differences in the costs of complying with accounting SAF-T in the Leiria district SME.

Keywords: compliance costs, SAF-T accounting, SME, Portugal

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Authors: Cristina Sá, Carlos Gomes, António Martins

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The reasons that explain different behaviors towards tax obligations in similar countries are not completely understood yet. The main purpose of this paper is to identify and compare the factors that influence tax morale levels in Portugal and Spain. We use data from European Values Study (EVS). Using a sample of 2,652 individuals, a factor analysis was used to extract the underlying dimensions of tax morale of Portuguese and Spanish taxpayers. Based on a factor analysis, the results of this paper show that sociological and behavioral factors, psychological factors and political factors are important for a good understanding of taxpayers’ behavior in Iberian Peninsula. This paper added value relies on the analyses of a wide range of variables and on the comparison between Portugal and Spain. Our conclusions provided insights that tax authorities and politicians can use to better focus their strategies and actions in order to increase compliance, reduce tax evasion, fight underground economy and increase country´s competitiveness.

Keywords: compliance, tax morale, Portugal, Spain

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Authors: Aisling Eves, Andrew Pieri, Ross McLean, Nerys Forester

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Background: The breast unit local guideline recommends that 12 cores should be used in a stereotactic-guided biopsy to diagnose DCIS. Twelve cores are regarded to provide good diagnostic value without removing more breast tissue than necessary. This study aimed to determine compliance with guidelines and investigated how the number of cores impacted upon the re-excision rate and size discrepancies. Methods: This single-centre retrospective cohort study of 72 consecutive breast screened patients with <15mm DCIS on radiological report underwent stereotactic-guided core biopsy and subsequent surgical excision. Clinical, radiological, and histological data were collected over 5 years, and ASCO guidelines for margin involvement of <2mm was used to guide the need for re-excision. Results: Forty-six (63.9%) patients had <12 cores taken, and 26 (36.1%) patients had ≥12 cores taken. Only six (8.3%) patients had 12 cores taken in their stereotactic biopsy. Incomplete surgical excision was seen in 17 patients overall (23.6%), and of these patients, twelve (70.6%) had fewer than 12 cores taken (p=0.55 for the difference between groups). Mammogram and biopsy underestimated the size of the DCIS in this subgroup by a median of 15mm (range: 6-135mm). Re-excision was required in 9 patients (12.5%), and five patients (6.9%) were found to have invasive ductal carcinoma on excision (80% had <12 cores, p=0.43). Discussion: There is poor compliance with the breast unit local guidelines and higher rates of re-excision in patients who did not have ≥12 cores taken. Taking ≥12 cores resulted in fewer missed invasive cancers lower incomplete excision and re-excision rates.

Keywords: stereotactic core biopsy, DCIS, breast screening, Re-excision rates, core biopsy

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Authors: Sarah Marie

Abstract:

In today's dynamic financial landscape, cryptocurrencies represent a paradigm shift characterized by innovation and intense debate. This study probes into their transformative potential and the challenges they present, offering a balanced perspective that recognizes both their promise and pitfalls. Emulating the engaging style of a TED Talk, this research goes beyond academic analysis, serving as a critical bridge to reconcile the perspectives of cryptocurrency skeptics and enthusiasts, fostering a well-informed dialogue. The study employs a mixed-method approach, analyzing current trends, regulatory landscapes, and public perceptions in the cryptocurrency domain. It distinguishes genuine innovators in this field from ostentatious opportunists, echoing the sentiment that real innovation should be separated from mere showmanship. If one is unfamiliar with who is being referenced, they can likely spot them leaning against their Lamborghinis outside "Crypto" conventions, looking greasy. Major findings reveal a complex scenario dominated by regulatory uncertainties, market volatility, and security issues, emphasizing the need for a coherent regulatory framework that balances innovation with risk management and sustainable practices. The study underscores the importance of transparency and consumer protection in fostering responsible growth within the cryptocurrency ecosystem. In conclusion, the research advocates for education, innovation, and ethical governance in the realm of cryptocurrencies. It calls for collaborative efforts to navigate the intricacies of this evolving landscape and to realize its full potential in a responsible, inclusive, and forward-thinking manner.

Keywords: financial landscape, innovation, public perception, transparency

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Authors: Jasini Waida, Usman Rilwan, S. I. Ikpughul, E. I. Ugwu

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Carcinogenic substances are those that induce tumours (benign or malignant), increase their incidence or malignancy, or shorten the time of tumour occurrence when they get into the body through inhalation, injection, dermal application, or ingestion. Using X-Ray Fluorescence, this study reveals the accumulation of heavy metals in Jos East. The results of this study showed that the Geo-Accumulation Index (Igeo) of water for different heavy metals decreased in the order of Cd (0.15) > Cr and As (0.03) > Pb (-0.13) > Ni (-0.6). The soil content for different heavy metals decreased in the order of As and Cd (0.4) > Ni, Cr and Pb (0.2). The edible plants for different heavy metals decreased in the order of Cd (0.512) > As (0.25) > Pb (0.23) > Ni (0.01) > Ni (-0.06). 21% of these points are uncontaminated, except for a few points that are found within the uncontaminated to moderately contaminated level. It is possible to conclude that the area is uncontaminated to moderately contaminated, necessitating regulation. Hence, this study can be used as reference data for regulatory bodies like the Nigerian Nuclear Regulatory Authority (NNRA) and the rest.

Keywords: heavy metals, soil, plants, water, contamination factor

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Authors: Iman M. Mansour, Rania A. Zayed, Fadwa S. Abdel-Azim, Lamyaa H. Abdel-Latif

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Background and Objectives: The microenvironment of acute myeloid leukemia (AML) is suppressive for immune cells. Regulatory T cells (Tregs) have been recognized to play a role in helping leukemic cells to evade immunesurveillance. The mesenchymal stem cells (MSCs) are essential contributors in immunomodulation of the microenvironment as they can promote differentiation of Tregs via the indoleamine 2,3-dioxygenase (IDO) pathway. The aim of the present work was to evaluate the expression of IDO in bone marrow derived MSCs and to study its correlation to percentage of Tregs. Methods: 37 adult bone marrow samples were cultured in appropriate culture medium to isolate MSCs. Successful harvest of MSCs was determined by plastic adherence, morphology and positive expression of CD271 and CD105; negative expression of CD34 and CD45 using flowcytometry. MSCs were examined for IDO expression by immunocytochemistry using anti-IDO monoclonal antibody. CD4+ CD25+ cells (Tregs) were measured in bone marrow samples by flowcytometry. Results: MSCs were successfully isolated from 20 of the 37 bone marrow samples cultured. MSCs showed higher expression of IDO and Tregs percentage was higher in AML patients compared to control subjects (p=0.002 and p<0.001 respectively). A positive correlation was found between IDO expression and Tregs percentage (p value=0.012, r=0.5). Conclusion: In this study, we revealed an association between high IDO expression in MSCs and elevated levels of Tregs which has an important role in the pathogenesis of AML, providing immunosuppressive microenvironment.

Keywords: acute myeloid leukemia, indoleamine 2, 3-dioxygenase, mesenchymal stem cells, T regulatory cells

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Authors: Adel Elomri

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The notion of carbon footprinting is ever more widespread as companies are becoming increasingly aware that tackling carbon emissions and being seen to do so is a key issue to face governments, customers and other stakeholders’ pressures towards delivering environmentally friendly services and activities. In this contest, many firms are taking self-initiatives to reduce their own carbon emissions while some other are constrained to obey to different regulations/policies (e.g. carbon tax or carbon Cap) designed by higher authorities targeting a low-carbon environment. Using buyer-vendor framework, this paper provides some insights on how effective are these self-initiatives and regulatory policies when only concerning firms at the individual level and not the whole supply chain they are part of. We show that when firms individually engage in reducing their direct carbon emissions either under self-initiatives or regulatory policy, an opposite expected outcome resulting in a higher global supply chain emission can occur. This effect is referred to as the carbon seesaw effect. Moreover, we show that coordinating or centralizing the supply chain -contrary to what one may think at first- is not often the appropriate solution to get rid of this effect.

Keywords: carbon emissions, supply chain coordination, EOQ, sustainable operations

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Authors: Rajib Husain, Mezbah Uddin, Mohammad Shamsal Islam, Rabeya Siddiquee

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Purpose: To determine the improvement of visual acuity in patients undergoing occlusion therapy. Methods: This was a prospective hospital-based study of newly diagnosed of amblyopia seen at the pediatric clinic of Chittagong Eye Infirmary & Training Complex. There were 32 refractive amblyopia subjects were examined & questionnaire was piloted. Included were all patients diagnosed with refractive amblyopia between 5 to 8 years, without previous amblyopia treatment, and whose parents were interested to participate in the study. Patients diagnosed with strabismic amblyopia were excluded. Patients were first corrected with the best correction for a month. When the VA in the amblyopic eye did not improve over a month, then occlusion treatment was started. Occlusion was done daily for 6-8 h together with vision therapy. The occlusion was carried out for three months. Results: Out of study 32 children, 31 of them have a good compliance of amblyopic treatment whereas one child has poor compliance. About 6% Children have amblyopia from Myopia, 7% Hyperopia, 32% from myopic astigmatism, 42% from hyperopic astigmatism and 13% have mixed astigmatism. The mean and Standard deviation of present average VA was 0.452±0.275 Log MAR and after an intervention of amblyopia therapy with vision therapy mean and Standard deviation VA was 0.155±0.157 Log MAR. Out of total respondent 21.85% have BCVA in range from (0-.2) log MAR, 37.5% have BCVA in range from (0.22-0.5) log MAR, 35.95% have in range from (0.52-0.8) log MAR, 4.7% have in range from (0.82-1) log MAR and after intervention of occlusion therapy with vision therapy 76.6% have VA in range from (0-.2) log MAR, 21.85% have VA in range from (0.22-0.5) log MAR, 1.5% have in range from (0.52-0.8) log MAR. Conclusion: Amblyopia is a most important factor in pediatric age group because it can lead to visual impairment. Thus, this study concludes that occlusion therapy with vision therapy is probably one of the best treatment methods for amblyopic patients (age 5-8 years), and compliance and age were the most critical factor predicting a successful outcome.

Keywords: amblyopia, occlusion therapy, vision therapy, eccentric fixation, visuoscopy

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Authors: Waheed Oseni

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This article reviews emergent global trends in intellectual property protection and identifies patenting as a strategic initiative. Recent developments in software and method of doing business patenting are fast transforming the e‐business landscape. The article discusses the emergent global regulatory framework concerning intellectual property rights and the strategic value of patenting. Important features of a corporate patenting portfolio are described. Superficially, the e‐commerce landscape appears to be dominated by dotcom start-ups or the “dotcomization” of existing brick and mortar companies. But, in reality, at its very bedrock is intellectual property (IP). In this connection, the recent avalanche of patenting of software and method‐of‐doing‐business (MDB) in the USA is a very significant development with regard to rules governing IP rights and, therefore, e‐commerce. Together with the World Trade Organization’s (WTO) IP rules, there is an emerging global regulatory framework for IP rights, an understanding of which is necessary for designing effective e‐commerce strategies.

Keywords: intellectual property, patents, methods, computer software

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Authors: Seon-Young Lee, Harkiran Sagoo, Katherine Whitehurst, Georgina Wellstead, Alexander Fowler, Riaz Agha, Dennis Orgill

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Introduction: Systematic reviews attempt to answer research questions by synthesising the data within primary papers. They are an increasingly important tool within evidence-based medicine, guiding clinical practice, future research and healthcare policy. We sought to determine the reporting quality of recent systematic reviews in plastic surgery. Methods: This systematic review was conducted in line with the Cochrane handbook, reported in line with the PRISMA statement and registered at the ResearchRegistry (UIN: reviewregistry18). MEDLINE and EMBASE databases were searched in 2013 and 2014 for systematic reviews by five major plastic surgery journals. Screening, identification and data extraction was performed independently by two teams. Results: From an initial set of 163 articles, 79 met the inclusion criteria. The median PRISMA score was 16 out of 27 items (59.3%; range 6-26, 95% CI 14-17). Compliance between individual PRISMA items showed high variability. It was poorest for items related to the use of review protocol (item 5; 5%) and presentation of data on risk of bias of each study (item 19; 18%), while being the highest for description of rationale (item 3; 99%) and sources of funding and other support (item 27; 95%), and for structured summary in the abstract (item 2; 95%). Conclusion: The reporting quality of systematic reviews in plastic surgery requires improvement. ‘Hard-wiring’ of compliance through journal submission systems, as well as improved education, awareness and a cohesive strategy among all stakeholders is called for.

Keywords: PRISMA, reporting quality, plastic surgery, systematic review, meta-analysis

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Authors: Hokuma Isgandarova, Khalil Aryanfar

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The patient's rights include all care items that the patient has the right to receive. Considering the growing importance of this important issue and its effect on improving treatment results and customer satisfaction, the present study was conducted with the aim of investigating the level of respect for patient rights in the physiotherapy clinic of the Faculty of Medicine University of Medical Sciences in 2023. In this study, the patients or companions who were referred to the clinic answered questions about the performance status of the clinic with respect to various aspects of the patient's rights. The aspects that were studied: choosing the service provider, having authority, respect, safety, prevention and access were found to have inappropriate performance scores. However, communication and interaction, continuity of service, quality of basic facilities and facilities, timely and immediate attention and trust had appropriate performance. Also, the results of the data analysis showed that there is no significant relationship between the total performance score and any of the demographic variables.

Keywords: compliance, patients' rights, physiotherapy clinic, performance level

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Authors: L. M. Hayyan ul Haq, Lalu Sabardi

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This research is aimed at exploring an appropriate regulatory model in coherencing a diametrical interest between the state, Adat legal community, and private interests in utilising and optimizing land in Indonesia. This work is also highly relevant to coherencing the obligation of the state to respect, to fulfill and to protect the fundamental rights of people, especially to protect the communal or adat community rights to the land. In visualizing those ideas, this research will use the normative legal research to elaborate the normative problem in land use, as well as redesigning and creating an appropriate regulatory model in bridging and protecting all interest parties, especially, the state, Adat legal community, and private parties. In addition, it will also employ an empirical legal research for identifying some operational problems in protecting and optimising the land. In detail, this research will not only identify the problems at the normative level, such as conflicted norms, the absence of the norms, and the unclear norm in land law, but also the problems at operational level, such as institutional relationship in managing the land use. At the end, this work offers an appropriate regulatory model at the systems level, which covers value and norms in land use, as well as the appropriate mechanism in managing the utilization of the land for the state, Adat legal community, and private sector. By manifesting this objective, the government will not only fulfill its obligation to regulate the land for people and private, but also to protect the fundamental rights of people, as mandated by the Indonesian 1945 Constitution.

Keywords: adat community rights, fundamental rights, investment, land law, private sector

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Authors: Roman Knizek, Denisa Knizkova

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This paper describes the development of a nanofiber membrane for sport and outdoor use at the Technical University of Liberec (TUL) and the following cooperation with a private Czech company which launched this product onto the market. For making this membrane, Polyurethan was electrospun on the Nanospider spinning machine, and a wire string electrode was used. The created nanofiber membrane with a nanofiber diameter of 150 nm was subsequently hydrophobisied using a low vacuum plasma and Fluorocarbon monomer C6 type. After this hydrophobic treatment, the nanofiber membrane contact angle was higher than 125o, and its oleophobicity was 6. The last step was a lamination of this nanofiber membrane with a woven or knitted fabric to create a 3-layer laminate. Gravure printing technology and polyurethane hot-melt adhesive were used. The gravure roller has a mesh of 17. The resulting 3-layer laminate has a water vapor permeability Ret of 1.6 [Pa.m2.W-1] (– measured in compliance with ISO 11092), it is 100% windproof (– measured in compliance with ISO 9237), and the water column is above 10 000 mm (– measured in compliance with ISO 20811). This nanofiber membrane which was developed in the laboratories of the Technical University of Liberec was then produced industrially by a private company. A low vacuum plasma line and a lamination line were needed for industrial production, and the process had to be fine-tuned to achieve the same parameters as those achieved in the TUL laboratories. The result of this work is a newly developed nanofiber membrane which offers much better properties, especially water vapor permeability, than other competitive membranes. It is an example of product development and the consequent fine-tuning for industrial production; it is also an example of the cooperation between a Czech state university and a private company.

Keywords: nanofiber membrane, start-up, state university, private company, product

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Authors: Mahiout Tassadit

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As part of the study of a compliance and quality aspect concerning one of the plant-based products: drugs for herbal teas sold in pharmacies, a survey targeting: the general population (100 people of different age groups) as well as dispensary pharmacists (40 pharmacists from rural or urban areas) of the wilaya of Tizi-Ouzou (central Algeria) was carried out followed by a macroscopic and microscopic analysis of 4 samples of the said drugs, the survey carried out using two questionnaires, the data of which were collected and then analyzed, made it possible to estimate the population's use of herbal products and medicinal plants, and the place occupied by herbal medicine in our pharmacies. The second part made it possible to control and evaluate the information present on the packaging of drugs for herbal teas; anomalies concerning the packaging, labeling and composition of these products were noted. As a result, it is more than necessary to establish regulations for this type of product; the community pharmacist again places himself as an essential element for the proper dispensation of these remedies.

Keywords: drugs, herbal teas, macroscopic analysis, microscopic analysis

Procedia PDF Downloads 55