Attenuation of water contamination in the Paraopeba River after the collapse of B1 tailings dam: Natural wash-off and dredging contributions.

Following the B1 dam collapse at Córrego do Feijão Mine, actions were taken to address environmental damage and enhance the quality of water in the Paraopeba River. Natural processes in the river involve gradual reduction of contamination through dispersion and downstream transportation of tailings-a slow, nature-driven process. Dredging, a human intervention, aimed to expedite recovery. Hence, this study aimed to explore dredging's role in reducing contamination in the impacted Paraopeba River zone. Analysis revealed a direct link between dredging and post-collapse turbidity, though recent trends suggest a lessening impact on pre-collapse conditions. Distinct seasonal variations were observed in iron and manganese concentrations, peaking during wet seasons and displaying notable upstream-downstream disparities. An analysis of ratios (downstream/upstream) was conducted to understand and even predict the return to pre-collapse conditions. Wet season averages for iron and manganese decreased by around 90 % over time, with standard deviations reducing by about 48 % and 58 %, respectively. In the dry season, the averages decreased by over 100 %, indicating water quality improvements surpassing pre-collapse levels. Standard deviations also decreased significantly, by approximately 67 % and 79 %, respectively. Employing an exponential decay model revealed that the contribution of dredging in the dry period is negligible, but in the wet period the contribution can be estimated at 28.6 % in the case of iron and 25 % in the case of manganese. While the models performed well based on extensive data, some limitations occur in estimating dredging contribution rates. The model's sensitivity might overlook influential factors, underscoring the importance of considering sediment nature and dredged area extent in understanding water quality dynamics. Despite these potential limitations, this investigation provides crucial insights into the intricate relationship between dredging and water quality in the Paraopeba River. These findings pave the way for future studies aimed at deeper exploration and more accurate assessments of this association.

Tramadol/Diclofenac Fixed-Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product.

The multimodal analgesia strategy for acute pain involves using 2 or more analgesic medications with distinct mechanisms of action. This study assessed the bioavailability and tolerability of 2 tramadol hydrochloride (50 mg)/diclofenac sodium (50 mg) fixed-dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open-label, randomized, single-dose, 2-period, 2-way crossover trial was conducted, including healthy subjects of both sexes. Subjects received a single dose of either the test or reference formulation of tramadol/diclofenac fixed-dose combination tablets with a 7-day washout period. Blood samples were collected up to 36 hours after dosing for tramadol and 12 hours for diclofenac and quantified using a validated liquid chromatography-tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration-time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%-125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice.

A systematic analysis on the efficiency and sustainability of green facades and roofs.

In the modern urban space, green infrastructures have been gaining increasing relevance due to their positive impacts on sustainability issues, visual appeal, and the well-being of individuals. On the other hand, environmental sustainability has become mandatory in the agenda of governments and organizations. Thus, a systematic analysis on the efficiency and sustainability of green facades and roofs spanning key applications, benefits and implementation constraints is welcome. In this paper, we employed the PRISMA method to investigate how these matters were addressed in the recent literature, comprising articles published in scientific journals indexed to the SCOPUS database. Following the web search, selection, systematization, and analysis of that literature, it was revealed that the efficiency of green facades and roofs has been mostly associated with energy and thermal performance in buildings, which brings unequivocal multiple benefits (e.g., consumption savings, mitigation of urban heat island effects) despite of some barriers (e.g., installation and maintenance costs). Other discussions about green facades and roofs involved their valuable roles in stormwater management, considering their retention capacity, and in the treatment of wastewater for reuse in non-potable applications, considering their filtering capacity. It was also discovered the need to improve green infrastructures through the use of cleaner technologies and recycled materials, selection of plants that are appropriate for the local climate, and minimization of construction, transportation, disposal and maintenance costs. Efficiency and sustainability in these cases was prognosed to succeed if the costs were minimized throughout the entire life cycle, and complemented with incentive policies (e.g., tax reduction, agile administrative processes) and collaboration among multidisciplinary teams comprising designers, builders, municipality planners and the academic and market worlds.

Sediment source fingerprints of natural processes and anthropogenic pressures: A contribution to manage the Paraopeba River basin impacted by the B1 tailings dam collapse.

Understanding the origins of sediment transport in river systems is crucial for effective watershed management, especially after catastrophic events. This information is essential for the development of integrated strategies that guarantee water security in river basins. The present study aimed to investigate the rupture of the B1 tailings dam of the Córrego do Feijão mine, which drastically affected the Brumadinho region (Minas Gerais, Brazil). To address this issue, a confluence-based sediment fingerprinting approach was developed through the SedSAT model. Uncertainty was assessed through Monte Carlo simulations and Mean Absolute Error (MAE). Estimates of the overall average contributions of each tributary were quantified for each station and annually during the period 2019-2021. It was observed that the sampling point PT-09, closest to the dam breach, contributed to almost 80% of the Paraopeba River in 2019. Despite the dredging efforts, this percentage increased to 90% in 2020 due to the need to restore the highly degraded area. Additionally, the main tributaries contributing to sediment increase in the river are Manso River "TT-03" (almost 36%), associated with an area with a high percentage of urban land use, and Cedro stream "TT-07" (almost 71%), whose geology promotes erosion, leading to higher sediment concentration. Uncertainties arise from the limited number of available tracers, variations caused by dredging activities, and reduced data in 2020 due to the pandemic. Parameters such as land use, riparian vegetation degradation, downstream basin geology, and increased precipitation are key factors for successfully assessing tributary contributions to the Paraopeba River. The obtained results are promising for a preliminary analysis, allowing the quantification of key areas due to higher erosion and studying how this disaster affected the watershed. This information is crucial for improving decision-making, environmental governance, and the development of mitigating measures to ensure water security. This study is pioneering in evaluating this methodology in watersheds affected by environmental disasters, where restoration efforts are ongoing.

Beyond land use planning and ecosystem services assessment with the conservation use potential framework: A study in the Upper Rio das Velhas basin, Brazil.

Human actions can damage the ecosystems and affect the services depending on them, with ample detrimental consequences. In earlier studies, the Conservation Use Potential (PCU) framework proved useful in assessing the capacity for aquifer recharge, suitable land uses and resistance to erosion at the river basin scale. On the other hand, the joint analysis of PCU and land uses allowed identifying the adequacy of current uses in relation to suitability (natural uses) in various basins. This was especially useful from the management perspective in basins with environmental conflicts, where current uses differed from suitability, because the PCU indicated how and where the conflicts should be mitigated. Besides the use as management tool, the PCU has potential to shed light over environmental issues such as ecosystem services, but that was not tempted so far. The aim of this work was therefore to bridge that knowledge gap and frame the PCU's application from the standpoint of Ecosystem Services (ES) assessment. We demonstrated how the PCU could be used to improve provision (recharge), support (sustainable agriculture) and regulation (resistance to erosion) services in a specific basin with land use conflicts (the Upper Rio das Velhas basin, located in Minas Gerais, Brazil), through the planning of suitable uses. It was noted that the studied basin is mostly composed of Very Low, Low and Medium potentials. These classes occur because steep slopes, fragile soils and lithologies with high denudation potential and low nutrient supply dominate in the basin. On the other hand, urban sprawl has a negative impact on all ES, while maintaining agricultural areas with appropriate management can effectively regulate erosion. As per the current results, the premise of using the PCU as joint management-environmental tool was fully accomplished, and is recommended a basis for public policy design and implementation in Brazil and elsewhere.

A framework model to integrate sources and pathways in the assessment of river water pollution.

Metal and nutrient pollution, soil erosion, and alterations in climate and hydrology are prevalent issues that impact the water quality of riverine systems. However, integrated approaches to assess and isolate causes and paths of river water pollution are scarce, especially in the case of watersheds impacted by multiple hazardous activities. Therefore, a framework model for investigating the multiple sources of river water pollution was developed. The chosen study area was the Paraopeba River basin located in the Minas Gerais, Brazil. Besides multiple agriculture, industrial, and urban pollution sources, this region was profoundly affected by the rupture of the B1 tailings dam (in January 2019) at the Córrego do Feijão mine, resulting in the release of metal-rich waste. Considering this situation, thirty-nine physicochemical and hydromorphological parameters were examined in the Paraopeba River basin, in the 2019-2023 period. The analysis involved various statistical techniques, including bivariate and multivariate methods such as correlation analysis, principal component analysis, and clustering. The Paraopeba River was mainly impacted by metal contamination resulting from the dam collapse, whereas nutrient contamination, mainly from urban and industrial discharges, predominantly affected its tributaries. Additionally, the elevated concentrations of aluminum, iron, nitrate, and sulfate in both main river and tributaries can be attributed to diffuse and point source pollution. In terms of hydromorphology and soil type, the interaction between woody vegetation and erosion-resistant soils, especially latosols, contributes to the stability of riverbanks in the main river. Meanwhile, in the tributaries, the presence of neosols and sparse vegetation in urbanized areas promoted riverbank erosion potentially amplifying pollution. While the study was conducted in a particular watershed, the findings are based on a methodology that can be applied universally. Hence, the insights on surface water quality from this research can be a valuable resource for researchers studying watersheds with diverse pollution sources.

Geomorphologic risk zoning to anticipate tailings dams' hazards: A study in the Brumadinho's mining area, Minas Gerais, Brazil.

The use of tailings dams in the mining industry is recurrent and a matter of concern given the risk of collapse. The planning of tailings dam's emplacement usually attends construction design criteria and site geotechnical properties, but often neglects the risk of installing the depositional facilities in potentially unstable landscapes, namely those characterized by steep slopes and(or) high drainage densities. In order to help bridging this gap, the present study developed a framework model whereby geomorphologic vulnerability is assessed by a set of morphometric parameters (e.g., drainage density; relief ratio; roughness coefficient). Using the Ribeirão Ferro-Carvão micro-basin (3265.16 ha) as test site, where six dams currently receive tailings from the mining of iron-ore deposits in the Brumadinho region (Minas Gerais, Brazil) and one has collapsed in 25 January 2019 (the B1 dam of Córrego do Feijão mine of Vale, S.A.), the risk of dam instability derived from geomorphologic vulnerability was assessed and alternative suitable locations were highlighted when applicable. The results made evident the location of five dams (including the collapsed B1) in high-risk regions and two in low-risk regions, which is preoccupying. The alternative locations represent 58 % of Ribeirão Ferro-Carvão micro-basin, which is a reasonable and workable share. Overall, the study exposed the fragility related with tailings dams' geography, which is not restricted to the studied micro-basin, because dozens of active tailings dams exist in the parent basin (the Paraopeba River basin) that can also be vulnerable to geomorphologically-dependent hydrologic hazards such as intensive erosion, valley incision or flash floods. Attention to this issue is therefore urgent to prevent future tragedies related with tailings dams' breaks, in the Paraopeba River basin or elsewhere, using the proposed framework model as guide.

Etoricoxib Coated Tablets: Bioequivalence Assessment between Two Formulations Administered under Fasting Conditions.

Etoricoxib is a non-steroidal anti-inflammatory drug with high selectivity for cyclooxygenase 2 (COX-2), exerting a pronounced anti-inflammatory effect with fewer adverse events when compared to COX-1 inhibitors. The present study aimed to evaluate the bioequivalence between two etoricoxib-coated tablet formulations to meet regulatory requirements for a branded generic product registration in Brazil. A crossover study with an open-label, randomized design and a single-dose regimen with two treatments and two periods was conducted on healthy Brazilians of both genders. Subjects randomly received a single dose of a 90 mg etoricoxib coated tablet of test product Xumer® 90 mg (Adium S.A.) and the reference product Arcoxia® 90 mg (Merck Sharp & Dohme Farmacêutica Ltda.) under fasting conditions separated by a 14-day period. Blood samples were collected sequentially for up to 96 h following drug administration, and the concentrations of etoricoxib in plasma were determined using a validated UPLC-MS/MS method. Pharmacokinetic parameters were computed utilizing non-compartmental analysis methods. A total of 32 healthy subjects were enrolled, and 25 subjects completed the study. Geometric mean ratios (90% confidence intervals) for Cmax, AUC0-t, and AUC0-inf were 103.98% (95.63-113.06), 96.82% (91.82-102.09), and 95.79% (90.70-101.16), respectively. In accordance with regulatory standards, the test formulation (Xumer® 90 mg) has been deemed bioequivalent to the reference product (Arcoxia® 90 mg). As a result, these formulations can be considered interchangeable in clinical practice, with both proving to be safe and well-tolerated. The need for in vivo testing for the Xumer® 60 mg strength was waived due to the proportional similarity of the formulations and the similar in vitro dissolution profiles observed across the various strengths.

Groundwater security indicators and their drivers: An assessment made in a region of tropical climate (Paraopeba River basin, Brazil).

Groundwater helps overcoming periods of drought buffering their effects on water supply to people, natural ecosystems and the economy. Following the latest Conference of the Parties (COP27), groundwater research gained renewed impulse because the Parties committed themselves to invest on environmental dimensions of water security related with aquifer characterization and protection. In that context, the purpose of this study was to help providing an integrated assessment to some fundamental issues about groundwater security, summarized as the three "how"s: how much, how ready and for how long can groundwater be delivered from watersheds? A complementary goal was to identify and quantify the role of watershed characteristics controlling these "how"s. The methodology combined hydrologic modeling and GIS and the results for the test site (Paraopeba River basin, Brazil) were: (1) the studied river tributaries mostly drain regolith aquifers with short hydrologic turnover times (1.3-23.7 yr) and small aquifer mobile storages (0.1-1.3 m), but high specific yields (0.2-8.2 m/yr), being generally prone to hydrologic droughts; (2) the specific discharge is primarily elevation controlled (via precipitation increases with altitude), but relates positively with drainage density as well; (3) the mobile storage in the Quadrilátero-Ferrífero mountain is larger than elsewhere, being influenced by a local geomorphologic setting (higher coverage with concave hillslopes); (4) the groundwater contribution to streamflow discharge is high (> 50 %, on average), being improved with the coverage of argisols; (5) vulnerability to droughts could be alleviated through expansion of water-retention infrastructure in specific regions, as well as through land use conversions targeting reduced evapotranspiration or sustainable land management of argisol and concave surface landscapes. Although applied to a specific catchment, our results stand on a site-independent methodological framework. Thus, the understanding about groundwater security gained with this study can be inspiring to other workers dealing with tropical climate landscapes.

Payment for Environmental Services: A critical review of schemes, concepts, and practice in Brazil.

The Payment for Environmental Services (PES) is often conceived through complex schemes without a clear definition of all concepts involved. This study presents the results of a systematic literature review on PES schemes in Brazil, accompanied by a critical assessment of their efficacy for potential environmental gains. The PES approaches were grouped into six categories based on the research focus, and those that were focused on PES policies were identified as the most studied. A particular emphasis has been given to the Amazon and Atlantic Forest biomes, where the ecosystem services studied were mostly centered on issues related to carbon and water, respectively. Approximately one-third of all schemes provided no clear definition of which ecosystem services are proposed for payment. In addition, the review showed no consensus among studies on the definition of services in similar schemes. Most schemes presented no payment system conditioned on the provision of environmental services. Furthermore, the review showed that the absence of clarity in the application of concepts may hinder the development of public policies to properly implement PES in Brazil. The conclusion is that standardizing terms used in the literature and in PES schemes is critical; therefore, the use of the Common International Classification of Ecosystem Services (CICES) as a reference is recommended to ensure clarity, objectivity and, more importantly, the expected environmental efficacy.

Scenarios of environmental deterioration in the Paraopeba River, in the three years after the breach of B1 tailings dam in Brumadinho (Minas Gerais, Brazil).

The collapse of B1 dam at the Córrego do Feijão mine of Vale, S.A., located in the Ferro-Carvão stream watershed (Brazil), released 11.7 Mm3 of tailings rich in iron and manganese, and 2.8 Mm3 entered the Paraopeba River 10 km downstream. Seeking to predict the evolution of environmental deterioration in the river since the dam break on January 25, 2019, the present study generated exploratory and normative scenarios based on predictive statistical models, and proposed mitigating measures and subsides to ongoing monitoring plans. The scenarios segmented the Paraopeba into three sectors: "anomalous" for distances ≤63.3 km from the B1 dam site, "transition" (63.3-155.3 km), and "natural" (meaning unimpacted by the mine tailings in 2019; >155.3 km). The exploratory scenarios predicted a spread of the tailings until reaching the "natural" sector in the rainy season of 2021, and their containment behind the weir of Igarapé thermoelectric plant located in the "anomalous" sector, in the dry season. Besides, they predicted the deterioration of water quality and changes to the vigor of riparian forests (NDVI index) along the Paraopeba River, in the rainy season, and a restriction of these impacts to the "anomalous" sector in the dry season. The normative scenarios indicated exceedances of chlorophyll-a in the period January 2019-January 2022, but not exclusively caused by the rupture of B1 dam as they also occurred in areas not affected by the accident. Conversely, the manganese exceedances clearly flagged the dam failure, and persist. The most effective mitigating measure is likely the dredging of the tailings in the "anomalous" sector, but currently it represents solely 4.6 % of what has entered the river. Monitoring is paramount to update the scenarios until the system enters a route towards rewilding, and must include water and sediments, the vigor of riparian vegetation, and the dredging.

Multicriteria spatial model to prioritize degraded areas for landscape restoration through agroforestry.

Reconciling the restoration of ecosystem services within agricultural landscapes is an effort that has been advancing within degraded areas restoration through agroforestry systems. However, to contribute to the effectiveness of these initiatives, it is essential to integrate landscape vulnerability and local demands to better highlight in which areas the implementation of agroforestry systems should be prioritized. Thus, we developed a spatial hierarchization methodology as a decision support tool as an active strategy for agroecosystem restoration. The proposed method constitutes a spatial indicator of priority areas to guide agroforestry interventions, including resource allocation and public policies for payment for environmental services. The methodology consists of Multicriteria Decision Analysis implemented in GIS software by combining input datasets based on biophysical conditions, environmental and socioeconomic aspects, that integrated promotes an assessment of the environment fragility, the pressures and responses to land use dynamic; a strategy for landscape restoration and conservation of the natural habitats, and multiple specific scenarios for decision making regarding the agricultural and the local actors demands. The output of the model provides the spatial distribution of areas suitable for the implementation of agroforestry systems, sorted into four priority levels (Low, Medium, High, and Extreme priority). The method is a promising tool proposal for territorial management and governance and subsidizes future research on the flows of ecosystem services.•Assessment of the environment fragility and the pressures and responses to land use dynamic.•Strategy for landscape restoration and conservation of remaining natural habitats.•Multiple specific scenarios for decision making regarding the agricultural and the local actors demands.

Bioequivalence of 2 formulations of montelukast (5 mg chewable tablet) in the fasting state: an open-label randomized, single-dose, 2-period, crossover study / Estudo de bioequivalência entre duas formulações de comprimidos mastigáveis de Montelucaste de 5 mg em condições de jejum: um estudo randomizado, de dose única, aberto, dois períodos, cruzado

Introduction: Montelukast, a selective and active leukotriene receptor antagonist, is one of the most common agents in asthma treatment for both adults and children. Objective: To assess whether the pharmacokinetic profiles of two formulations of montelukast were similar after a single 5 mg dose (chewable tablets), administered orally under fasting conditions, sampling blood before and 36 hours after administration. Methods: This was a randomized, 2-sequence, 2-period, crossover study of 2 chewable tablet formulations of the drug: Singulair®, provided by Merck Sharp and Dohme Farmacêutica Ltda. (reference), and generic montelukast, manufactured by Eurofarma Laboratórios S.A. (test). Plasma samples obtained from 35 participants were analyzed for montelukast through high-performance liquid chromatography coupled to tandem mass spectrometry, with montelukast-d6 as the internal standard. Peak montelukast concentrations were 299.313 (SD, 11.039) ng/mL for the reference formulation and 279.803 (SD, 10.085) ng/mL for test formulation. Results: Statistical analysis showed no significant differences between AUC0-36h, AUC0-inf, or Cmax between formulations, with the following test/reference ratios: 102.458 for AUC0-36h, 102.522 for AUC0-inf, and 93.490 for Cmax. No serious adverse events were reported during the trial. Our results demonstrated the bioequivalence of Singulair® and Eurofarma's generic montelukast. Conclusions: Our results revealed that the new generic tablets are clinically safe and can be used interchangeably with the brand name product. Eurofarma's montelukast offers a safe, effective, and cheaper treatment option for people with asthma or allergic rhinitis.

Introdução: O montelucaste, um antagonista seletivo e ativo dos receptores de leucotrienos, é um dos agentes mais comumente usados na prática clínica no tratamento da asma, tanto em adultos quanto em crianças. Objetivo: Avaliar se os perfis farmacocinéticos de duas formulações de montelucaste eram semelhantes após uma dose única de comprimidos mastigáveis de 5 mg, administrados por via oral em jejum, coletando amostras de sangue desde antes da administração até 36 horas depois disso. Métodos: Estudo comparativo randomizado, 2 sequências e 2 períodos, cruzado, de dois medicamentos em comprimidos mastigáveis: Singulair®, fornecido pela Merck Sharp e Dohme Farmacêutica Ltda. (referência) e Montelucaste 5 mg, fabricado pela Eurofarma Laboratórios S.A. (teste). Amostras de plasma obtidas de 35 indivíduos elegíveis foram analisadas para montelucaste por cromatografia líquida de alta eficiência acoplada a espectrometria de massa em tandem, tendo Montelucaste-d6 como padrão interno. As concentrações máximas de montelucaste foram 299,313±11,039 ng/mL para referência e 279,803±10,085 ng/mL para formulação de teste. Resultados: A análise estatística não mostrou diferenças significativas para AUC0-36h, AUC0-inf e nem para Cmax entre as formulações, apresentando as razões Teste/Referência: 102,458 para AUC0-36h, 102,522 para AUC0-inf e 93,490 para Cmax. Nenhum evento adverso grave foi relatado durante o estudo. De acordo com a regulamentação brasileira, o atual estudo farmacocinético demonstrou bioequivalência entre os agentes individuais e forneceu evidências de bioequivalência entre Singulair® e Montelukast fabricado pela Eurofarma. Resultado: Os resultados mostraram que os novos comprimidos genéricos são clinicamente seguros e podem ser trocados pela marca original. O montelucaste da Eurofarma oferece uma opção de tratamento mais barata, segura e eficaz para indivíduos com asma ou rinite alérgica.

The COP27 screened through the lens of global water security.

Water security is an expression of resilience. In the recent past, scientists and public organizations have built considerable work around this concept launched in 2013 by the United Nations as "the capacity of a population to safeguard sustainable access to adequate quantities of acceptable quality water for sustaining livelihoods, human well-being, and socio-economic development, for ensuring protection against water-borne pollution and water-related disasters, and for preserving ecosystems in a climate of peace and political stability". In the 27th Conference of the Parties (COP27), held in Sharm El-Sheikh (Egypt) in last November, water security was considered a priority in the climate agenda, especially in the adaption and loss and damage axes. This discussion paper represents the authors' opinion about how the conference coped with water security and what challenges remain to attend. As discussion paper, it had the purpose to stimulate further discussion in a broader scientific forum.

Bioequivalence/bioavailability Study of a New Formulation of Imatinib Mesylate 100 mg Coated Tablets versus Glivec® in Brazilian Healthy Male Volunteers in Fed State / Estudo de Bioequivalência/Biodisponibilidade de uma Nova Formulação de Mesilato de Imatinibe versus Glivec® em Voluntários Saudáveis Brasileiros em Condições Alimentares / Estudio de Bioequivalencia/Biodisponibilidad de una Nueva Formulación de Mesilato de Imatinib versus Glivec® en Voluntarios Saludables Brasileños Bajo Condiciones Alimentarias

Introduction: Imatinib mesylate is currently the first-line oral treatment for all stages of chronic myeloid leukemia (CML) and is also used in some cases of gastrointestinal stromal tumor (GIST) and acute lymphoblastic leukemia (ALL). Objective: Investigate the bioavailability of two products containing imatinib mesylate, 100 mg coated tablet, to determine if they are bioequivalent. Method: The study was conducted using an open-label, randomized, balanced design and the formulations were administered orally in a single dose to 48 healthy adult males, in fed state, followed by sequential blood withdraws for the next 72 hours. Forty-eight male healthy volunteers were selected to participate in the study. Test formulation from Eurofarma Laboratórios S.A. Brazil was compared to from Novartis Biociências S.A. The comparative bioavailability of the formulations was assessed based on statistical comparisons of relevant pharmacokinetic parameters obtained from drug concentration data from collected blood samples measured using an analytical method based on high-performance liquid chromatography coupled to mass spectrometry. Results: The ratio of the geometric means between the test and the reference, with a 90% confidence interval, of pharmacokinetic parameters for Cmax was 102.26% (94.17-111.04%) and for AUC0-t was 101.24% (95.19-107.68%). Conclusion: Imatinib mesylate 100 mg (test product) from Eurofarma Laboratórios S.A. was considered bioequivalent to the reference Glivec® 100 mg manufactured by Novartis Biociências S.A, and the test product can be interchangeable with the reference, based on their pharmacokinetic performance

Introdução: O mesilato de imatinibe é atualmente o tratamento oral de primeira linha para todos os estágios de leucemia mieloide crônica (LMC) e é usado também em alguns casos de tumores gastrointestinais (GIST) e na leucemia linfoide aguda (LLA). Objetivo: Investigar a biodisponibilidade de dois produtos contendo mesilato de imatinibe de 100 mg em comprimidos revestidos para determinar se são bioequivalentes. Método: Estudo conduzido usando um desenho aberto, randomizado e balanceado. As formulações foram administradas de forma oral em única dose a 48 participantes saudáveis do sexo masculino após alimentação, seguido de coletas de sangue por 72 horas. Quarenta e oito participantes saudáveis foram selecionados para participar do estudo. A formulação teste da Eurofarma Laboratórios S.A. foi comparada com a formulação referência da Novartis Biociências S.A. A biodisponibilidade relativa das formulações foi avaliada em comparações estatísticas dos parâmetros farmacocinéticos relevantes obtidos de concentrações de droga das amostras coletadas mediante a utilização de um método analítico baseado em cromatografia líquida de alta performance acoplada à espectrometria de massas. Resultados: A razão das médias geométricas entre teste e referência com intervalo de confiança 90% dos parâmetros farmacocinéticos para Cmáx foi de 102,26% (94,17-111,04%) e para ASC0-t foi de 101,24% (95,19-107,68). Conclusão: Mesilato de imatinib 100 mg (produto teste) da Eurofarma Laboratórios S.A. foi considerado bioequivalente ao Glivec® 100 mg produzido por Novartis Biociências S.A., e o produto teste pode ser intercambiável como referência com base em seu desempenho farmacocinético

Introducción: El mesilato de imatinibe es actualmente el tratamiento oral de primera línea para todos los estadios de leucemia mieloide crónica (LMC) y es usado también en algunos casos de tumores gastrointestinales (GIST) y leucemia linfoide aguda (LLA). Objetivo: Investigar la biodisponibilidad de dos productos de mesilato de imatinibe de 100 mg en comprimidos revestidos para determinar si son bioequivalentes. Método: Estudio ejecutado usando un diseño abierto, aleatorizado y balanceado. Las formulaciones fueron administradas de forma oral en dosis única a 48 participantes saludables de sexo masculino en condiciones de alimentación, seguidas de muestras de sangre por 72 horas. Cuarenta y ocho participantes saludables fueron seleccionados para participar del estudio. La formulación de prueba de Eurofarma Laboratórios S.A. fue comparada con la formulación referencia de Novartis Biociências S.A. La biodisponibilidad relativa de las formulaciones fue evaluada mediante comparaciones estadísticas de los parámetros farmacocinéticos relevantes obtenidos de concentraciones del fármaco de muestras recolectadas con la utilización de un método analítico basado en cromatografía de alto rendimiento acoplada a espectrometría de masas. Resultados: La relación de las medias geométricas entre la prueba y la referencia con un intervalo de confianza del 90% de los parámetros farmacocinéticos para Cmax fue 102,26% (94,17-111,04%) y para AUC0-t fue 101,24% (95,19-107,68). Conclusión: El mesilato de imatinib 100 mg (producto de prueba) de Eurofarma Laboratórios S.A. fue considerado bioequivalente al Glivec® 100 mg producido por Novartis Biociências S.A. y el producto de prueba puede ser intercambiable con el de referencia en función de su desempeño farmacocinético

Assessment of high spatial resolution satellite imagery for monitoring riparian vegetation: riverine management in the smallholding.

Riverine habitats are essential ecotones that bridge aquatic and terrestrial ecosystems, providing multiple ecosystem services. This study analyses the potential use of high-resolution satellite imagery, provided by the WorldView-2 satellite, in order to assess its viability for monitoring riparian ecosystems. It is performed by calculating the riparian strip quality index (RSQI) and calibrating it with the riparian quality index (QBR). The methodology was implemented in the Umia River, which is characterised by elevated anthropogenic pressures (located in the northwest of Spain). The results obtained by the method have a 92% of veracity and a kappa coefficient of 0.88. The average quality value obtained for the RSQI index was 71.57, while the average value for the QBR was 55.88. This difference could be attributed to the fact that the former does not differ between autochthonous and non-autochthonous vegetation. The areas with more accurate mapping corresponded to stretches of vegetation with optimal cover (80-50%), with good connectivity with the adjacent forest ecosystem and few or no presence of invasive plants. The worst-scoring sites had the next characteristics: low connectivity (< 10%), low forest cover (< 10%) and a higher presence of invasive plants. The degradation of vegetation could be explained by the presence of agriculture and deficient land use rationing caused by the type of ownership of the study area. The application of this index through satellite images will facilitate the environmental governance of multiple ecosystems and in special riparian ecosystems, obtaining a quick and objective methodology, easily replicable in other basins.

A framework model to determine groundwater contamination risk based on a L-Matrix of aquifer vulnerability and hazardous activity indices.

The method presented in this study assesses groundwater contamination risk using a L-Matrix system approach. The L-Matrix in this case is a cartesian diagram where the XX-axis represents aquifer vulnerability (0≤V≤1) determined by the well-known DRASTIC model, and the YY-axis represents the potential hazardousness (0≤H≤1) of an activity (infrastructural development, industrial activities, livestock and agriculture) measured by a European Commission approach. The diagram is divided into four regions, the boundaries of which are set to V = 0.5 and H = 0.5. Watersheds are represented in this diagram considering their V and H indices, and assigned a potential contamination risk if groundwater sites located within their limits show contaminant concentrations above legal limits for a given use. Depending on the region the watershed falls in the L-Matrix diagram, different management or contamination prevention actions are highlighted: activity development, activity monitoring, activity planning or activity inspecting. Watersheds located in the inspecting region and simultaneously evidencing contamination risk require immediate action, namely conditioning or even suspension of use. The method is tested in the Paraopeba River basin (Minas Gerais, Brazil), a densely industrialized basin that was recently affected by an iron-ore mine tailings dam break.•The L-Matrix diagram highlights different groundwater susceptibility realities experienced by watersheds with different combinations of aquifer vulnerability and activity hazardousness, namely possibility for potential expansion of new hazardous activities but also the necessity to periodically inspect and eventually condition or suspend others.•The L-Matrix diagram is likely a better approach to implement contamination prevention measures in watersheds, than the integrated contamination risk index used by most methods.

A partial least squares-path model of environmental degradation in the Paraopeba River, for rainy seasons after the rupture of B1 tailings dam, Brumadinho, Brazil.

The present study aimed to investigate the rupture of B1 tailings dam of Córrego do Feijão mine, which drastically affected the region of Brumadinho (Minas Gerais, Brazil). The contamination of water resources reached 155.3 km from the dam site. In the river channel, high concentrations of Mn, Al, As and Fe were detected and correlated to the spillage of the tailings in the river. The presence of the tailings also affected the chlorophyll-a content in the water, as well as the reflectance of riparian forests. With the increase of metal(oid) concentrations above permitted levels, water management authorities suspended the use of Paraopeba River as resource in the impacted areas, namely the drinking water supply to the Metropolitan region of Belo Horizonte. This study aimed to evaluate possible links between tailings distribution, river water quality, and environmental degradation, which worked as latent variables in partial least squares regression models. The latent variables were represented by numerous physical and chemical parameters of water and sediment, measured four times in 22 locations during the rainy season of 2019, in addition to stream flow and to NDVI evaluated in satellite images processed daily. The modeling results suggested a relationship between river flow turbulence and increased arsenic release from sand fractions, as well as desorption of Mn from metal oxides, both representing causes of water quality reduction. They also revealed increasing iron concentrations affecting the forest NDVI (greening), which was interpreted as environmental degradation. The increase of chlorophyll-a concentrations (related with turbidity decreases), as well as the increase of river flows (responsible for dilution effects), seemed to work out as attenuators of degradation. Although applied to a specific site, our modeling approach can be transposed to equivalent dam failures and climate contexts, helping water resource management authorities to decide upon appropriate recovery solutions.

A groundwater security model based on hydraulic turnover times and flow compartments.

Starting with a log-linear relationship between groundwater discharge per unit drainage area (Q/A b), hydraulic turnover time (t) and aquifer mobile storage (z), this study builds a groundwater security method at catchment scale. The method embeds previously published approaches to calculate Q/A b, t and z, and relies solely on stream flow discharges and watershed areas. The ability to build a method on a couple of variables is remarkable. The method recasts the calculated variables as aquifer security indicators (S Q, S t and S z), relating S Q with yield capacity, S t with self-depuration capacity and S z with resilience. Groundwater security is the weighted product of S Q, S t and S z. The method is validated with stream flow discharges and drainage areas concerning 294 hydrometric stations and their watersheds, located in continental Portugal. The results revealed a majority of moderately to highly secure watersheds, especially as regards S t (> 62%), while 7-10% were classified as very highly secured in general (S Q-S t-S z). The least secured basins are located in the more arid regions of continental Portugal (Northeast and south regions), as expected. The method can be easily transposed to any other region worldwide, with the necessary adaptions to regional climate, geological and topographic settings. • Compile stream flow discharge data and organize them as natural logarithms and logarithmic variations as function of time, to estimate Q, t and z; • Recast the Q, t and z values as S Q, S t and S z ratings, respectively, using the appropriate reclassification scales, and estimate watershed security levels, namely average security or customized (weighted) securities that highlight the contributions of Q/A b (watershed yield), t (aquifer's self-depuration capacity) or z (aquifer's resilience); • Use the results to draw illustrative diagrams and spatial distribution maps.

Spatial indicator of priority areas for the implementation of agroforestry systems: An optimization strategy for agricultural landscapes restoration.

The ecological functions restoration in agricultural areas is a major challenge on a landscape scale. In the specific case of active restoration through Agroforestry Systems (AFS), the absence of a specific direction hinders ecological restoration processes, especially in regions that prefer intensive agriculture. Thus, this study aims to develop a Spatial Indicator of Priority Areas to guide Agroforestry Systems implementation in agricultural landscapes. A spatial multicriteria decision analysis (MDCA) was carried out based on environmental factors: soil, geology and slope (which determine the natural vulnerability of the land) and anthropogenic factors: land use and land cover, forest fragments, potential land use capacity and legal protected areas in rural properties (which reflects human pressure and land use suitability). Subsequently, four priority levels were classified for agroforestry interventions: (1) Low priority; (2) Average priority; (3) High priority; (4) Extreme priority. A final map was made to identify priority areas for landscape recovery in 9 cities located at the mouth of the Mogi Guaçu River Hydrographic Basin, State of São Paulo, Brazil. Considering the natural vulnerability of the land and the multifunctional aspects of the landscape, the scenarios projection allowed a consensus for forest conservation and agricultural suitability perspectives. A final combination of the explored aspects culminated in the spatial indicator, which model foresees 22,300 ha available for urgent actions for restoration, reforestation and sustainable exploitation through agroforestry systems. We emphasize the challenges in reconciling the socioeconomic and ecological functions in the agroecosystem, however, the metric provides a more inclusive and assertive management strategy for natural resources and advances towards the goal of reforestation and implementation of payment for environmental services (PES) schemes.