Introduction Identifying individual characteristics or underlying conditions linked to adverse drug reactions (ADRs) can help optimise the benefit–risk ratio for individuals. A systematic evaluation of statistical methods to identify subgroups potentially at risk using spontaneous ADR report datasets is lacking. Objectives In this study, we aimed to assess concordance between subgroup disproportionality scores and European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) discussions of potential subgroup risk. Methods The subgroup disproportionality method described by Sandberg et al., and variants, were applied to statistically screen for subgroups at potential increased risk of ADRs, using data from the US FDA Adverse Event Reporting System (FAERS) cumulative from 2004 to quarter 2 2021. The reference set used to assess concordance was manually extracted from PRAC minutes from 2015 to 2019. Mentions of subgroups presenting potential differentiated risk and overlapping with the Sandberg method were included. Results Twenty-seven PRAC subgroup examples representing 1719 subgroup drug–event combinations (DECs) in FAERS were included. Using the Sandberg methodology, 2 of the 27 could be detected (one for age and one for sex). No subgroup examples for pregnancy and underlying condition were detected. With a methodological variant, 14 of 27 examples could be detected. Conclusions We observed low concordance between subgroup disproportionality scores and PRAC discussions of potential subgroup risk. Subgroup analyses performed better for age and sex, while for covariates not well-captured in FAERS, such as underlying condition and pregnancy, additional data sources should be considered. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-023-01306-3.
In response to the trend toward sustainable management of by-products from the pulp and paper industry as well as plant waste, practical and economical methods are being developed to use them in a way that does not pose a threat to the environment. The main aim of the research was to study the possibility of using lignin and plant biomass as biosorbents for the removal of zinc ions from aqueous solutions. The secondary aim was to build an optimal multilayer system made of biosorbents selected during the research in order to obtain the highest sorption efficiency and to determine the best conditions of the sorption process. The effectiveness of zinc ion sorption was assessed using an appropriate combination of sorbents such as lignin, oat bran, rice husk, chitosan, pectin, sodium alginate, pine bark, coconut fiber and activated carbon, selected on the basis of literature data and the preliminary results of tests carried out using FTIR and AAS. The main component of the sorption system was lignin separated from black liquor. Results indicate that the best Zn sorption system was based on coconut fiber, lignin, and pine bark, for which the maximum sorption efficiency was 95%. The research also showed that the increase in the process temperature, the mass of biosorbents used and the alkaline pH are the factors that increase the efficiency of the sorption. It can be concluded that lignin and plant biomass can be used as ecological sorbents of zinc ions from water solutions. They are safe for the environment, produced from renewable sources, and are by-products or waste materials, which is part of the sustainable development and circular economy currently promoted in the EU.
The four compounds, namely: 5-nitro-2-furaldehyde thiosemicarbazone (1); 5-nitro-2-thiophene thiosemicarbazone (2); 5-nitro-2-furaldehyde semicarbazone (3); and 5-nitro-2-thiophene semicarbazone (4) were synthesized and crystallized. The three new crystal structures of 1, 2, and 4 were determined and compared to three already known crystal structures of 3. Additionally, two new polymorphic forms of 1 solvate were synthesized and studied. The influence of the exchange of 2-thiophene to 2-furaldehyde as well as thiosemicarbazone and semicarbazone on the self-assembly of supramolecular nets was elucidated and discussed in terms of the formed synthons and assemblies accompanied by Full Interaction Maps analysis. Changes in the strength of IR oscillators caused by the molecular and crystal packing effects are described and explained in terms of changes of electron density.
Three magnesium coordination compounds were obtained to explore the influence of carboxylate anions on the pattern of the formed hydrogen bonds. For their synthesis, various salts of magnesium carboxylic acid (formate, acetate, and propionate) were utilized. As an N-donor ligand, hexamethylenetetramine was employed. The supramolecular structures of the obtained compounds were determined and evaluated in Hirshfeld analysis. The length of the carbon chain of the used carboxylate anions has been proven to have a considerable impact on the self-organization of the supramolecular system by altering the three-dimensional net of the created hydrogen bonds. IR spectroscopy was used to characterize the obtained compounds, revealing significant differences between distinct systems. The thermal analysis of the investigated compounds also shows noticeable differences, demonstrating better stability of the systems containing formate anions.
The overproduction of pollutants resulting from the development of industry causes the deposition of large amounts of toxic and carcinogenic substances, including heavy metals, in the aquatic ecosystem and other ecosystems. This is a civilisation problem of the present times, posing a serious threat to the natural environment, including humans. For this reason, it has recently become extremely important to develop effective methods to minimise the concentration of heavy metal ions in the aquatic systems and thus reduce their negative impact on the environment. One such technique is adsorption, which is believed to be an effective method of removing contaminants such as heavy metal ions from aqueous solutions. Looking at the available literature of the last few years, it can be concluded that adsorbents of natural origin are becoming more and more important. These are agricultural waste, all kinds of biomass, and waste from various industries. The study attempts to present and evaluate the sorption capacity of materials of natural origin, including oat bran, chitosan, alginate, tree bark, coconut fibre, and lignin. The use of such biosorbents is more friendly for the environment compared to their synthetic counterparts and perfectly fits the concept of sustainable development and the circular economy.
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