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- Reilev, M, et al.
(författare)
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Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study
- 2023
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 13:2, s. e066057-
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Tidskriftsartikel (refereegranskat)abstract
- Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections.Methods and analysisBRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites.Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included.In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use.In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed.Ethics and disseminationThe study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals.Trial registration numberEUPAS30280.
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| 4. |
- Reilev, M, et al.
(författare)
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Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study
- 2023
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 13:2, s. e066057-
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Tidskriftsartikel (refereegranskat)abstract
- Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections.Methods and analysisBRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites.Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included.In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use.In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed.Ethics and disseminationThe study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals.Trial registration numberEUPAS30280.
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- Gini, L., et al.
(författare)
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Part-Load Behaviour And Control Philosophy Of A Recuperated Supercritical Co2Cycle
- 2022
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Ingår i: Proceedings of the ASME Turbo Expo. - : American Society of Mechanical Engineers (ASME).
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Konferensbidrag (refereegranskat)abstract
- High efficiency, flexibility and competitive capital costs make supercritical CO2 (sCO2) systems a promising technology for renewable power generation in a low carbon energy scenario. Recently, innovative supercritical systems have been studied in the literature and proposed by DOE-NETL (STEP project) and a few projects in the EU Horizon 2020 program aiming to demonstrate supercritical CO2 Brayton power plants, promising superior techno-economic features than steam cycles particularly at high temperatures. The H2020 SOLARSCO2OL project1, which started in 2020, is building the first European MW-scale sCO2 demonstration plant and has been specifically tailored for Concentrating Solar Power (CSP) applications. This paper presents the first offdesign analysis of such a demonstrator, which is based on a simply recuperated sCO2 cycle. The part-load analysis ranged from 50% of nominal up to a 105% peak load, discussing the impact on compressor and turbine operating conditions. The whole system dynamic model has been developed in TRANSEO MATLAB® environment. Full operational envelop has been determined considering cycle main constraints, such as maximum turbine inlet temperature and minimum pressure at compressor inlet. The off-design performance analysis highlights the most relevant relationships among the main part-load regulating parameters, namely mass flow rate, total mass in the loop, and available heat source. The results show specific features of different control approaches, discussing the pros and cons of each solution, considering also its upscale towards commercial applications. In particular, the analysis shows that at 51% of load an efficiency decrease of 20% is expected.
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- Mayer, Ludovic, et al.
(författare)
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Widespread Pesticide Distribution in the European Atmosphere Questions their Degradability in Air
- 2024
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Ingår i: Environmental Science and Technology. - 0013-936X. ; 58:7, s. 3342-3352
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Tidskriftsartikel (refereegranskat)abstract
- Risk assessment of pesticide impacts on remote ecosystems makes use of model-estimated degradation in air. Recent studies suggest these degradation rates to be overestimated, questioning current pesticide regulation. Here, we investigated the concentrations of 76 pesticides in Europe at 29 rural, coastal, mountain, and polar sites during the agricultural application season. Overall, 58 pesticides were observed in the European atmosphere. Low spatial variation of 7 pesticides suggests continental-scale atmospheric dispersal. Based on concentrations in free tropospheric air and at Arctic sites, 22 pesticides were identified to be prone to long-range atmospheric transport, which included 15 substances approved for agricultural use in Europe and 7 banned ones. Comparison between concentrations at remote sites and those found at pesticide source areas suggests long atmospheric lifetimes of atrazine, cyprodinil, spiroxamine, tebuconazole, terbuthylazine, and thiacloprid. In general, our findings suggest that atmospheric transport and persistence of pesticides have been underestimated and that their risk assessment needs to be improved.
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- Peretti, R., et al.
(författare)
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Room temperature operation of a deep etched buried heterostructure photonic crystal quantum cascade laser
- 2016
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Ingår i: Laser & Photonics reviews. - : Wiley-VCH Verlagsgesellschaft. - 1863-8880 .- 1863-8899. ; 10:5, s. 843-848
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Tidskriftsartikel (refereegranskat)abstract
- High power single mode quantum cascade lasers with a narrow far field are important for several applications including surgery or military countermeasure. Existing technologies suffer from drawbacks such as operation temperature and scalability. In this paper we introduce a fabrication approach that potentially solves simultaneously these remaining limitations. We demonstrate and characterize deep etched, buried photonic crystal quantum cascade lasers emitting around a wavelength of 8.5 μm. The active region was dry etched before being regrown with semi-insulating Fe:InP. This fabrication strategy results in a refractive index contrast of 10% allowing good photonic mode control, and simultaneously provides good thermal extraction during operation. Single mode emission with narrow far field pattern and peak powers up to 0.88 W at 263 K were recorded from the facet of the photonic crystal laser, and lasing operation was maintained up to room temperature. The lasing modes emitted from square photonic crystal mesas with a side length of 550μm, were identified as slow Bloch photonic crystal modes by means of three-dimensional photonic simulations and measurements. (Figure presented.).
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