Influence of radiation on endotoxin test using the PTS TM for 18-FDG radiopharmaceutical

O FDG-18 é o radiofármaco mais utilizado nos exames de PET e PET CT. O FDA recentemente aprovou o uso do PTS TM (Portable Test System) como método alternativo ao teste padrão de endotoxina, proposto pela Farmacopéia Americana, considerando que no primeiro há um tempo de espera de 1 hora frente a somente 15 minutos do segundo. Estudo recentes demonstram que a radiação poderia interferir no teste do PTS TM. De modo a avaliar os efeitos da radiação no teste PTS TM foram analisados 27 lotes de F-18 FDG produzidos no Instituto de Engenharia Nuclear. Os resultados demonstraram que em todos os casos nenhuma correlação direta com a radiação foi observada.F-18 FDG (2-[18-F] fluoro-2-deoxy-D-glucose) is the most frequently used radiopharmaceutical for PET and PET CT imaging exams. The FDA recently approved the use of the PTS TM (Portable Test System) as an alternative to the standard test proposed by the United States Pharmacopeia using the LAL (Limulus Amebocyte Lysates), that takes longer to perform (about 1h) than the PTS TM (15 min). Recent studies have demonstrated that radiation could interfere with the PTS TM test. In order to study the effects of radiation on the PTS TM test and/or equipment, 27 batches of F-18 FDG produced in the Nuclear Engineering Institute were analyzed. The results showed that no direct correlation with radiation was found in any of the cases

Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction

Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn.Diversos casos de interações medicamentosas com radiofármacos ocorrem diariamente na rotina hospitalar, contudo muitos deles não são notificados ou mesmo percebidos. Informações a respeito desse tipo de reação não é abundante e os profissionais da medicina nuclear muitas vezes estão assoberbados por essas informações. De modo a entender esse tipo de reação e auxiliar a medicina nuclear a lidar com essa situação uma revisão da literatura foi realizada. Os resultados mostraram que a totalidade dos radiofármacos comercializados no mundo apresentam interação medicamentosa com uma enorme variedade de outros medicamentos. Dessa forma sugere-se que revisões sobre radiofármacos inclua um capítulo sobre efeitos adversos. Além disso, um esforço mundial para notificar efeitos adversos deve ser realizado, pois somente dessa forma se terá um quadro real da situação referente interações medicamentosas com radiofármacos

Are radiopharmaceuticals safe? the case of FDG-18

5 p.Too many false-positive and adverse reactions related to radiopharmaceuticals take place every day in hospitals routine, but many are not reported or even sensed. Information concerning these kind of reactions is not abundant and nuclear medicine staff is usually overwhelmed by this information. As every healthcare intervention carries some risk of harm, clinical decision making needs to be supported by a systematic assessment of the balance of benefit to harm. A systematic review that considers only the favorable outcomes of an intervention, without also assessing the adverse effects and false positives reactions, can mislead by introducing a bias favoring the intervention that in the case o radiopharmaceuticals may to render a important factor related not even to the quality of the drug but even to the quality of the diagnosis. The results suggest a logical framework to make decisions in reviews that incorporate false positive and adverse reactions. Also, was explored situations where a comprehensive investigation of false positive reactions and adverse effects was warranted and suggest strategies to identify practicable and clinically useful outcomes. We concluded that there is the necessity to include and to recognize how strategic choices made in the review process determine what harms are found, and how the findings may affect clinical decisions. Researchers undertaking a systematic review that incorporates false positive reaction and adverse reactions must understand the rationale for the suggested methods and be able to implement them in their review. Beyond a world effort should be made to report as many cases of false positive and adverse reactions with radiopharmaceuticals as possible. Only if this is done a complete picture of false positive reactions with radiopharmaceuticals can be drawn

Simulating Fleet Noise for Notional UAM Vehicles and Operations in New York

This paper presents the results of systems-level simulations using Metrosim that were conducted for notional Urban Air Mobility (UAM)-style vehicles analyzed for two different scenarios for New York (NY). UAM is an aviation industry term for passenger or cargo-carrying air transportation services, which are often automated, operating in an urban/city environment. UAM-style vehicles are expected to use vertical takeoff and landing with fixed wing cruise flight. Metrosim is a metroplex-wide route and airport planning tool that can also be used in standalone mode as a simulation tool. The scenarios described and reported in this paper were used to evaluate a fleet noise prediction capability for this tool. The work was a collaborative effort between the National Aeronautics and Space Administration (NASA), Intelligent Automation, Inc (IAI), and the Port Authority of New York and New Jersey (PANYNJ). One scenario was designed to represent an expanded air-taxi operation from existing helipads around Manhattan to the major New York airports. The other case represented a farther term vision case with commuters using personal air vehicles to hub locations just outside New York, with an air-taxi service running frequent connector trips to a few key locations inside Manhattan. For both scenarios, the trajectories created for the entire fleet were passed to the Aircraft Environmental Design Tool (AEDT) to generate Day-Night Level (DNL) noise contours for inspection. Without data for actual UAM vehicles available, surrogate AEDT empirical Noise-Power-Distance (NPD) tables used a similar sized current day helicopter as the Baseline, and a version of that same data linearly scaled as a first guess at possible UAM noise data. Details are provided for each of the two scenario configurations, and the output noise contours are presented for the Baseline and reduced noise DNL cases

Detection of a Star Forming Galaxy in the Center of a Low-Mass Galaxy Cluster

Brightest Cluster Galaxies (BCGs) residing in the centers of galaxy clusters are typically quenched giant ellipticals. A recent study hinted that star-forming galaxies with large disks, so-called superluminous spirals and lenticulars, are the BCGs of a subset of galaxy clusters. Based on the existing optical data it was not possible to constrain whether the superluminous disk galaxies reside at the center of galaxy clusters. In this work, we utilize XMM-Newton X-ray observations of five galaxy clusters to map the morphology of the intracluster medium (ICM), characterize the galaxy clusters, determine the position of the cluster center, and measure the offset between the cluster center and the superluminous disk galaxies. We demonstrate that one superluminous lenticular galaxy, 2MASX J10405643-0103584, resides at the center of a low-mass ($M_{\rm 500} = 10^{14} \ \rm{M_{\odot}}$) galaxy cluster. This represents the first conclusive evidence that a superluminous disk galaxy is the central BCG of a galaxy cluster. We speculate that the progenitor of 2MASX J10405643-0103584 was an elliptical galaxy, whose extended disk was re-formed due to the merger of galaxies. We exclude the possibility that the other four superluminous disk galaxies reside at the center of galaxy clusters, as their projected distance from the cluster center is $150-1070$ kpc, which corresponds to $(0.27-1.18)R_{\rm 500}$. We conclude that these clusters host quiescent massive elliptical galaxies at their center.Comment: 7 pages, 3 figures, accepted for publication in the Astrophysical Journa

Dark Matter Subhalos and the X-ray Morphology of the Coma Cluster

Structure formation models predict that clusters of galaxies contain numerous massive subhalos. The gravity of a subhalo in a cluster compresses the surrounding intracluster gas and enhances its X-ray emission. We present a simple model, which treats subhalos as slow moving and gasless, for computing this effect. Recent weak lensing measurements by Okabe et al. have determined masses of ~ 10^13 solar masses for three mass concentrations projected within 300 kpc of the center of the Coma Cluster, two of which are centered on the giant elliptical galaxies NGC 4889 and NGC 4874. Adopting a smooth spheroidal beta-model for the gas distribution in the unperturbed cluster, we model the effect of these subhalos on the X-ray morphology of the Coma Cluster, comparing our results to Chandra and XMM-Newton X-ray data. The agreement between the models and the X-ray morphology of the central Coma Cluster is striking. With subhalo parameters from the lensing measurements, the distances of the three subhalos from the Coma Cluster midplane along our line of sight are all tightly constrained. Using the model to fit the subhalo masses for NGC 4889 and NGC 4874 gives 9.1 x 10^12 and 7.6 x 10^12 solar masses, respectively, in good agreement with the lensing masses. These results lend strong support to the argument that NGC 4889 and NGC 4874 are each associated with a subhalo that resides near the center of the Coma Cluster. In addition to constraining the masses and 3-d location of subhalos, the X-ray data show promise as a means of probing the structure of central subhalos.Comment: ApJ, in press. Matches the published versio

Benefits and Limitations of Remote Work to LGBTQIA+ Software Professionals

Background. The mass transition to remote work amid the COVID-19 pandemic profoundly affected software professionals, who abruptly shifted into ostensibly temporary home offices. The effects of this transition on these professionals are complex, depending on the particularities of the context and individuals. Recent studies advocate for remote structures to create opportunities for many equity-deserving groups; however, remote work can also be challenging for some individuals, such as women and individuals with disabilities. Objective. This study aims to investigate the effects of remote work on LGBTQIA+ software professionals. Method. Grounded theory methodology was applied based on information collected from two main sources: a survey questionnaire with a sample of 57 LGBTQIA+ software professionals and nine follow-up interviews with individuals from this sample. This sample included professionals of different genders, ethnicities, sexual orientations, and levels of experience. Findings. Our findings demonstrate that (1) remote work benefits LGBTQIA+ people by increasing security and visibility; (2) remote work harms LGBTQIA+ software professionals through isolation and invisibility; (3) the benefits outweigh the drawbacks; (4) the drawbacks can be mitigated by supportive measures developed by software companies. Conclusion. This paper investigated how remote work can affect LGBTQIA+ software professionals and presented a set of recommendations on how software companies can address the benefits and limitations associated with this work model. In summary, we concluded that remote work is crucial in increasing diversity and inclusion in the software industry.Comment: 10 page

Development and validation of UV/VIS spectroscopy method for determination of atezolizumab in pharmaceutical products

Aim: The aim of this study was to develop and validate a simple, fast, and reliable UV visible methodology for the determination of atezolizumab in pharmaceutical products. Methods: The maximum wavelength of atezolizumab was determined using a UV/Vis spectrum and the calibration curve has been established. Validation studies were carried out to determine the reliability of the spectrophotometer method used in quantification of pharmaceutical products. Results: According to the experimental data, the developed method was linear in a range varying from 0.10 to 1.50 mg.mL-1 determined by 6 individuals calibrations points. The r2 value was 0.9995 indicating a 99.95% correlation in linearity and precision. The robustness showed good and similar values and the limit of detection and limit of quantification were 0.005 mg.mL-1 and 0.018 mg.mL-1, respectively. Conclusion: The data corroborates the reliability as applicability of the developed UV/Vis spectroscopy method for quantitatively determining the amount of atezolizumab in pharmaceutical products