Control Tests Research Articles

ACPSEM position paper: recommendations for a digital general X-ray quality assurance program

This guideline has been prepared by the ACPSEM to provide a standardised quality assurance program to be used within General X-ray imaging environments. The guideline includes the responsibilities of various multidisciplinary team members within medical imaging facilities. It must be noted that the listed tests and testing frequencies are not intended to replace or become regulatory requirements. Implementing a quality assurance program as outlined in this position paper is there to ensure best practice for imaging facilities by providing a framework to establish and monitor correct equipment performance. The current document has been produced through an extensive review of current international practices and local experience within the Australasian healthcare environment. Due to the constant evolution of digital radiographic equipment, there is no current consensus in international quality assurance guidelines as they continue to be adapted and updated. This document describes the current state of the use of digital General X-ray equipment in the Australasian environment and provides recommendations of test procedures that may be best suited for the current medical imaging climate in Australasia. Due to the everchanging developments in the medical imaging environment and the ability of new technologies to perform more complex tasks it is believed that in the future this document will be further reviewed in the hopes of producing a more globally agreed upon standard quality assurance program. Any such adjustments that are deemed to be necessary to Version 1.0 of this document will be provided in electronic format on the ACPSEM website with a notification to all parties involved in the use of digital General X-ray equipment. This guideline does not provide detailed methodologies for all the quality control tests recommended as it is it is expected that the professionals implementing aspects of this quality assurance program have the working knowledge and access to appropriate resources to develop testing methodologies appropriate for their local imaging environment.

Highly Active Nano-Porous Thin-Films for Water Electrolysis Using an Automated Print Technology Based on Spark Ablation

Accelerating hydrogen (H2) deployment via renewable electricity is a key G7 strategy for sustainable transitions in hard-to-decarbonize sectors (e.g., circular-plastics, -steel, -fertilizers,shipping, and aviation) therefore, Alkaline (AWE) and Polymer Electrolyte Membrane water electrolysis (PEMWE) play a crucial role amongst low-temperature power-to-X technologies for establishing a hydrogen network. Assuming all hydrogen will be green by 2030 (with ca. 150 million metric tons), a significant increase in electrolyser capacity to 3,000 gigawatts is necessary, given the current capacity of 0.3 gigawatts. However, the adoption of electrolysers faces a bottleneck due to scarce platinum group materials (PGMs) used as catalyst, specifically Iridium and Platinum. The commercial PGM loading per membrane electrode assembly (MEA) is at 3 mg/cm2, requiring substantial efforts to redesign electrocatalyst materials through a nano-architecture, necessitating a thousandfold increase in surface area (µm to nm scale) and a tenfold reduction in mass loading (mg to µg). The realization of this objective is conceivable through innovative surface engineering and manufacturing techniques, exemplified by. VSPARTICLE is actively advancing its manufacturing technology for green H2, bridging academia and industry . We developed a unique nano-printing technology which utilizes spark ablation for generating nano-porous electrocatalyst thin films across diverse elements and alloys. Unlike traditional methods, it eliminates the need for chemical precursors or binders, reducing waste and extra pre- / post-process steps. The VSP-P1 nano-printer serves as a crucial R&D tool for dry-synthesis, enabling both the production of complex electrocatalyst layers and also sample arrays high-throughput screening. This accelerates the discovery of new catalysts, fostering the creation and application of novel nanomaterials in specialized setups. Our oral presentation will unveil the latest findings concerning oxygen evolution electrodes, employing Ir-based and Ni-based catalysts produced through the innovative VSP-P1 nano-printing technology, which exhibit notable activity in acidic and alkaline water electrolysis, respectively, even at low loadings, such as 0.4 mg/cm2. Therefore, our oral presentation aims to show the latest findings on accelerated electrocatalysts discovery concerning oxygen evolution reaction (OER) produced through the innovative VSP-P1 nano-printing technology. In parallel to comprehensive flow-cell experiments, meticulous control tests and characterization techniques (XRD, XRF, HR-SEM) on proxy samples were conducted, leveraging the versatility of VSP-P1 to create identical nano-porous films on various substrates such as Si-wafer, conductive glass, and glassy carbon disks. The scalability of this dry manufacturing process, coupled with the rapid iteration capability for tuning material parameters and test-beds, promises a tenfold acceleration in electrocatalyst utilization. In summary, this presentation intends to reveal a methodology that not only shows an efficient strategy for catalyst utilization through nano-printed layers, but also shortens the time required to bring novel materials to market. Figure 1

In vivo comparative study of hemp straw exposure and cannabidiol oil administration in horse urine.

The non-psychoactive cannabinoids cannabidiol (CBD) and cannabidiolic acid (CBDA) are available on the market in different forms, mostly for their anti-inflammatory and potential analgesic properties. These substances are prohibited during equine competitions. CBD and CBDA are naturally present in hemp straw, commonly used as a bedding substitute for wheat straw. Unfortunately, horses can eat it, which therefore could lead to a possible risk of positive findings for CBD/CBDA in biological samples after doping control tests. The goals of this study were, first, to provide recommendations on the use of hemp straw before competition and, second, to assess if discrimination between hemp bedding exposure and CBD oil administration is possible. Several CBD equine in vivo studies have been conducted, including one on hemp straw used as bedding and one after administration of CBD oil by topical and sublingual routes. In hemp straw, CBDA was detected in higher quantities than CBD, and other cannabinoids have been observed. After hemp straw exposure, CBDA was also detected in higher quantities than CBD in all urine samples. It appeared that hemp straw should not be used as bedding for equine competition except if a delay of at least 48 h is respected. Regarding the CBD oil product analysis, CBD was the main compound detected. After administration, 7-hydroxy CBD was identified in the urine. In conclusion, based on these data, we highlighted that it could be possible to discriminate the exposure of a horse to hemp straw from an administration of a CBD oil product thanks to the main presence of CBDA.

Checks and balances: a meta-analysis on the known-groups validity of functional postural control tests in children.

Pediatric physical therapists commonly treat children with postural control deficits. Ideally, pediatric functional postural control tests should therefore be able to identify postural control deficits in children with various disorders. Despite a plethora of available tests, evidence for their validity - especially known-groups - remains scarce. This review aims to determine the known-group validity of available functional postural control tests to differentiate various pediatric pathological groups of different ages from their typically developing (TD) peers. PubMed, Web of Science and Scopus were systematically searched (last update: February 2023; PROSPERO: CRD42023408982). Forty case-control studies with a pathological pediatric sample (N.=1331) and TD peers (N.=1889) were included and selected for data-extraction and -analysis. Risk of bias was assessed using the SIGN checklist and level of evidence was scored using GRADE. Random-effect meta-analyses were performed to estimate pooled standardized mean differences (SMD) for the various test types and subclassified based on pathology and/or age. When compared with TD peers, children with underlying pathologies performed significantly worse on pediatric functional postural control test batteries (SMD=-2.21), the Timed Up and Go Test and variants (SMD=2.30), the One Leg Stance test and variants (SMD=-2.14), while the Reach tests showed a smaller difference (SMD=-1.19). Subclassification within the meta-analyses showed that pathology was an influencing factor for the test batteries and the one leg stance test and variants. Age was an influencing factor for the reach tests. None of the included functional postural control tests exceeded a low level of evidence. Pediatric functional postural control tests that assess multiple aspects of postural control (such as test batteries) seem to offer higher known-groups validity than single-task tests (e.g. reach tests). The underlying pathology has a larger impact on the validity of these tests than age. There remains an overall low level of evidence for the known-groups validity of pediatric functional postural control tests indicating the need for research with more homogenous groups and norm reference data.

Applying the six-sigma methodology to determine the limits of quality control (QC) tests for a specific linear accelerator.

We aimed to show the framework of the six-sigma methodology (SSM) that can be used to determine the limits of QC tests for the linear accelerator (Linac). Limits for QC tests are individually determined using the SSM. The SSM is based on the define-measure-analyze-improve-control (DMAIC) stages to improve the process. In the "define" stage, the limits of QC tests were determined. In the "measure" stage, a retrospective collection of daily QC data using a Machine Performance Check platform was performed from January 2020 to December 2022. In the "analyze" stage, the process of determining the limits was proposed using statistical analyses and process capability indices. In the "improve" stage, the capability index was used to calculate the action limits. The tolerance limit was established using the larger one of the control limits in the individual control chart (I-chart). In the "control" stage, daily QC data were collected prospectively from January 2023 to May 2023 to monitor the effect of action limits and tolerance limits. A total of 798 sets of QC data including beam, isocenter, collimation, couch, and gantry tests were collected and analyzed. The Collimation Rotation offset test had the min-Cp, min-Cpk, min-Pp, and min-Ppk at 2.53, 1.99, 1.59, and 1.25, respectively. The Couch Rtn test had the max-Cp, max-Cpk, max-Pp, and max-Ppk at 31.5, 29.9, 23.4, and 22.2, respectively. There are three QC tests with higher action limits than the original tolerance. Some data on the I-chart of the beam output change, isocenter KV offset, and jaw X1 exceeded the lower tolerance and action limit, which indicated that a system deviation occurred and reminded the physicist to take action to improve the process. The SSM is an excellent framework to use in determining the limits of QC tests. The process capability index is an important parameter that provides quantitative information on determining the limits of QC tests.

Research on Safety Control Technology for Dual Robots Based on Kinematic Models

The industrial robots play an important role in modern industrial manufacturing processes, and their applications are becoming increasingly widespread, greatly improving manufacturing efficiency and significantly enhancing the digitalization level of the manufacturing industry. Therefore, achieving safe control of multi robot collaborative work is of great significance for the stable and efficient operation of robot systems. This article proposes a dual robot safety control technology based on the kinematic model of industrial robots. Firstly, a mathematical model of the kinematic space of the dual robots is constructed using D-H parameters; Then, use recursive traversal algorithm to calculate the minimum distance between each joint arm of the two robots in real time; Finally, the minimum distance between each joint arm will be calculated and compared with the set safety threshold to achieve real-time assessment and control of collision risk during the movement of the dual robots. A dual robot safety control testing platform was built using two KUKA industrial robots, integrated control software was developed, and relevant algorithms were validated. Through experiments, it was verified that this method can evaluate the collision risk of dual robots in real time during motion and effectively control the collision risk during the motion of dual robots.

Association between thyroid hormone resistance and obesity: a cross-sectional study and mouse stimulation test.

Thyroid hormone influences key metabolic pathways, and reduced sensitivity to thyroid hormone is considered a new risk factor for adverse metabolic outcomes. However, the association between thyroid hormone resistance and obesity in euthyroid individuals is still unknown. We enrolled 8021 euthyroid individuals, calculated thyroid hormone resistance indices, and analyzed the association between thyroid hormone resistance and obesity by regression analysis. Furthermore, we conducted the thyrotropin-releasing hormone stimulation test in both control and obese mice (n = 5) to demonstrate the association. The euthyroid adults with overweight and obesity had increased thyroid hormone resistance indices (all p < 0.05). BMI and prevalence of overweight and obesity increased (odds ratio of thyroid feedback quantile-based index [ORTFQI] = 1.164, p = 0.036; OR of free triiodothyronine/free thyroxine [ORFT3/FT4] = 1.508, p < 0.001) following the elevation of thyroid hormone resistance indices. Mediation analysis indicated a complete mediation effect (beta coefficient of indirect effect [βInd]= 6.838, p < 0.001) of metabolic disorders in the relationship. Furthermore, in the mice with obesity, the thyrotropin response to thyrotropin-releasing hormone stimulation (68.33-90.89 pg/mL) was comparatively blunted (p = 0.029). Euthyroid individuals with obesity exhibit both central and peripheral thyroid hormone resistance, a phenomenon that is more pronounced in individuals with metabolic abnormalities. Thyroid hormone resistance is associated with an increased prevalence of overweight and obesity mediated by metabolic disorders.

APPLICATION OF ANALYTICAL EXERCISES AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION FOR STATIC, DYNAMIC BALANCE AND POSTURAL CONTROL IMPROVEMENT

Purpose: to assess the recovery of static, dynamic balance and postural control while overcoming muscle imbalance after an anterior cruciate ligament reconstruction by applying analytical exercises. Material and methods: Material: 15 men (mean age 25.16) were observed in the span of 14 weeks (three and a half months) after anterior cruciate ligament reconstruction. They underwent physiotherapy, including analytical kinetic chain exercises in hospital, ambulatory and at home conditions. Research, measurement, and evaluation methods include range of motion in the knee joint, manual muscle testing (MMT), static and dynamic balance tests, and postural control tests. Statistical methods include statistical data grouping, Cronbach’s test, descriptive method, testing of statistical hypotheses, and correlation analysis. The data was processed with SPSS v.24.0 for Windows. Results: The results show a change in the static postural control with a 1/4-point deviation from the standard. This requires the inclusion of additional sensorimotor exercises in combination with other specific and general strengthening exercises. Conclusion: From the performed observation and the obtained results, compared to those of 20 healthy men, the following conclusion has been drawn: the analytical exercises for lower extremities lead to the overcoming of dysfunction and increased stability in the extremities. The physiotherapy programme should include sensory stimulation exercises tailored for strengthening the weakened muscles and should contribute to the overcoming of muscle imbalance.

Allogenic and autologous nondiluted serum eye drops-validation strategy compliant with good manufacturing practice.

Serum eye drops alleviate ocular symptoms of diseases such as sicca syndrome, or chronic graft-versus-host disease. This study was designed for good manufacturing practice validation of our standard manufacturing, storage and transport processes for both autologous and allogenic SEDs. Specifications of quality parameters are lacking and were aimed to be defined. Using sterile collected, coagulated whole blood, serum was separated by centrifugation and filled into single-use eye drop applicator vials. Quality control tests included visual inspection, sterility, leukocyte concentration, pH, vitamin A, TGF-ß and VEGF-A. Samples were collected after manufacture and after 24 h and 6 months of frozen storage (-20°C). Sterility testing was performed after opening the SED applicators at specified intervals. For transport validation, SEDs were packed in insulated transport bags and stored at 20-24°C and 30-32°C for 8 h. Vitamin A, TGF-ß and VEGF-A assays showed no difference in concentration between fresh and 24 h frozen serum. All specifications for pH (aim 7.4) and cellular contamination were met and microbiological contamination tests were negative. Shelf-life was defined as 6 months at -20°C. Once opened, the product must be used within 24 h to avoid bacterial outgrowth. Transporting frozen SEDs from the manufacturer via a local pharmacy to the patient within a maximum of 4 h was demonstrated. The GMP compliance of our production, storage and transport processes for autologous and allogenic SEDs was successfully validated. 100% serum eye drops in single-use applicators can be safely used for up to 24 h after opening.

Deficits in congenital amusia: Pitch, music, speech, and beyond

Congenital amusia is a neurodevelopmental disorder characterized by deficits of music perception and production, which are related to altered pitch processing. The present study used a wide variety of tasks to test potential patterns of processing impairment in individuals with congenital amusia (N = 18) in comparison to matched controls (N = 19), notably classical pitch processing tests (i.e., pitch change detection, pitch direction of change identification, and pitch short-term memory tasks) together with tasks assessing other aspects of pitch-related auditory cognition, such as emotion recognition in speech, sound segregation in tone sequences, and speech-in-noise perception. Additional behavioral measures were also collected, including text reading/copying tests, visual control tasks, and a subjective assessment of hearing abilities. As expected, amusics' performance was impaired for the three pitch-specific tasks compared to controls. This deficit of pitch perception had a self-perceived impact on amusics’ quality of hearing. Moreover, participants with amusia were impaired in emotion recognition in vowels compared to controls, but no group difference was observed for emotion recognition in sentences, replicating previous data. Despite pitch processing deficits, participants with amusia did not differ from controls in sound segregation and speech-in-noise perception. Text reading and visual control tests did not reveal any impairments in participants with amusia compared to controls. However, the copying test revealed more numerous eye-movements and a smaller memory span. These results allow us to refine the pattern of pitch processing and memory deficits in congenital amusia, thus contributing further to understand pitch-related auditory cognition. Together with previous reports suggesting a comorbidity between congenital amusia and dyslexia, the findings call for further investigation of language-related abilities in this disorder even in the absence of neurodevelopmental language disorder diagnosis.

Effects of Lower Limb Proprioceptive Training on Balance and Trunk Control Among the Adult Stroke Population.

Background and objective Balance and trunk control are major concerns among older adults during stroke rehabilitation. Loss of proprioception in the affected limb has a greater influence on motor learning and reeducation during balance training. Available studies stress the relevance of strength and functional training in regaining balance and trunk control. Proprioception training, in addition to available rehabilitation, can optimize the balance among this population. Our study aimed to find out the effects of proprioceptive training on balance and trunk control among the chronic stroke population. Methodology Out of 45 subjects enrolled at the Indian Head Injury Foundation, New Delhi, India, 30 subjects were selected based on selection criteria and randomized into two groups using the chit method, with 15 subjects in each group. The control group received conventional training, which included a range of motion, stretching, and strengthening exercises, while the intervention group received additional proprioceptive training five days per week for four consecutive weeks. Subjects were assessed on the Berg Balance Scale and Trunk Control Test for balance and trunk control on day one and after four weeks. A paired t-test was used to analyze the difference within the groups, and unpaired t-tests were used between the groups, keeping p < 0.05 as a significance level. Results After four weeks of intervention, statistically significant improvements were seen in the balance and trunk control groups, with p < 0.05 in both groups. However, a significant improvement in balance was observed in the experimental group when compared across groups (p = 0.001), whereas no statistically significant improvement in trunk control was found (p = 0.061). Conclusion We conclude that proprioceptive training and conventional physiotherapy both help to improve balance. Proprioceptive training is better for improving balance, but it has no significant effects on trunk control. It is likely that an extended intervention time or a different form of intervention may be required to achieve substantial gains in these areas. Future research might look at other outcome measures or the impacts of other types of therapies to see which ones are most helpful at increasing trunk control.

Comparison of patients with chronic and episodic migraine with healthy individuals by brain volume and cognitive functions

Objectives: Migraine is a complex neurological disease. In addition to headache, individuals with migraine may develop structural changes inside the brain and cognitive impairment. There is increased evidence associated with impairments in brain volume and cognitive functions in patients with migraine. The present study aimed to investigate the impairment in memory function in individuals with migraine using brain magnetic resonance imaging, volume measurement, and neuropsychological tests. Methods: The study included 20 patients with episodic migraine, 20 patients with chronic migraine, and 20 healthy controls. Subcortical volumes of all participants were measured by FreeSurfer, an automatic segmentation method. The Wechsler Memory Scale-Revised Form (WMS-R), Stroop test, Raven’s Standard Progressive Matrices, Verbal Fluency Test, and Lines Orientation Test were applied in all the study participants. Results: Putamen volume decreased as migraine duration increased, and subcortical gray matter, left cerebellar cortex, and bilateral thalamus volumes were lower in the chronic and episodic group compared to the control group, bilateral putamen and right cerebellar cortex volumes were lower in patients with chronic migraine compared to patients in episodic migraine and control groups. Upon neuropsychological examination, delayed memory was affected as the duration of migraine increased, and there was impairment in patients with chronic migraine upon fluency tests and mental control tests. Conclusions: Changes in subcortical volume and cognitive effects in patients with migraine raise questions about whether migraine qualifies as a benign disease. Structural changes and cognitive impairment may contribute to migraine-associated disability, and therefore, these causalities should be investigated by future studies. Silent infarcts, white matter damage, and cortical spreading depression, which occur in migraine cases, may be associated with subcortical volume changes and thus, cognitive effects. In the context, studies with larger samples to achieve a better understanding are needed.

Verification of the reactivity of immunoglobulins in dried blood spots collected for onchocerciasis sero-surveillance by an Escherichia coli ELISA

The World Health Organization guidelines for verification of onchocerciasis elimination include demonstrating that the prevalence of exposure to the parasite in individuals born since transmission was interrupted needs to be less than 0.1%. The guidelines recommend using seropositivity to an Onchocerca volvulus specific antigen (Ov16) for this purpose. Ov16 seropositivity has most often been assessed using the Ov16 ELISA assay. Currently, the Ov16 ELISA assay includes internal positive and negative controls to monitor for proper assay performance but does not control for the quality of the dried blood spots (DBS) being tested. Previous studies have reported a high prevalence of antibodies recognizing Escherichia coli in children. Through the development of an ELISA assay to detect antibodies recognizing E. coli, a common commensal in humans, DBS may be prescreened for quality assurance prior to testing for Ov16. Results demonstrated antibodies to E. coli were detected in 100% of randomly selected serum samples collected from O. volvulus infected individuals residing in an onchocerciasis hyperendemic area. Furthermore, when DBS were improperly stored, the E. coli antibodies were found to decay over a period of one week, while remaining unchanged over the same period in properly stored samples. Similarly, E. coli antibodies were detected in 100% of a batch of field collected properly stored DBS, while being present only in 5% of a batch of improperly stored spots. This study demonstrates the value of E. coli ELISA for DBS quality control testing and validation of proper storage of collections of DBS for the Ov16 ELISA.

A cognitive neural circuit biotype of depression showing functional and behavioral improvement after transcranial magnetic stimulation in the B-SMART-fMRI trial

We previously identified a cognitive biotype of depression characterized by treatment resistance, impaired cognitive control behavioral performance and dysfunction in the cognitive control circuit, comprising the dorsolateral prefrontal cortex (dLPFC) and dorsal anterior cingulate cortex (dACC). Therapeutic transcranial magnetic stimulation (TMS) to the left dLPFC is a promising option for individuals whose depression does not respond to pharmacotherapy. Here, 43 veterans with treatment-resistant depression were assessed before TMS, after early TMS and post-TMS using functional magnetic resonance imaging during a Go–NoGo paradigm, behavioral cognitive control tests and symptom questionnaires. Stratifying veterans at baseline based on task-evoked dLPFC–dACC connectivity, we demonstrate that TMS-related improvement in cognitive control circuit connectivity and behavioral performance is specific to individuals with reduced connectivity at baseline (cognitive biotype +), whereas individuals with intact connectivity at baseline (cognitive biotype −) did not demonstrate significant changes. Our findings show that dLPFC–dACC connectivity during cognitive control is both a promising diagnostic biomarker for a cognitive biotype of depression and a response biomarker for cognitive improvement after TMS applied to the dLPFC.

Testinaming. Strategic Molecularizations Through Endocrine and Genetic Testing

ABSTRACT What do tests performed on human bodies tell us? Hormones and genetics have become increasingly central to contemporary understandings of identities and kinship. In this article, narratives around hormone and genetic testing are examined through two examples: the use of DNA testing in migration control and hormone testing in sports. In the name of “fair sport” and “fair migration”, people are being tested because of regulations by the federation or by the state. Testing is said to produce better knowledge, where knowledge without testing is unreliable and defined as a problem which constitutes a risk to fair participation or belonging. In the narratives examined in this article, there is a simultaneous stabilization and destabilization of identity, gender and race. We argue for a slightly different articulation of molecularization, compared to how it has previously been conceptualized in canonized scholarly work. When considered as strategic and entangled with gender, race, and sexuality, molecularization appears as not only a development within or from biopolitics but also as a part of necropolitics. The relation between politics and molecularization is here centred on control by knowing the individual through biological tests, a form of control which we call testinaming.

The whole genome sequence of Polish vaccine strain Mycobacterium bovis BCG Moreau.

The whole genome sequence obtained is the only genomic sequence of the strain that has been used for vaccine production in Poland since 1955. Sequencing of different BCG lots showed that the strain was stable over a period of 59 years. The comprehensive genomic analysis performed not only enriches knowledge about the microevolution and attenuation of the BCG vaccine substrains but also enables the utilization of identified markers as a reference point in the genetic control and identity tests of the stability of the vaccine strain in the future.

Effects of input gradient regularization on neural networks time-series forecasting of thermal power systems

This study proposes using neural networks, specifically gated recurrent unit (GRU), long-short-term memory (LSTM), and transformer networks, to improve control strategies in a 450 MW coal-fired power plant. However, neural networks face issues of becoming overly dependent on just a few variables to make predictions, which negatively impacts control decisions that rely on the model to determine the value of all manipulated variables. The paper introduces regularization techniques, including noise injection and input gradient regularization, during the training phase. The work presents novel contributions in adapting neural networks to control industrial systems and applying regularization techniques from computer vision to industrial process control. Results demonstrate the effectiveness of input gradient regularization in reducing model dependence on subsets of variables, emphasizing the balance between fidelity and controllability. Further exploration is recommended, including the development of recurrent transformers, closed-loop control testing, and a sensitivity analysis on computer models to provide further insight.

Dendritic cell vaccines as cancer treatment: focus on 13 years of manufacturing and quality control experience in advanced therapy medicinal products

Background aimsDendritic cells (DCs) are professional antigen-presenting cells of the mammalian immune system. Ex vivo differentiated DCs represent a unique Advanced Therapy Medicinal Product (ATMP), used in several clinical trials as personalized cancer immunotherapy. The therapy's reliability depends on its capacity to produce high-quality mature DCs (mDCs) in compliance with Good Manufacturing Practices. AimsFrom March 2010 to December 2023, 103 patients were enrolled in multiple clinical trials at the Immuno-Gene Therapy Factory at IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”. Six hundred forty-two doses were produced, and the manufacturing process was implemented to optimize production. Our study is a retrospective analysis focusing on the quality control results. MethodsWe retrospectively analyzed the results of the quality control tests carried out on each produced batch, evaluating viability, purity and phenotype of mDCs and their quality in terms of microbiological safety. The data obtained are given with median and interquartile range. ResultsThe batches were found to be microbiologically safe in terms of sterility, mycoplasma, and endotoxins. An increase in DC maturation markers was found. The release criteria checks showed a high percentage of viability and purity was maintained during the production process. ConclusionsOur findings have confirmed that the measures implemented have ensured the safety of the products and have contributed to the establishing a robust “Pharmaceutical Quality System.” This has enabled many safe mDCs to be produced for clinical trials.

Utilization of the FTIR spectroscopic method for the quantitative determination of the narrow therapeutic index levothyroxine sodium in pharmaceutical tablets

Levothyroxine sodium is a narrow therapeutic index drug used for the treatment of hypothyroidism. The medication is marketed in tablet form with very low doses ranging from 25 to 150 µg, which requires the development of a sensitive quantitative analytical method to ensure a safe and effective pharmacological response. In the present work, a Fourier transform infrared method has been developed and validated for levothyroxine sodium determination in various pharmaceutical formulations. The proposed method involves selectively extracting levothyroxine sodium from the studied tablets using chloroform as solvent, then depositing it on a KBr pellet, followed by infrared measurements and spectra analysis. The peak band area corresponding to the C=C centered at 1409 cm-1 has been chosen for the quantification. The method has been validated according to ICH guidelines and was found to be simple, precise, accurate, and specific. The linearity, detection, and quantitation limits are 25–800, 8.121, and 24.545 µg/pellet, respectively. These values confer the method’s sensitivity and applicability for the determination of different pharmaceutical tablets with various dosages. A statistical comparison with a reference HPLC method showed no significant difference. Accordingly, the developed method can be employed for quality control testing of levothyroxine sodium due to its simplicity and the absence of sophisticated instrumentation and procedures. Graphical abstract:

Iterative Error‐Driven Ensemble Labeling (IEDEL) Algorithm for Enhanced Data Quality Control for the Atmospheric Radiation Measurement (ARM) Program User Facility

AbstractFor over three decades, the Atmospheric Radiation Measurement (ARM) Program user facility has provided researchers with invaluable benchmark atmospheric data. Ensuring the accuracy and integrity of ARM data is vital, and to achieve this, the ARM Data Quality Office (DQO) has implemented customized quality control tests tailored to each variable, with guidance from instrument mentors. These tests are designed to pinpoint common issues, such as data exceeding valid ranges or persisting with little change over extended periods, and ARM offers tools for users to review and exclude contaminated data efficiently. However, certain quality issues, such as spikes in time series or data drift over time, sometimes evade detection by existing tests and require manual identification by data analysts and instrument mentors through visualization tools. To tackle these challenges more efficiently, the DQO has developed and implemented the Iterative Error‐Driven Ensemble Labeling (IEDEL) algorithm with unanimous voting and transfer learning techniques to efficiently generate labeled data at scale. This initiative has empowered the creation of high‐performing machine learning models, enabling real‐time monitoring of data quality issues within the ARM data and thereby enhancing data integrity and accessibility.