Acceptance Criteria Research Articles

Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion.

The ICH M10 guideline establishes global standards for bioanalytical method validation for pharmacokinetic assays, focusing on data reliability and accuracy across studies. A significant component is cross-validation, which should be performed to ensure data comparability when multiple methods or laboratories are involved in a single study or across studies where comparison will be performed. However, ICH M10 does not specify acceptance criteria for cross-validation, creating challenges for the industry because traditionally many laboratories have always utilized acceptance criteria to "pass" or "fail" the study. This editorial discusses how bioanalytical labs should conduct cross-validation for PK assays post-ICH M10, highlighting the role of statistical methods and the need for close collaboration with clinical pharmacology and biostatistics departments. Proper implementation and strategic focus on relevant studies are essential for effective cross-validation.

Appraisal of six sigma in pre-analytical phase of clinical biochemistry laboratory

Objectives: The aim of the study is to measure the performance of pre-analytical phase of a clinical biochemistry laboratory using sigma metrics and the six sigma scale. Materials and Methods: The study included documented data of blood sample rejection from March 2023 to February 2024 and follow-up data from March 2024 to August 2024. International Federation of Clinical Chemistry and Laboratory Medicine developed Quality Indicators (QIs) used are QI-9 Wrong tubes; QI-10 Hemolyzed samples; QI-11 Clotted samples; QI-12 Insufficient samples; QI-14 Damaged samples in transport; and QI-15 Mislabeled samples. Based on “Six Sigma Quality Design and Control” established by Dr. Westgard, the sigma metric was calculated for the above-mentioned QIs. Statistical analysis: Obtained data were entered and analyzed using Microsoft Excel 2021. Results: Out of 162,380 received samples, 547 samples were rejected as not satisfied with the sample acceptance criteria. The most common pre-analytical error in the observed QIs is hemolyzed samples (458), followed by insufficient sample volume (55). The Sigma score of QI-10 was determined to be 4.81, whereas QI-9, QI-11, QI-12, and QI-15 were well maintained and graded excellent. Following training sessions, the follow-up month revealed a sigma score of 4.98 for QI-10. Conclusions: Six sigma metrics are a competent means to measure the performance of pre-analytical QIs in a clinical biochemistry laboratory. The observed QIs were effectively managed (>4 σ).

Sensitive imaging of actinide materials in shielded radioactive waste

This paper reports on the development of a method for enhanced non-destructive assay (NDA) of radioactive waste using the novel technique neutron-gamma emission tomography (NGET). The technique relies on the detection of correlated fast neutrons and gamma rays emitted in spontaneous or induced fission. It is based on fast organic scintillators and enables sensitive detection and three-dimensional (3D) localization of the fission events. The technique is passive and does not require moving components. In this work, we apply the NGET technique to the category of radioactive waste which is often referred to as historic or legacy waste. This can include mixed wastes encased in shielded containers many decades ago, before the advent of detailed waste description criteria. These low or intermediate level wastes are often associated with lacking, limited or conflicting documentation. This poses a challenge when assigning the waste to the proper disposal route as well as in deciding whether the waste needs to undergo sorting and conditioning to fulfil waste acceptance criteria both with regards to safe interim storage and to its ultimate disposal. Actinides, such as isotopes of uranium and plutonium, with their typically long half-lives and decay chains are of special interest in this regard since they may challenge the long-term safety assessment in repositories predicated on mainly shorter half-life radionuclides if undetected. Accurate identification and localisation of actinides is also important from a safeguards perspective, especially since they are generally difficult to detect and localise by established passive means due to their relatively weak radiation emissions, in particular in shielded containments and in the presence of strong radiation fields from other radioactive materials. In this paper we present findings of measurements on shielded containments of long-lived radioactive waste performed at the Studsvik site in Sweden, as well as measurements on a laboratory assembly simulating a grouted waste drum. Similarities and differences between the novel NGET technique and a commercially available gamma imaging system are also briefly discussed.

Development and Validation of an Analytical Procedure for Determining Convallatoxin in Medicinal Products Containing Cardiac Glycosides of Lily of the Valley

INTRODUCTION. The safe use of lily-of-the-valley medicinal products requires adequately controlling the content of cardiac glycosides. The State Pharmacopoeia of the Russian Federation stipulates that the content of cardiac glycosides in lily-of-the-valley medicinal products should be quantified using bioassays and spectrophotometry. However, the determination of cardiac glycosides needs more accurate and selective physicochemical methods, such as high-performance liquid chromatography (HPLC).AIM. This study aimed to develop and validate an HPLC analytical procedure for the quantitative determination of cardiac glycosides (convallatoxin) in lily-of-the-valley herbal medicinal products.MATERIALS AND METHODS. The study examined the Lily-of-the-Valley Tincture, Zelenin Drops, Valocormid, Carniland®, and Lily-of-the-Valley Extract Reference Standard samples. The content of cardiac glycosides was determined by comparison with a reference standard for convallatoxin by HPLC and spectrophotometry. The samples were prepared as outlined in Monograph 3.4.0003.18 Lily-of-the-Valley Herb Tincture of the State Pharmacopoeia of the Russian Federation. Mixed cardiac glycosides were separated on a Luna 5 µm C18(2) column by gradient elution with 0.1% orthophosphoric acid in water and acetonitrile. The analysis was performed using an autoinjector with sample cooling to 5 °C.RESULTS. The developed analytical procedure met the acceptance criteria for specificity, intermediate precision, linearity (correlation coefficient of 0.99985), and repeatability (relative standard deviation of convallatoxin measurements of 1.61%). The analytical procedure is suitable for the quantitative determination of convallatoxin in lily-of-the-valley herbal medicinal products because it produces reliable and repeatable results.CONCLUSIONS. The authors developed a highly sensitive and selective HPLC analytical procedure for the quantitative determination of convallatoxin in lily-of-the-valley herbal medicinal products. The content of convallatoxin ranged from 0.012 to 0.018 mg/mL in the liquid active substance Lily-of-the-Valley Tincture, from 0.004 to 0.013 mg/mL in the medicinal product Zelenin Drops, and from 0.005 to 0.007 mg/mL in the medicinal products Carniland® and Valocormid. For the Lily-of-the-Valley Extract Reference Standard, the content of convallatoxin amounted to 0.029 mg/mL.

How to build a powerline: Fast policies for decarbonization, the slow work of public participation, and the profitability of energy capital

Community opposition to new low-carbon energy infrastructure – and resulting project delays and cancellations – is increasingly taken by some climate activists, policymakers, and scholars as evidence of the incompatibility between urgent decarbonization and expanded public participation. This paper argues that too narrow a focus on this duality risks overlooking an additional mandate: the profitability of energy capital. This paper intervenes in the ‘rapid vs. just transitions’ debate by arguing that building low-carbon energy infrastructure requires a balancing of trade-offs between speed, local support, and profit for private developers. Using a case study of a controversial transmission project in the northeastern United States, I argue that project delays are attributable not (just) to uncooperative publics, but to energy capital's drive for profit, which discourages compromises with host communities that would increase project costs but cultivate local support. By treating the social legitimacy of low-carbon energy infrastructure as contingent on its ability to meet criteria for public acceptability, this paper argues that the slow work of public participation can in fact be the route to ‘fast policies’ for decarbonization when it fosters developer norms in line with community expectations for projects.

Quantifying thermoplastic mask quality for precision radiotherapy in head and neck cancer: A 3D stress test and 6D-axis error analysis.

Patients with head and neck cancers often require radiotherapy, where immobilization devices like thermoplastic masks ensure precise radiation delivery by minimizing movement. However, the quality of these masks lacks standard reference data. This study aimed to establish institutional acceptance criteria for thermoplastic mask quality and quantify their effectiveness using a 3 dimensional stress test and verified the setup errors using daily megavoltage computed tomography (MVCT). Between April and June 2022, 30 patients underwent radiotherapy with thermoplastic masks. Four key facial points (forehead, bilateral cheekbones, and chin) were tested for supporting force. Mean forces ranged from 3.97 N to 8.8 N. MVCT was used to assess 6 dimensional-axis errors, with mean translational errors (x, y, z) of 0.32 mm, -1.09 mm, and 2.24 mm, respectively, and rotational errors (yaw, pitch, roll) of -0.12°, 0.22°, and 0.35°, respectively. The results demonstrated that the thermoplastic masks provided precise immobilization, minimizing setup errors in 6 dimensions. Our findings offer a quantifiable method to ensure high-quality immobilization during radiotherapy for patients with head and neck cancers.

Understanding Voriconazole Metabolism: A Middle-Out Physiologically-Based Pharmacokinetic Modelling Framework Integrating In Vitro and Clinical Insights.

Voriconazole (VRC), a broad-spectrum antifungal drug, exhibits nonlinear pharmacokinetics (PK) due to saturable metabolic processes, autoinhibition and metabolite-mediated inhibition on their own formation. VRC PK is also characterised by high inter- and intraindividual variability, primarily associated with cytochrome P450 (CYP)2C19 genetic polymorphism. Additionally, recent in vitro findings indicate that VRC main metabolites, voriconazole N-oxide (NO) and hydroxyvoriconazole (OHVRC), inhibit CYP enzymes responsible for VRC metabolism, adding to its PK variability. This variability poses a significant risk of therapeutic failure or adverse events, which are major challenges in VRC therapy. Understanding the underlying processes and sources of these variabilities is essentialfor safe and effective therapy. This work aimed to develop a whole-body physiologically-based pharmacokinetic (PBPK) modelling framework that elucidates the complex metabolism of VRC and the impact of its metabolites, NO and OHVRC, on the PK of the parent, leveraging both in vitro and in vivo clinical data in a middle-out approach. A coupled parent-metabolite PBPK model for VRC, NO and OHVRC was developed in a stepwise manner using PK-Sim® and MoBi®. Based on available in vitro data, NO formation was assumed to be mediated by CYP2C19, CYP3A4, and CYP2C9, while OHVRC formation was attributed solely to CYP3A4. Both metabolites were assumed to be excreted via renal clearance, with hepatic elimination also considered for NO. Inhibition functions were implemented to describe the complex interaction network of VRC autoinhibition and metabolite-mediated inhibition on each CYP enzyme. Using a combined bottom-up and middle-out approach, incorporating data from multiple clinical studies and existing literature, the model accurately predicted plasma concentration-time profiles across various intravenous dosing regimens in healthy adults, of different CYP2C19 genotype-predicted phenotypes. All (100%) of the predicted area under the concentration-time curve (AUC) and 94% of maximum concentration (Cmax) values of VRC met the 1.25-fold acceptance criterion, with overall absolute average fold errors of 1.12 and 1.14, respectively. Furthermore, all predicted AUC and Cmax values of NO and OHVRC met the twofold acceptance criterion. This comprehensive parent-metabolite PBPK model of VRC quantitatively elucidated the complex metabolism of the drug and emphasised the substantial impact of the primary metabolites on VRC PK. The comprehensive approachcombining bottom-up and middle-out modelling, therebyaccounting for VRC autoinhibition, metabolite-mediated inhibition, and the impact of CYP2C19 genetic polymorphisms, enhances our understanding of VRC PK. Moreover, the model can be pivotal in designing further in vitro experiments, ultimately allowing for extrapolation to paediatric populations, enhance treatment individualisation and improve clinical outcomes.

A new method development and validation for simultaneous estimation of ramipril and telmisartan by RP-HPLC method in combined dosage form

The present research work was development and validation of new RP-HPLC method for simultaneous estimation of Ramipril and Telmisartan in combined dosage form. In simultaneous RP-HPLC method development, Waters 2695 Separations Module with PDA Detector and column used is C8 SB ZORBAX (150 X 4.6mm) column with 3.5-micron particle size. Injection volume of 10 µL is injected and eluted with the mobile phase selected after optimization was Phosphate buffer and Acetonitrile in the ratio of 70:30 was found to be ideal. The optimized flow rate was at 1.0 mL/min. Detection was carried out at 230 nm. This system produced symmetric peak shape, good resolution and reasonable retention times of Ramipril and Telmisartan were found to be 2.275 and 4.261 minutes respectively. The Ramipril and Telmisartan showed linearity in the range of 20-60 µg/mL and 160-480 µg/mL respectively. The %RSD values for precision was found to be within the acceptable limit, which revealed that the developed method was precise. The developed method was found to be robust and the %RSD value for percentage recovery of Ramipril and Telmisartan was found to be within the acceptance criteria. The results indicate satisfactory accuracy of method for simultaneous estimation of the Ramipril and Telmisartan.

OPTIMIZATION ALGORITHM OF PUBLIC SERVICE FACILITIES LAYOUT IN EARTHQUAKE-STRICKEN AREAS BASED ON SA ALGORITHM

The environment in earthquake-stricken areas is complex and changeable. The optimization of public service facility layout usually involves multiple objectives, such as maximizing coverage, minimizing service distance, optimizing resource allocation, etc. The coupling conflict between these objectives weakens the functions of public service facilities in earthquake-stricken areas. To improve the emergency response speed of the earthquake-stricken regions and reduce disaster losses, a simulated annealing (SA) based optimization algorithm for the layout of public service facilities in earthquake-stricken areas is proposed. Considering the public service demand in different stages of the earthquake-stricken area, set the minimum maximum weighted distance, the minimum number of facility points, and the minimum total weighted distance of the service demand point area within the service area of the public service facility point as the objective function, and set constraints such as each demand point is covered by at least one facility point, and the minimum number of public service facility points, build a multi-objective optimization model of public service facilities layout to avoid coupling conflicts between multiple objectives. The SA algorithm is used to solve the multi-objective optimization model of public service facility layout. SA algorithm adopts temperature update function and sets heuristic cooling criteria. Combining the success-failure method and the variable scale method, a new solution is generated using the effective offset. The improved Metropolis algorithm is used to set the acceptance criteria for the solution to obtain the optimal layout result for public service facilities in earthquake-stricken areas. The experimental results show that the algorithm can effectively optimize the layout of public service facilities in earthquake-stricken areas, and improve facility coverage and resource utilization.

Probabilistic Approach for Assessing the Occupational Risk of Olfactometric Examiners: Methodology Description and Application to Real Exposure Scenario

Human examiners, known as panelists, are exposed to an unknown occupational exposure risk while determining odor concentration (Cod) using dynamic olfactometry. In the literature, a few papers, based on a deterministic approach, have been proposed to establish this occupational risk. As a result, the purpose of this study is to develop and apply a probabilistic approach, based on the randomization of exposure parameters, for assessing and evaluating the occupational exposure risk among olfactometric examiners. In this methodology, the risk is assessed by computing the hazard index (HI) and inhalation risk (IR) to determine the non-carcinogenic and carcinogenic risks. To randomize the exposure parameters, a Monte Carlo simulation was described and then applied in real exposure scenario to establish the exposure risk in terms of probability. Therefore, a one-year survey of the working activity of olfactometric examiners of Laboratorio Olfattometrico of Politecnico di Milano university was conducted. Based on this data collection (exposure parameters and chemical data, divided according to sample categories), a randomized exposure scenario was constructed to estimate the probability and cumulative distribution function of risk parameters. Different distributions were obtained for different industrial samples categories and were compared with respect to acceptability criteria (the value of HI and IR at 95th percentile of distribution). The elaboration provided evidence that negligible non-carcinogenic and carcinogenic risks are associated with the panelists’ activity, according to an entire annual dataset. The application of probabilistic risk assessment provides a more comprehensive and effective characterization of the general exposure scenario for olfactometric examiners, surpassing the limitations of a deterministic approach. This method can be extended to future exposure scenarios and enables the selection of the most effective risk management strategies to protect the health of olfactometric examiners.

Challenges of environmental impact assessment in addressing environmental risk: insights from Brazilian practice in mining dams

ABSTRACT Environmental Impact Assessment (EIA) and Risk Assessment (RA) are critical tools for assessing and managing environmental impacts and risks of projects. However, their integration remains a challenge. This study examines how EIA practices account for risks in evaluating the environmental feasibility of mining dam projects in the state of Minas Gerais, Brazil. We analyzed licensing processes for projects approved between 2004 and 2022, using data from the state’s environmental agency. Methods included documentary and content analysis of Environmental Impact Statements (EIS) and review reports. Among the 25 cases analyzed, most focused solely on risk control without performing RA. Only two cases included RA, and two others lacked any risk-related information. Review reports revealed that only two went beyond considering risk control when assessing environmental feasibility. This suggests decision-making relies on a narrow focus on risk control. Furthermore, there is a misalignment between the EIS content and the criteria for project acceptability in review reports. Finally, we explore how politicization may undermine the EIA’s role in objective, and evidence-based decision-making. These findings underscore the superficial and fragmented approach to addressing environmental risk in mining dam assessments in Minas Gerais.

Improvement of the Surveillance Protocols After Experiencing a Pseudo-Epidemic After 2018 Central Sulawesi Earthquake in Indonesia.

Following a disaster, a pseudo-epidemic can occur due to redundant and duplicated data caused by infrastructure and information system disruptions. This study aims to investigate whether there have been improvements the post-disaster surveillance system in the comparison of diarrhea incidents between Central Sulawesi, Indonesia, and Cianjur, West Java, Indonesia. We conducted an analysis of the epidemic-prone disease diarrhea before and during disasters, comparing the data with secondary data from the Early Warning Alert and Response System (EWARS) and the District Health Information System V.02 (DHIS-2). In central Sulawesi in 2018 and Cianjur in 2022, we observed an upsurge in diarrhea cases in the first week after the disaster. Although diarrhea cases increased after the disaster, they remained within acceptable outbreak criteria. Multiplication and redundant data were detected in the DHIS-2 system in Central Sulawesi, likely leading to erroneous overreporting. Changes in surveillance officers and their personal experiences during the disaster contributed to data inconsistencies. As compared to Central Sulawesi, the DHIS-2 reporting form in Cianjur was simplified as an individual form to enhance efficiency and accuracy. Enhancing valid assessment and conducting thorough investigations are essential to improve surveillance protocols for epidemic-prone diseases following disasters.

Formulation and Characteristics of Hydrogel Patch Containing Pineapple Peel (Ananas comosus L.) Ethanol Extract

Abstract Pineapple peel (Ananas comosus L.) contains bioactive compounds such as flavonoids and the enzyme bromelain, which possess antioxidant, anti-inflammatory, antibacterial, and anticancer properties, and the ability to accelerate wound healing. Hydrogel patches, as a formulation for transdermal delivery, are effective in wound healing due to their hydrophilic properties that maintain moisture and prevent bacterial infection in open wounds. This study aims to develop and test the characteristics of hydrogel patch formulations containing ethanol extracts of pineapple peel with varying concentrations of 10%, 20%, and 30%, compared to a control (hydrogel patch without pineapple peel extract). A series of evaluation tests were conducted to assess the patch characteristics, including organoleptic tests, pH, absorbency, weight uniformity, swelling ratio, patch thickness, and folding endurance. The results showed that the concentration of pineapple peel extract affects the hydrogel patch characteristics. The higher the extract concentration, the darker the patch color, but the pH, absorbency, and swelling ratio decrease. Patches with higher extract concentrations also showed an increase in weight. Absorbency tests indicated that none of the formulas met the acceptance criteria (<10%), with absorbency results of 22.97%, 11.60%, and 21.95% for 10%, 20%, and 30% extract concentrations, respectively, and 23.43% for the control. Swelling ratio and thickness tests showed the best results for the control, followed by the 10%, 20%, and 30% extract concentrations. The folding endurance test showed that the control and 10% extract formula had good results (>300 folds), while higher extract concentrations reduced the folding endurance of the hydrogel patch .Keywords: extract, pineapple peel, hydrogel patch, formulation, patch characteristics

The psychometric properties of Chinese version of the Gilles de la Tourette syndrome-quality of life scale (GTS-QOL) for children and adolescents

BackgroundGilles de la Tourette syndrome (GTS) is a persistent neurological disorder that profoundly affects the quality of life for afflicted individuals, however, tailored health-related quality of life (QOL) measures for Chinese pediatric GTS patients are lacking. This pioneering study aims to develop a QOL scale for Chinese children with GTS.MethodsA cohort of 1,121 children (aged 6–16 years) diagnosed with GTS participated in scale development. Internal consistency was evaluated using Cronbach’s alpha. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were performed to assess the factor structure of the GTS-QOL-Chinese, examining goodness-of-fit indices, factor loadings of individual items, and covariances between factors. Validity was determined through interscale correlations and comparisons with external measures to establish convergent and discriminant validity.ResultsFollowing reliability and validity analyses, a Chinese version of the 24-item GTS-specific quality of life scale was conclusively established, encompassing five subscales (psychological, compulsive, cognitive, physical, social). The scale demonstrated high internal consistency with a Cronbach’s alpha coefficient of 0.93, and validity was substantiated through interscale correlations ranging from 0.46 to 0.68. EFA identified five factors, explaining 61.26% of the total variation. CFA further confirmed the scale’s robustness, with all goodness-of-fit indicators meeting acceptable criteria (AGFI = 0.86, PCFI = 0.78, GFI = 0.89, CFI = 0.89, RMSEA = 0.07, SRMR = 0.06).ConclusionsThe Chinese version of the GTS-QOL scale has exhibits robust reliability and validity and is valuable for assessing the quality of life of Chinese children and adolescents with GTS. This scale may assist in tailoring interventions and improving patient care.

Cleaning Method Validation for Determination of Residues in Anti-Cancer Drug product for Injection by Using RP-HPLC Technique

Cleaning method validation is a part of good practices in pharmaceutical sector and need to seek the contamination present in production area. OBJECTIVE: An RP-HPLC method for the cleaning samples analysis for Anti-Cancer Drug product Melphalan Hydrochloride for Injection was develop and validated. The method was developed and validated for quantitation of Cleaning of residue left in the vessels of the production equipment’s. The analytical method used to determine the complete cleaning for Melphalan Hydrochloride for Injection by HPLC method. METHOD: The Cleaning validation was performed on Inertsil ODS,C18,(150mm×4.6mm,5μm) chromatographic column temperature at 40°C, and the detection wavelength was set at 260nm. Mobile Phase-A:10mL ammonium acetate, 88mL Purified water, 10mL acetic acid, 2mL Triethylamine, and Mobile Phase-B: 1mL Buffer, 10mL acetonitrile,190mL Purified water, and at a flow rate of 1.5 mL/min, and the injection volume was 10μL. RESULTS: The validation results of Melphalan Hydrochloride were linear over the concentration from 0.10 µg/mL to 0.75µg/mL (r = 1.00) and the recoveries from LOQ to 150% and precision ranged from 50% to 76% (RSD < 30%, n =9). CONCLUSION: This method has been validated successfully and all the results met the acceptance criteria. Hence method of Cleaning Validation is suitable for testing of residue sample of Melphalan Hydrochloride for Injection.

A novel quantitative method for the determination of 10B-carrier boronophenylalanine in rat plasma by UHPLC-MS/MS and comparison with ICP-MS

L-Boronophenylalanine (BPA), a widely used 10B carrier for clinical boron neutron capture therapy (BNCT), was quantified in rat plasma through a simple, effective and stable ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method. Chromatographic separation was performed on an ACQUITY UPLC HSS T3 (100 mm × 2.1 mm, 1.8 μm) column with the mobile phase of 0.5 % formic acid aqueous solution and acetonitrile. For the detector, the m/z ion pairs used for quantification were 209.1→120.1 for BPA and 210.1→120.1 for internal standard in a positive mode by electrospray ionization (ESI) using multiple reaction monitoring (MRM). The method is specific and robust with rare affection by endogenous substances in the matrix. A good linear relationship was observed over 80–80000 ng/mL (r2 = 0.9993). The values of inter- and intra-day accuracy and precision were within the acceptance criteria of ±15 %. BPA was found to be stable under different experimental conditions. This developed method was successfully applied on a pharmacokinetic experiment on Sprague-Dawley rats (intravenous injection, 125 mg/kg) and a comparation between UHPLC-MS/MS and ICP-MS for BPA was carried out.

Beyond the walls of the classroom: the psychodynamics of professional commitment and job involvement among female primary school teachers.

This research used structural equation modeling (SEM) to explore the relationship between professional commitment, self-efficacy, psychological resilience, perceived organizational support and job involvement of female teachers in Chinese primary schools. The purpose of the study was to understand how these psychological and organizational factors work together on teachers' job involvement. Based on the questionnaire survey of 596 female teachers in primary schools, the data were collected and analyzed by AMOS software. The results show that professional commitment plays a central role in teachers' job involvement, and self-efficacy and psychological resilience, as important psychological resources, significantly affect job involvement through the mediation of perceived organizational support. The model fitting indicators CFI, RMSEA and SRMR were in line with the acceptance criteria, which verified the adaptability of the hypothesis model. The findings not only reinforce the application of resource conservation theory in the field of education, but also provide school administrators with strategies to improve teachers' job involvement, especially by enhancing the importance of organizational support and resilience. In addition, the results have practical implications for the design of targeted teacher professional development programs.

Development and validation of an ICP-MS method and its application in assessing heavy metals in whole blood samples among occupationally exposed lead smelting plant workers.

Occupational exposure to heavy metals affects various organ systems and poses a significant health risk to workers. Consequently, its precise estimation is of clinical concern and warrants the need for an analytical method with reliable precision and accuracy. The current study aimed to develop an analytical method using inductively coupled plasma‒mass spectrometry (ICP-MS) to detect trace to elevated levels of potentially toxic elements in human blood. The sample preparation was optimized using a two-step ramp temperature microwave acid digestion program. The toxic elements were quantified using ICP-MS operating in kinetic energy discrimination (KED) mode, adjusting the data acquisition parameters and instrumental settings. The analytical method was validated using standard performance parameters. Each validation parameter was aligned with the acceptable criteria outlined in standard guidelines. The method achieved optimal linearity (r2 > 0.99), recovery (85.60-112.00%), and precision (1.35-7.03%), was capable of detecting the lowest concentrations of 0.32, 0.28, 0.28, and 0.19µg/L, and was capable of quantifying trace levels of 1.01, 0.88, 0.90, and 0.62µg/L for arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb), respectively. Post-validation, the method was applied to estimate heavy metals in blood samples from 250 Pb-smelting plant workers, revealing potential health implications of occupational exposure. The cohort analysis revealed that demographic and employment factors were associated with elevated blood Pb levels, leading to symptoms and health risks. Clinical analysis revealed that 33.6% of the participants experienced hypertension. These findings highlight the significant health risks associated with elevated blood Pb levels. The weak but significant correlation with systolic blood pressure underscores the need for improved monitoring and workplace safety. This emphasizes the importance of continuous monitoring, targeted interventions, and enhanced occupational hygiene to protect workers' well-being.

Estimating quantiles in acceptance criteria for structural components

The probabilistic foundations of methods to control the characteristic properties of structural materials, expressed as p-quantiles, are discussed. We argue that the acceptance criteria in the quality control should be based on quantile estimators complying with the definition of the quantile. We introduce the distribution-free concept of definition-based quantile estimator. For normal distribution, an application of different types of estimators, as well as some attribute methods and mixed methods presently used, are illustrated by operating characteristic curves. We recommend the prediction method by which the subjective limit values of the mixed methods are eliminated, information from the sample will be used more effectively than in the attribute methods, and the questions about the proper confidence level or a “known” variation coefficient need not be considered. However, the direct application of the prediction method results in stricter quality control than that presently used. Therefore, we recommend adopting p’ > p in such a way that if the predicted p’-quantile estimate is equal to or higher than the lower lilmit L, the required value of the p-quantile, the lot is accepted in the quality control. If the present quality level is appropriate, the value of p’ can be chosen in such a way that the present level is maintained. If not, necessary modifications are possible simply by adjusting p’.

Laboratory performances during proficiency tests for the analysis of active substances in pesticide formulations during 2021–2023

During the period 2021–2023, the Italian National Institute of Health (ISS) organised, in collaboration with the Italian Health Ministry, proficiency testing (PTs) for about 22 Italian and other EU laboratories involved in the monitoring programmes for Plant Protection Products (PPPs). The aim of the PTs was to determine the amount of active ingredient in various formulations of PPPs. Overall, the type of formulations to be analysed were soluble concentrate (SL), suspension concentrate (SC), capsule suspension (CS), emulsion water oil (EW), soluble water granule (SG), dustable powder (DP), water dispersible granule (WDG) and emulsion concentrate (EC). In 2021, the ISS organised PTs for the determination of Imazamox, Fenhexamid and Trinexapac-ethyl in three different PPPs as soluble concentrate (SL), suspension concentrate (SC), and capsule suspension (CS), respectively. In 2022, PTs for the determination of Bentazone, Spinosad and Tau-Fluvalinate were organised. For this PTs, commercial PPPs were obtained from the Italian market as SC, emulsion oil water (EW) and soluble water granule (SG). In 2023, the PT was organised to determine the active ingredient Trifloxystrobin, Deltamethrin and Cyprodinil in the commercial product as water dispersible granule (WDG), dustable powder (DP) and emulsion concentrate (EC), respectively. Homogeneity and stability, performed for all PT samples, fulfilled the acceptability criteria. The Jarque–Bera test was used to verify the hypothesis of normality of the data distributions before to calculate the z-score values. Laboratory performances, expressed in terms of z-scores, were satisfactory for almost all participants for all substances.