Search

AbstractIntroductionMethodsResultsDiscussionConclusionsKratom is commonly used by consumers, and the elemental impurity exposure that consumers would have at different kratom ingestion doses has been determined.This assessment used original data from independent third-party laboratory testing of kratom products to identify the percentage of products that exceeded permissible daily exposure limits for lead (5 µg/day), nickel (200 µg/day), arsenic (15 µg/day), and cadmium (5 µg/day), the interim reference level for lead in adults (12.5 µg/day), and the tolerable upper intake level for manganese (11 mg/day) and nickel (1 mg/day). We assessed all products regardless of type and then evaluated non-extract products, extract products, and a soda preparation separately for elemental impurities.Three assessments of elemental impurities in kratom products have been published, totaling 68 products. Assessing all products and assuming a 3 g daily dose of kratom, 7.4% would exceed the permissible daily exposure limits for lead, 0% for nickel, 3.1% for arsenic, and 0% for cadmium. At a kratom dose of 25 g daily, 70.6% would exceed the permissible daily exposure limits for lead, 20.6% for nickel, 9.4% for arsenic, and 0% for cadmium. The interim reference level for lead would be exceeded by 1.5% of products at a kratom daily dose of 3 g and 33.8% of products at 25 g. The tolerable upper intake level for manganese would be exceeded by 12.5% of products at a kratom daily dose of 3 g and 41.7% of products at 25 g. Non-extract products generally contain greater concentrations of elemental impurities than extract products or the soda preparation.Apart from their concentrations in a gram of product, assessing the amount of exposure to elemental impurities at different kratom ingestion doses is also important. Elemental impurities exceeding regulatory permissible concentrations for many products, especially with greater daily kratom ingestion doses, may impact human health.Some kratom products contain excessive concentrations of elemental impurities of toxicological concern, such as lead and arsenic. Non-extract products (powders, capsules, tablets) generally contain greater concentrations of elemental impurities than extract products or the soda preparation. Daily use of these products can result in exposures exceeding regulatory thresholds and adverse health effects. [ABSTRACT FROM AUTHOR]

Introduction Menthol has long been incorporated as a flavor additive in tobacco products and can impact use behaviors. Despite its inclusion in some of the most popular flavored smokeless tobacco (ST) products (eg, "mint" flavored products), few studies have systematically investigated the impact of menthol on ST use behaviors in prospective empirical studies. Rigorous investigation of ST menthol content on behavioral and physiological outcomes requires ST products with stable and precise levels of menthol; however, commercial product composition variability prevents product comparisons when evaluating the effects of systematic changes in menthol content on clinical outcomes. Aims and Methods We developed amended loose moist snuff ST products by treating commercially available, unflavored loose ST with an ethanol-based menthol spiking solution or a nonmentholated ethanol control solution to develop test products with different levels of menthol: 0, 1, 3, and 5 mg menthol/g tobacco. We evaluated the stability of menthol content in these products over 24 months and evaluated menthol exposure associated with the products through pharmacokinetic analysis of plasma menthol-glucuronide in human participants (n  = 22). Results Menthol content of the amended products was on target, homogenous, and stable for up to 24 months. Menthol exposure (menthol-glucuronide Cmax and AUC) significantly differed between each test product. Conclusions These data suggest that stable products with nonoverlapping menthol content can be developed using a menthol spiking solution and can be subsequently administered for clinical assessments of mentholated loose ST. Implications The results from this study suggest that a menthol spiking solution can be used to mentholate unflavored, loose ST to a target menthol content. With this method, the ST menthol content was stable for at least 24 months, and the products exposed users to menthol in a dose-dependent manner. This method yielded loose ST products with precise, stable levels of menthol to allow systematic evaluation of ST menthol content on clinical outcomes. The method may have applications for systematically evaluating changes in other tobacco product ingredients. [ABSTRACT FROM AUTHOR]

ABSTRACT For topical, dermatological drug products, an in vitro option to determine bioequivalence (BE) between test and reference products is recommended. In particular, in vitro permeation test (IVPT) data analysis uses a reference‐scaled approach for two primary endpoints, cumulative penetration amount (AMT) and maximum flux (Jmax), which takes the within donor variability into consideration. In 2022, the Food and Drug Administration (FDA) published a draft IVPT guidance that includes statistical analysis methods for both balanced and unbalanced cases of IVPT study data. This work presents a comprehensive evaluation of various methodologies used to estimate critical parameters essential in assessing BE. Specifically, we investigate the performance of the FDA draft IVPT guidance approach alongside alternative empirical and model‐based methods utilizing mixed‐effects models. Our analyses include both simulated scenarios and real‐world studies. In simulated scenarios, empirical formulas consistently demonstrate robustness in approximating the true model, particularly in effectively addressing treatment–donor interactions. Conversely, the effectiveness of model‐based approaches heavily relies on precise model selection, which significantly influences their results. The research emphasizes the importance of accurate model selection in model‐based BE assessment methodologies. It sheds light on the advantages of empirical formulas, highlighting their reliability compared to model‐based approaches and offers valuable implications for BE assessments. Our findings underscore the significance of robust methodologies and provide essential insights to advance their understanding and application in the assessment of BE, employed in IVPT data analysis. [ABSTRACT FROM AUTHOR]

Given the need to provide clear communication to diverse audiences in the United States during public health emergencies, this assessment of images in COVID-19 communication materials identified ways to improve visual communication design. Qualitative interviews were conducted with 74 participants from various racial and ethnic backgrounds to gauge the clarity of images without associated text used in two infographics. Most images were understood by participants, but for each image at least some participants had an interpretation different from intended or only captured a portion of the message. Some images were interpreted by most or all participants as representing something other than intended. Participant recommendations were used to develop seven practical ways to improve image clarity: realistic graphics, exaggerated body position and actions, details to show image context and background, icons to encourage or discourage actions, symbols to show movement, consistency in recommended behavior in each image, and closely matching image to associated text. These elements can be applied in combination with existing health equity guiding principles for creating visual communication products before testing and validating products with intended audiences of different sociodemographic and cultural background to ensure appropriateness and clarity of images. [ABSTRACT FROM AUTHOR]

Granulation is the critical process for the pharmaceutical development of poorly water-soluble drug products. Poorly formulated products have challenges in dissolution and bioequivalence studies. Rivaroxaban (RXB) is a poorly soluble drug and has 66% fasting bioavailability at a high strength of 20 mg. Establishing the bioequivalence between test and reference products for high strength requires comparative dissolution profiles and bioequivalence. Improper granulation products and the rest of the batches failed in virtual bioequivalence. The present study provided insight into the optimization of the wet granulation process for manufacturing RXB generic immediate-release tablets using PBPK modeling and simulations. Furthermore, PBPK models are not only useful for formulation optimization but also for process optimization during pharmaceutical product development. [ABSTRACT FROM AUTHOR]

Male urinary incontinence (UI) is most prevalent in older men, with one in three men aged 65 and above having problems maintaining continence. Addressing health inequalities, male-female disparities in continence services, and low health-seeking among men emphasizes the necessity for co-creating an intervention that empowers them to self-manage their UI. We aim to co-create a self-management intervention with an older men and Health care provider (HCP) group and assess its usability and/or acceptability among older men with UI. The intervention mapping (IM) framework, a co-creation strategy, will be used to co-create a self-management tool, followed by usability and/or acceptability testing. The study will be guided by the first four IM steps: the logic model of the problem, the logic model of change, program/intervention design, and program/intervention production, followed by preliminary testing. A participatory group of older men with UI recruited from an existing group of patient partners, and continence care experts will be involved in all steps of the IM process. Usability and/or acceptability testing will be conducted on a sample of 20 users recruited through seniors' associations and retirement living facilities. After accessing the self-management tool for a week, participants will complete a product usability testing scale (aka System Usability Scale-SUS) and/or an acceptability test, depending on the preferred mode(s) of intervention delivery. Data will be analyzed using descriptive statistics. A benchmark overall mean usability score of 70 represents a good/usable product, based on the large database of SUS scores. [ABSTRACT FROM AUTHOR]

Snow Lotus Seed (SLS), esteemed for its nutritional and market value, faces challenges of authentication due to the absence of appropriate testing standards and methods. This results in frequent adulteration of SLS sourced from Gleditsia sinensis (G. sinensis) with other plant seeds endosperm. Traditional chloroplast DNA barcoding methods are inadequate for species identification due to the absence of chloroplasts in G. sinensis seeds endosperm. In this study, the homology of 11 ITS genes among 6 common Gleditsia species was analyzed. Universal primers suitable for these species were designed and screened. A DNA barcoding method for distinguishing SLS species was developed using Sanger sequencing technology, leveraging existing GenBank and Barcode of Life Data System (BOLD) databases. Optimized sample pretreatment facilitated effective DNA extraction from phytopolysaccharide-rich SLS. Through testing of commercial SLS products, the species origin has been successfully identified. Additionally, a novel instance of food fraud was uncovered, where the Caesalpinia spinosa endosperm was used to counterfeit SLS for the first time. The study established that the developed DNA barcoding method is effective for authenticating SLS species. It is of great significance for combating food fraud related to SLS, ensuring food safety, and promoting the healthy development of the SLS industry. [ABSTRACT FROM AUTHOR]

The present study aimed to assess the bioequivalence of a new apixaban generic with reference formulation. Twenty‐six healthy volunteers were recruited for an open‐label, balanced, randomized, 2‐treatment, 2‐sequence, 2‐period, single oral dose study. Following overnight fasting, each volunteer received 5 mg of apixaban test and reference formulations as single doses, separated by a 1‐week washout period. Twenty blood samples were collected at predose and multiple time points between 0.5 and 72 hours after dosing. A validated ultra‐performance liquid chromatography‐tandem mass spectrometry detection method following a protein precipitation step was implemented to determine apixaban concentrations. Noncompartmental analysis was used to derive the pharmacokinetic parameters, which were then compared between the test and reference products using a multivariate analysis of variance. The pharmacokinetic parameters of the test product were not statistically different from the reference product, and the 90% confidence intervals of apixaban natural log‐transformed area under the concentration‐time curve from time 0 to infinity, area under the concentration‐time curve from time 0 to the last measurable concentration, and maximum concentration were within 80%‐125% based on the bioequivalence acceptance range criteria. The test and reference formulations of apixaban are bioequivalent in healthy subjects under fasting conditions. [ABSTRACT FROM AUTHOR]

Pharmacopeia monographs are not intended to establish biosimilarity. However, the US Food and Drug Administration (FDA) has stopped the US Pharmacopeia (USP) from creating monographs for biological drugs due to the need for side-by-side comparisons with the reference products. The USP can create Biological Product Specifications (BPS), not to be labeled as monographs, based on the analytical testing of reference products and validated test methods that will remove the need for side-by-side analytical testing of biosimilars with reference products. Scientific arguments confirm that this plan is logical and capable of creating global quality standards for biosimilars to allow their interchangeability with other biosimilars. While the regulatory agencies have waived many high-cost biosimilar tests, analytical assessment is the most sensitive test; reducing its cost will further enhance the entry of biosimilars with no clinically meaningful difference. [ABSTRACT FROM AUTHOR]

The western drywood termite, Incisitermes minor (Hagen), causes significant economic damage to wood structures in the United States of America, especially California. When infestation is not widespread, localized insecticide injections may be useful for remedial control. However, the extensive gallery structure of drywood termites and their tendency to aggregate at specific parts of the galleries can impact the efficacy of localized insecticide injection. Chemicals that attract termites from a distance may improve the localized insecticide injection by increasing the number of termites contacting the insecticide residues. Two volatile terpenes, α-pinene and β-pinene, commonly found in many coniferous timber trees, were applied to artificial termite galleries to determine if termites were attracted from their original aggregation site. Furthermore, we examined if adding these pinenes would improve the overall efficacy of some insecticide products for drywood termite control. Behavioral assay results showed that the treatment with pinenes increased the likelihood that drywood termites would leave their original aggregation site and contact the treated part of the gallery. When tested with the pesticide products applied in a small area away from the termite aggregation, β-pinene significantly accelerated the time course of mortality for the aqueous fipronil. The efficacy of disodium octaborate tetrahydrate dust was not influenced by the addition of pinenes. Implications for drywood termite management and future research directions are discussed. [ABSTRACT FROM AUTHOR]

Featured Application: Assessment of the mechanical properties of the weld lines between wrought and laser-based directed energy deposition overlays. The combination of wrought materials and laser-based directed energy deposition (DED-LB) is being increasingly used for manufacturing new and repairing old or damaged components in several industries. Aerospace components made of Inconel 718 featuring small-thickness DED-LB buildups are a remarkable example of such a combination due to the high added value it brings. Despite that these are usually critical components, the miniature testing methods to assess the local mechanical properties in the buildup area are not fully developed. This work contributes to this miniature testing development with an improvement of the small punch testing (SPT) technique for measuring the mechanical properties of the weld line between the DED-LB and the wrought substrate. A new criterion for weld line positioning in the SPT specimens is proposed and applied on samples of hybrid wrought/DED-LB Inconel 718. The results of positioning the weld line at the necking site of the SPT specimen show that the proposed approach is valid for assessing the properties of the transition zone between the wrought and additive states. For the specific conditions tested and taking the wrought material as a reference, the strength of the Inconel 718 drops 10% in the weld line and 20% in the buildup. [ABSTRACT FROM AUTHOR]

Objectives: Ginger extacts contain 6-shogaol and 6-gingerol that are known to increase energy expenditure by acting on TRPV1 and promoting adrenaline secretion from the adrenal medulla via adrenal sympathetic nerves. This study aimed to examine the effects of a supplement product containing ginger extract powder E on the inhibition of visceral fat accumulation. Methods: A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 68 participants. Participants were randomly assigned to receive either the test product containing lOOmg ginger extract powder E or placebo daily for 12 weeks. We evaluated the inhibition of visceral fat accumulation by measuring abdominal visceral fat area. Results: The abdominal visceral fat area was significantly improved in the test group compered with the placebo group at 12 weeks. Conclusions: The result suggested that ginger extract ingestion inhibits visceral fat accumulation. [ABSTRACT FROM AUTHOR]

Objectives: Ginger extacts contain 6-shogaol and 6・gingerolthat exhibit antioxidant activity，an d are likely to reduce fatigue. 百lisstudy aimed to exarnine the effects of a supplement product containing ginger extract powder E on reducing fatigue caused by work1oad. Methods: Arandomized，do uble-blind，pl acebo-con佐ol1ed，para11el-group study was conducted in 64 participants. Participants were random1y assigned to receive either the test product contl血ing100mg ginger extract powder E or placebo daily for 4 weeks. We eva1uated the subjective sensation of fatigue primari1y by the visual analogue sca1e (VAS). Resullω:百leVAS score when work1oad is applied was significant1y improved恒也etest group compered with也e placebo group at 4 weeks. Conclusions: The result suggested that g泊gere甜actingestion reduces fatigue caused by work1oad. (UMIN ID: l.瓜1IN000051174). [ABSTRACT FROM AUTHOR]

Multimodal analgesia is defined as using several drugs or techniques simultaneously to target different pain pathways or receptors to avoid pain propagation. This study evaluated the pharmacokinetic profile and comparative bioavailability of etoricoxib 90 mg and tramadol 50 mg dosing alone (reference drugs) or in a novel fixed‐dose combination (test drug) under fasting conditions in Mexican healthy volunteers. This was a randomized, open‐label, 3‐way, crossover, single‐dose, prospective, and longitudinal study with a 14‐day washout period. Eligible subjects were healthy Mexican adult volunteers. The drugs were dosing orally, according to the randomization sequence, after 10 hours of fasting and 4 hours before breakfast with 250 mL of water at room temperature. Serial blood samples were collected before and after dosing, both drugs were quantified using high‐performance liquid chromatography coupled with tandem mass spectrometry. Forty‐two subjects were enrolled and 38 completed the study (28 men and 14 women, mean age 25.2 years, mean weight 66.6 kg). Test products were considered to have comparative bioavailability if confidence intervals of natural log‐transformed for (maximum plasma drug concentration (Cmax), (area under the plasma drug concentration‐time curve form 0 up to last sampling time (AUC0‐t), and (area under the plasma drug concentration‐time curve from 0 up to infinity (AUC0‐∞) data were within the range of 80%‐125%. Non‐serious adverse events were observed. The results demonstrate that the pharmacokinetic profile and bioavailability of the etoricoxib/tramadol fixed‐dose combination are comparable to those of the reference products. [ABSTRACT FROM AUTHOR]

Objectives Methods Results Conclusion This paper aims to develop and validate a taxonomy for the assessment of the subjective experience of curly hair manageability. It represents the latter of two iterative stages of a mixed‐method design interdisciplinary project.The qualitative stage of the study incorporated thematic analysis of 14 interview transcripts generated using a video‐ethnographic method (SEBE). A survey‐based instrument assessing different elements of the construct of hair manageability designed during the first stage of this project was further developed following consultations with experts with extensive experience in hair research, product development, testing and trichology. The instrument was tested online with 506 female participants self‐reporting natural curly hair, types 3A and higher according to the Andre Walker Curl Classification.The initial construct of four groups of hair goals received positive content validity from the experts. High scale reliability was achieved for the aesthetic, haptic and emotive goals' scales as well as for hair esteem (Cronbach's alpha >0.75). Curl type was the only personal hair attribute that was correlated with hair goals and perceptions. From the demographic and lifestyle data, only age was correlated with goals and willingness to try new products. Common hair practices and product usage were also correlated with hair curl and goals.The appropriateness of the instrument for measuring the strength of different hair goals and perceptions relevant to hair curvature degree and hair esteem has been validated. The instrument will support the development and testing of products better aligned with the manageability needs of very curly and textured hair. It was also confirmed that hair curvature is the most significant determinant of practices, and age of product attitudes. [ABSTRACT FROM AUTHOR]

This paper primarily analyzes the costs and benefits of establishing and implementing the HACCP system in food production enterprises from the perspective of enterprise perception. The results show that investment in certification fees, testing costs, operating costs of the quality department, and employee training accounts for most of the establishing and implementing costs. The main benefits are that enterprises can better control risks in the food production process, and achieve good social benefits in improving food safety management capabilities, enhancing employee food safety awareness, improving product quality, and reducing the occurrence of food safety accidents. Additionally, implementing the HACCP system has certain economic benefits in reducing scrap and rework rates, increasing product sales, reducing investment in finished product testing, and raising product prices. [ABSTRACT FROM AUTHOR]

AbstractPrebiotic and probiotic combinations may lead to a synbiotic effect, demonstrating superior health benefits over either component alone. Using the Mucosal Simulator of the Human Intestinal Microbial Ecosystem (M-SHIME®) model, the effects of repeated supplementation with inulin (prebiotic, which is expected to provide a source of nutrition for the live microorganisms in the gut to potentially support optimal digestive health), Bacillus coagulans lactospore (probiotic), and a low and high dose of a synbiotic combination of the two on the gut microbial community activity and composition were evaluated. Test product supplementation increased the health-promoting short-chain fatty acids acetate and butyrate compared with levels recorded during the control period, demonstrating a stimulation of saccharolytic fermentation. This was likely the result of the increased abundance of several saccharolytic bacterial groups, including Megamonas, Bifidobacterium, and Faecalibacterium, following test product supplementation. The stimulation of acetate and butyrate production, as well as the increased abundance of saccharolytic bacterial groups were more evident in treatment week 3 compared with treatment week 1, demonstrating the value of repeated product administration. Further, the synbiotic formulations tended to result in greater changes compared with prebiotic or probiotic alone. Overall, the findings demonstrate a synbiotic potential for inulin and B. coagulans lactospore and support repeated administration of these products, indicating a potential for promoting gut health. [ABSTRACT FROM AUTHOR]

The Na,K-ATPase is an α–β heterodimer. It is well known that the Na,K-ATPase β subunit is required for the biosynthesis and trafficking of the α subunit to the plasma membrane. During investigation of properties of human ATP1A3 mutations in 293 cells, we observed a reciprocal loss of endogenous ATP1A1 when expressing ATP1A3. Scattered reports going back as far as 1991 have shown that experimental expression of one subunit can result in reduction in another, suggesting that the total amount is strictly limited. It seems logical that either α or β subunit should be rate-limiting for assembly and functional expression. Here, we present evidence that neither α nor β may be limiting and that there is another level of control that limits the amount of Na,K-ATPase to physiological levels. We propose that α subunits compete for something specific, like a private chaperone, required to finalize their biosynthesis or to prevent their degradation in the endoplasmic reticulum. [ABSTRACT FROM AUTHOR]

In this study, scalp tissues from Korean adults between 20 and 80 without skin disease were used. Scalp tissues were processed, and hair follicles were isolated and cultured with different treatments (including Bioscalp, Ultra Exo Booster, and Ultra S Line Plus) from Ultra V company. Over 12 days, observations and measurements of hair follicle characteristics were recorded at intervals (Days 0, 3, 6, 9, and 12). The study assessed the impact of these substances on hair follicle growth and morphology. Bioscalp, combined with Ultra Exo Booster and Ultra S Line Plus, showed significant hair elongation in ex vivo. Preservation of hair bulb diameter was observed, indicating potential for sustained hair growth by exosome‐based products. The hair growth cycle analysis suggested a lower transition to the catagen stage in test products from Ultra V compared to non‐treated groups. The research findings indicated that the tested formulations, especially the combination of Bioscalp, Ultra Exo Booster, and Ultra S Line Plus, demonstrated significant effectiveness in promoting hair growth, maintaining the integrity of the hair bulb, and reducing the transition to the catagen stage. The study suggests promising alternative treatments for hair loss, illustrating results that were as good as those of the conventional testing product groups. [ABSTRACT FROM AUTHOR]

Background: The normally acidic skin pH changes in atopic dermatitis (AD) to alkaline, which contributes to the associated skin-barrier dysfunction. Hence, acidic cleansers would be preferred, but such information is scarce. Objective: Guiding health-care providers and patients on selecting skin cleansers with a pH optimal for AD. Methods: A total of 250 products were tested: 37 soaps (32 bars, 5 liquid) and 213 syndets (14 bars, 199 liquid); 10% solutions were tested for pH by using a pH meter; pH values 6.65–7.35 were considered neutral. Results: The pH of the tested skin cleansers varied widely (3.59–10.83). All 37 soaps were highly alkaline. In the 14 syndet bars, the pH was neutral in 6, alkaline in 8, and acidic in none. In the 199 syndet liquids, the pH was acidic in 84.9%, neutral in 11.1%, and alkaline in 4.0%. The product’s pH was disclosed in none of the 37 soaps and in only 32 syndets (15%), of which 9 bars were labeled “balanced,” whose measured pH was neutral in 6 and alkaline in 3. Of the other 23 syndets, the labeled pH was referred to as “balanced” in 20 whose measured pH was neutral in 2 (6.80, 6.88) and acidic in 18 (3.59–6.59). The pH in the other three syndets was 4.25–6.00. Conclusion: All tested soaps had undesirable pH, whereas 84.9% of the liquid syndets were acidic (which is desirable) and 11.1% were neutral (which could be acceptable). Only 12.8% of the products disclosed the pH, an issue in need of improvement [ABSTRACT FROM AUTHOR]

Environmental exposure data are a key component of chemical and ecological assessments, supporting and guiding environmental management decisions and regulations. Measures taken to protect the environment based on exposure data can have social and economic implications. Flawed information may lead to measures being taken in the wrong place or to important action not being taken. Although the advantages of harmonizing evaluation methods have been demonstrated for hazard information, no comparable approach is established for exposure data evaluation. The goal of Criteria for Reporting and Evaluating Exposure Datasets (CREED) is to improve the transparency and consistency with which exposure data are evaluated regarding usability in environmental assessments. Here, we describe the synthesis of the CREED process, and propose methods and tools to summarize and interpret the outcomes of the data usability evaluation in support of decision‐making and communication. The CREED outcome includes a summary that reports any key gaps or shortcomings in the reliability (data quality) and relevance (fitness for purpose) of the data being considered. The approach has been implemented in a workbook template (provided as Supporting Information), for assessors to readily follow the workflow and create a report card for any given dataset. The report card communicates the outcome of the CREED evaluation and summarizes important dataset attributes, providing a concise reference pertaining to the dataset usability for a specified purpose and documenting data limitations that may restrict data use or increase environmental assessment uncertainty. The application of CREED is demonstrated through three case studies, which also were used during beta testing of the methodology. As experience with the CREED approach application develops, further improvements may be identified and incorporated into the framework. Such development is to be encouraged in the interest of better science and decision‐making, and to make environmental monitoring and assessment more cost‐effective. Integr Environ Assess Manag 2024;20:1019–1034. © 2024 SETAC Key Points: We present a synthesis of the "Criteria for Reporting and Evaluating Exposure Datasets" (CREED) approach for evaluating the reliability and relevance of exposure data for use in environmental assessment.We present methods for summarizing and interpreting the outcomes of the data usability evaluation in support of decision‐making and communication.We developed a scoring system and report card to communicate the outcome of the CREED data usability evaluation and summarize important dataset attributes and limitations.We describe key findings of a beta test that tested the utility of the CREED approach and present three case studies that illustrate its application. [ABSTRACT FROM AUTHOR]

Three-dimensional printing is an emerging service delivery method for on-demand access to customized assistive technology devices. However, barriers exist in locating and designing appropriate models and having the devices printed. The purpose of this work is to outline the development of an app, 3DAdapt, which allows users to overcome these issues by searching within a curated list of 3D printable assistive devices, customizing models that support it, and ordering the device to be printed by manufacturers linked within the app or shared with local 3D printing operators. The app integrates searching and filters based on the International Classification of Functioning, Disability, and Health, with the available devices including those developed from fieldwork collaborations with multiple professionals and students within clinical, community, and educational settings. It provides users the ability to customize select models to meet their needs. The model can then be shared, downloaded, or ordered from a third-party 3D printing service. This development and expert testing phase to assess feasibility and modify the app based on identified themes then prepared the team for the next phases of beta testing to reach the overall aim of 3DAdapt to connect individuals to affordable and customizable devices to increase independence and quality of life. [ABSTRACT FROM AUTHOR]

Objective: To assess the pharmacokinetics and bioequivalence of Dapagliflozin 10mg + Vildagliptin Sustained Release (SR) 100mg + Metformin SR 1000mg fixed dose combination (FDC) tablets with DAPAMAC V 10 (Dapagliflozin 10mg + Vildagliptin SR 100mg tablets) and Glycomet 1g (Metformin SR 1000 mg tablets) in healthy adult male subjects under fasting conditions. Material and Methods: This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study. Volunteers were randomized to receive either a test product or a reference product under the fasting condition with a seven-day washout period. The pharmacokinetics parameters evaluated were maximum plasma concentration (Cmax), the area under the curve (AUC) at time t (AUC0-t), and the total area under the curve (AUC0-∞). Adverse events were also assessed as safety endpoints. Results: Twenty-four healthy adult male subjects were randomized, and 24 completed the study. The mean values for Cmax, AUC0-t, and AUC0-∞ were almost identical for test and reference products. The 90% confidence intervals of the ratios of adjusted geometric means for the pharmacokinetic parameters, i.e. Cmax, AUC0-t, and AUC0-∞ of the test product, were within the predefined bioequivalence limits of 80.00 to 125.00%. No adverse events or serious adverse events or deaths were reported during the study. All treatments were well tolerated. Conclusion: The test formulation, Dapagliflozin 10mg + Vildagliptin SR 100mg + Metformin SR 1000mg FDC, were bioequivalent to DAPAMAC V 10 (Dapagliflozin 10mg + Vildagliptin SR 100mg tablets) and Glycomet 1g (Metformin 1000mg SR tablets) in healthy adult male subjects under fasting conditions. [ABSTRACT FROM AUTHOR]

Tooth color is a major driver of facial esthetics. While permanent changes in tooth shade can be achieved by bleaching and restorations, there is a need for cosmetic products that can cause reversible color changes. This randomized controlled clinical study assessed the effectiveness and safety of a novel color-correcting product (Hismile™ V34 Color Corrector Serum™) versus a placebo (vehicle control lacking the color-change dyes). A single-center, randomized, controlled, examiner-blind, two-group, parallel design, single-use study design was followed. The test products were applied on a cotton bud for 30 s, and then, rinsed off. Tooth shade for maxillary central incisors was measured at baseline, immediately, and at 30 and 60 min, using the Vita Bleachedguide 3D-Master® Shade Guide and the EasyShade Advanced 4.0 spectrophotometer (for determining values of L*a*b*). The subjects (N = 60) had a baseline shade of 1M2 (rank 9) or darker. A single application of the test product resulted in an immediate and significant (p < 0.001) three shade improvement (26.2%) according to the shade guide, and the same significant benefits extended to 30 and 60 min. The placebo product did not alter tooth shade (p = 0.326). These changes were accompanied by significant improvements in the L value (whiteness) up to 30 min, and a reduction in b* (yellowness) for up to 60 min. Two-thirds of subjects using the test product stated in a survey that their teeth appeared both whiter and brighter. No safety issues arose from the use of the test product or vehicle control. These results indicate that using a color corrector can achieve worthwhile changes to tooth shade for up to 60 min. [ABSTRACT FROM AUTHOR]

Codesign is a methodology that includes active collaboration between stakeholders in designing solutions and has been used in the development and implementation of palliative care (PC) interventions. To synthesize the state of evidence for codesign in the development of PC interventions. We searched PubMed, EMBASE, and CINAHL for peer-reviewed studies published after 1995 that reported evidence of codesigned interventions and outcomes in patients receiving palliative, hospice, or end-of-life care. We screened studies through independent and blinded dual review within Covidence and assessed study quality with the 2018 Mixed Methods Appraisal Tool. We narratively synthesized codesign duration, engagement approach, stakeholders involved, intervention designs, follow-ups, and outcomes, comparing among codesigns reporting meaningful improvement in outcomes. We created a best practice checklist which we used to evaluate codesign use in each study. About 1,036 abstracts and 54 full text articles were screened. Twenty-eight studies met inclusion criteria and were abstracted. Feedback collection modalities ranged from iterative drafting, pilot testing, advisory panels, workshops, focus groups, and interviews. Thirteen studies applied pretesting/prototyping through pretest post-test, focus groups, prototypes, alpha and beta testing, and mock-ups. Eleven studies reported improved outcomes, eight of which utilized iterative codesign. All the studies reporting improved outcomes mentioned meeting with stakeholders at least twice. Two studies met all criteria in our codesign best practice checklist. Codesigned PC interventions demonstrate high variance in the modality of acquiring feedback and application of codesign. Successful codesign leading to improvement in outcomes is achieved by involving patients, caregivers, and providers in iterating intervention design. [ABSTRACT FROM AUTHOR]

This review collects the synthetic modifications performed on andrographolide, a natural molecule derived from Andrographis paniculata, for oncology applications. Various pharmacomodulations were carried out, and the products were tested on different cancer cell lines. The impact of these modifications was analyzed with the aim of mapping the positions essential for activity to facilitate future research in this field. However, this study makes it clear that, in addition to structural modifications of the molecule, which can result in varying degrees of effectiveness in targeting interactions, the lipophilic capacity of the structures obtained through hemisynthesis is of significant importance. [ABSTRACT FROM AUTHOR]

Background and Objective: Venlafaxine hydrochloride extended-release (ER) capsules are commonly used to treat depression and anxiety disorders. Evaluation of the bioequivalence of generic formulations with reference products is essential to ensure therapeutic equivalence. The objective of this study was to evaluate the bioequivalence, safety, and tolerability of Chinese-manufactured venlafaxine hydrochloride extended-release capsules compared with USA-manufactured EFFEXOR® XR in healthy Chinese volunteers under fed conditions. Methods: A randomized, open-label, single-dose, crossover study was conducted. Subjects were randomly assigned to receive the test formulation (one 150-mg ER capsule manufactured in China) or the reference formulation (one 150-mg ER capsule manufactured in the USA). The bioequivalence of the two drugs was assessed using the area under the plasma concentration–time curve from time zero to the last sampling time (AUC0–t) and the maximum observed concentration (Cmax). Results: A total of 28 subjects were enrolled and randomly assigned to receive a single dose of either the test or reference capsule. All the subjects completed the study and were included in the pharmacokinetic (PK) and safety analyses. The mean AUC0–t and Cmax of venlafaxine and its active metabolite O-desmethylvenlafaxine were comparable between the test and reference products with both parameters close to 100% and the corresponding 90% confidence intervals within the specified 80–125% bioequivalence boundary. Safety was also assessed between the two products and all adverse events (AEs) in this study were mild in severity. Conclusions: Both the test and reference venlafaxine hydrochloride ER capsules were bioequivalent and showed a similar safety and tolerability profile in the population studied. Clinical Trials Registration: This study was registered at the Drug Clinical Trial Registration and Information Publicity Platform (http://www.chinadrugtrials.org.cn/index.html) with registration number CTR20211243, date: June 1, 2021. [ABSTRACT FROM AUTHOR]

Routes of modification of 5,6,7,8-tetrafluoro-3-methoxycarbonyl-2-(4-methoxyphenyl)-4H-chromen-4-one and its decarboxylated analogs in the reactions with aliphatic amines were studied and the biological activity of both the starting compounds and the products was tested. It was found that 5,6,7,8-tetrafluoro-3-methoxycarbonyl-2-(4-methoxyphenyl)-4H-chromen-4-one under the action of primary amines underwent the flavone-coumarin rearrangement through the addition of the amine at the C(2) atom. 7-Amino-substituted flavones were formed as by-products in the reactions with methyl- and benzylamines and as major products in the reactions with pyrrolidine. The process of nucleophilic aromatic substitution at the C(7) atom becomes a key one in the reactions of decarboxylated tetrafluoroflavones with primary amines and pyrrolidine. Mechanisms for the studied transformations were proposed. The starting tetrafluoroflavones were found to exhibit high antifungal activity, while antigonorrheal agents were revealed among the products of their transformations. [ABSTRACT FROM AUTHOR]

The ongoing cladding crisis within the United Kingdom has elevated the need for designers and risk assessors to have the knowledge and tools to evaluate the fire safety of proposed and existing cladding systems. This paper documents efforts to develop a test that could be used to evaluate the fire safety hazards of cladding products that were either proposed for use in design or that were found on existing buildings. Specifically, the products of interest were composite products (i.e., those comprised of multiple layers). The conceptual approach of the European harmonised system was used as a basis for investigating whether a small‐scale test could be used to evaluate product fire hazards. A relevant fire scenario was identified, this was linked to candidate large‐scale reference tests, and this was linked to performance in a candidate small‐scale test. The candidate test showed remarkable agreement with the reference large‐scale test, however, many issues were also identified. It was found that, even when specifically intended to accommodate composite products, the small‐scale test was unable to always evaluate hazards. Thus the authors were left with the conclusion—regardless of the testing system, there are always products that will not fit the testing system, however hard one tries. [ABSTRACT FROM AUTHOR]

The market development trend of foldable AMOLED screen is introduced in the article, and then the core links of the industry chain of foldable mobile phones is drawn off. Furthermore, that improving the bending ability is an urgent problem to be solved in achieving lightweight is proposed. Based on this demand, a specific structural scheme and a complete set of bending ability evaluation methods to achieve lightweight affect are put forward. By combining bending simulation and product failure test, the mechanism is analyzed, and also, the main and secondary factor affecting bending ability are proposed. After that, a standardized improvement system for bending ability, including optimization of membrane quality, structural optimization, and process optimization, is validated and applied. On condition that an average bending radius of 1.5mm for Panel and 1.3mm for MDL are achieved ultimately, that has reached the international leading level. Moreover, based on the stress simulation research, a nonlinear model relationship between the strain of the TLD film layer (SiNx) and the clamp distance, which is a key factor affecting the bending ability and can predict the bending ability, is established. Finally, the future development direction and research direction of improving the bending ability of foldable AMOLED screen are prospected. [ABSTRACT FROM AUTHOR]

In foldable display products, an adhesive is affected by the fatigue delamination force. F‐d curve and Gc value of dynamic and static test do not exhibit a significant difference, but microbubbles are observed in dynamic folding. In this study, the fatigue delamination of adhesive in real user scene is investigated and its measurement methodology is constructed. [ABSTRACT FROM AUTHOR]

16‐inch FHD+ (Full High Definition Plus, 1920*1200) LCD featuring LTPS TFTs with a new low‐resistance alloy gate metal and fast response AFFS (Advanced Fringe Field Switching) liquid crystal technology has been developed, which achieves a ClearMR value of 9000 at 480Hz frame rate and fulfills the requirement for product reliability test. These technologies, including the new gate metal TFTs and employing Fast‐Response time liquid crystal, have also been implemented in a 17.3‐inch FHD (Full High Definition, 1920*1080) gaming laptop LCD. This larger panel operates at an even higher frame rate of 660Hz and higher ClearMR values with GtG (Gray to Gray) liquid crystal response time within 1ms. These advancements mark significant progress in the field of high‐performance gaming displays. [ABSTRACT FROM AUTHOR]

Background: The physical, paper-based Georgia TB Reference Guide has served as the clinical reference handbook on tuberculosis (TB) diagnostic and treatment guidelines for the state of Georgia in the United States. Supported by the Georgia Department of Public Health, the production of the 112-page palm-sized booklet was previously led by a team of Georgia-based TB experts at Emory University and printed every three-five years with updates to clinical management guidelines and TB consult contact information. However, the costs associated with editorial printing combined with delays in updating a static printed booklet with revised guidance hampered the utility of the tool. Considering the barriers with paper-based production and based on the beneficial use of apps to support the dissemination of clinical management guidance in other settings, the booklet was converted into a mobile application. This paper describes the process of developing a mobile app version of the Georgia TB Reference Guide in an easy-to-update and readily available format. Methods: We employed a user-centered design approach to develop the app, including a series of qualitative interviews and quantitative surveys. Participants included a mix of state officials and local TB experts. First, initial foundational interviews were conducted to conceptualize current utilization practices of both the paper and PDF versions of the tool. Second, the findings from the initial interviews were organized thematically and informed the design of the app, which was then beta tested by a round of previously unsampled TB experts as well as a re-sample from the initial interviews. Third, the designs were coded into developmental phases and beta tested among users of the current Georgia TB Reference Guide. Fourth, the app was published and downloaded by a pre-selected group of local users who provided answers to a follow-up survey after using the app for one month. Fifth, user growth, self-reported demographics, and app usage between February and July 2022 were recorded through automatic data metrics built into the app. Results: The paper copy Georgia TB Reference Guide usage themes included commonly referenced content, navigation paths, and desired features and content. The themes were converted into features and designs such as prioritizing commonly reviewed topics and guide customization with bookmarks and notes. Iterations of the designs were driven by feedback from TB experts and included home page featured content, improving content readability, and improving the search feature. The follow-up survey revealed a 90% preference for the app over the paper version of the guide. In the six months following the app's release, the app was downloaded by 281 individuals in the United States. The majority of downloads were in Georgia and the app also expanded organically to 19 other states. Conclusion: The experience of converting the Georgia TB Reference Guide offers specific and effective steps to converting a medical reference guide into a mobile application tool that is readily available, easy to use, and easy to update. The organic dissemination of the app beyond the state of Georgia's borders within the first six months of app launch underscores desire among TB healthcare professionals for high-quality digital reference content outside the state. This experience offers clear outlines for replication in other contexts and demonstrates the utility of similar mobile medical reference tools. [ABSTRACT FROM AUTHOR]

Nifedipine is a potent antihypertensive medication classified as a dihydropyridine calcium channel blocker. The objective of this trial was to assess the bioequivalence of a 30‐mg nifedipine controlled‐release tablet and a reference drug in a cohort of healthy Chinese individuals. Two independent open‐label, randomized, single‐dose, crossover studies were conducted, 1 under fasting conditions (N = 44, with 1 participant dropping out midway) and the other under fed conditions (N = 44, with 4 participants dropping out midway). Plasma concentrations of nifedipine were determined using liquid chromatography‐mass spectrometry, and pharmacokinetic (PK) parameters were calculated using noncompartmental analysis with Phoenix WinNonlin 8.0 software. In both fasting and fed studies, reasonable bioequivalence was observed for the PK parameters of both the test product and the reference drug. A good safety profile was demonstrated for both the test product and reference drug, with no serious adverse events reported, and both were similarly well tolerated. An important observation with food coadministration was that systemic exposure to nifedipine (based on area under the curve, AUC0‐∞) was reduced by approximately 12%. The bioequivalence of the test product and reference drug under fasting/fed conditions in healthy subjects in China was demonstrated by the study results. [ABSTRACT FROM AUTHOR]

• Thickened acetic and nitric acid are effective to remove CaCO 3 surface deposits. • Residues of calcium acetate were identified on the ceramic mock-ups by ATR-FTIR. • No mineralogical changes were detected on the mock-ups after the treatments. • Even on low fired pieces without deposits, the composition remained unaltered. One of the most frequent alterations to archaeological objects is the presence of calcium carbonate deposits, which usually appear on stone and pottery. Their existence makes analysing these historical artefacts more difficult, so their removal becomes necessary. Nonetheless, the most popular methods for their elimination include applying a combination of chemicals followed by a mechanical action, both of which have the potential to harm the artefacts. Since the 1980s, thickened products have been widely employed as safer substitutes for conservation treatment procedures. They are not yet widespread in the archaeological community, though. This research arose from the need of determining the possible changes that pottery objects might suffer due to the use of thickened acid products to remove surface calcium carbonate deposits. Acetic and nitric solutions thickened with xanthan gum were used to remove the artificial deposits generated over ceramic mock-ups fired up to different temperatures. The results were satisfactory based on visual and colorimetric evaluation. Nevertheless, the confined acetic acid on mock-ups fired below 1100 °C showed surface stains or colour changes, that were connected to calcium acetate residues by TG-DSC and ATR-FTIR techniques. However, mock-ups treated with the confined nitric acid showed no signs of soluble salts remaining. Besides, no mineralogical changes were detected on the ceramic mock-ups treated, regardless of the acid used. Furthermore, tests were performed on low fired mock-ups without calcium carbonate deposits as a worst-case scenario to establish the safety of the designed treatments. The findings indicated that there were no compositional changes caused by the removal procedures. As a result, it may be inferred that the thickening acid-based treatments were safe and effective on the ceramic mock-ups and could be applied to other similar pottery findings. [ABSTRACT FROM AUTHOR]

Purpose: This research examines the effects of physical proximity (close vs distant) of retailers' private label brands (PLBs) relative to national brands (NBs) and brand display orientation (horizontal [brands occupy the same shelf] vs vertical [brands occupy different shelves]) on consumers' PLB quality perceptions and PLB evaluations. Design/methodology/approach: Two experiments involving real brands in different product categories tested the hypotheses. Findings: A PLB positioned close (vs distant) to a NB is evaluated more favorably and this effect is mediated by increased PLB quality perceptions, but only in a horizontal brand display. In a vertical brand display, a PLB positioned close (vs distant) to a NB is evaluated less favorably and this effect is mediated by decreased PLB quality perceptions. Research limitations/implications: The findings suggest that to enhance consumers' PLB quality perceptions and evaluations, PLBs be positioned next to (rather than on separate shelves) and close to (rather than distant from) NBs in the same product category. Originality/value: Although the literature suggests that the best shelf position for PLBs is close to NBs, there is a lack of empirical research on the effects of relative shelf positioning on consumers' quality perceptions and subsequent PLB evaluations. This research finds that both physical proximity and brand display orientation play an important role. [ABSTRACT FROM AUTHOR]

Sulfur hexafluoride (SF6) is a typical fluorine gas with excellent insulation and arc extinguishing properties that has been widely used in large-scale power equipment. The detection of SF6 gas in high-power electrical equipment is a necessary measure to ensure the reliability and safety of power grid operation. A failure of SF6 insulated electrical equipment, such as discharging or overheating conditions, can cause SF6 gas decomposition, resulting in various decomposition products. The decomposed gases inside the equipment decrease the insulating properties and are toxic. The leakage of SF6 can also decrease the insulating properties. Therefore, it is crucial to monitor the leakage of SF6 decomposed gases from electrical equipment. Quantitative testing of decomposition products allows us to assess the insulation state of the equipment, identify internal faults, and maintain the equipment. This review comprehensively introduces the decomposition formation mechanism of SF6 gas and the current detection technology of decomposition products from the aspects of principle and structure, materials, test effect, and practicability. Finally, the development trends of SF6 and decomposition gas detection technology for the reliability and safety of power grid operation are prospected. [ABSTRACT FROM AUTHOR]

Bifidobacterium longum subsp. longum UABl-14™ is an important probiotic strain that was found to support digestive health. Here we present the development and validation of real-time PCR methods for strain-specific identification and enumeration of this important strain. The identification method was evaluated for specificity using 22 target samples and 30 non-target samples. All target samples successfully amplified, while no amplification was observed from any non-target samples including other B. longum strains. The identification method was evaluated for sensitivity using three DNA dilution series and the limit of detection was 2 pg. of DNA. Coupled with a viability dye, the method was further validated for quantitative use to enumerate viable cells of UABl-14. The viability dye treatment (PMAxx) was optimized, and a final concentration of 50 μM was found as an effective concentration to inactivate DNA in dead cells from reacting in PCR. The reaction efficiency, linear dynamic range, repeatability, and reproducibility were also evaluated. The reaction efficiency was determined to be 97.2, 95.2, and 95.0% with R2 values of 99%, in three replicates. The linear dynamic range was 1.3 x 10² to 1.3 x 105 genomes. The relative standard deviation (RSD%) for repeatability ranged from 0.03 to 2.80, and for reproducibility ranged from 0.04 to 2.18. The ability of the validated enumeration method to monitor cell counts during shelf life was evaluated by determining the viable counts and total counts of strain UABl-14 in 18 multi-strain finished products. The viable counts were lower than label claims in seven products tested post-expiration and were higher than label claims in products tested pre-expiration, with a slight decrease in viable counts below label claim in three samples that were tested 2-3 months pre-expiration. Interestingly, the total counts of strain UABl-14 were consistently higher than label claims in all 18 products. Thus, the method enables strain-specific stability monitoring in finished products during shelf life, which can be difficult or impossible to achieve using the standard plate count method. The validated methods allow for simultaneous and cost-effective identification and enumeration of strain UABl-14 and represent an advancement in the quality control and quality assurance of probiotics. [ABSTRACT FROM AUTHOR]

Hydrolyzed collagen (HC) derived from salmon (Oncorhynchus nerka) skin possesses properties that can nourish the skin, and it is one of the active ingredients used in cosmeceutical products for moisturizing the facial skin. However, HC solution gives off a fishy odor and it is gray in color that makes the product unacceptable for cosmetic purposes. This study aimed to use liposome-encapsulated hydrolyzed salmon collagen to improve its physical appearance, skin permeation, and eliminate the fishy odor. Two percent of HC and vitamin B3 (VitB3) were used as active ingredients to incorporate into liposomes. Phosphatidylcholine, cholesterol, and Tween 80 at a suitable weight ratio of 8 : 2 : 1 produced nano-sized vesicles (170.6 ± 0.70 nm) with the highest percentage of entrapment efficiency (95.72 ± 2.00%) of VitB3 and (49.63 ± 1.74%) of HC. Skin permeation and odor detection of the HC-VitB3 liposome were studied using Franz's diffusion cell and gas chromatography, respectively, and compared with HC-VitB3 solution. Subsequently, facial serums were formulated using HC-VitB3 liposomes and HC-VitB3 solutions, and a product satisfaction test was conducted with 100 volunteers to determine their preferred product. The results of the studies of HC-VitB3 liposome serum showed improved formulation appearance, enhanced skin permeation, and better odor elimination compared to the HC-VitB3 serum. Furthermore, seventy-three volunteers in the product satisfaction test preferred and selected the liposomal serum for its superior scent. From all the experimental results, it could be seen that liposomes can help increase skin penetration, and undesirable odors and colors can be masked by the appropriate lipid bilayer structure of liposomes. [ABSTRACT FROM AUTHOR]

Extreme events of climate change are increasing, such as droughts and heat waves, causing limitations on growth and yield in relevant food crops, as well as threatening global food security. Brassinosteroids (BRs) are natural or synthetic steroids with significant properties that promote plant growth and development. In the current world scenario, research and solutions that can improve plant tolerance to climate change are strategic to ensure food security. The distinctiveness and novelty of this review lie in its comprehensive and detailed approach to the role of BRs in plants under biotic and abiotic stresses. We consolidate information on the action mechanisms on specific organs, providing detailed experimental conclusions of these plant growth regulators, including also commercial products and concentrations tested aiming to mitigate the adverse effects of the stresses. This practical approach highlights the potential of BRs in agriculture and plant protection against stresses. Additionally, our review presents results with plant models and essential food crops, focusing on multidisciplinary approaches and using physiological, biochemical, nutritional, anatomical and agronomic tools to explain the mechanisms of action of brassinosteroids in plants exposed to abiotic and biotic stresses. [ABSTRACT FROM AUTHOR]