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Coptidis Rhizoma (CR) holds significant clinical importance. In this study, we conducted a comparative analysis of CR's dispensing granule decoction (DGD) and traditional decoction (TD) to establish a comprehensive evaluation method for the quality of DGD. We selected nine batches of DGD (three from each of manufacturers A, B and C) and 10 batches of decoction pieces for analysis. We determined the content of representative components using high‐performance liquid chromatography and assessed the content of blood components in vivo post‐administration using ultra‐performance liquid chromatography–mass spectrometry. The antibacterial activity was measured using the drug‐sensitive tablet method. To evaluate the overall consistency of DGD and TD, we employed the CRITIC method and Grey relational analysis method. Our CRITIC results indicated no significant difference between the CRITIC scores of DGD‐B and TD, with DGD‐B exhibiting the highest consistency and overall quality. However, DGD‐A and DGD‐C showed variations in CRITIC scores compared with TD. After equivalent correction, the quality of DGD‐A and DGD‐C approached that of TD. Furthermore, our Grey relational analysis results supported the findings of the CRITIC method. This study offers a novel approach to evaluate the consistency between DGD and TD, providing insights into improving the quality of DGD. [ABSTRACT FROM AUTHOR]

Background: The prediction of response to immunotherapy mostly depends on the programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) status, and the 22C3 pharmDx assay has been approved in esophageal squamous cell carcinoma (ESCC). However, the widespread use of the 22C3 pharmDx assay is limited due to its availability. Thus, alternative PD-L1 assays are needed. We aimed to investigate the analytical and clinical diagnostic performances of four PD-L1 assays and to compare their concordances with the 22C3 pharmDx assay. Methods: The PD-L1 22C3 pharmDx assay was performed on the Dako Autostainer Link 48 platform, three testing assays (PD-L1 E1L3N XP antibody [Ab], PD-L1 BP6099 Ab and PD-L1 CST E1L3N Ab) on the Leica BOND-MAX/III platform, and one testing assay (PD-L1 MXR006 Ab) on the Roche VENTANA Benchmark Ultra platform. A total of 218 ESCC cases from four centers were included in this retrospective study. Professionals from each center stained and read the IHC slides independently and determined the combined positive score (CPS) and the tumor proportion score (TPS). Results: Regarding analytical performance, the four testing assays demonstrated good correlations with the 22C3 pharmDx assay when evaluated by the TPS or CPS (ρ > 0.8 for all four assays). Regarding diagnostic performance (CPS ≥ 10 was used as the cutoff), the four testing assays showed moderate concordances with the 22C3 pharmDx assay (kappa > 0.7 for all four assays). The overall percent agreements between each testing assay and the 22C3 pharmDx assay was at least 87.2 %. Conclusion: This study provides insight into the potential interchangeability of the four PD-L1 assays with the 22C3 pharmDx assay.

The application of traditional Chinese medicine dispensing granules is becoming increasingly prevalent. However, the consistency of dispensing granules with traditional decoction remains controversial. In this study, the consistency of peptide composition and pharmacodynamics between dispensing granules and traditional decoction of Bombyx batryticatus (BB) were assessed. A peptidomics method based on LC–tandem mass spectrometry technology was used to evaluate peptide composition similarity between BB traditional decoction and dispensing granules. The results revealed notable differences in peptide sequences between the two dosage forms, with only 8.55% of peptides shared between them. To evaluate the potential pharmacodynamic effects of the two dosage forms on epilepsy, virtual screening was used to identify potential active peptides, including blood–brain barrier permeability, toxicity prediction, and molecular docking. BB traditional decoction demonstrated a higher number and greater abundance of potential active peptides than BB dispensing granules, suggesting that BB traditional decoction may have a more favorable effect in treating epilepsy compared with BB dispensing granules. Moreover, molecular docking and molecular dynamics simulation studies confirmed the mechanism of action of active peptides to γ‐aminobutyric acid transporter 1 (GAT‐1). This study provides a scientific basis for the evaluation of quality consistency between BB traditional decoction and dispensing granules. [ABSTRACT FROM AUTHOR]

With the increasing globalization of drug development and the publication of the International Council for Harmonisation (ICH) E17 guideline (ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 2017), multi-regional clinical trials (MRCTs) have become a preferred option to accelerate the availability of new medical products by design, execution and simultaneous submission under one protocol. MRCTs, with the participation of all major regions including countries from both developed and emerging markets, surely make new drug development more efficient. Even though the proposed estimand framework (ICH E9 (R1) (2019), came later in 2019 and was not mentioned in ICH E17, the application of the estimand framework has the potential to enhance the design, execution, and analysis in MRCTs. Defining an estimand within the regional context in MRCTs is an important issue that requires careful consideration. Given that consistency evaluation of treatment effects across regions is critical in MRCTs, the utilization of the estimand framework for regional consistency evaluation is also worth discussion. This paper aims to address these two questions. The five attributes of the estimand definition are discussed within a multi-regional context. It is imperative to thoroughly consider regional intrinsic/extrinsic factors when planning the estimand and estimation of MRCTs. A holistic approach is summarized to conduct consistency evaluation. When a regional inconsistency is observed, the possible reasons need to be further explored under five attributes of the estimand framework. Two real case studies are discussed to illustrate the application of the estimand framework in the consistency evaluation. [ABSTRACT FROM AUTHOR]

Objective To evaluate the consistency of multiple parameters between the Micro-Motion-Sensitive Mattress Sleep Monitoring System (MSMSMS) and polysomnography (PSG) in the diagnosis of obstructive sleep apnea (OSA) and sleep assessment. Methods Sixty-seven subjects suspected of having OSA underwent PSG and MSMSMS simultaneously to record multiple sleep parameters. The consistency between PSG and MSMSMS in the diagnosis and grading of OSA, as well as the consistency in respiratory events, blood oxygen events, sleep basic information, and sleep structure parameters, was compared. Paired t-test, Bland-Altman analysis, and intraclass correlation coefficient (ICC) were used for continuous data, and weighted kappa analysis was used for categorical data. Results Compared with PSG, the areas under the curve for diagnosing mild, moderate, and severe OSA were 1,0. 999,and 0. 967, respectively (P ＜0. 001); the weighted kappa coefficient for the two diagnostic results was 0. 841 (95% CI: 0. 766-0. 928,P ＜ 0. 001). The intraclass correlation coefficients of the apnea-hypopnea index (AHI), apnea index (AI), and blood oxygen indexes were 0. 967 (0. 943,0. 980), 0. 937 (0. 900,0. 961), and 0. 900 (0. 837,0. 939), respectively, and 0. 936 (0. 891,0. 962). Except for the hypopnea index (HI) [0. 181（-0. 032,0. 387), P = 0. 036], there was high consistency in the interpretation of other respiratory events and blood oxygen indexes (P ＜ 0. 001). There was a moderate level of consistency between the two methods in the interpretation of sleep structure, including the proportion and time of light sleep and the time of deep sleep. Conclusion MSMSMS has high sensitivity and specificity in the diagnosis and grading of OSA compared with PSG. In addition to strong consistency in respiratory events and blood oxygen indexes, MSMSMS also has certain significance in evaluating the sleep structure of OSA patients. [ABSTRACT FROM AUTHOR]

IntroductionThe study assessed the correlation and concordance of 25-hydroxyvitamin D [25(OH)D] levels in capillary and venous plasma collected simultaneously after vitamin D3 supplementation in 42 healthy adults. They were randomly divided into three groups by random number table method. Group A took 1,000 IU vitamin D3 daily, group B took 10,000 IU vitamin D3 every 10 days, and group C took 30,000 IU vitamin D3 every 30 days until the end of the 12th month. Venous blood serum 25(OH)D level was detected by chemiluminescence immunoassay (CLIA) and mass spectrometry (LC-MS) at day 1, day 14, day 28, month 6, and month 12 respectively, the capillary blood serum 25(OH)D level was detected by chemiluminescence immunoassay (CLIA) at the same time. Pearson correlation analysis and linear regression analysis were employed to investigate the relationship and transformation equation between the findings of the two samples and the results obtained from different detection methods within the same sample. The Bland-Altman method, Kappa analysis, and receiver operating characteristic (ROC) curve were utilized for assessing consistency, sensitivity, and specificity.ResultsThe three groups all reached a stable peak at 6 months, and the average levels of the three groups were 49.21, 42.50 and 43.025 nmol/L, respectively. The average levels of group A were higher than those of group B and group C (P < 0.001). The mean values of serum 25(OH)D measured by LC-MS and CLIA in 42 healthy adults were 45.32 nmol/L and 49.88 nmol/L, respectively, and the mean values of 25(OH)D measured by LC-MS in capillary blood were 52.03 nmol/L, and the difference was statistically significant (P < 0.001). Pearson correlation analysis showed that the linear fitting formula of scatter data was as follows: venous 25(OH)D concentration (nmol/L) = 1.105 * capillary 25(OH)D concentration −7.532 nmol/L, R2 = 0.625. Good agreement was observed between venous and corrected capillary 25(OH)D levels in clinical diagnosis (Kappa value 0.75). The adjusted serum 25(OH)D in capillary blood had a high clinical predictive value.ConclusionsThe agreement between the two methods is good when the measured 25(OH)D level is higher. Standardized capillary blood chemiluminescence method can be used for 25(OH)D detection.

Dispensing granules of Chinese medicine (DGCM) have emerged as a more convenient alternative to traditional decoction (TD) of Chinese medicine, gaining popularity in recent years. However, the debate surrounding the consistency of DGCM compared to TD remains unresolved. In this study, three batches of Baishao and Gancao DGCM were obtained from manufacturers A, B, and C, and 15 batches of crude drugs were procured from hospital pharmacies for the preparation of dispensing granule decoction (DGD) and TD of Shaoyao‐Gancao decoction (SGD). The HPLC‐UV method was employed to determine the levels of gallic acid, paeoniflorin, albiflorin, liquiritin, liquiritin apioside, isoliquiritin apioside, isoliquiritin, glycyrrhizic acid, and isoliquiritigenin. The analgesic and antispasmodic effects were assessed using the hot plate and acetic acid writhing test in mice. To evaluate the consistency of chemical constituents and pharmacological effects between the two decoctions, the Criteria Importance Though Intercriteria Correlation (CRITIC) method combined with chemometrics was employed. Grey relation analysis (GRA) was used to assess the comprehensive quality consistency of the two decoctions. The CRITIC results revealed certain differences in chemical constituents and pharmacological effects between the selected DGCM and TD. Notably, DGD‐A/C exhibited a significant difference from TD (p > 0.05), whereas DGD‐B demonstrated no significant difference from TD (p > 0.05). The GRA analysis demonstrated that the overall quality consistency between DGD‐B and TD was the highest among the three manufacturers. This study presents a method for evaluating the quality consistency of DGCM and TD of SGD, offering novel insights into the evaluation of consistency between DGCM and TD. [ABSTRACT FROM AUTHOR]

The chlorophyll-a (Chla) concentration is a key parameter to evaluate the eutrophication conditions of water, which is very important for monitoring algal blooms. Although Geostationary Ocean Color Imager (GOCI) has been widely used in Chla inversion, the consistency of the Rayleigh-corrected reflectance (Rrc) of GOCI and GOCI-II sensors still needs to be further evaluated, and a model suitable for lakes with complex optical properties needs to be constructed. The results show that (1) the derived Chla values of the GOCI and GOCI-II synchronous data were relatively consistent and continuous in three lakes in China. (2) The accuracy of the random forest (RF) model (R2 = 0.84, root mean square error (RMSE) =11.77 μg/L) was higher than that of the empirical model (R2 = 0.79, RMSE = 12.63 μg/L) based on the alternative floating algae index (AFAI). (3) The interannual variation trend fluctuated, with high Chla levels in Lake Chaohu in 2015 and 2019, while those in Lake Hongze were high in 2013, 2015, and 2022, and those in Lake Taihu reached their peak in 2017 and 2019. There were three types of diurnal variation patterns, namely, near-continuous increase (Class 1), near-continuous decrease (Class 2), and first an increase and then a decrease (Class 3), among which Lake Chaohu and Lake Taihu occupied the highest proportion in Class 3. The results analyzed the temporal and spatial variations of Chla in three lakes for 12 years and provided support for the use of GOCI and GOCI-II data and monitoring of Chla in optical complex inland waters. [ABSTRACT FROM AUTHOR]

Evaluating the consistency of herb injectable formulations could improve their product quality and clinical safety, particularly concerning the composition and content levels of trace ingredients. Panax notoginseng Saponins Injection (PNSI), widely used in China for treating acute cardiovascular diseases, contains low-abundance (10%–25%) and trace saponins in addition to its five main constituents (notoginsenoside R 1 , ginsenoside Rg 1 , ginsenoside Re, ginsenoside Rb 1 , and ginsenoside Rd). This study aimed to establish a robust analytical method and assess the variability in trace saponin levels within PNSI from different vendors and formulation types. To achieve this, a liquid chromatography-triple quadrupole mass spectrometry (LC-MS/MS) method employing multiple ions monitoring (MIM) was developed. A "post-column valve switching" strategy was implemented to eliminate highly abundant peaks (NR 1 , Rg 1 , and Re) at 26 min. A total of 51 saponins in PNSI were quantified or relatively quantified using 18 saponin standards, with digoxin as the internal standard. This study evaluated 119 batches of PNSI from seven vendors, revealing significant variability in trace saponin levels among different vendors and formulation types. These findings highlight the importance of consistent content in low-abundance and trace saponins to ensure product control and clinical safety. Standardization of these ingredients is crucial for maintaining the quality and effectiveness of PNSI in treating acute cardiovascular diseases. [ABSTRACT FROM AUTHOR]

Jie Song,1 Danfeng Yin,2 Xiaohui Liu,3 Xiaohui Li,1 Kewu Huang2 1Department of Respiratory and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People’s Republic of China; 3Department of Evidence-Based Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, People’s Republic of ChinaCorrespondence: Kewu Huang, Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People’s Republic of China, Tel +861085231167, Email kewuhuang@126.comPurpose: This study aimed to assess the consistency of hand-held electronic incremental threshold loading device (I-TLD) and traditional constant threshold loading device (C-TLD) in measuring the perception of dyspnea (POD) in humans.Patients and methods: Thirty-eight patients with stable chronic obstructive pulmonary disease (COPD) and 41 non-COPD subjects were recruited for the study, all of whom were subjected to an external loading breathing test by gradually increasing the inspiratory load starting from 0 to 5, 10, 20, and 30 cmH2O oral pressure using I-TLD and C-TLD. The Borg score measurement was performed immediately after the loading breath of each level. The linear regression slope a of Borg scores vs percentage of oral pressure from the patients’ maximum represented patients’ POD. The consistency of POD measured by the two devices was analyzed by two Related Samples Wilcoxon test, Spearman correlation analysis, and Bland-Altman analysis.Results: There was no significant difference in slope a measured by the two devices in all subjects. The Spearman correlation analysis revealed that the slope a measured by the two devices in the inspiratory loading breath test had a significant correlation: in COPD patients, r = 0.678, (p < 0.001) and in non-COPD subjects, r = 0.603, (p < 0.001). For the results of the Bland-Altman analysis of the whole subjects, 3.8% (3/79) points were outside of the 95% LoA confidence interval (CI) (− 10.380, 9.457), and the LoA CI was acceptable, which depicted that the two devices were consistent in their estimation.Conclusion: I-TLD was consistent with C-TLD in measuring POD in COPD patients and non-COPD subjects. I-TLD may be used as an alternative method to replace C-TLD to measure POD in COPD patients and non-COPD subjects.Keywords: consistency evaluation, chronic obstructive pulmonary disease, external load breathing test, perception of dyspnea

Ceftriaxone sodium is an antibiotic used clinically.We have developed a strategy for evaluation of the consistency of ceftriaxone sodium for injection and used it to replicate the formulation. Comparison of the quality of generic and original raw materials and analysis of the process of drug production revealed that the quality of ceftriaxone sodium raw material is the most important factor in replicating the formulation, and a key factor affecting the quality of raw materials is the ceftriaxone sodium crystallisation process. Secondly, the solution clarity of the formulation, another key aspect, was addressed by controlling the leachable components found in rubber closures used in the packaging. The time to achieve therapeutic efficacy of the preparation could be preliminarily evaluated by determining the rates of salt formation and protein binding. Finally, the key quality control index and drug quality standards were evaluated by systematic comparison of the pharmaceutical index of generic products with that of the original preparation, particularly the impurity profile. On this basis, a strategy for the evaluation of ceftriaxone sodium for injection has been developed. [ABSTRACT FROM AUTHOR]

Background: Ulcer area is a critical parameter in diabetic foot ulcer assessment but existing methods have deficiencies for routine measurement. Aim: We hypothesized that the Image J‐based Computer Analysis method has a high level of agreement with the commonly used Maximum Length and Width and the Transparent Dressing‐based Square Grid methods and aimed to test the consistency and verify the feasibility of the Image J‐based Computer Analysis method in the routine assessment of ulcers. Methods: Outpatient attendees with diabetic foot ulcers at the Department of Endocrinology of Sun Yat‐sen Memorial Hospital were enrolled between October 2020 and October 2021. The three methods sequentially assessed the area of 65 included ulcers. Results were analysed using one‐way analysis of variance and Bland–Altman plots to perform consistency analysis. Results: The mean ± standard deviation ulcer area measured using the three methods were 14.79 ± 5.39, 14.35 ± 5.26, and 14.30 ± 5.26 cm2, respectively. The measurement differences among the three groups or between any two were not statistically significant. Bland–Altman plots showed good consistency between the Image J‐based Computer Analysis and the other two methods. Conclusion: The Image J‐based Computer Analysis method can be interchanged with the other methods to assess ulcer areas. It is freely accessible, accurate and home‐operable, thus worth consideration by nurses for routine ulcer area assessment. Summary statement: What is already known about this topic? Ulcer area is a critical parameter in diabetic foot ulcer assessment, monitoring and for predicting the outcome of treatment efficacy.The Maximum Length and Width and the Transparent Dressing‐based Square Grid methods bear some deficiencies in daily ulcer area monitoring. What this paper adds? This study measured the area of diabetic foot ulcers using the Image J‐based Computer Analysis method and verified its consistency of measurement compared to current common methods, and its feasibility for routine assessment of ulcers. The implications of this paper: The Image J‐based Computer Analysis method is freely accessible, accurate and feasible for routine area assessment of diabetic foot wounds; the home measurable feature is especially applicable for patients with diabetic foot who need plantar decompression, rendering it a practical tool for home wound monitoring. [ABSTRACT FROM AUTHOR]

This study explores the dissolution mechanism and absorption process of compound Danshen tablets (CDTs) and compound Danshen capsules (CDCs) in vitro. Taking the cell index as the evaluation index of dissolution and absorption of multi-component solid preparations of CDTs and CDCs, it breaks through the idea of traditional research. We used real-time cell-based assay (RTCA) to provide a new idea and method for the consistency evaluation of traditional Chinese medicine (TCM) compound preparations. The drug dissolution and absorption simulation system (DDASS) was established to obtain the dissolution and absorption samples of compound Danshen solid preparations at different time points. The cell index (CI) of the sample to H9C2 cells was detected by RTCA technology, and the dissolution and absorption percentage were calculated based on this index to obtain the dissolution and absorption kinetics model. Meanwhile, one batch of tablets and one batch of capsules (batch numbers ZKC1816 and 202101001) were selected to conduct the overall animal pharmacodynamic experiment to verify the feasibility of drug effect evaluation with cell index as an indicator. The best fitting model of dissolution curves of each batch of CDTs and CDCs is the Weibull model. There was a good correlation (r > 0.86) between the dissolution-absorption-pharmacodynamic curve. Based on RTCA technology, we have established the comprehensive evaluation method for cell biology of compound Danshen solid preparations in line with the overall concept of TCM and a synchronous evaluation system of dissolution and absorption in vitro of new TCM compound solid preparations. [ABSTRACT FROM AUTHOR]

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Combining Landsat-8 and Sentinel-2 images is an effective approach to obtain high spatiotemporal resolution data for Earth observation and remote sensing modeling. The differences between Landsat-8 and Sentinel-2 products, such as the reflectance at the top of atmosphere (TOA) and land surface, should be compared and evaluated to make sure they are spectrally consistent. Their consistency has been evaluated and the differences have been empirically corrected at mid-low latitudes, but in high latitude areas with a higher solar zenith angle (SZA), the similar work has not been explored. In this study, Landsat-8 and Sentinel-2 TOA and surface reflectance in Alaska as well as some surface parameters, such as the normalized difference vegetation index (NDVI) and normalized difference snow index (NDSI), were compared using the massive data distributed on Google earth engine (GEE) online platform, and their consistency was evaluated and the uncertainty was analyzed. Some empirical models were suggested to convert Sentinel-2 products to be consistent with Landsat-8 products at all bands. The results show that TOA reflectance is more consistent than surface reflectance in Alaska. This study suggests that the consistency between Landsat-8 and Sentinel-2 at high latitudes should be paid more attention because their consistency is lower than that at mid-low latitudes. [ABSTRACT FROM AUTHOR]

A new approach to re‐evaluating consistency in the analytic hierarchy process (AHP) using simulated consistent matrices is presented. The proposed consistency evaluation method makes use of statistically significant deviations from the average consistency measure for the simulated matrices. This addresses most of the deficiencies of the conventional consistency ratio (CR) method. A pairwise comparison matrix (PCM) is adjudged inconsistent by the proposed method if its consistency measure exceeds the modeled consistency threshold. Comparison of the consistency evaluation for simulated nearly‐consistent matrices using the proposed method shows a statistically significant reduction of the order‐specific bias in comparison with the CR method. The proportion of nearly consistent matrices which are evaluated as 'inconsistent' increases more than three‐folds when the evaluation is done using the CR method. Several examples are presented which illustrate the advantages of the proposed method and differences in classification with the CR approach. Evaluation of consistency using the proposed method of statistically derived thresholds from simulated, nearly consistent matrices is more nuanced and objective, as well as intuitive in its interpretability. [ABSTRACT FROM AUTHOR]

Objectives: The consistency of spatial distribution pattern before and after generalization is an important factor to evaluate the quality of land use data. Considering the lack of quantitative analysis and visualization in spatial distribution model evaluation of data, we put forward a new evaluation method based on the unique autocorrelation of spatial data. Methods: Firstly, we establish the spatial weight matrix using the semantic distance of data and calculate global and local autocorrelation of data before and after processing by Moran's I index. Secondly, we use Moran scatter plot and LISA (local indicators of spatial association) aggregation map to visualize the quality of spatial distribution patterns. Results: Compared with the traditional data quality evaluation method, the proposed method can better evaluate the consistency of spatial distribution pattern of global map by taking into account the semantic relation of the data, obtaining the quantifiable aggregation degree and contrasting by the visual method. Conclusions: In cognitive experiments, we take the land type data been scale transformed which cause data quality problems mostly as an example. The experimental results accord with human cognitions and the experimental method is practical. [ABSTRACT FROM AUTHOR]

The consistency evaluation, which is largely unexplored is crucial in regulating the quality and efficacy of generic drugs. In this report, after generic ibuprofen (IBU) sustained-release pellets were developed and validated as bioequivalent to the reference list drug (RLD) in 48 healthy human volunteers (p

A series of Landsat satellites has been widely used to monitor water quality in coastal and inland complex water, but a solo Landsat satellite may not provide enough information because of its long revisit time (16-day) and frequent cloud cover, and hence sometimes it is necessary to fuse or combine the images from two or more satellites, for example, Landsat-7 and Landsat-8. However, the consistency of the two satellites has not been fully evaluated when they are used to estimate the colored dissolved organic matter (CDOM), an important water quality indicator. In this study, we used 210 Landsat-7 images and 185 neighboring Landsat-8 images from April 8, 2013 to December 26, 2018 in Sacramento River and Northern San Francisco Bay, USA, and extracted 225,265 paired samples to make the evaluation. A new Landsat-7 CDOM remote sensing model was established using these samples. The results show that the two satellites have good consistency for estimating low-level CDOM (R2 = 0.79, RMSE = 0.05 m–1, and MRE = 11.8%). This study shows that by combining Landsat-7 and Landsat-8 data, the available cloud-free observation frequency can be doubled compared with the frequency of using solo Landsat-8, and hence provide more detailed information for monitoring quality of complex water. [ABSTRACT FROM AUTHOR]

The interchangeable use of different herbs to prepare the same formulation is a common practice in Traditional Chinese Medicine (TCM). However, this practice would require the component herbs to share similar compositions, at least in terms of the bioactive agents, to ensure they can replace each other in drug preparation. In this study, we developed an effective and comprehensive high-performance liquid chromatography-diode array detector (HPLC-DAD) method for simultaneous analysis of 11 phenolic compounds in the methanol extracts of Dendrobium huoshanense, Dendrobium nobile (D. nobile), Dendrobium chrysotoxum (D. chrysotoxum), and Dendrobium fimbriatum (D. fimbriatum), which have been identified as interchangeable ingredients for the same TCM preparation “Shihu” in the Chinese pharmacopeia (ChP). The consistency of the four Dendrobium species was evaluated on the basis of the presence of the 11 investigated compounds and the HPLC fingerprints of the methanol extracts of the plants. When gradient elution was performed with a solvent system of acetonitrile and water on a Zorbax Eclipse XDB-C18 (150 mm × 4.6 mm, 5 μm) with monitoring at 220 nm, all 11 investigated compounds were isolated at the baseline. The established HPLC method showed excellent linearity (all analytical curves showed relative coefficients [R2] > 0.999), sensitivity, precision (relative standard deviation [RSD] < 2%), and accuracy (recovery, 90.65–99.17%). These findings confirmed that the method we constructed was reliable. Quantification analysis showed significant differences in the contents of the investigated polyphenols in the four Dendrobium species. Evaluations of consistency revealed that the similarities among the four species were 0.299–0.906 in assessments based on the 11 polyphenols and 0.685–0.968 in assessments based on HPLC fingerprints. Thus, the components of the four Dendrobium species may be significantly different, and more experiments are required to determine whether they can be used interchangeably in the same amounts for preparing the formulation according to ChP.

Abstract Background Cohen’s κ coefficient is often used as an index to measure the agreement of inter-rater determinations. However, κ varies greatly depending on the marginal distribution of the target population and overestimates the probability of agreement occurring by chance. To overcome these limitations, an alternative and more stable agreement coefficient was proposed, referred to as Gwet’s AC1. When it is desired to combine results from multiple agreement studies, such as in a meta-analysis, or to perform stratified analysis with subject covariates that affect agreement, it is of interest to compare several agreement coefficients and present a common agreement index. A homogeneity test of κ was developed; however, there are no reports on homogeneity tests for AC1 or on an estimator of common AC1. In this article, a homogeneity score test for AC1 is therefore derived, in the case of two raters with binary outcomes from K independent strata and its performance is investigated. An estimation of the common AC1 between strata and its confidence intervals is also discussed. Methods Two homogeneity tests are provided: a score test and a goodness-of-fit test. In this study, the confidence intervals are derived by asymptotic, Fisher’s Z transformation and profile variance methods. Monte Carlo simulation studies were conducted to examine the validity of the proposed methods. An example using clinical data is also provided. Results Type I error rates of the proposed score test were close to the nominal level when conducting simulations with small and moderate sample sizes. The confidence intervals based on Fisher’s Z transformation and the profile variance method provided coverage levels close to nominal over a wide range of parameter combination. Conclusions The method proposed in this study is considered to be useful for summarizing evaluations of consistency performed in multiple or stratified inter-rater agreement studies, for meta-analysis of reports from multiple groups and for stratified analysis.

The methods of consistency evaluation are introduced for the finite element simulation and test of the aircraft structure. First,the strain interpolation method is studied based on the element shape functions,and the transformation method is given for the consistency between simulation and test strain gauges; Second,linearization correction for the test strain gauges was obtained by using the least squares principle. The consistency evaluation methods are investigated based on graph partition and probability respectively. Finally consistency evaluation is carried out for the computation and test of the civil aircraft structure. It is shown that the evaluation results can provide support for the modification of the model.

An in-line monitoring method for the elution process of Ginkgo biloba L. leaves using visible and near-infrared spectroscopy in conjunction with multivariate statistical process control (MSPC) was established. Experiments, including normal operating batches and abnormal ones, were designed and carried out. The MSPC model for the elution process was developed and validated. The abnormalities were detected successfully by the control charts of principal component scores, Hotelling T2, or DModX (distance to the model). The results suggested that the established method can be used for the in-line monitoring and batch-to-batch consistency evaluation of the elution process.

Objective To evaluate the consistency of three chemiluminescence detection systems for specific IgG and IgM antibodies of novel coronaviruses（SARS-CoV-2）. Methods Forty-six serum samples，including 23 positive cases of SARS-CoV-2 and 23 negative cases，were collected. We used the three systems A，B，C and their supporting re⁃ agents to detect SARS-CoV-2 antibodies on 46 serum samples. Referring to CLSI EP15-A3 and EP9-A3 protocols，precision evaluation and methodological comparison were carried out. The quantitative results were compared and analyzed by using passing-bablok. Chi-square test was used to analyze the difference among qualitative results. The difference was respectively analyzed between the qualitative results and final nucleic acid test results. Results The precision of IgG antibody detection of systems A，B and C was 4. 59%-5. 08%，4. 4%-4. 91%，and 4. 25%-8. 09% while the precision of IgM was 4. 92%-5. 39%，3. 97%-4. 19% and 4. 18%-8. 44%，respectively. The correlation coefficient（r）of regression equation among the specific IgG antibody quantitative results of the three detection systems was within 0. 835-0. 871，the intercept was 0. 017-0. 025，and the slope was 0. 034-0. 173，respectively. The correlation coefficient（r）of the regression equation among the specific IgM antibody quantitative test results was within 0. 671-0. 885，the intercept was -0. 090- 0. 025，and the slope was 0. 098-0. 437，respectively. The coincidence rate between the specific IgG antibody test results and the final clinical diagnosis was 91. 4%-95. 6%；and the coincidence rate between the specific IgM antibody test results and the final clinical diagnosis was 65. 2%-86. 9%. Conclusion The results of detection of IgG antibodies by the three systems are in good agreement，but the results of detection of IgM antibodies are different from those of nucleic acid detection and clinical diagnosis；the serum antibody detection will play an important role in the clinical diagnosis and epidemiological investigation for SARS-CoV-2 infection. [ABSTRACT FROM AUTHOR]

Introduction: Dispensing granule, an innovative product of traditional Chinese medicine decoction, is widely practiced in clinic. As a prerequisite to support the clinical medication, quality consistency between dispensing granule and traditional decoction need to be evaluated. Furthermore, a generally applicable strategy for consistency evaluation of dispensing granule is needed. Objective: In this study, we aimed to propose an integrated quality‐based strategy to assess consistency between dispensing granule and traditional decoction taking Coptidis Rhizoma (CR) as a case study. Methodology: For chemical consistency evaluation, efficacy‐related Coptis alkaloids were quantified with high‐performance liquid chromatography (HPLC). The "Mean ± 3SD" of analyte contents in traditional decoction was considered as the criterion of consistency. And, as auxiliary analysis, principal component analysis (PCA) was employed for data visualisation. For biological consistency evaluation, two one‐side t‐tests and 90% confidence intervals of the geometric mean ratio of antibacterial zone diameter and 50% inhibitory concentration (IC50) of α‐glucosidase inhibition were calculated. The scope of 80.00% to 125.00% was taken as in vitro bioequivalence interval. It was considered internally consistent with traditional decoction when the chemical and biological indices of dispensing granule fulfilled the preset criteria simultaneously. Results: Eight out of 20 batches of CR dispensing granule were demonstrated consistent with traditional decoction in chemistry and biological activities. Conclusions: A generally applicable strategy was recommended that integrates chemical and biological characteristics for consistency evaluation of dispensing granule. The study aimed at proposing a generally applicable strategy for consistency evaluation between dispensing granule and traditional decoction both in chemistry and bioactivity. Coptidis Rhizoma was used as a case study. Principal component analysis and "Mean ± 3SD" were employed to evaluate chemical consistency. Two one‐side t‐tests and 90% confidence interval were calculated and the scope of 80.00% to 125.00% was taken as in vitro bioequivalence interval. [ABSTRACT FROM AUTHOR]

Abstract To improve the accuracy of fault location system, several short-circuit tests need to be conducted before being brought into service in autotransformer (AT) feeding systems for high-speed railways in China. However, no systematic algorithm yet exists to evaluate the consistency of the current distribution of short-circuit tests. A methodology is proposed in this paper to address this problem. Based on Kirchhoff’s current law and the generalized method of symmetrical components, the current deviations of the AT feeding systems are analysed and then normalized with the short-circuit current as they vary greatly with systems and short-circuit sites. It is also found that the short-circuit current varies with the calculation methods, and its unbiased standard deviation also reflects the consistency of the short-circuit test. The mean and maximum of the current deviations, as well as the unbiased standard deviation of the short-circuit current, show the consistency of the short-circuit test from different aspects, although the last two items are highly relevant. Therefore, a unified evaluation index is defined as the sum of the three items, and then applied in two case studies to test its performance. The results show that, the proposed index can clearly distinguish the consistency of the short-circuit tests and may be used to sort the short-circuit tests for fault location systems. Besides, some short-circuit tests may have very poor consistency indices, and thus are not applicable to the tuning of fault location systems. In the authors’ opinion, the determination of the threshold of the proposed index needs further investigation.

Abstract Background Quality assessment of medical images is highly related to the quality assurance, image interpretation and decision making. As to magnetic resonance (MR) images, signal-to-noise ratio (SNR) is routinely used as a quality indicator, while little knowledge is known of its consistency regarding different observers. Methods In total, 192, 88, 76 and 55 brain images are acquired using T2 *, T1, T2 and contrast-enhanced T1 (T1C) weighted MR imaging sequences, respectively. To each imaging protocol, the consistency of SNR measurement is verified between and within two observers, and white matter (WM) and cerebral spinal fluid (CSF) are alternately used as the tissue region of interest (TOI) for SNR measurement. The procedure is repeated on another day within 30 days. At first, overlapped voxels in TOIs are quantified with Dice index. Then, test-retest reliability is assessed in terms of intra-class correlation coefficient (ICC). After that, four models (BIQI, BLIINDS-II, BRISQUE and NIQE) primarily used for the quality assessment of natural images are borrowed to predict the quality of MR images. And in the end, the correlation between SNR values and predicted results is analyzed. Results To the same TOI in each MR imaging sequence, less than 6% voxels are overlapped between manual delineations. In the quality estimation of MR images, statistical analysis indicates no significant difference between observers (Wilcoxon rank sum test, p w ≥ 0.11; paired-sample t test, p p ≥ 0.26), and good to very good intra- and inter-observer reliability are found (ICC, p icc ≥ 0.74). Furthermore, Pearson correlation coefficient (r p ) suggests that SNRwm correlates strongly with BIQI, BLIINDS-II and BRISQUE in T2 * (r p ≥ 0.78), BRISQUE and NIQE in T1 (r p ≥ 0.77), BLIINDS-II in T2 (r p ≥ 0.68) and BRISQUE and NIQE in T1C (r p ≥ 0.62) weighted MR images, while SNRcsf correlates strongly with BLIINDS-II in T2 * (r p ≥ 0.63) and in T2 (r p ≥ 0.64) weighted MR images. Conclusions The consistency of SNR measurement is validated regarding various observers and MR imaging protocols. When SNR measurement performs as the quality indicator of MR images, BRISQUE and BLIINDS-II can be conditionally used for the automated quality estimation of human brain MR images.

Matrix metalloproteinase‐12 (MMP‐12) is an attractive therapeutic target for drug design and discovery for many human conditions. In this study, six swarm intelligence optimization algorithms were applied to optimize the parameters of the model generated using the LibSVM toolkit in MATLAB to identify potential MMP‐12 inhibitors (MMP‐12is); six types of optimized support vector machine (SVM) models were established. The highest prediction accuracy obtained was 98.89 %, which was equivalent to the effect of the optimal "RF+opt" model. All six models passed the Y‐randomization test and showed excellent performance with reliable results. Virtual screening identified 371 molecules with a predictive probability score greater than 0.9. The optimized SVM models, in addition to "RF+opt" and "SVM2" models, were combined to establish a consistency evaluation system. Our results revealed six non‐toxic potential MMP‐12is. This process provides a strong theoretical basis for the design, synthesis, and development of novel drugs targeting MMP‐12. [ABSTRACT FROM AUTHOR]

The quality control of Chinese medicinal decoction pieces is one of the key tasks in the traditional Chinese medicine industry. In this study, multi-source information fusion was employed to fuse the data from near-infrared spectroscopy, electronic tongues, and other tests and establish an overall quality consistency evaluation method for Atractylodis Macrocephalae Rhizoma, which provided methodological support for the overall quality evaluation of Atractylodis Macrocephalae Rhizoma. The near-infrared spectroscopy information was measured in both static and dynamic states for 23 batches of Atractylodis Macrocephalae Rhizoma samples from different sources, and the electronic tongue sensory information, moisture content, and leachate content were measured. The overall quality of Atractylodis Macrocephalae Rhizoma was evaluated by multi-source information fusion. The results showed that the near-infrared spectroscopy information of 16122103, 801000509, 801000352, 701003656, HX21L01, and 160956 was different from that of other batches of Atractylodis Macrocephalae Rhizoma powder in the static state, and 701003298, 16122103, 701003656, 701003107, 801000229, and 18090404 were the different batches in the dynamic state. The moisture content showed no significant difference between batches. The leachate content in the batch 801000509 was different from that in other batches. The electronic tongue sensory information of 150721004, 151237, 160703004, HX21M01, HX21K04, HX21K01, and 601003516 was different from that of other batches. Furthermore, data layer fusion was employed to analyze the overall quality of Atractylodis Macrocephalae Rhizoma. Four batches, 150721004, HX21M01, HX21K04, and HX21K01, showed the parameters exceeding the 95% control limits and differed from the other samples in terms of the overall quality. This study integrated the information of moisture, near-infrared spectroscopy, and other sources to evaluate the quality consistency among 23 batches of Atractylodis Macrocephalae Rhizoma samples, which provides a reference for the quality consistency evaluation of Chinese medicinal decoction pieces.

Objective To develop and verify the sample size formulas for quantitative data consistency evaluation based on the least square regression method. Methods According to the principle of least square regression-based quantitative consistency evaluation,statistical inference,and formula derivation,we developed the formulas for calculating sample size based on regression constant and regression coefficient.Furthermore,the accuracy of the formulas was verified by the data of three examples,and the results were compared with those of the sample size formula established based on the Bland-Altman(BA)method. Results The sample size formulas for regression-based quantitative consistency evaluation were deduced,and the accuracy of the formulas was verified by three examples.In addition,the results obtained with this formula had differences compared with those of the sample size formula established based on the BA method.Furthermore,consistent conclusions could be obtained by regression analysis and BA analysis with the sample size calculated with the regression method.However,with the sample size calculated based on the BA method,the consistency conclusion of regression analysis and BA analysis was sometimes not valid. Conclusion A sample size formula for quantitative consistency evaluation based on the regression method was proposed for the first time,which provided methodological support for the research in this field.

Background: Cohen's κ coefficient is often used as an index to measure the agreement of inter-rater determinations. However, κ varies greatly depending on the marginal distribution of the target population and overestimates the probability of agreement occurring by chance. To overcome these limitations, an alternative and more stable agreement coefficient was proposed, referred to as Gwet's AC1. When it is desired to combine results from multiple agreement studies, such as in a meta-analysis, or to perform stratified analysis with subject covariates that affect agreement, it is of interest to compare several agreement coefficients and present a common agreement index. A homogeneity test of κ was developed; however, there are no reports on homogeneity tests for AC1 or on an estimator of common AC1. In this article, a homogeneity score test for AC1 is therefore derived, in the case of two raters with binary outcomes from K independent strata and its performance is investigated. An estimation of the common AC1 between strata and its confidence intervals is also discussed.Methods: Two homogeneity tests are provided: a score test and a goodness-of-fit test. In this study, the confidence intervals are derived by asymptotic, Fisher's Z transformation and profile variance methods. Monte Carlo simulation studies were conducted to examine the validity of the proposed methods. An example using clinical data is also provided.Results: Type I error rates of the proposed score test were close to the nominal level when conducting simulations with small and moderate sample sizes. The confidence intervals based on Fisher's Z transformation and the profile variance method provided coverage levels close to nominal over a wide range of parameter combination.Conclusions: The method proposed in this study is considered to be useful for summarizing evaluations of consistency performed in multiple or stratified inter-rater agreement studies, for meta-analysis of reports from multiple groups and for stratified analysis. [ABSTRACT FROM AUTHOR]

Pairwise comparisons have been a long-standing technique for comparing alternatives/criteria and their role has been pivotal in the development of modern decision-making methods. Since several types of pairwise comparison matrices (e.g., multiplicative, additive, fuzzy) are proposed in literature, in this paper, we investigate, for which type of matrix, decision-makers are more coherent when they express their subjective preferences. By performing an experiment, we found that the additive approach provides the worst level of coherence. [ABSTRACT FROM AUTHOR]

Land cover plays an important role in the climate and biogeochemistry of the Earth system. It is of great significance to produce and evaluate the global land cover (GLC) data when applying the data to the practice at a specific spatial scale. The objective of this study is to evaluate and validate the consistency of the Moderate Resolution Imaging Spectroradiometer (MODIS) land cover product (MCD12Q1) at a provincial scale (Anhui Province, China) based on the Chinese 30 m GLC product (GlobeLand30). A harmonization method is firstly used to reclassify the land cover types between five classification schemes (International Geosphere Biosphere Programme (IGBP) global vegetation classification, University of Maryland (UMD), MODIS-derived Leaf Area Index and Fractional Photosynthetically Active Radiation (LAI/FPAR), MODIS-derived Net Primary Production (NPP), and Plant Functional Type (PFT)) of MCD12Q1 and ten classes of GlobeLand30, based on the knowledge rule (KR) and C4.5 decision tree (DT) classification algorithm. A total of five harmonized land cover types are derived including woodland, grassland, cropland, wetland and artificial surfaces, and four evaluation indicators are selected including the area consistency, spatial consistency, classification accuracy and landscape diversity in the three sub-regions of Wanbei, Wanzhong and Wannan. The results indicate that the consistency of IGBP is the best among the five schemes of MCD12Q1 according to the correlation coefficient (R). The “woodland” LAI/FPAR is the worst, with a spatial similarity (O) of 58.17% due to the misclassification between “woodland” and “others”. The consistency of NPP is the worst among the five schemes as the agreement varied from 1.61% to 56.23% in the three sub-regions. Furthermore, with the biggest difference of diversity indices between LAI/FPAR and GlobeLand30, the consistency of LAI/FPAR is the weakest. This study provides a methodological reference for evaluating the consistency of different GLC products derived from multi-source and multi-resolution remote sensing datasets on various spatial scales.

In the present study, we aimed to compare the pharmacokinetics and pharmacodynamics between Glucophage ® and a generic metformin formulation in a diabetic rat model in order to assess the bioequivalence of the generic formulation. Adult male Zucker diabetes fatty rats received Glucophage ® or the generic metformin through gastric gavage at a dose of 180 mg/kg (n = 6 per condition). Both pharmacokinetic parameters (AUC0-t, AUC0-∞, Cmax) of metformin and plasma glucose levels were compared between the two groups. For pharmacodynamics, rats received Glucophage® or the generic metformin at doses of 180 and 300 mg·kg-1·d-1 for 6 weeks. The measurements included body weight, fasting plasma glucose, glycosylated serum protein (GSP) and serum insulin. Data were analyzed with SPSS 22.0 and Prism 7. The level of statistical significance was set at P<0.05. In single dosing experiments, pharmacokinetic parameters (t1/2, AUC0-t and Cmax) did not differ between Glucophage® and the generic metformin (P>0.05). However, plasma glucose was significantly higher in the generic metformin group at 2 h (P = 0.03) and 4 h (P = 0.04) after drug treatment. In repeated dosing experiments, fasting glucose, HOMA-IR and body weight in rats receiving high-dose Glucophage® were significantly lower at the end of the 6-week treatment period than those in rats receiving high-dose generic metformin (P<0.05 for all). GSP and serum insulin did not differ significantly between the two groups. In rats receiving low-dose metformin, fasting glucose was lower in the Glucophage® group. HOMA-IR and body weight did not differ between the two groups. Moreover, blood lipids did not differ significantly between the two groups. The generic metformin used in the current study did not differ significantly in pharmacokinetic characteristics with Glucophage®. However, Glucophage® was superior in terms of glucose control, body weight loss and insulin sensitivity in repeated administration. [ABSTRACT FROM AUTHOR]

To improve the accuracy of fault location system, several short-circuit tests need to be conducted before being brought into service in autotransformer (AT) feeding systems for high-speed railways in China. However, no systematic algorithm yet exists to evaluate the consistency of the current distribution of short-circuit tests. A methodology is proposed in this paper to address this problem. Based on Kirchhoff’s current law and the generalized method of symmetrical components, the current deviations of the AT feeding systems are analysed and then normalized with the short-circuit current as they vary greatly with systems and short-circuit sites. It is also found that the short-circuit current varies with the calculation methods, and its unbiased standard deviation also reflects the consistency of the short-circuit test. The mean and maximum of the current deviations, as well as the unbiased standard deviation of the short-circuit current, show the consistency of the short-circuit test from different aspects, although the last two items are highly relevant. Therefore, a unified evaluation index is defined as the sum of the three items, and then applied in two case studies to test its performance. The results show that, the proposed index can clearly distinguish the consistency of the short-circuit tests and may be used to sort the short-circuit tests for fault location systems. Besides, some short-circuit tests may have very poor consistency indices, and thus are not applicable to the tuning of fault location systems. In the authors’ opinion, the determination of the threshold of the proposed index needs further investigation. [ABSTRACT FROM AUTHOR]

Inland lakes are generally an important source of drinking water, and information on their water quality needs to be obtained in real time. To date, Moderate-resolution imaging spectroradiometer (MODIS) data have played a critical, effective and long-term role in fulfilling this function. However, the MODIS instruments on board both the Terra and Aqua satellites have operated beyond their designed five-year mission lifespans (Terra was launched in 1999, whereas Aqua was launched in 2002), and these instruments may stop running at any time in the near future. The Visible Infrared Imager Radiometer Suite (VIIRS) on board the Suomi National Polar-Orbiting Partnership (Suomi NPP, which was launched in Oct 2011) is expected to provide a consistent, long-term data record and continue the series of observations initiated by MODIS. To date, few evaluations of the consistency between VIIRS and MODIS have been conducted for turbid inland waters. In this study, we first used synchronous MODIS/Aqua and VIIRS/NPP data (±1 h) collected during 2012–2015 to evaluate the consistency of Rayleigh-corrected reflectance ( R rc ) observations over Lake Hongze (the fourth-largest freshwater lake in China), since accurate remote sensing reflectance ( R rs ) values cannot be acquired over turbid inland waters. Second, we used recently developed algorithms based on R rc in the red band to estimate the concentrations of suspended particulate matter (SPM) from MODIS/Aqua and VIIRS/NPP data. Finally, we assessed the consistency of the SPM products derived from MODIS/Aqua and VIIRS/NPP. The results show the following. (1) The differences in R rc among the green (VIIRS 551 nm and MODIS 555 nm) and red bands (VIIRS 671 nm and MODIS 645 nm) indicate a satisfactory consistency, and the unbiased percentage difference (UPD) is <12%. Meanwhile, the results for the near infrared (NIR) band (MODIS 859 nm and VIIRS 862 nm) indicate relatively large differences ( UPD = 21.84%). (2) The satellite-derived SPM products obtained using MODIS/Aqua and VIIRS/NPP have a satisfactory degree of consistency (0–150 mg/L SPM: R 2 = 0.81, UPD < 16% and 0–80 mg/L SPM: R 2 = 0.85, UPD < 12%, respectively). These results demonstrate that VIIRS/NPP can continue to record the SPM observations initiated by MODIS/Aqua for turbid inland waters and establish environmental datasets over long time periods to support water quality management endeavors. [ABSTRACT FROM AUTHOR]

Array transducer and transducer combination technologies are evolving rapidly. While adapting transmitter combination technologies, the parameter consistencies between each transmitter are extremely important because they can determine a combined effort directly. This study presents a consistency evaluation and calibration method for piezoelectric transmitters by using impedance analyzers. Firstly, electronic parameters of transmitters that can be measured by impedance analyzers are introduced. A variety of transmitter acoustic energies that are caused by these parameter differences are then analyzed and certified and, thereafter, transmitter consistency is evaluated. Lastly, based on the evaluations, consistency can be calibrated by changing the corresponding excitation voltage. Acoustic experiments show that this method accurately evaluates and calibrates transducer consistencies, and is easy to realize. [ABSTRACT FROM AUTHOR]

Ceftriaxone sodium for injection is an antibiotic used clinically. Here, we developed a strategy for evaluating the consistency of ceftriaxone sodium for injection. Comparison of the quality of the generic and original raw materials, and analysis of the production process revealed that the quality of the ceftriaxone sodium raw material is the most important factor affecting the quality of preparation, while the ceftriaxone sodium crystallization process is the key factor affecting the quality of raw materials. The solution clarity of the formulation, another key aspect, was addressed by controlling the leachable components found in the rubber closures used in the packaging. The time to achieve therapeutic efficacy of the preparation could be preliminarily evaluated by evaluating the rate of salt formation and the protein binding rate. Finally, the results of the tests (including water, pH, impurity profile and solution clarity) and assay were compared with the original preparation. On this basis, the critical quality attributes (CQAs) that reflect the quality of the product could be determined and a strategy for evaluating ceftriaxone sodium for injection was developed.

In this paper, a new framework to correlate the experimental data of the 304L stainless steel under multi-axial fatigue loadings using a reference curve identified from the experimental data of standard uni-axial fatigue tests is proposed. A total of 15 available fatigue crack initiation criteria are tested on the experimental data of 225 fatigue tests collected from EDF (formerly known as Electricity of France), its partners and the literature. Based on the computational results, it appears that most of the crack initiation parameters of the 15 available criteria can be used to correlate the experimental fatigue data for the 304L stainless steel under uni-axial loadings. Under bi-axial loadings, most of these parameters appear not to be quite consistent. Two criteria are modified in order to better correlate the experimental fatigue data under bi-axial loads. A simple statistical approach to evaluate the consistency of the crack initiation criteria is also proposed. Based on the limited available experimental fagtigue data and within the new framework in this paper, the computational results show that the equivalent crack initiation parameters of the Varvani-Farahani’s criterion, the modified Lagoda–Macha–Sakane’s criterion and the modified Varvani-Farahani’s criterion can be used to correlate the experimental fatigue data under both uni-axial and bi-axial loadings for the 304L stainless steel. These criteria may be used to predict the fatigue life of the material under different loading and testing conditions by using the experimental data from the standard uni-axial fatigue tests. [ABSTRACT FROM AUTHOR]

A typical approach to handle the complexity of multi-faceted decision-making problems is to use multi-attribute decision-making (MADM) methods based on pairwise comparisons. Fuzzy set theory has also been employed to cope with the uncertainty and vagueness involved in conducting the comparisons between components of a decision model. An important issue regarding the reliability of the output is the consistency of pairwise comparisons provided by the decision maker(s). Using the MADM method developed by Lu et al. (2007) as a foundation, this paper proposes an algorithm for evaluating the consistency level of pairwise comparison matrices, where linguistic data are used. A crisp numeric scale has been introduced to consider the priority of linguistic data and to avoid the complexity of handling fuzzy calculations in consistency evaluation of pairwise comparison matrices. As an advantage, the proposed method of consistency evaluation is capable of assessing the degree of inconsistency among the pairwise comparisons. Therefore, the acceptance or rejection of the pairwise comparisons can be determined based on the desired degree of tolerance in accepting inconsistent judgments. An application of a revised MADM method is then demonstrated in a case study involving flood mitigation project selection in Australia. [ABSTRACT FROM AUTHOR]

Dispensing granules of Chinese herbal medicines are gaining more and more recognition. Despite this, how to evaluate the quality consistency between traditional decoction and its corresponding dispensing granules is a challenging task. In this work, we attempted to propose a comprehensive strategy through in vitro and in vivo comparisons to overcome this challenge, taking Gardeniae Fructus as a typical case. On one hand, HPLC fingerprinting and multi-component quantification were performed to evaluate chemical similarity. On the other hand, pharmacokinetic profiling was conducted to estimate bioequivalence in terms of concentration-time curve and key pharmacokinetic parameters. The in vitro and in vivo comparison results demonstrated that there were no significant differences between these two dosage forms. This proposed strategy is applicable not only for quality consistency evaluation between dispensing granules and traditional decoction but also for broader application scenarios. [Display omitted] • A strategy was proposed to evaluate the quality consistency of herbal medicines. • Chemical similarity was evaluated through fingerprint analysis and quantification. • Bioequivalence was estimated by pharmacokinetic analysis. • The proposed strategy might be applicable for broader application scenarios. [ABSTRACT FROM AUTHOR]

• Establish complete fuel cell excitation-response model in integral form. • Originally propose analytic method of MEA parameters by micro-current excitation. • Validate accuracy, stability, robustness, and adaptability to general excitation. • Reveal evolution tendencies of MEA parameters along with operating conditions. • Practically applied in consistency evaluation of a seven-cell fuel cell stack. Consistency evaluation and degradation diagnosis of membrane electrode assemblies (MEAs) in a large-scale fuel cell stack remain critical problems despite the accelerated commercialization. In this paper, a novel analytic method of MEA parameters is proposed with high accuracy and stability, which does not require high sampling frequency and data filtering of voltage signals anymore. By means of micro-current excitation, regardless of whether it is galvanostatic or not, four key parameters of each MEA can be calculated simultaneously based on complete excitation model, including hydrogen crossover current density, electrochemical surface area (ECSA), double-layer capacitance, and short-circuit resistance. The universality of the method is demonstrated by the high consistency between galvanostatic and non-constant current excitation results. Effects of condition parameters, including operating temperature, relative humidity, and back pressure, on MEA parameters are further investigated. Low temperature, high relative humidity, and high back pressure make high ECSA. Elevated temperature and back pressure increase hydrogen crossover. Relative humidity is proved to determine the hydrogen crossover by affecting both anodic hydrogen partial pressure and membrane water content. Finally, the method is applied to evaluate the MEA consistency of a long-time-stored seven-cell stack and recognizes part of the membranes ineffective. This method shows a promising prospect in consistency-based MEA screening, aging evaluation of MEAs in a stack, and recombination of old and broken stacks. [ABSTRACT FROM AUTHOR]

In the clinical application of Traditional Chinese Medicine (TCM) substitutes, the consistency evaluation of TCM substitutes from different sources is recognized as the main bottleneck. As the most widely used analytical method in TCM consistency evaluation, fingerprint similarity evaluation suffers from insufficient method sensitivity and poor conformity with the actual characteristics of TCM, which is difficult to adapt to the analytical needs of complex substance systems of TCM. This work aims to develop an effective and more accurate method for consistency evaluation using omics strategy and machine learning algorithms. The natural calculus bovis (NCB) were graded into three groups according to the similarity to in vitro cultured bovis (IVCB), and chemical markers between samples of each grade were screened out. Support vector machine (SVM) models with different kernels were then constructed by using the chemical markers as feature variables. The results showed that the classification accuracy of the SVM classifier of NCB and the consistency evaluation SVM model classifier was 95.74% and 100.0%, respectively. The approach demonstrated in the study presented a good analytical performance with higher sensitivity, accuracy for consistency evaluation of TCM. Research strategies to ensure component consistencyof Traditional Chinese Medicine. [Display omitted] • Consistency evaluation of TCM is one of the key priorities in the application. • "grades classification-feature extraction-SVM models establishment" was described. • A more accurate method for the consistency evaluation of TCM has been established. [ABSTRACT FROM AUTHOR]

Shenmai Injection is a Chinese medicinal injection prepared from Ginseng Radix et Rhizoma Rubra and Ophiopogonis Radix, which is widely used in clinical practice for the treatment and adjuvant therapy of cardiovascular diseases with significant pharmacological effects. Proton nuclear magnetic resonance spectroscopy(~1H-NMR) has the advantages of simple and nondestructive sample pretreatment, fast analysis, abundant chemical information, quantification and no need to follow the standard curve. It is widely used in the analysis and research of complex mixtures of traditional Chinese medicine, clinical blood and urine samples. In this study, the ~1H-NMR fingerprint of Shenmai Injection was established. Thirty-two chemical components were identified, including seven amino acids, eight small molecular organic acids, one alkaloid, four sugars, two nucleosides, seven saponins, and three other components. Pearson's correlation coefficient and multivariate analysis of variance(principal component analysis combined with hierarchical cluster analysis) were applied based on the ~1H-NMR fingerprint to evaluate the quality consistency. The results showed high-quality consistency of 82 batches of Shenmai Injection. This study confirms that the ~1H-NMR fingerprint has great potential in the application of quality control of Chinese medicinal injection.

• A comprehensive approach was proposed to evaluate the quality consistency of CHG. • Metabolic profiles changes were performed to assess the similarity between two formulations of CHG. • Changes of endogenous metabolites with time are studied by using the ideas of pharmacokinetics for reference. Consistency evaluation of Traditional Chinese Medicinal preparations (TCMPs) with complex chemical composition is challenging. Chaihuang granules (CHG), as a well-known TCMP, consists of Chaihu (Bupleuri Radix) and Huangqin (Scutellariae Radix) extract. In this work, we used pharmacokinetics and metabolomics to evaluate consistency of CHG products from two different manufacturers. In the pharmacokinetic study, a liquid chromatography tandem mass spectrometry (LC–MS/MS) method was applied to determine the plasma concentration-time profiles of baicalin in rat plasma. Pharmacokinetic parameters, including the maximum concentration in blood (C max), area under the curve (AUC), the time to reach C max (T max), and half-life (T 1/2), were calculated to assess the consistency preliminarily. And there was no significant difference in these pharmacokinetic parameters between the two CHG. In LC–MS-based metabolomics, the metabolic response profiles changes based on relative distance values (RDV) to different CHG products were compared. Meanwhile, the kinetic process of 31 differential endogenous metabolites that altered by CHG were determined. Metabolomics data showed the similar metabolic regulation effects to rats of the two formulations. Both pharmacokinetic and metabolomics results indicated there was no significant difference between CHG products. Furthermore, metabolic pathways significantly altered by CHG were elucidated, including phenylalanine, tyrosine and tryptophan biosynthesis, valine, leucine and isoleucine biosynthesis, phenylalanine metabolism, and sphingolipid metabolism. Pharmacokinetics combined with metabolomics could provide a comprehensive perspective for consistency evaluation of CHG. [ABSTRACT FROM AUTHOR]