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Development and Validation of a UPLC Method for the Determination of Docetaxel and Its Related Substances in Pharmaceutical Dosage Forms, an Antineoplastic Agent
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作者 Srinivasulu Kasa Sreenivas Pippalla +1 位作者 Mopidevi Narasimha Naidu Dipak Goyal 《American Journal of Analytical Chemistry》 CAS 2024年第10期333-346,共14页
A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. ... A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. The stability-indicating capability of the method was demonstrated through forced degradation studies and a comprehensive mass balance evaluation. Chromatographic separation was achieved using an ACQUITY UPLC BEH C18 column (100 × 2.1 mm, 1.7 µm), with gradient elution. The mobile phase A comprised a mixture of water, methanol, and acetonitrile (500:300:200, v/v/v), while mobile phase B was acetonitrile and water (800:200, v/v). The flow rate was set at 0.4 mL/min, with detection at 232 nm using a photodiode array detector. The method exhibited excellent performance, with a tailing factor of 1.10 for Docetaxel. The method was rigorously validated for precision, accuracy, linearity, LOD, LOQ, ruggedness, specificity, and robustness. Forced degradation studies confirmed the method’s suitability for stability analysis. Stability testing on the drug substance was conducted following ICH guidelines. 展开更多
关键词 UPLC Method Development validation DOCETAXEL IMPURITIES ICH
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Method Development and Validation of the Simultaneous Analysis of Methylisothiazolinone, Methylchloroisothiazolinone, Benzisothiazolinone and Bronopol in Washing-Up Liquid
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作者 Etienne Jooken Ruis Amery Boudewijn Meesschaert 《American Journal of Analytical Chemistry》 CAS 2024年第1期43-55,共13页
A method of analysis for the simultaneous determination of methylisothiazolinone (MI), methylchloroisothiazolinone (CMI), benzisothiazolinone (BIT) and Bronopol (BNP) in washing-up liquid was established. The method c... A method of analysis for the simultaneous determination of methylisothiazolinone (MI), methylchloroisothiazolinone (CMI), benzisothiazolinone (BIT) and Bronopol (BNP) in washing-up liquid was established. The method consisted of a gradient HPLC analysis at three different wavelengths. The four compounds could be analyzed with good precision and accuracy. 展开更多
关键词 PRESERVATIVES Analytical validation METHYLISOTHIAZOLINONE Methylchloroisothiazolinone Benzisothiazolinone BRONOPOL HPLC Washing-Up Liquid
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Robustness Study and Superior Method Development and Validation for Analytical Assay Method of Atropine Sulfate in Pharmaceutical Ophthalmic Solution
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作者 Md. Nazmus Sakib Chowdhury Sreekanta Nath Dalal +4 位作者 Md. Ariful Islam Md. Anwar Hossain Pranab Kumar Das Shakawat Hossain Parajit Das 《American Journal of Analytical Chemistry》 CAS 2024年第5期151-164,共14页
Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical ... Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation;flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. Method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD for the six sample assay of developed method was 0.4% where the % RSD of the compendial method was 1.2%. The reproducibility between two analysts was 100.4% for developed method on the contrary the compendial method was 98.4%. 展开更多
关键词 ROBUSTNESS Method validation HPLC Compendial Method Method Development GDP LOQ
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Modeling and Validation of Diamagnetic Rotor Levitated by Permanent Magnetics
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作者 Yuanping Xu Yue Zhang +1 位作者 Jin Zhou Chaowu Jin 《Chinese Journal of Mechanical Engineering》 SCIE EI CAS CSCD 2024年第3期224-235,共12页
As an innovative,low-power consuming,and low-stiffness suspension approach,the diamagnetic levitation technique has attracted considerable interest because of its potential applicability in miniaturized mechanical sys... As an innovative,low-power consuming,and low-stiffness suspension approach,the diamagnetic levitation technique has attracted considerable interest because of its potential applicability in miniaturized mechanical systems.The foundation of a diamagnetic levitation system is mathematical modeling,which is essential for operating performance optimization and stability prediction.However,few studies on systematic mathematical modeling have been reported.In this study,a systematic mathematical model for a disc-shaped diamagnetically levitated rotor on a permanent magnet array is proposed.Based on the proposed model,the magnetic field distribution characteristics,diamagnetic levitation force characteristics(i.e.,levitation height and stiffness),and optimized theoretical conditions for realizing stable levitation are determined.Experiments are conducted to verify the feasibility of the proposed mathematical model.Theoretical predictions and experimental results indicate that increasing the levitation height enlarges the stable region.Moreover,with a further increase in the rotor radius,the stable regions of the rotor gradually diminish and even vanish.Thus,when the levitation height is fixed,a moderate rotor radius permits stable levitation.This study proposes a mathematical modeling method for a diamagnetic levitation system that has potential applications in miniaturized mechanical systems. 展开更多
关键词 Diamagnetic levitation Magnetic levitation ROTOR MODELING validation STABILITY
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Development and validation of a novel questionnaire regarding vision screening among preschool teachers in Malaysia
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作者 Shazrina Ariffin Saadah Mohamed Akhir Sumithira Narayanasamy 《International Journal of Ophthalmology(English edition)》 SCIE CAS 2024年第6期1102-1109,共8页
AIM:To develop and evaluate the validity and reliability of a knowledge,attitude,and practice questionnaire related to vision screening(KAP-VST)among preschool teachers in Malaysia.METHODS:The questionnaire was develo... AIM:To develop and evaluate the validity and reliability of a knowledge,attitude,and practice questionnaire related to vision screening(KAP-VST)among preschool teachers in Malaysia.METHODS:The questionnaire was developed through a literature review and discussions with experts.Content and face validation were conducted by a panel of experts(n=10)and preschool teachers(n=10),respectively.A pilot study was conducted for construct validation(n=161)and test-retest reliability(n=60)of the newly developed questionnaire.RESULTS:Based on the content and face validation,71 items were generated,and 68 items were selected after exploratory factor analysis.The content validity index for items(I-CVI)score ranged from 0.8-1.0,and the content validity index for scale(S-CVI)/Ave was 0.99.Internal consistency was KR^(2)0=0.93 for knowledge,Cronbach’s alpha=0.758 for attitude,and Cronbach’s alpha=0.856 for practice.CONCLUSION:The KAP-VST is a valid and reliable instrument for assessing knowledge,attitude,and practice in relation to vision screening among preschool teachers in Malaysia. 展开更多
关键词 validity RELIABILITY preschool teachers vision screening QUESTIONNAIRE
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Validation of a Method for Characterization of Ethanol in Water by HS-GC-FID to Serve the Traceability of Halal Measurements
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作者 Adel B. Shehata Abdulrahman R. Al Askar +3 位作者 Mohammed A. Al Rasheed Abdulrahman M. Al Zahrany Fahd A. Al Kharraa Sowailem A. Al Sowailem 《Green and Sustainable Chemistry》 2024年第2期17-28,共12页
The determination of the ethanol content in food products is of fundamental importance for HALAL certification. In this work, an analytical method for the determination of ethanol in water by headspace gas chromatogra... The determination of the ethanol content in food products is of fundamental importance for HALAL certification. In this work, an analytical method for the determination of ethanol in water by headspace gas chromatography with flame ionization detector (HS-GC-FID) has been developed and validated for the use in characterization of ethanol reference materials. The validation study was carried out in the linear calibration range 100 - 1500 mg/kg using the NIST SRM 2900, nominal 95.6%. The studied performance characteristics of the method were the limit of detection, LOD, the limit of quantification LOQ, selectivity, linearity, precision, recovery and bias. The validation results showed that the method is selective, precise, accurate and free from any significant bias. The LOD and LOQ were 1.27 and 3.86 mg/kg respectively and the estimated expanded uncertainty was 2% indicating that the method is fit for the purpose of certification of ethanol in water reference materials. 展开更多
关键词 ETHANOL HS-GC-FID validation LINEARITY Precision Bias
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System design and validation of Queqiao-2 lunar relay communication satellite
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作者 ZHANG Lihua XIONG Liang +11 位作者 SUN Ji CHEN Luojing XIAO Chuan ZHOU Wenyan WANG Yong LIU Wangwang GUAN Yifeng CHEN Tao YU Xiaochuan XU Jin CHEN Guohui CAO Xiaoping 《中国空间科学技术(中英文)》 CSCD 北大核心 2024年第5期23-39,共17页
In order to provide relay communication supports for future Chinese lunar exploration program,Queqiao-2 relay communication satellite was developed.Queqiao-2 can perform scientific observations with three kinds of sci... In order to provide relay communication supports for future Chinese lunar exploration program,Queqiao-2 relay communication satellite was developed.Queqiao-2 can perform scientific observations with three kinds of scientific instruments on board.The system design of Queqiao-2,including mission orbit and transfer orbit design,configuration and layout design,housekeeping and information flow design,power supply and distribution design,GNC and propulsion system design,communication links design,etc.,was accomplished through comprehensive tradeoff and evaluation on technical maturity,availability,schedule,cost,and so on.With a view to reducing development risk,both the platform and relay communication payloads were developed based on significant heritage from previous Queqiao relay satellite and other relevant spacecraft.Queqiao-2 features flexible system architecture to support multiple frequencies,modulations,data rates and software reconfigurations to meet new user requirements.Subsequent to a successful launch on March 20,2024,by means of 5 orbit maneuvers,Queqiao-2 was inserted into a highly elliptical frozen mission orbit around the moon with a 24h period on schedule.Following on-orbit tests and calibrations,Queqiao-2 has possessed the capacity to provide reliable relay communication services to multiple lunar exploration missions,as well as the capacity to perform scientific observations.Under the support of Queqiao-2,Chang′e-6 achieved its ambitious mission goal to collect and return samples from the moon′s mysterious far side.In the meanwhile,Queqiao-2 has also paved the way for the following Chinese lunar exploration missions including Chang′e-7 and Chang′e-8.The design life time of Queqiao-2 is more than 8 years.Benefit from flexibility and extensibility of relay communication system design,it is convenient to provide relay communication services for future lunar exploration missions of both China and other countries.In addition,innovative scientific observations would be performed during the period that no relay communication task is arranged.The system design of Queqiao-2 reflects the development philosophy of technical innovations and inheritance integration.Based on highly flexible and extensible system architecture,multiple and concurrent relay communication mission requirements can be met.It can provide strong supports for future lunar exploration missions.Successful launching,orbit entering and on-orbit tests of Queqiao-2 verified the correct design principle and versatility.By means of Queqiao-2,more innovative scientific outcomes are anticipated and lunar exploration activities can be facilitated. 展开更多
关键词 lunar explorations relay communication Queqiao system design TEST validation
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Method Verification and Validation of Hydralazine Hydrochloride: Spectrophotometric Analysis in Pure and Pharmaceutical Formulations
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作者 Laila Abdullah Alshatti 《American Journal of Analytical Chemistry》 CAS 2024年第7期219-228,共10页
The new method proposed is based on the formation of hydralazine-Bromophenol blue ion pair simply and without further extraction or heating. The ion pair was prepared in the presence of pH 3 citrate buffer forming a y... The new method proposed is based on the formation of hydralazine-Bromophenol blue ion pair simply and without further extraction or heating. The ion pair was prepared in the presence of pH 3 citrate buffer forming a yellow-colored chromogen. A new maximum UV-visible band formed at 416 nm. The color was stable for more than 10 hours and obeyed Beer’s Law over the concentration range of 10 - 50 µg/mL. The calculated molar absorptivity and Sandell’s sensitivity were 1.01 × 104 L∙mol−1∙cm−1 and 0.0514 µg/mL, respectively. The elements of method validation stipulated by The International Conference on Harmonization [Q2 (R1)] were applied for hydralazine hydrochloride assay in pure and pharmaceutical tablet formulation. The average recoveries of the pure solution and the pharmaceutical formulation were 98.94% and 99.50%, respectively. The results were statistically compared by F-test, which indicates that the method can be precise and repeatable for both pure and pharmaceutical solutions. The method was found to be accurate, reproducible, and cost-effective, and validated for the assay of hydralazine in terms of the routine quality control. 展开更多
关键词 SPECTROPHOTOMETRY validation Hydralazine Hydrochloride International Conference on Harmonization Q2 (R1)
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An internal ballistic model of electromagnetic railgun based on PFN coupled with multi-physical field and experimental validation
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作者 Benfeng Gu Haiyuan Li Baoming Li 《Defence Technology(防务技术)》 SCIE EI CAS CSCD 2024年第2期254-261,共8页
To accelerate the practicality of electromagnetic railguns,it is necessary to use a combination of threedimensional numerical simulation and experiments to study the mechanism of bore damage.In this paper,a three-dime... To accelerate the practicality of electromagnetic railguns,it is necessary to use a combination of threedimensional numerical simulation and experiments to study the mechanism of bore damage.In this paper,a three-dimensional numerical model of the augmented railgun with four parallel unconventional rails is introduced to simulate the internal ballistic process and realize the multi-physics field coupling calculation of the rail gun,and a test experiment of a medium-caliber electromagnetic launcher powered by pulse formation network(PFN)is carried out.Various test methods such as spectrometer,fiber grating and high-speed camera are used to test several parameters such as muzzle initial velocity,transient magnetic field strength and stress-strain of rail.Combining the simulation results and experimental data,the damage condition of the contact surface is analyzed. 展开更多
关键词 Internal ballistic modeling Electromagnetic rail gun Multi-physics field coupling Experimental validation PFN
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Adaptive Robust Servo Control for Vertical Electric Stabilization System of Tank and Experimental Validation
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作者 Darui Lin Xiuye Wang +1 位作者 Yimin Wang Guolai Yang 《Defence Technology(防务技术)》 SCIE EI CAS CSCD 2024年第1期326-342,共17页
A tracking stability control problem for the vertical electric stabilization system of moving tank based on adaptive robust servo control is addressed.This paper mainly focuses on two types of possibly fast timevaryin... A tracking stability control problem for the vertical electric stabilization system of moving tank based on adaptive robust servo control is addressed.This paper mainly focuses on two types of possibly fast timevarying but bounded uncertainty within the vertical electric stabilization system:model parameter uncertainty and uncertain nonlinearity.First,the vertical electric stabilization system is constructed as an uncertain nonlinear dynamic system that can reflect the practical mechanics transfer process of the system.Second,the dynamical equation in the form of state space is established by designing the angular tracking error.Third,the comprehensive parameter of system uncertainty is designed to estimate the most conservative effects of uncertainty.Finally,an adaptive robust servo control which can effectively handle the combined effects of complex nonlinearity and uncertainty is proposed.The feasibility of the proposed control strategy under the practical physical condition is validated through the tests on the experimental platform.This paper pioneers the introduction of the internal nonlinearity and uncertainty of the vertical electric stabilization system into the settlement of the tracking stability control problem,and validates the advanced servo control strategy through experiment for the first time. 展开更多
关键词 Adaptive robust servo control Experimental validation Nonlinearity compensation System uncertainty Vertical electric stabilization system
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Exploring Xiaojianzhong decoction's potential in gastric cancer treatment:Integrative insights and experimental validation
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作者 Chun-Han Cheng Wen-Rui Hao Tzu-Hurng Cheng 《World Journal of Gastrointestinal Oncology》 SCIE 2024年第12期4553-4558,共6页
Gastric cancer(GC)remains a formidable global health concern with significant morbidity and mortality rates,despite the fact that numerous advances have been made to improve conventional therapies.Xiaojianzhong decoct... Gastric cancer(GC)remains a formidable global health concern with significant morbidity and mortality rates,despite the fact that numerous advances have been made to improve conventional therapies.Xiaojianzhong decoction(XJZ),a traditional Chinese medicine,has garnered academic attention as a multicomponent,multitarget approach to managing GC.The present editorial explores the potential of XJZ in the treatment of GC through a comprehensive analysis of network pharmacology and experimental validation.Network pharmacology was used to identify key molecular targets of XJZ,including interleukin 6,prostaglandin-endoperoxide synthase 2,and matrix metalloproteinase 9,and in vitro experiments were used to confirm the efficacy of XJZ in inhibiting cell proliferation,inducing apoptosis,and modulating gene expression associated with GC progression.This editorial highlights XJZ as a promising therapeutic strategy for GC and indicates a need for further clinical exploration and validation of its efficacy. 展开更多
关键词 Xiaojianzhong decoction Gastric cancer Network pharmacology Traditional Chinese medicine Experimental validation
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Development and validation of a circulating tumor DNA-based optimization-prediction model for short-term postoperative recurrence of endometrial cancer
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作者 Yuan Liu Xiao-Ning Lu +3 位作者 Hui-Ming Guo Chan Bao Juan Zhang Yu-Ni Jin 《World Journal of Clinical Cases》 SCIE 2024年第18期3385-3394,共10页
BACKGROUND Endometrial cancer(EC)is a common gynecological malignancy that typically requires prompt surgical intervention;however,the advantage of surgical management is limited by the high postoperative recurrence r... BACKGROUND Endometrial cancer(EC)is a common gynecological malignancy that typically requires prompt surgical intervention;however,the advantage of surgical management is limited by the high postoperative recurrence rates and adverse outcomes.Previous studies have highlighted the prognostic potential of circulating tumor DNA(ctDNA)monitoring for minimal residual disease in patients with EC.AIM To develop and validate an optimized ctDNA-based model for predicting shortterm postoperative EC recurrence.METHODS We retrospectively analyzed 294 EC patients treated surgically from 2015-2019 to devise a short-term recurrence prediction model,which was validated on 143 EC patients operated between 2020 and 2021.Prognostic factors were identified using univariate Cox,Lasso,and multivariate Cox regressions.A nomogram was created to predict the 1,1.5,and 2-year recurrence-free survival(RFS).Model performance was assessed via receiver operating characteristic(ROC),calibration,and decision curve analyses(DCA),leading to a recurrence risk stratification system.RESULTS Based on the regression analysis and the nomogram created,patients with postoperative ctDNA-negativity,postoperative carcinoembryonic antigen 125(CA125)levels of<19 U/mL,and grade G1 tumors had improved RFS after surgery.The nomogram’s efficacy for recurrence prediction was confirmed through ROC analysis,calibration curves,and DCA methods,highlighting its high accuracy and clinical utility.Furthermore,using the nomogram,the patients were successfully classified into three risk subgroups.CONCLUSION The nomogram accurately predicted RFS after EC surgery at 1,1.5,and 2 years.This model will help clinicians personalize treatments,stratify risks,and enhance clinical outcomes for patients with EC. 展开更多
关键词 Circulating tumor DNA Endometrial cancer Short-term recurrence Predictive model Prospective validation
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A Framework for Cloud Validation in Pharma
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作者 Pravin Ullagaddi 《Journal of Computer and Communications》 2024年第9期103-118,共16页
The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in ... The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing. 展开更多
关键词 Computerized Systems validation Risk-Based Approach Data Integrity Pharmaceutical Manufacturing Cloud validation
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Optimization and Validation of a Simple Spectrophotometric Based DPPH Method for Analysis of Antioxidant Activity in Aerated, Semi-Aerated and Non-Aerated Tea Products
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作者 Simon Mwangi Kingori Sylvester Cheruiyot +2 位作者 Aron Cheruiyot Kirui Rugema Grace Uwamahoro Agnes Wangui Mwangi 《Open Journal of Applied Sciences》 2024年第8期2207-2222,共16页
In this study, the simple DPPH UV-spectrophotometric analytical procedures were optimized and validated for the estimation of antioxidant properties in aerated, semi-aerated and non-aerated tea products as per the AOA... In this study, the simple DPPH UV-spectrophotometric analytical procedures were optimized and validated for the estimation of antioxidant properties in aerated, semi-aerated and non-aerated tea products as per the AOAC guidelines. The method was found to be simple, rapid, accurate and economical in estimating antioxidant properties in the different tea products. A (0.0100 ± 0.0001) g well ground tea sample was extracted directly in 80% v/v methanol in distilled water. The precision of the method had an RSD% of 1.695 with a linear relation equation of Y = 200.7X + 5.25 (r2 = 0.997). The method proved to be a reliable and effective tool in analysis of anti-oxidant properties in varied tea cultivars and their processed products. 展开更多
关键词 UV-Spectrophotometric Optimized validated Antioxidant
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Direct Pointwise Comparison of FE Predictions to StereoDIC Measurements:Developments and Validation Using Double Edge-Notched Tensile Specimen
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作者 Troy Myers Michael A.Sutton +2 位作者 Hubert Schreier Alistair Tofts Sreehari Rajan Kattil 《Computer Modeling in Engineering & Sciences》 SCIE EI 2024年第8期1263-1298,共36页
To compare finite element analysis(FEA)predictions and stereovision digital image correlation(StereoDIC)strain measurements at the same spatial positions throughout a region of interest,a field comparison procedure is... To compare finite element analysis(FEA)predictions and stereovision digital image correlation(StereoDIC)strain measurements at the same spatial positions throughout a region of interest,a field comparison procedure is developed.The procedure includes(a)conversion of the finite element data into a triangular mesh,(b)selection of a common coordinate system,(c)determination of the rigid body transformation to place both measurements and FEA data in the same system and(d)interpolation of the FEA nodal information to the same spatial locations as the StereoDIC measurements using barycentric coordinates.For an aluminum Al-6061 double edge notched tensile specimen,FEA results are obtained using both the von Mises isotropic yield criterion and Hill’s quadratic anisotropic yield criterion,with the unknown Hill model parameters determined using full-field specimen strain measurements for the nominally plane stress specimen.Using Hill’s quadratic anisotropic yield criterion,the point-by-point comparison of experimentally based full-field strains and stresses to finite element predictions are shown to be in excellent agreement,confirming the effectiveness of the field comparison process. 展开更多
关键词 StereoDIC spatial co-registration data transformation finite element simulations point-wise comparison of measurements and FEA predictions double edge notch specimen model validation
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Development and validation of an instrument to assess knowledge,attitudes,and practices on digital health among nursing officers
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作者 Maheshika Madhuwanthi Sunethra Jayathilake +1 位作者 Neranga Liyanaarachchige Rohana Marasinghe 《Frontiers of Nursing》 2024年第3期275-284,共10页
Objective:Validation is an important aspect of an instrument,and it ensures the confidence of researchers to employ the instrument in their studies.This study was conducted to develop and validate an instrument to ass... Objective:Validation is an important aspect of an instrument,and it ensures the confidence of researchers to employ the instrument in their studies.This study was conducted to develop and validate an instrument to assess knowledge,attitudes,and practices(KAP) on digital health among nurses since digital health capacity is a major concern in health care that needs to be assessed.Methods:We conducted a methodological study to assess the content validity and reliability of the instrument.First,items were generated through a comprehensive literature review and by obtaining an expert opinion.Second,content and face validity were assessed by a panel of 7 experts.Both the item-level content validity index(I-CVI) and the scale-level content validity index(S-CVI) were established.Moreover,test–retest reliability and internal consistency of the instrument were assessed.Data were analyzed using SPSS version 25.Results:The initial pool consisted of 60 items and after obtaining content,face,and construct validity,51 items remained.Items with an I-CVI <0.78 were considered relevant.The S-CVI for relevancy,clarity,ambiguity,and simplicity were 0.93,0.91,0.94,and 0.92,respectively.Five subcomponents were constructed in each knowledge and attitudes domain,and the test–retest reliability test revealed that the instrument has good reliability,showing correlation coefficient values for the KAP domains and the total questionnaire of 0.76,0.98,0.99,and 0.99,respectively.The independent Cronbach's α for all items was 0.76,indicating good internal consistency.Conclusions:The present study established the acceptable validity and ensured the good reliability and internal consistency of the instrument,which can serve as an assessment tool of KAP on digital health among healthcare professionals. 展开更多
关键词 assess DEVELOPMENT DIGITAL HEALTH instrument validations
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Practical Use of the Subjective Mathematical Model of Bayes and Its External Validation in Dental Medicine & Dentistry
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作者 Muyembi Muinaminayi Pierre Kayembe Mwimbi David +9 位作者 Nyimi Boshabu Fidèle Panoumvita Kapamona Junior Nsudila Mpoyi Monique Tubanza Mulongo Simplot Sekele Issouradi-Bourley Jean-Paul Mantshumba Milolo Augustin Kalala Kazadi Em Mabela Rosti Munyanga Mukongo Sylvain Dan Wang 《Open Journal of Statistics》 2024年第5期553-575,共23页
Objective: Our study aims to validate the subjective Bayes mathematical model using the mathematical model of logistic regression. Expert systems are being utilized increasingly in medical fields for the purposes of a... Objective: Our study aims to validate the subjective Bayes mathematical model using the mathematical model of logistic regression. Expert systems are being utilized increasingly in medical fields for the purposes of assisting diagnosis and treatment planning in Dentistry. Existing systems used few symptoms for dental diagnosis. In Dentistry, few symptoms are not enough for diagnosis. In this research, a conditional probability model (Bayes rule) was developed with increased number of symptoms associated with a disease for diagnosis. A test set of recurrent cases was then used to test the diagnostic capacity of the system. The generated diagnosis matched that of the human experts. The system was also tested for its capacity to handle uncommon dental diseases and the system portrayed useful potential. Method: The study used the Subjective Mathematical Bayes Model (SBM) approach and employed Logistic Regression Mathematical Model (LMR) techniques. The external validation of the subjective mathematical Bayes model (MSB) concerns the real cases of 625 patients who developed alveolar osteitis (OA). We propose strategies for reproducibility and reporting standards, outlining an updated WAMBS (when to Worry and how to Avoid the Misuse of Bayesian Statistics) checklist. Finally, we outline the impact of Bayesian analysis Logistic Regression Mathematical Model (LMR) techniques and on artificial intelligence, a major goal in the next decade. Results: The internal validation had identified seven (7) etiological factors of OA, which will be compared to the cases of MRL, for the external validation which retained six (6) etiological factors of OA. The experts in the internal validation of the MSB had generated 40 cases of OA and a COP of (0.5), which will be compared to the MRL that collected 625 real cases of OA to produce a Cop of (0.6) in the external validation, which discriminates between healthy patients (Se) and sick patients (Sp). Compared to real cases and the logistic regression model, the Bayesian model is efficient and its validity is established. 展开更多
关键词 External validation-MSB-MRL Mathematical Model
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基于铜死亡相关lncRNAs的胰腺癌预后模型构建与验证 被引量:1
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作者 黄菲菲 杨馨奕 +2 位作者 秦振溜 张杰 金约朋 《肝胆胰外科杂志》 CAS 2024年第6期348-359,共12页
目的研究铜死亡相关lncRNAs在胰腺癌(PAAD)患者中的预后预测价值,并进一步构建预后预测模型。方法从TCGA数据库中下载胰腺癌患者的转录组测序数据和相应临床信息,通过Pearson相关性分析筛选与预后相关的铜死亡相关lncRNAs,先后利用单因... 目的研究铜死亡相关lncRNAs在胰腺癌(PAAD)患者中的预后预测价值,并进一步构建预后预测模型。方法从TCGA数据库中下载胰腺癌患者的转录组测序数据和相应临床信息,通过Pearson相关性分析筛选与预后相关的铜死亡相关lncRNAs,先后利用单因素Cox回归和Lasso回归分析并进一步构建预后模型。根据模型的风险评分中位数,将所有患者分为高风险组和低风险组。通过Kaplan-Meier生存分析、亚组分析、ROC曲线分析及一致性指数分析评估模型的预后预测价值,并利用单因素和多因素回归分析验证模型的独立性。对高、低风险组的差异表达基因进行GO及KEGG功能富集分析,并对高、低风险组患者进行肿瘤突变负荷(TMB)分析、免疫治疗反应预测以及药物敏感性分析。结果通过Pearson相关性分析,确定了127个铜死亡相关的lncRNAs,先后利用单因素Cox回归分析及Lasso回归分析构建了一个基于6个铜死亡相关lncRNAs的预后预测模型。根据模型计算结果将PAAD患者队列分成高风险组和低风险组,Kaplan-Meier生存分析表明低风险组患者的生存时间要长于高风险组(P<0.05)。ROC曲线证明了该模型对胰腺癌患者预后的预测性能良好:1、3、5年ROC曲线下面积分别为0.687、0.753、0.771;基因功能富集分析表明,高、低风险组差异表达基因主要富集于免疫相关通路。此外,高风险组患者的TMB值明显大于低风险组,而TIDE评分明显低于低风险组。最后,通过药物敏感性分析发现不同组的胰腺癌患者对特定药物的敏感性存在统计学差异,对临床用药具有一定的指导意义。结论本研究基于铜死亡相关lncRNAs成功构建了一个PAAD患者预后模型,可精准预测PAAD患者的预后,并为患者的临床药物治疗选择提供个性化指导。 展开更多
关键词 胰腺癌 铜死亡 长链非编码RNA(lncRNAs) 预后模型 构建与验证
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我国24家检验检测机构洁净环境照度检测能力验证 被引量:1
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作者 田霖 刘雅丹 +2 位作者 项新华 谢兰桂 杨会英 《中国药业》 CAS 2024年第2期68-71,共4页
目的评价我国检验检测机构对洁净环境照度的检测能力。方法回顾性分析中国食品药品检定研究院于2022年在全国范围内首次设计并组织实施的洁净环境照度能力验证项目。基于洁净环境检测的行业特点,该项目分为笔试和实际操作(简称实操)两... 目的评价我国检验检测机构对洁净环境照度的检测能力。方法回顾性分析中国食品药品检定研究院于2022年在全国范围内首次设计并组织实施的洁净环境照度能力验证项目。基于洁净环境检测的行业特点,该项目分为笔试和实际操作(简称实操)两部分。笔试部分,共3题(限时40 min完成),考察参加测试(简称参测)实验室对检测标准正确理解和掌握的程度,根据专家商议确定的评分标准评分(满分50分)。实操部分,以该院药用辅料和包装材料检定所的2台洁净工作台为现场考核样品,以参测实验室的现场测试结果考察参测实验室的仪器操作和实验水平(限时5 min完成),以Z值进行评价(︱Z︱≤2,>2~<3,≥3分别为满意、有问题、不满意)并打分(满分50分)。以笔试和实操评分之和评价参测实验室的检测能力(≥60分为合格)。结果共24家实验室参加了能力验证并按要求提交了结果报告。笔试,评分为45~50分,满分21家(87.50%)。实操,样品A,满意21家(87.50%),有问题3家(12.50%);样品B,满意23家(95.83%),有问题1家(4.17%),2个样品均无不满意的实验室。24家实验室总评分均合格。结论该次能力验证结果显示,各实验室的检测能力维持良好,但部分实验室存在对标准的理解和掌握仍有欠缺或未按校准周期对照度计进行计量等问题,建议检测人员加深对洁净环境检测标准的理解,相应机构重视仪器的校准,持续提高检测能力。 展开更多
关键词 检验检测机构 洁净环境 照度 能力验证
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玉米逆境胁迫响应基因ZmbZIP84的克隆与功能验证 被引量:1
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作者 曹丽茹 庞芸芸 +4 位作者 叶飞宇 马晨晨 张新 王振华 鲁晓民 《核农学报》 CAS CSCD 北大核心 2024年第4期644-653,共10页
碱性亮氨酸拉链(Basic leucine zipper,bZIP)转录因子是真核生物中分布最广泛、结构极其保守的家族之一,在植物生长进程中发挥重要作用。为验证bZIP转录因子在逆境胁迫中发挥的作用,本研究通过分析转录组数据,筛选到27个参与干旱-复水... 碱性亮氨酸拉链(Basic leucine zipper,bZIP)转录因子是真核生物中分布最广泛、结构极其保守的家族之一,在植物生长进程中发挥重要作用。为验证bZIP转录因子在逆境胁迫中发挥的作用,本研究通过分析转录组数据,筛选到27个参与干旱-复水胁迫的bZIP基因,计算相关性系数、构建共表达网络图发现ZmbZIP84(Zm00001d053988)是核心节点基因;该基因位于玉米第4号染色体,具有高度保守的bZIP结构域;分析理化性质,发现该基因是亲水性蛋白且属于不稳定蛋白;构建系统发育树,发现该基因与柳枝稷和高粱的亲缘关系最近;实时荧光定量PCR(qRT-PCR)结果显示,ZmbZIP84在玉米各组织中均有表达,成熟根中的表达量最高;设置20%聚乙二醇(PEG)-6000、42℃高温、200 mmol·L^(-1)NaCl以及缺乏铵态氮等模拟试验,发现该基因在高温、干旱、氮处理下表达量显著上调,而在NaCl处理下表达量下调,说明ZmbZIP84基因积极参与并响应非生物胁迫;利用CRISPR/Cas9技术获得ZmbZIP84基因的拟南芥同源基因缺失型纯合突变体,发现在高温、干旱胁迫处理下突变体植株生长受到严重抑制、叶片萎蔫、甚至干死,而野生型植株影响较小,说明在干旱、高温胁迫处理下,ZmbZIP84基因敲除后抗旱、耐高温能力下降;亚细胞定位发现该基因编码的蛋白位于细胞核。本研究结果可为后续研究ZmbZIP84基因的功能及下游靶基因的调控机制奠定基础,为培育抗逆性玉米新品种提供参考。 展开更多
关键词 玉米 转录因子 非生物胁迫 功能验证 亚细胞定位
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