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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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The pharmacokinetics and bioequivalence of a newly developed extended-released (ER) tablet containing 400 mg pentoxifylline as a test product was compared with the reference brand product Trental® 400 mg ER tablet produced by Sanofi-Aventis. Two separate studies were conducted simultaneously. The first study was conducted under fasting condition, whereas, the second study was conducted under fed condition; using the same batches of the test and reference products in both studies. In each study, both products were administered to 32 healthy male adult volunteers applying a single-dose, two-treatment, two-period, two-sequence, randomized crossover design with one-week washout period between dosing. Twenty two blood samples were withdrawn from each volunteer over 24 hours period.  Pentoxifylline concentrations were determined in plasma by a validated HPLC method according to FDA Bioanalytical Method Validation Guidance using UV detection and chloramphenicol as internal standard. The lower limit of quantitation of the drug in plasma was 5 ng/ml and the upper limit of quantitation was 500 ng/ml. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax,  AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, Tmax, lZ & T0.5; were calculated applying non-compartmental analysis. Data of the test and reference products were statistically analyzed to test for bioequivalence of the two products, using criteria of FDA and EMEA Guidance.  The pharmacokinetic parameters mentioned above were statistically analyzed by descriptive statistics, ANOVA test and 90% Confidence Interval (CI). ANOVA test involved the calculation of the effects of: treatment, period, sequence and subjects nested in sequence. According to the above guidance, the primary pharmacokinetic parameters used for bioequivalence testing, namely Cmax, AUC0-t and AUC0-Â¥ were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values  Cmax,  AUC0-t , AUC0-Â¥ , Cmax/AUC0-Â¥ , Tmax, lZ & T0.5 for the test formula obtained from the fasting study  were; 144.4 ng/ml,  845.4 ng.hr/ml, 868.4 ng.hr/ml, 0.186 hr-1, 3.29 hr, 0.561 hr-1 and 1.65 hr, respectively; and the mean values of these parameters for the reference formula were; 150.0 ng/ml,  871.1 ng.hr/ml, 893.7 ng.hr/ml, 0.177 hr-1, 3.70 hr, 0.558 hr-1 and 1.59 hr,  respectively.  The mean values of the above mentioned parameters for the test formula obtained from the fed study were; 157.8 ng/ml, 826.5 ng.hr/ml, 853.8 ng.hr/ml, 0.198 hr-1, 5.4 hr, 0.458 hr-1 and 2.06 hr, respectively; and the mean values of these parameters for the reference formula were; 162.1 ng/ml, 869.7 ng.hr/ml, 894.8 ng.hr/ml, 0.196 hr-1, 4.1 hr, 0.525 hr-1 and 1.80 hr, respectively.  Based on criteria of FDA and   EMEA Guidance on Bioavailability and Bioequivalence, the results of the fasting and fed studies demonstrated bioequivalence of the two products under either condition. Accordingly, it is concluded that the newly developed ER tablet containing 400 mg pentoxifylline is bioequivalent to Trental® 400 mg ER tablet produced by Sanofi-Aventis.

Keywords: Pentoxifylline, Pharmacokinetics, Bioequivalence.

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Publication Date
Wed Dec 01 2021
Journal Name
Baghdad Science Journal
Antimicrobial Effect of Eco- Friendly Silver Nanoparticles Synthesis by Iraqi Date Palm (Phoenix dactylifera) on Gram-Negative Biofilm-Forming Bacteria
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Date palm silver nanoparticles are a green synthesis method used as antibacterial agents. Today,
there is a considerable interest in it because it is safe, nontoxic, low costly and ecofriendly. Biofilm bacteria
existing in marketed local milk is at highly risk on population health and may be life-threatening as most
biofilm-forming bacteria are multidrug resistance. The goal of current study is to eradicate biofilm-forming
bacteria by alternative treatment green synthesis silver nanoparticles. The biofilm formation by bacterial
isolates was detected by Congo red method. The silver nanoparticles were prepared from date palm
(khestawy) fruit extract. The formed nanoparticles were characterized with UV-Vis

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Publication Date
Mon Aug 28 2023
Journal Name
Journal Of Planner And Development
Estimation of urban land price within holly cities by using integrated GIS-regression models: case study Al-Kufa city- Iraq
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        Urban land price is the primary indicator of land development in urban areas. Land prices in holly cities have rapidly increased due to tourism and religious activities. Public agencies are usually facing challenges in managing land prices in religious areas. Therefore, they require developed models or tools to understand land prices within religious cities. Predicting land prices can efficiently retain future management and develop urban lands within religious cities. This study proposed a new methodology to predict urban land prices within holy cities. The methodology is based on two models, Linear Regression (LR) and Support Vector Regression (SVR), and nine variables (land price, land area,

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Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
The Iraqi opposition press from The P.M. Yaseen Al-Hashimi second term till the death of king Ghazi ( 1935 – 1939 )
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At the beginning of 1935 theMinistry of (Yasin AL-Hashimi) was formed which was the result of the (Sulayikh)Conference .The new ministys policy was towards the authority of the one party and the exclusivity of power.The policy of (Yasin AL-Hashemi)has faced severe campaigns from the AL-Ekhaa and AL-Ahaly newspapers.The new ministry like its predecessor ministries . When it faces criticism from opposition newspapers .its shutting down newspapers and not accepting requests for them. Some opposition newspapers named Yassin AL-Hashemi (the dictator).Iraqi opposition newspapers have been neglected and deprived of press freedom although they were the main factor in educating the community and representing the public opinion of people . Lt appe

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Publication Date
Wed Dec 29 2021
Journal Name
Journal Of The College Of Education For Women
The Skills of Intended Meaning behind the Context when Reading Poetry among Fifth Grade Students- Literary Branch from Teachers’ Perspectives
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        The current research aims to investigate the skills of the intended meaning beyond the context when reading poetry among fifth literary students. To achieve the aim of the research, the researcher has followed the descriptive approach and used two tools: an open questionnaire that includes an inquiry about the skills of the intended meaning beyond the poetic context, and a closed questionnaire that were examined by the juries, and modified accordingly. Besides, its validity and stability were examined by applying the study on an exploratory sample of (15) teachers to reach its final version and determine the time required to answer it. Then, the researcher applied it on the research sample of (9

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Publication Date
Thu Oct 25 2018
Journal Name
Al-nahrain Journal Of Science
Synthesis of some New 3-Substituted Heterocyclic Compounds Containing Bridgehead Nitrogen from 2-Amino Pyridine with Study Their Biological Activity
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Publication Date
Sun Dec 15 2019
Journal Name
Al-academy
The Effect of The Illustration Program on Fashion Design Inspired by Historical Costumes: تهاني ناصر العجاجي -هدى عبد العزيز المقرن
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This research aims to identify the role and impact of illustrations in contemporary fashion design inspired by historical costumes. Historical fashion aesthetics are adapted to design drawings. The experimental method was followed and a sample of 31 students in the department of fashion and textile design, third level were selected. Each student carried out two original historical and contemporary design. The models were executed two times: one with the usage of the program and the other without program help. The tools that were used are the program, the scale, the pre-skill test, and the post-skill test. One of the most relevant results of the research is the possibility of using historical costumes to highlight creativity and innovatio

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Publication Date
Tue Jun 11 2024
Journal Name
International Journal Of Civil Engineering
Strength Evaluation of CFRP-Strengthened RC Slab-Beams System by Load Test to Satisfy the Safety Requirements: A Case Study
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The primary goal of in-situ load testing is to evaluate the safety and performance of a structural system under particular loading conditions. Advancements in building techniques, analytical tools, and monitoring instruments are prompting the evaluation of the appropriate loading value, loading process, and examination criteria. The procedure for testing reinforced concrete (RC) structures on-site, as outlined in the ACI Building Code, involves conducting a 24-h load test and applying specific evaluation criteria. This article detailed a retrofitting project for an RC slab-beams system by utilizing carbon fiber-reinforced polymer (CFRP) sheets to strengthen the structure following a fire incident. The RC structure showed indicators of deter

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Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Physics: Conference Series
Neural Network Model for Synthesis of Thermally Sprayed (AI/AI<sub>2</sub>O<sub>3</sub>) Composite Protective Coatings
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Abstract<p>Al<sub>2</sub>O<sub>3</sub> and Al<sub>2</sub>O<sub>3</sub>–Al composite coatings were deposited on steel specimens using Oxy-acetylene gas thermal spray gun. Alumina was mixed with Aluminum in six groups of concentrations (0, 5, 10,12,15 and 20% ) Al2O3, Specimens were tested for corrosion using Potentiodynamic polarization technique. Further tests were conducted for the effect of temperature on polarization curve and the hardness tests for the coated specimens. At first, Modelling was carried out using MINITAB-19, least square method, as a 2nd degree nonlinear model, bad results were achieved because of the high nonlinearity. Better result w</p> ... Show More
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Publication Date
Mon Feb 13 2023
Journal Name
Journal Of Educational And Psychological Researches
A Proposed Strategy to Develop Postgraduate Studies at King Khalid University to Support the Achievement of the Kingdom's 2030 Vision
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Abstract

The aim of this research is to formulate a proposed strategy for developing graduate studies at King Khalid University to support the achievement of the Kingdom's vision (2030). The research used the descriptive survey approach. The research community consisted of all graduate students at King Khalid University. The research was conducted on a random sample included (623) Male and female students, this research relied on the questionnaire as the main tool for collecting its data. The results revealed that the research sample believes that all the proposals included in this research are very important for the development of postgraduate studies at King Khalid University to support the achievement of the K

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Publication Date
Sun Jun 30 2024
Journal Name
Anbar Journal Of Agricultural Sciences
THE GENETIC DIAGNOSIS OF THE BACTERIA ISOLATED FROM THE AGRICULTURAL SOIL SUSTAINED FARMS BY THE POLYMERASE CHAIN REACTION TECHNIQUE QPCR
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The measurements and tests of the samples conducted in the laboratories of the College of Agriculture included isolating bio-fertilizers and testing the efficiency of isolates that fix atmospheric nitrogen and solubilize phosphorous compounds. Bacteria were isolated and identified from the rhizosphere soils of different plants collected from various agricultural areas. A total of 74 bacterial isolates were obtained based on the phenotypic characteristics of the developing colonies, as well as biochemical and microscopic traits. The results of isolation and identification showed that among the 74 bacterial isolates, there were 15 isolates of A. chroococcum, 13 of Az. lipoferum, 13 of B. megaterium, 10 of P. putida, 10 of Actinomycetes, and n

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