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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Journal Of Physics: Conference Series
A comparison and classification of land use land cover to estimate their effect on environment: case study in Baghdad city
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Abstract<p>This study compared and classified of land use and land cover changes by using Remote Sensing (RS) and Geographic Information Systems (GIS) on two cities (Al-Saydiya city and Al-Hurriya) in Baghdad province, capital of Iraq. In this study, Landsat satellite image for 2020 were used for (Land Use/Land Cover) classification. The change in the size of the surface area of each class in the Al-Saydiya city and Al-Hurriya cities was also calculated to estimate their effect on environment. The major change identified, in the study, was in agricultural area in Al-Saydiya city compare with Al-Hurriya city in Baghdad province. The results of the research showed that the percentage of the green </p> ... Show More
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Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
The use of two indicators of market value-added and return on capital invested in measuring the performance of the Iraqi banking sector
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For a long time, the intensification of profit represented a major goal for the company management ,but this goal confirmed a series of restrictions such the constriction on short period, the time rather than on long and medium strategic goal, the relationships with customers ,the supplies, employees , This goal is replaced by another one (intensification of the company's value) ,and the fortune of the share holders itself ,for the purpose  of creating value, the company must generate  great outcomes to cover the operating expense and to insure the a suitable compensation to the invested capital (the market value added) is  the indication used to estimate the company ability to create value –added the development

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Publication Date
Sat Jan 19 2019
Journal Name
Iraqi Journal Of Agricultural Sciences
EFFECT OF TWO HARROWING SYSTEMS ON DECOMPOSITION OF ORGANIC MATTER, SOME SOIL PROPERTIES, GROWTH AND PRODUCTIVITY OF MAIZE
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A field experiment was conducted at Abu-Ghrib during 2013- 2014 season to study the effect of harrowing systems on the decomposition and fermentation on organic matter(OM) when added and mixed with the soil under special technology, as well as its effect on the growth parameters and productivity of (Zea mays L. 5018). The experiment was laid out using factorial randomized complete block design (RCBD) in split-split design with three replications in SCL bare soil with a percent of moisture ranged from 16 – 18 %. The main plots were designated to the two systems of harrowing (Rotary Harrowand Disc Harrow ). The sub main plots were specified for two organic matters ( Sheep manure ,cow manure ) . Data were statistically analyzed, and

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Publication Date
Thu Jan 01 2026
Journal Name
Modern Sport
Design and standardization of two scoring tests for the initial selection of people with simple mental disabilities in five-a- Side Soccer
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The five-a- Side Soccer for simple mental disability is as interesting and caring as many other sporting events. Therefore, the researchers believe that their basic skills tests are compatible with then level of the tested individuals in terms of age and mental ability. As a means of selecting those who are qualified to practice this game in a simple way, the problem of research has been identified in the design and standardization of two scoring skills that belong to this category and are approved by the training staff during the initial selection process. The research community is determined by people with mental disabilities who belong to the governmental and private institutes and the Special Olympics Union in Baghdad and for the year 2

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Publication Date
Thu Jan 01 2026
Journal Name
Iraqi Journal Of Science
UNSTEADY PRESSURE DROP AND HEAT TRANSFER OFMAGNETOHYDRODYNAMIC ANNULAR TWO-PHASE INRECTANGULAR CHANNEL
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An annular two-phase, steady and unsteady, flow model in which a conductingfluid flow under the action of magnetic field is concavely. Two models arepresented, in the model one; the magnetic field is perpendicular to the long side ofthe channel, while in the model two is perpendicular to the short side. Also, westudy, to some extent the single-phase liquid flow.It is found that the motion and heat transfer equations are controlled by differentdimensionless parameters namely, Reynolds, Hartmann, Prandtl, and Poiseuilleparameters. The Laplace transform technique is used to solve each of the motion andheat transfer equations. The effects of each of dimensionless parameters upon thevelocity and heat transfer is analyzed.A comprehensive study fo

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Publication Date
Sun Jun 12 2011
Journal Name
Baghdad Science Journal
Satellite Images Unsupervised Classification Using Two Methods Fast Otsu and K-means
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Two unsupervised classifiers for optimum multithreshold are presented; fast Otsu and k-means. The unparametric methods produce an efficient procedure to separate the regions (classes) by select optimum levels, either on the gray levels of image histogram (as Otsu classifier), or on the gray levels of image intensities(as k-mean classifier), which are represent threshold values of the classes. In order to compare between the experimental results of these classifiers, the computation time is recorded and the needed iterations for k-means classifier to converge with optimum classes centers. The variation in the recorded computation time for k-means classifier is discussed.

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Publication Date
Tue Dec 03 2013
Journal Name
Baghdad Science Journal
Satellite Images Unsupervised Classification Using Two Methods Fast Otsu and K-means
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Publication Date
Sat Sep 30 2023
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Determinants of Investment Allocations in the Agricultural Sector in Iraq : A Comparison Between the Method of least Squares Approach and the errror Correction Model
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Abstract

                 The research aimed to test the relationship between the size of investment allocations in the agricultural sector in Iraq and their determinants using the Ordinary Least Squares (OLS) method compared to the Error Correction Model (ECM) approach. The time series data for the period from 1990 to 2021 was utilized. The analysis showed that the estimates obtained using the ECM were more accurate and significant than those obtained using the OLS method. Johansen's test indicated the presence of a long-term equilibrium relationship between the size of investment allocations and their determinants. The results of th

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Publication Date
Tue Jun 01 2021
Journal Name
Al-khwarizmi Engineering Journal
Prediction of Surface Roughness after Turning of Duplex Stainless Steel (DSS)
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Feed Forward Back Propagation artificial neural network (ANN) model utilizing the MATLAB Neural Network Toolbox is designed for the prediction of surface roughness of Duplex Stainless Steel during orthogonal turning with uncoated carbide insert tool. Turning experiments were performed at various process conditions (feed rate, cutting speed, and cutting depth). Utilizing the Taguchi experimental design method, an optimum ANN architecture with the Levenberg-Marquardt training algorithm was obtained. Parametric research was performed with the optimized ANN architecture to report the impact of every turning parameter on the roughness of the surface. The results suggested that machining at a cutting speed of 355 rpm with a feed rate of 0.07 m

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Publication Date
Sun Aug 01 2021
Journal Name
International Journal Of Electrical And Computer Engineering (ijece)
Simulation based comparison of routing protocols in wireless multihop adhoc networks
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Routing protocols are responsible for providing reliable communication between the source and destination nodes. The performance of these protocols in the ad hoc network family is influenced by several factors such as mobility model, traffic load, transmission range, and the number of mobile nodes which represents a great issue. Several simulation studies have explored routing protocol with performance parameters, but few relate to various protocols concerning routing and Quality of Service (QoS) metrics. This paper presents a simulation-based comparison of proactive, reactive, and multipath routing protocols in mobile ad hoc networks (MANETs). Specifically, the performance of AODV, DSDV, and AOMDV protocols are evaluated and analyz

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