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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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
Fri Aug 15 2025
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
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
Sun Mar 06 2016
Journal Name
Baghdad Science Journal
Comparison Between Conventional and Microwave Methods For Extraction Pectin and Degree of Esterification from Orange (Citrus sinesis) and Grapefruit (Citrus paradisi) Peels
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In this study Microwave and conventional methods have been used to extract and estimate pectin and its degree of esterification from dried grapefruit and orange peels. Acidified solution water with nitric acid in pH (1.5) was used. In conventional method, different temperature degrees for extraction pectin from grape fruit and orange(85 ,90 , 95 and 100?C) for 1 h were used The results showed grapefruit peels contained 12.82, 17.05, 18.47, 15.89% respectively, while the corresponding values were 5.96, 6.74, 7.41 and 8.00 %, respectively in orange peels. In microwave method, times were 90, 100, 110 and 120 seconds. Grapefruit peels contain 13.86, 16.57, 18.69, and 17.87%, respectively, while the corresponding values were of 6.53, 6.68, 7.2

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Publication Date
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Estimates Nonparametric In Multiple Regression Analysis Function (Gamma ,Beta)
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The use of non-parametric models and subsequent estimation methods requires that many of the initial conditions that must be met to represent those models of society under study are appropriate, prompting researchers to look for more flexible models, which are represented by non-parametric models                  

          In this study, the most important and most widespread estimations of the estimation of the nonlinear regression function were investigated using Nadaraya-Watson and Regression Local Ploynomial, which are one of the types of non-linear

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Publication Date
Thu Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Microbiology of active chronic otitis media: in comparison with abroad studies
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Background: Chronic otitis media (COM) of mucosal or squamous type is a common problem in otolaryngology practice, the active form of COM is characterized by discharge of pus and is treated by antibiotics to start with, the appropriate antibiotic should be prescribed to avoid antibiotic abuse and guarantee good outcome. Objectives:The objective of this study is to identify the causative organisms of active chronic active otitis media both (mucosal, squamous) type and test their sensitivity to various anti- microbial agents &compare with abroad studies.Methods:A prospective study was done on eighty patients, different ages and sexes were taken and carful history and examination was done, examination under microscope was done with carf

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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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Publication Date
Mon Feb 27 2023
Journal Name
Applied Sciences
Comparison of ML/DL Approaches for Detecting DDoS Attacks in SDN
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Software-defined networking (SDN) presents novel security and privacy risks, including distributed denial-of-service (DDoS) attacks. In response to these threats, machine learning (ML) and deep learning (DL) have emerged as effective approaches for quickly identifying and mitigating anomalies. To this end, this research employs various classification methods, including support vector machines (SVMs), K-nearest neighbors (KNNs), decision trees (DTs), multiple layer perceptron (MLP), and convolutional neural networks (CNNs), and compares their performance. CNN exhibits the highest train accuracy at 97.808%, yet the lowest prediction accuracy at 90.08%. In contrast, SVM demonstrates the highest prediction accuracy of 95.5%. As such, an

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Publication Date
Fri Jan 01 2021
Journal Name
Fme Transactions
Unsteady nonlinear panel method with mixed boundary conditions
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A new panel method had been developed to account for unsteady nonlinear subsonic flow. Two boundary conditions were used to solve the potential flow about complex configurations of airplanes. Dirichlet boundary condition and Neumann formulation are frequently applied to the configurations that have thick and thin surfaces respectively. Mixed boundary conditions were used in the present work to simulate the connection between thick fuselage and thin wing surfaces. The matrix of linear equations was solved every time step in a marching technique with Kelvin's theorem for the unsteady wake modeling. To make the method closer to the experimental data, a Nonlinear stripe theory which is based on a two-dimensional viscous-inviscid interac

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