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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Oct 17 2018
Journal Name
Journal Of Economics And Administrative Sciences
A Comparison of Bayes Estimators for the parameter of Rayleigh Distribution with Simulation
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   A comparison of double informative and non- informative priors assumed for the parameter of Rayleigh distribution is considered. Three different sets of double priors are included, for a single unknown parameter of Rayleigh distribution. We have assumed three double priors: the square root inverted gamma (SRIG) - the natural conjugate family of priors distribution, the square root inverted gamma – the non-informative distribution, and the natural conjugate family of priors - the non-informative distribution as double priors .The data is generating form three cases from Rayleigh distribution for different samples sizes (small, medium, and large). And Bayes estimators for the parameter is derived under a squared erro

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Publication Date
Thu Sep 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating Mixture of Linear Regression Models with Application
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 A mixture model is used to model data that come from more than one component. In recent years, it became an effective tool in drawing inferences about the complex data that we might come across in real life. Moreover, it can represent a tremendous confirmatory tool in classification observations based on similarities amongst them. In this paper, several mixture regression-based methods were conducted under the assumption that the data come from a finite number of components. A comparison of these methods has been made according to their results in estimating component parameters. Also, observation membership has been inferred and assessed for these methods. The results showed that the flexible mixture model outperformed the

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Publication Date
Thu Mar 06 2025
Journal Name
International Journal Of Applied Mechanics And Engineering
Comparison of The Mechanical Properties of Low-Cost Bio Fiber Reinforced Polymer Composites
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In this study, the physical, and mechanical properties of low-cost and biocomposites were evaluated. The walnut shell and date palm frond fibers were thermally treated in an oven at a temperature of 70°C and then chemically treated with NaOH and distilled water solution, after these treatments, the biocomposite materials will be thermally treated again at 50°C. This procedure was performed for three types of biocomposite; Walnut shell Fiber Reinforced Polymer (WFRP), Date palm Fiber Reinforced Polymer (DFRP), and Hybrid Fiber Reinforced Polymer (HFRP), whereas the biocomposite sheets consisting of 30% biofibers and 70% unsaturated polyester, the mechanical test specimens were cut by a CNC machine according to ASTM standards. The e

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Publication Date
Thu Apr 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Branch and Bound Algorithm with Penalty Function Method for solving Non-linear Bi-level programming with application
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The problem of Bi-level programming is to reduce or maximize the function of the target by having another target function within the constraints. This problem has received a great deal of attention in the programming community due to the proliferation of applications and the use of evolutionary algorithms in addressing this kind of problem. Two non-linear bi-level programming methods are used in this paper. The goal is to achieve the optimal solution through the simulation method using the Monte Carlo method using different small and large sample sizes. The research reached the Branch Bound algorithm was preferred in solving the problem of non-linear two-level programming this is because the results were better.

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Publication Date
Sun Feb 04 2018
Journal Name
Journal Of The College Of Education For Women
Phrenic nerve paralysis during cryoballoon ablation for atrial fibrillation: A comparison between the first- and second-generation balloon
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The present study deals with the effect of teaching speaking Strategies (SS) on EFL Iraqi College students. The use of speaking strategies not only solves learners’ communication problems, but also enhances the learner’s interaction in target language, and improves their oral proficiency .The aim of the study is to find out the effect of teaching SS used by EFL College students .The learner of the first stage is population of the study at the Department of English, College of Education /Ibn-Rushd .The sample consists of (60) students distributed on experimental group(A) as well as control group(B) each group contains (30) students . In order to achieve the aim of the study, questionnaire has been constructed to be taught on the experime

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Publication Date
Mon Jan 01 2024
Journal Name
Journal Of The College Of Languages (jcl)
The neology in the Iraqi dialect after the invasion of 2003 and the level of imaginative comprehension: La neología en el dialecto Iraqui tras la invasión de 2003 y el nivel de la comprensión imaginativa
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       The article analyzes the neologisms that arose in the Iraqi dialect after the 2003 US-British invasion and the fall of Saddam Hussein's regime, according to the theory I advocate: "The Basic Outline of Reference," a developed theory of Arab legacy and cognitive theory, which came out in 1987 in America, so we have used the terminology of cognitive grammar. In this theory it is stated that the reference is the interaction between four components: perception, imagination, imaginative comprehension and the linguistic sign or symbolization (the neological word in this article), which are closely related, so that none of them can be lacking, because they constitute a holistic whole that belongs to a deeper level. Let us

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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of the Marginal Fitness of the Ceramic Crowns Fabricated with Different CAD/CAM Systems (An In Vitro Study)
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Background: The marginal fit is the most characteristic that closely related to the longevity or success of a restoration, which is absolutely affected by the fabrication technique. The objective of present in vitro study was to evaluate the effect of four different CAD/CAM systems on the marginal fit of lithiµm disilicate all ceramic crowns. Materials and Methods: Adentoform tooth of a right mandibular first molar was prepared to receive all ceramic crown restoration with deep chamfer finishing line (1mm) and axial reduction convergence angle of 6 degree, dentoform model duplicated to have Nickel-Chromiµm master die. Thirty two stone dies produce from master die and distributed randomly in to four groups (8 dies for each group) accor

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Publication Date
Fri Jan 23 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Dissolution of calcium ion from teeth treated with different concentrations of siwak water extract in comparison with sodium fluoride
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Background: The miswak is a teeth cleaning twig made from a twig of the Salvadora persica tree (known as arak in Arabic).A traditional alternative to the modern toothbrush, it has a long, well-documented history and is reputed for its medicinal benefits. It also features prominently in Islamic hygienical jurisprudence. Materials and methods: Twenty maxillary first premolars were treated with the selected solutions which included siwak water extract (5%, 10%) and sodium fluoride 0.05% for 2minutes once daily for 20 days interval, deionized water was used as control negative. Then the concentration of the dissolved calcium ion in the etching solution of 2N HCL was measured. Results: The least amount of the dissolved calcium ion was registere

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Publication Date
Wed Jan 01 2025
Journal Name
Medical Journal Armed Forces India
Efficacy of hypochlorous acid solution in comparison with povidone iodine solution for the management of infected diabetic foot ulcers
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Publication Date
Fri Aug 20 2021
Journal Name
Iraqi Journal Of Laser
Permeability of Radicular Dentine after Using Different Irrigant Activation Techniques Including Photo Induce Photoacoustic Streaming Technique
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Background: preparation of root canals is an important step in root canal treatment. Mechanical instrumentation of root canals cause an irregular layer of debris, known as the smear layer. As a result, several studies reported that preferring the removal of the smear layer. Objective: To study the influence of the energy (100 mJ) of Erbium, Chromium: Yttrium Scandium Gallium Garnet (Er,Cr:YSGG) laser at short pulse duration (60 μs)  on smear layer removal of apical third after using Photon induced photoacoustic streaming technique. Materials and methods: Eighteen straight single-rooted mandibular premolars were used. The roots length were uniform to 14mm from the anatomic apex and

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