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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Dec 01 2011
Journal Name
Journal Of Engineering
Effect of Steering Wheel Vibration on drivers Hands in a Two-Wheel Drivers Hand tractor
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The paper presents research results of the vibration transmitted from the steering wheel of the
tractor with a 2-wheel drive to the driver’s hands. The vibration measurements were carried out on the
tractor randomly chosen from the collage of agriculture / university of Baghdad. Before testing the
tractor was examined and adjusted following the producer’s recommendations. The vibration levels
were measured during the operation tillage at idling and at full load .The field was 3١٫٧ m above level
sea. Soil was treated at soil constant moisture (1٧-20 %) with depth of plowing (١٧ cm). During
operation the weather temperature was measured (15 C) and humidity was ( 27 % ) The vibration level
on the steering whee

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Publication Date
Wed Jan 21 2026
Journal Name
Journal Of Baghdad College Of Dentistry
In vivo plaque count of Streptococcus Mutans around orthodontic brackets bonded with two different adhesives
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Background: The prevention of the enamel demineralization at the periphery of the brackets is a significant challenge to orthodontic professionals. The aim of this clinical study was to compare the Streptococcus mutants count in the plaque surrounding two orthodontic adhesive types, Fuji Ortho LC and Enlight (Ormco). Materials and methods: A total of 13 patients (7 male and 6 female) needing fixed orthodontic appliance therapy were participated. A split mouth technique was followed with appliances bonded by two orthodontic adhesive types, Fuji Ortho LC and Enlight (Ormco). Saliva was collected before placement of appliances (T0) and again at three weeks (T1) and six weeks (T2) after placement of appliances. Plaque was collected from areas a

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Publication Date
Sat Dec 17 2011
Journal Name
Journal Of Engineering
Effect of Steering Wheel Vibration on drivers Hands in a Two-Wheel Drivers Hand tractor
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The paper presents research results of the vibration transmitted from the steering wheel of the tractor with a 2-wheel drive to the driver’s hands. The vibration measurements were carried out on the tractor randomly chosen from the collage of agriculture / university of Baghdad. Before testing the tractor was examined and adjusted following the producer’s recommendations. The vibration levels were measured during the operation tillage at idling and at full load .The field was 31.7 m above level sea. Soil was treated at soil constant moisture (17-20 %) with depth of plowing (17 cm). During operation the weather temperature was measured (15 C) and humidity was ( 27 % ) The vibration level on the steering wheel was measured and analyzed .T

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Publication Date
Fri Apr 01 2016
Journal Name
Journal Of Engineering
Aerobic biodegradation of phenol by Immobilized Pseudomonas sp. cells in two different bio-carrier matrices
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Biotreatment using immobilized cells (IC) technology has proved to be the most promising and most economical approach for the removal of many toxic organic pollutants found in petroleum-refinery wastewater (PRW) such as phenol. This study was undertaken to evaluate the degradation of phenol by Pseudomonas cells individually immobilized in two different bio-carrier matrices including polyvinyl alcohol-guar gum (PVA-GG) and polyvinyl alcohol-agar agar (PVA-AA). Results of batch experiments revealed that complete removal of phenol was attained in the first cycle after 150 min using immobilized cells (IC) in both PVA-GG and PVA-AA. Additional cycles were confirmed to evaluate the validity of recycling beads of immob

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Publication Date
Sun Dec 27 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn: 1683 - 3597 , E-issn : 2521 - 3512)
Estimation of Beta Two Microglobulins, Fetuin-A, Resistin Serum Level in Iraqi Multiple Myeloma Patients
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Multiple myeloma is hematological disease produces many complications in the bone, kidney, neural and other complications. The study aims to measure serum biomolecules like fetuin-A and resistin and determined the possibility to use these biomarkers as disease predictor. blood samples were isolated from 58 patients and 24 sex and age-matched control, serum then isolated, and proper ELISA kit then used to a determined level of B2 microglobulin, resistin, and fetuin-A. The result demonstrated significant increase in   B2 microglobulin, fetuin-A and resistin in patients compare to control (1.3470.714 vs. 0.9130.253), p = 0.000, (14.00310.352 vs. 9.2594.264), p= 0.005, (1.9673.595 vs. 0.6040.622), p = 0.009, respectively.   These di

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Publication Date
Wed Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Shear Bond Strength of Three Different Brackets Bonded on Zirconium Surfaces (In Vitro Study)
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Background: With the increased in the demands of adult orthodontics, the challenge of direct bonding to non-enamel surface (zirconium) had been increased. The present study was carried out to compare the shear bond strength of three different brackets (stainless steel, sapphire and composite) bonded to zirconium surface and study the mode of bond failure. Materials and methods: The sample was comprised of 30 models (8mm *6mm*1.5mm) of full contour zirconium veneers. They were divided into three groups according to the brackets type; all samples were treated first by sandblast with aluminum oxide particle 50 µm then coated by z-prime plus primer. A central incisor bracket of each group was bonded to the prepared zirconium surface with lig

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Publication Date
Sun Feb 24 2019
Journal Name
Iraqi Journal Of Physics
Comparison of three interpolation methods for the average monthly temperature in the south of Iraqi zone
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This study focuses on evaluating the suitability of three interpolation methods in terms of their accuracy at climate data for some provinces of south of Iraq. Two data sets of maximum and minimum temperature in February 2008 from nine meteorological stations located in the south of Iraq using three interpolation methods. ArcGIS is used to produce the spatially distributed temperature data by using IDW, ordinary kriging, and spline. Four statistical methods are applied to analyze the results obtained from three interpolation methods. These methods are RMSE, RMSE as a percentage of the mean, Model efficiency (E) and Bias, which showed that the ordinary krigingis the best for this data from other methods by the results that have b

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Publication Date
Tue Sep 01 2020
Journal Name
Baghdad Science Journal
Diversity and Geographical Distribution of Sand Flies Phlebotomus papatasi (Diptera: Phlebotominae) by using Geometric Morphometric Technique from two Iraqi Provinces
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            The variation in wing morphological features was investigated using geometric morphometric technique of the Sand Fly from two Iraqi provinces Babylon and Diyala . We distributed eleven landmarks on the wings of Sand Fly species. By using the centroid size and shape together, all species were clearly distinguished.  It is clear from these results that the wing analysis is an essential method for future geometric morphometry studies to distinguish the species of Sand Flies in Iraq.

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Publication Date
Thu Dec 01 2011
Journal Name
Engineering Analysis With Boundary Elements
Numerical solution of two-dimensional mixed problems with variable coefficients by the boundary-domain integral and integro-differential equation methods
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Publication Date
Tue Jan 30 2024
Journal Name
International Journal Of Engineering Pedagogy (ijep)
The Impact of Two Proposed Strategies Based on Active Learning on Students' Achievement at the Computer and Their Social Intelligence
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Active learning is a teaching method that involves students actively participating in activities, exercises, and projects within a rich and diverse educational environment. The teacher plays a role in encouraging students to take responsibility for their own education under their scientific and pedagogical supervision and motivates them to achieve ambitious educational goals that focus on developing an integrated personality for today’s students and tomorrow’s leaders. It is important to understand the impact of two proposed strategies based on active learning on the academic performance of first-class intermediate students in computer subjects and their social intelligence. The research sample was intentionally selected, consis

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