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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Sep 07 2008
Journal Name
Baghdad Science Journal
Mutagenic Effect of Crucifers Lepidium sativum and Eruca sativa in Comparison to Carrot Daucus carota
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The mutagenic effect of some crucifers widely consumed Lepiduim sativum (Garden cress) and Arugula (Eruca sativa) was studied in comparison to carrot (Daucus carota), using bacterial mutagenic system composed of three bacterial isolates; (Bacillus spp)G3 (Arthrobacter spp)G12, and (Brevibacterium spp)G27 ,. Treatment of isolates with plant extracts led to reduction in survival fraction (Sx)at different levels except that Aurgula extract did not show any inhibitory effect in isolates G12 and G27. Crucifers extracts induced streptomycin resistant mutants in G12 at higher level than G3 , but not in G27. No resistance to rifimpacin was detected in all isolates.

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Publication Date
Fri Feb 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of classical method and optimization methods for estimating parameters in nonlinear ordinary differential equation
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  This study is concerned with the estimation of constant  and time-varying parameters in non-linear ordinary differential equations, which do not have analytical solutions. The estimation is done in a multi-stage method where constant and time-varying parameters are estimated in a straight sequential way from several stages. In the first stage, the model of the differential equations is converted to a regression model that includes the state variables with their derivatives and then the estimation of the state variables and their derivatives in a penalized splines method and compensating the estimations in the regression model. In the second stage, the pseudo- least squares method was used to es

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Publication Date
Sun Feb 15 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The value of ultrasound and color Doppler ultrasonography in the evaluation of periapical lesions in comparison to histopathological and/or surgical findings
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Background: Imaging techniques play a very important role in the specialty of endodontic. The ultrasonographic technique is non-expensive procedure, safe, and reproducible. The aim of the study was to determine the sensitivity, specificity, and accuracy of ultrasound and color Doppler ultrasonography in evaluation of periapical lesions (cyst, granuloma, mixed lesion “cyst within graulomas mass”, and abscess. Subject, Material and method: The sample consists of prospective study for 64 Iraqi participants who attended Karbalaa Specialized Center for Dentistry (males & females). Those patients were diagnosed clinically and radiographically as having periapical lesions of dental origin. They were examined by real time ultrasound and color

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Publication Date
Wed Sep 30 2009
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Methanol Effect on color stability and shelf life of phenolic Resin compound under acidic conditions
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The object of this work is to investigate the effect of the addition of methanol on the shelf life and color characteristics of novolak resin. Different percentages were added and two mechanisms were suggested for the addition. High ortho structure (1, 2-3) novolak resin was prepared and used in the above investigation. Experimental determination using FT-IR and UV-spectroscopy showed that on the addition of 30% of methanol and according to the second mechanism of addition novolak shelf life increased to 12 months without obvious decomposition and color change. It is suggested that methanol plays an important role in the inhabitation of the reactive sites on the resin that are responsible for the oxidation of the polymer when exposed to

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Publication Date
Fri Jan 01 2021
Journal Name
Journal Of Animal Behaviour And Biometeorology
Optimization of some environmental and nutritional conditions using microtiter plate for Pseudomonas aeruginosa biofilm formation
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One of the most important virulence factors in Pseudomonas aeruginosa is biofilm formation, as it works as a barrier for entering antibiotics into the bacterial cell. Different environmental and nutritional conditions were used to optimize biofilm formation using microtitre plate assay by P. aeruginosa. The low nutrient level of the medium represented by tryptic soy broth (TSB) was better in biofilm formation than the high nutrient level of the medium with Luria Broth (LB). The optimized condition for biofilm production at room temperature (25 °C) is better than at host temperature (37 °C). Moreover, the staining with 0.1% crystal violet and reading the biofilm with wavelength 360 are considered essential factors in

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Publication Date
Sun Oct 01 2023
Journal Name
Baghdad Science Journal
The Necessary and Sufficient Optimality Conditions for a System of FOCPs with Caputo–Katugampola Derivatives
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The necessary optimality conditions with Lagrange multipliers  are studied and derived for a new class that includes the system of CaputoKatugampola fractional derivatives to the optimal control problems with considering the end time free. The formula for the integral by parts has been proven for the left CaputoKatugampola fractional derivative that contributes to the finding and deriving the necessary optimality conditions. Also, three special cases are obtained, including the study of the necessary optimality conditions when both the final time  and the final state  are fixed. According to convexity assumptions prove that necessary optimality conditions are sufficient optimality conditions.

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Publication Date
Mon Oct 01 2018
Journal Name
Journal Of Engineering
Synthesis and Characterization of Magnetic Iron Oxide Nanoparticles by Co-Precipitation Method at Different Conditions
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Magnetic nanoparticles (MNPs) of iron oxide (Fe3O4) represent the most promising materials in many applications. MNPs have been synthesized by co-precipitation of ferric and ferrous ions in alkaline solution. Two methods of synthesis were conducted with different parameters, such as temperature (25 and 80 ̊C), adding a base to the reactants and the opposite process, and using nitrogen as an inert gas. The product of the first method (MNPs-1) and the second method (MNPs-2) were characterized by x-ray diffractometer (XRD), Zeta Potential, atomic force microscope (AFM) and scanning electron microscope (SEM). AFM results showed convergent particle size of (MNPs-1) and (MNPs-2) with (86.01) and (74.14)

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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Immunohistochemical Expression of DNMT3B among Oral, Laryngeal and Skin SCC
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Background: Recently epigenetic alterations have received increased attention because of theirimportant role in the process of tumerigenesis. It has been found that more than half of genetic changes were epigenetic. Epigenetic alterations are catalyzed by DNMTs enzymes. Increased knowledge about this molecular event may achieve progress in the war against cancer. The aim of this study was to evaluate and compare the expression of DNMT3B among oral, laryngeal and skin SCC. Materials and Methods: This study was performed on (120) formalin-fixed, paraffin-embedded blocks, histopathologically diagnosed as oral, laryngeal and skin SCC). Immunohistochemical staining of DNMT3B antibody was performed on each case of this study. Results: The immunoh

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Publication Date
Wed Jul 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Experimental and Numerical Comparison of Prestressed Perforated Concrete Rafters of Different Configurations
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Abstract<p>This paper demonstrates an experimental and numerical study aimed to compare the influence of openings of different configurations on the flexural behavior of prestressed concrete rafters. The experimental program consisted of testing six simply supported prestressed concrete rafters; 5 rafters are perforated, and the other one is solid as a reference. All rafters were tested under monotonic midpoint load. The variable which has been investigated in this work was the opening’s configuration (quadrilateral or circular) with the same upper and lower chords depths. The results indicate improvement in the beam flexural behavior using the circular openings compared to the quadrilateral o</p> ... Show More
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Publication Date
Mon Jun 01 2015
Journal Name
Journal Of The College Of Languages (jcl)
A Stylistic Analysis of Two Selected, English and Arabic, War Poems
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War as a human phenomenon, has its own literature. Poetry is a major genre in this literature. This paper is an attempt to investigate and analyse some stylistic features in two selected, English and Arabic, war poems. These poems share the same theme.Both promote the principle of sacrificing one’s own life for the sake of homeland.  This paper limits itself to analyse, thecontent words, tenses, semantic grouping of vocabulary and foregrounding in the two poems. The areas of analysis show great similarities in distributing the general content words (nouns, verbs, adjectives, and adverbs). In the analysis of the semantic areas of each content word, these poems reveal some similarities and some differences in their frequency rates.

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