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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Dec 31 2021
Journal Name
Political Sciences Journal
The US-Iranian dispute and its repercussions on Iraq After 2003
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Receipt date: 8/8/2020 acceptance date: 9/11/2020 Publication date: 31/12/2021

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

           The American-Iranian relations have been characterized by tensions since the arrival of the guardian jurist regime in Iran to leadership in 1979, as it was considered a turning point not only in the cont

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Publication Date
Fri Dec 01 2023
Journal Name
Political Sciences Journal
China's Soft Power and Diplomacy towards Middle East Region after 2011
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The study deals with China's soft power and diplomacy in the Middle East, and it focuses specifically on the tools and foundations of China's soft diplomacy and how it achieves its goals in the region in addition to its challenges in the region. In this regard, the study also focuses on the Chinese Belt and Road Initiative and its soft foundations and how they serve China’s diplomacy and soft power in the region. The study ends with a set of conclusions, perhaps the most prominent of which is that diplomacy and soft power have become a fundamental pillar of China's foreign policy to achieve its foreign goals and to establish an international system compatible with China's principles. As for the Middle East, China has established a poli

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Publication Date
Mon Feb 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Partial Least Squares and Principal Components Methods by Simulation
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Abstract                                                                                              

The methods of the Principal Components and Partial Least Squares can be regard very important methods  in the regression analysis, whe

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Publication Date
Wed Dec 20 2006
Journal Name
Al-nahrain Journal Of Science
perparation and Comparison Study of Some New bis (Arylimido) Triruthenum Complexes‏
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A comparison study was made for the reaction of triruthenium carbonyl Ru3(CO)12 with azoarene ArN=NAr . This reaction was monitored in two kinds of solvents , toluene , and n- octane , which yielded new triruthenium carbonyl complex Ru3(μ3-NAr)2(CO)9 . The reactions of azoarenes ArN=NAr with Ru3(CO)12 formed the following trinuclear compound of Ru3((μ3- NAr)2(CO)9 (Ar-C6H4Br-4) in law yield . In addition , to new isomers species of mononuclear cyclometallated of Ru(BrC6H4N-NC6H4NBr-4)2(CO)2 in different percentages . The mechanism of the reaction domenstrates that the formation of trinuclear bis arylimido complexes , and ortho metallated was , the result of cleavage of nitrogen –nitrogen bond . Monitoring this gave evidence that the rea

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Publication Date
Mon Jun 05 2023
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Poisson Regression and Conway Maxwell Poisson Models Using Simulation
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Regression models are one of the most important models used in modern studies, especially research and health studies because of the important results they achieve. Two regression models were used: Poisson Regression Model and Conway-Max Well-  Poisson), where this study aimed to make a comparison between the two models and choose the best one between them using the simulation method and at different sample sizes (n = 25,50,100) and with repetitions (r = 1000). The Matlab program was adopted.) to conduct a simulation experiment, where the results showed the superiority of the Poisson model through the mean square error criterion (MSE) and also through the Akaiki criterion (AIC) for the same distribution.

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Publication Date
Wed Jan 01 2025
Journal Name
Lecture Notes In Networks And Systems
Comparison Between the Performance of Human Translators and AI-Supported Applications
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This study aims to conduct an exhaustive comparison between the performance of human translators and artificial intelligence-powered machine translation systems, specifically examining the top three systems: Spider-AI, Metacate, and DeepL. A variety of texts from distinct categories were evaluated to gain a profound understanding of the qualitative differences, as well as the strengths and weaknesses, between human and machine translations. The results demonstrated that human translation significantly outperforms machine translation, with larger gaps in literary texts and texts characterized by high linguistic complexity. However, the performance of machine translation systems, particularly DeepL, has improved and in some contexts

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Publication Date
Thu Jun 01 2023
Journal Name
Baghdad Science Journal
Comparison of Faster R-CNN and YOLOv5 for Overlapping Objects Recognition
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Classifying an overlapping object is one of the main challenges faced by researchers who work in object detection and recognition. Most of the available algorithms that have been developed are only able to classify or recognize objects which are either individually separated from each other or a single object in a scene(s), but not overlapping kitchen utensil objects. In this project, Faster R-CNN and YOLOv5 algorithms were proposed to detect and classify an overlapping object in a kitchen area.  The YOLOv5 and Faster R-CNN were applied to overlapping objects where the filter or kernel that are expected to be able to separate the overlapping object in the dedicated layer of applying models. A kitchen utensil benchmark image database and

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Publication Date
Mon Jun 01 2009
Journal Name
Journal Of Economics And Administrative Sciences
Use sensitivity analysis in evaluating projects Investment under the conditions of risk and uncertainty Case study of glass bottles project in Anbar province
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This paper studies the investment project evaluation under the condition of uncertainty. Evaluation of investment project under risk and uncertainty is possible to be carried out through application of various methods and techniques. The best known methods are : Risk-adjusted discount rate , certainty equivalent method , Sensitivity analysis and Simulation method The objective of this study is using the sensitivity analysis in evaluation Glass Bottles project  in Anbar province under the condition of risk and uncertainty.

After applying sensitivity analysis we found that the glass bottles project  sensitive to the following factors (cash flow, the cost of investment, and the pro

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Publication Date
Mon Dec 21 2020
Journal Name
Journal Of Petroleum Research And Studies
Alteration wettability of carbonate rocks by Nano fluids and comparison with PEG and SDS
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This work was conducted to study limestone rock wettability alteration to enhance oil recovery by flooding using different Nano silica (NS) sizes suspended in saline water and compared with flooding solution of polyethylene glycol (PEG) polymer and sodium dodecyl sulfate (SDS) surfactant, the stability of nanofluids measured by zeta potential. In the flooding system, the secondary recovery by silica nanofluids (0.01 wt. % NS concentration) achieved an oil recovery of 35vol. % and 26.08 vol. % for 10, 52 nm after primary recovery respectively, while PEG polymer and SDS surfactant achieved oil recovery of 5 vol. % and 10 vol. % only respectively. The stability of pressure difference approved that silica nanoparticle never causes any p

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Publication Date
Sat Dec 04 2021
Journal Name
International Journal Of Drug Delivery Technology
Evaluation of the Anti-inflammatory and Anti-oxidant Activity of Crab Components and Crab Shell in Experimental Rats in Comparison with Dexamethasone and Diclofenac Sodium
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Crabs belong to the crustacean family (Decapods crustacean), and their shells contain natural ingredients from which the bioactive compounds are derived. It has been used as folklore medicine in cancer treatment. We investigate the possible anti-inflammatory and anti-oxidant effects for crab shells and whole crabs. Thirty-six rats (150–200 gm) from both sexes were used, divided into six groups, the anti-inflammatory and anti-oxidant activity measured using cotton pellet induce granuloma model. Detection of tumor necrosis factor alpha (TNF α), Interleukin 1 beta (IL-1β), superoxide (SOD), and malondialdehyde (MDA) levels using ELISA Kits. The data analysis by one-way ANOVA followed by the Tukey test. Values are significant at (p < 0.05).

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