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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 04 2025
Journal Name
Kufa Journal For Agricultural Sciences – 2025:17(2) : 56- 65
Efficacy of different Conidial concentrations, fungal Filtrations and silver nanoparticles Mycosynthesis using two isolates of Metarhizium anisoplae against Two Stored-grain Insects
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Publication Date
Thu Dec 14 2023
Journal Name
Iop Conf. Series: Earth And Environmental Science
Calculating some Powers and Traction Force for Two Plows in Primary Tillage
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Traction force and power requirement when performing primary tillage occupy the minds of almost farmers, this field research had aim to determine and calculate the pulling force of the most commonly used moldboard and chisel plows, the research conducted in silt clay loam for chisel and moldboard plows as the main factor, two depths of tillage 18 and 25 cm as a second factor and three speeds of tractor 2.55, 4.30 and 6.15 km.h-1 as a third factor. Moldboard plow recorded least traction force 7.550 kN, drawbar power 11.583 hp, power losses due to slippage 1.088 hp, power on the rear axle of the tractor 15.770 hp and brake horse power 17.495 hp. Chisel plow recorded best traction efficiency 76.217 % and total traction efficiency 68.659 %. Dep

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Publication Date
Sun Mar 08 2026
Journal Name
Statistics, Optimization And Information Computing
Adult Dengue Fever in Bangladesh: A One-Sample Rank-Based Test of Hematologic Location Against Healthy References
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Dengue fever is a mosquito-borne viral infection that produces characteristic abnormalities in routine blood tests, yet these hematologic changes are typically analysed separately for each parameter rather than as a combined multivariate profile. This study investigated whether the joint hematologic profile of adult dengue patients in Bangladesh is systematically displaced from healthy adult reference values. We analysed a cohort of laboratory-confirmed adult dengue cases from a Bangladeshi hospital and focused on four core hematologic indices: haemoglobin, white blood cell count, platelet count, and platelet distribution width (PDW). External adult reference means were used to define a healthy location vector, and robust multivariate infer

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Publication Date
Fri Jun 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
Handling a problem of transport solid waste in Baghdad City to Healthy landfill sites using transportation Model
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 A problem of solid waste became in the present day common global problem among all countries, whether developing or developed countries, and can say that no country in the world today is immuning from this dilemma which must find appropriate solutions. The problem has reached a stage that can not ignore or delay, but has became a daily problem occupies the minds of ecologists, economists and politicians took occupies center front in the lists of  priorities for the countries in terms of finding solutions to the rapid scientific and radical them. and that transport costs constitute an important component of total costs borne by the municipal districts in the process of disposal of solid waste, so any improvement in the

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Publication Date
Fri Jun 01 2018
Journal Name
Journal Of Cranio-maxillofacial Surgery
Assessment of regional asymmetry of the face before and after surgical correction of unilateral cleft lip
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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
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
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 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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