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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 05 2018
Journal Name
Acs Applied Nano Materials
Direct Formation of 2D-MnO<sub><i>x</i></sub> under Conditions of Water Oxidation Catalysis
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We describe the synthesis and characterization of a novel 2D-MnOx material using a combination of HR-TEM, XAS, XRD, and reactivity measurements. The ease with which the 2D material can be made and the conditions under which it can be made implies that water oxidation catalysts previously described as “birnessite-like” (3D) may be better thought of as 2D materials with very limited layer stacking. The distinction between the materials as being “birnessite-like” and “2D” is important because it impacts on our understanding of the function of these materials in the environment and as catalysts. The 2D-MnOx material is noted to be a substantially stronger chemical oxidant than previously noted for other birnessite-like manganese oxi

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Publication Date
Tue Jun 16 2026
Journal Name
Sciences Journal Of Physical Education
Cognitive bias and its relationship to the performance of the two skills of standing on (hands and the human wheel) on the floor movement carpet device in the artistic gymnastics for women
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Publication Date
Fri Sep 30 2022
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating the Survival Function and Failure Rate for the Exponentiated Expanded Power Function Distribution
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     We have presented the distribution of the exponentiated expanded power function (EEPF) with four parameters, where this distribution was created by the exponentiated expanded method created by the scientist Gupta to expand the exponential distribution by adding a new shape parameter to the cumulative function of the distribution, resulting in a new distribution, and this method is characterized by obtaining a distribution that belongs for the exponential family. We also obtained a function of survival rate and failure rate for this distribution, where some mathematical properties were derived, then we used the method of maximum likelihood (ML) and method least squares developed  (LSD)

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Publication Date
Fri Sep 30 2022
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating the Survival Function and Failure Rate for the Exponentiated Expanded Power Function Distribution
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       We have presented the distribution of the exponentiated expanded power function (EEPF) with four parameters, where this distribution was created by the exponentiated expanded method created by the scientist Gupta to expand the exponential distribution by adding a new shape parameter to the cumulative function of the distribution, resulting in a new distribution, and this method is characterized by obtaining a distribution that belongs for the exponential family. We also obtained a function of survival rate and failure rate for this distribution, where some mathematical properties were derived, then we used the method of maximum likelihood (ML) and method least squares developed  (LSD) to estimate the parameters an

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Publication Date
Sat Dec 01 2018
Journal Name
Engineering And Technology Journal
Comparison between the Biological Activity of Agaricus bisporus Fruiting Bodies and Albizzia lebbeck Leaves Extract against Different Pathogenic Microoganisms
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Publication Date
Sat Sep 01 2007
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Between Ordinary Method and Robust Method to estimate the Parameters of the Univariate Mixed Model with Low Order
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A condense study was done to compare between the ordinary estimators. In particular the maximum likelihood estimator and the robust estimator, to estimate the parameters of the mixed model of order one, namely ARMA(1,1) model.

Simulation study was done for a varieties the model.  using: small, moderate and large sample sizes, were some new results were obtained. MAPE was used as a statistical criterion for comparison.

 

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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
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
Thu Jun 15 2023
Journal Name
Jornal Of Al-muthanna For Agricultural Sciences
Effect of different levels of Adrenocorticotropic hormone (ACTH) on physiological performance of broiler under heat stress conditions.
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This experiment was holdup in A-Faris poultry farms from 1st March to 11 of Aprile 2019. (ACTH) hormone infusion was tested in this experiment on acid-base regulation in broiler chickens. For 7 days, osmotic pumps dispensed 8 IU of ACTH in saline/kg of BW/d, or the same volume of saline as in ACTH at 1 l/h. On days 0 and 14, after the beginning of the infusions, blood samples were obtained to establish a baseline. The plasma concentrations of Na+, K+, and Cl- were decreased, whereas the partial pressure of CO2, anion gap, corticosterone, mean corpuscular hemoglobin concentration, and blood concentrations of hemoglobin and HCO - were all elevated due to the ACTH administration. When given ACTH, neither blood pH nor plasma Ca2+ levels changed

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Publication Date
Sat Oct 01 2022
Journal Name
Baghdad Science Journal
Toxicity of Nanomulsion of Castor Oil on the Fourth larval stage of Culex quinquefsciatus under Laboratory Conditions
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Mosquitoes like Culex quinquefasciatus are the primary vector that transmits many causes of diseases such as filariasis, Japanese encephalitis, and West Nile virus, in many countries around the world. The development in the scientific fields, such as nanotechnology, leads to use this technique in control programs of insects including mosquitoes through the use of green synthesis of nanoemulsions based on plant products such as castor oil.  Castor oil nanoemulsion was formulated in various ratios comprising of castor oil, ethanol, tween 80, and deionized water by ultrasonication. Thermodynamic assay improved that the formula of (10 ml) of castor oil, ethanol (5ml), tween 80 (14 ml) and deionized water (71ml)   was mor

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