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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Dec 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between some of linear classification models with practical application
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Linear discriminant analysis and logistic regression are the most widely used in multivariate statistical methods for analysis of data with categorical outcome variables .Both of them are appropriate for the development of linear  classification models .linear discriminant analysis has been that the data of explanatory variables must be distributed multivariate normal distribution. While logistic regression no assumptions on the distribution of the explanatory data. Hence ,It is assumed that logistic regression is the more flexible and more robust method in case of violations of these assumptions.

In this paper we have been focus for the comparison between three forms for classification data belongs

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Publication Date
Sat Sep 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
A comparison Of Some Semiparametric Estimators For consumption function Regression
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    This article aims to explore the importance of estimating the a semiparametric regression function ,where we suggest a new estimator beside the other combined estimators and then we make a comparison among them by using simulation technique . Through the simulation results we find  that the suggest estimator is the best with the first and second models ,wherealse for the third model we find Burman and Chaudhuri (B&C) is best.

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Publication Date
Thu Mar 30 2023
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating Nonparametric Binary Logistic Regression
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In this research, the methods of Kernel estimator (nonparametric density estimator) were relied upon in estimating the two-response logistic regression, where the comparison was used between the method of Nadaraya-Watson and the method of Local Scoring algorithm, and optimal Smoothing parameter λ was estimated by the methods of Cross-validation and generalized Cross-validation, bandwidth optimal λ has a clear effect in the estimation process. It also has a key role in smoothing the curve as it approaches the real curve, and the goal of using the Kernel estimator is to modify the observations so that we can obtain estimators with characteristics close to the properties of real parameters, and based on medical data for patients with chro

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Publication Date
Thu Jan 22 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of shear bond strength of zirconia to tooth structure after different zirconia surface treatment techniques
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Background: This study aimed to evaluate the effect of zirconia different surface treatments (primer, sandblast with 50μmAl2O3, Er,Cr:YSGG laser) on shear bond strength between zirconia surface and resin cement. Material and methods: Sixty presintered Y-TZP zirconia cylinder specimens (IPS e.max ZirCAD, Ivoclar vivadent) will be fabricated and sintered in high temperature furnace of (1500 C for 8 hours) according to manufacturer’s instructions to the selected size and shape of (5mm. in diameter and 6mm in height). All specimens were ground flat using 600.800.1000.1200, aluminum oxide abrasive paper to obtain a standardized surface roughness. Surface roughness values were then recorded in µm using surface roughness tester (profi

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Publication Date
Thu Nov 02 2023
Journal Name
Journal Of Engineering
An Overview of How the Petrophysical Properties of Rock Influenced After Being Exposed to Cryogenic Fluid
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Exposure to cryogenic liquids can significantly impact the petrophysical properties of rock, affecting its density, porosity, permeability, and elastic properties. These effects can have important implications for various applications, including oil and gas production and carbon sequestration. Cryogenic liquid fracturing is a promising alternative to traditional hydraulic fracturing for exploiting unconventional oil and gas resources and geothermal energy. This technology offers several advantages over traditional hydraulic fracturing, including reduced water consumption, reduced formation damage, and a reduced risk of flow-back fluid contamination. In this study, an updated review of recent studies demonstrates how the

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Publication Date
Fri Jan 10 2020
Journal Name
Polymers
Influence of Polyphosphates on the Physicochemical Properties of Poly (Vinyl Chloride) after Irradiation with Ultraviolet Light
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Three new polyphosphates were synthesized in good yields by reacting diethylenetriamine with the appropriate phosphate ester in ethanol under acidic conditions. The polyphosphate structures were determined using FT-IR and 1H-NMR spectroscopies, and their elemental compositions were confirmed by EDX spectroscopy. Polyphosphates were added to poly(vinyl chloride) (PVC) at low concentrations to fabricate thin films. The PVC films were irradiated with ultraviolet light for long periods, and the effect of polyphosphates as the photostabilizer was investigated by determining changes in the infrared spectra (intensity of specific functional group peaks), reduction in molecular weight, weight loss, and surface morphology. Minimal changes we

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Publication Date
Wed Jun 06 2001
Journal Name
المجلة العراقية للعلوم الاحصائية
Suggest formulas for estimating carry-over effects in two-period changeover design
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This research aims to suggest formulas to estimate carry-over effects with two-period change-over design, and then, all other effects in the analysis of variance of this design, and find the efficiency of the two-period change-over design relative to another design (say, completely randomized design).

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Publication Date
Sat Feb 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Implication of Yield Lines Theory in Method Three of the ACI Code for Two-Way Reinforced Concrete Slabs
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Abstract<p>Reinforced concrete slabs are one of the most important and complicated elements of a building. For supported edges slabs, if the ratio of long span to short span is equal or less than two then the slab is considered as two-way slab otherwise is consider as one-way slab. Two-way reinforced concrete slabs are common in use in reinforced concrete buildings due to geometrically arrangement of columns suggested by architects who prefer a symmetric distribution of columns in their plans. Elastic theory is usually used for analysis of concrete slabs. However, for several reasons design methods based on elastic principles are limited in their function. Correspondingly, limit state analysis o</p> ... Show More
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Publication Date
Tue Mar 20 2018
Journal Name
Mustansiria Dental Journal
A comparative Study in the Antibacterial effect of Eugenol as Hand Wash Material with two Types of Soap
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Hands have consistently been an important vehicle in the transmission of disease (1). Thus, thorough hand-washing remains the single most important factor in preventing infection specially in hospitals and labs.Twenty-nine non-clinical volunteers (do not work or come in contact with a clinical or hospital setting) that lacked visible skin injuries, eczema or apparent skin disease were used, those subjects were all tested by a material of each of the three used in the study weekly and laboratory tests were done pre- and post washing.All three material were effective , Eugenol extract as effective as the bar and lotion soap. And this was confirmed statistically.Eugenol has a great antibacterial action even in small concentration and t

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Publication Date
Thu Nov 01 2018
Journal Name
Computers &amp; Fluids
Assessing moment-based boundary conditions for the lattice Boltzmann equation: A study of dipole-wall collisions
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