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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 03 2023
Journal Name
Journal Of Electronics,computer Networking And Applied Mathematics
Comparison of Some Estimator Methods of Regression Mixed Model for the Multilinearity Problem and High – Dimensional Data
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In order to obtain a mixed model with high significance and accurate alertness, it is necessary to search for the method that performs the task of selecting the most important variables to be included in the model, especially when the data under study suffers from the problem of multicollinearity as well as the problem of high dimensions. The research aims to compare some methods of choosing the explanatory variables and the estimation of the parameters of the regression model, which are Bayesian Ridge Regression (unbiased) and the adaptive Lasso regression model, using simulation. MSE was used to compare the methods.

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Publication Date
Fri Oct 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of some of reliability and Hazard estimation methods for Rayleigh logarithmic distribution using simulation with application
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The question of estimation took a great interest in some engineering, statistical applications, various applied, human sciences, the methods provided by it helped to identify and accurately the many random processes.

In this paper, methods were used through which the reliability function, risk function, and estimation of the distribution parameters were used, and the methods are (Moment Method, Maximum Likelihood Method), where an experimental study was conducted using a simulation method for the purpose of comparing the methods to show which of these methods are competent in practical application This is based on the observations generated from the Rayleigh logarithmic distribution (RL) with sample sizes

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Publication Date
Wed Dec 30 2015
Journal Name
Al-kindy College Medical Journal
Precision of pachymetric measurements with Scheimpflug –Placido disc cornealTopography and comparison of these measurements with ultrasonic pachymetry
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Back ground: Several devices with different physical bases have been developed for the clinical measurement of corneal thickness, they classified into 4 categories: Scheimpflug photography based, Slit –Scanning topography, optical coherence tomography (OCT) based and ultrasound (US) based.Objective:To evaluatethe precision of the new Scheimpflug –Placido disc corneal topography in measurement of corneal thickness and to compare the measured values with that obtained by US pachymetry.Methods: Setting of this study is Lasik center in Eye Specialty Private Hospital. Baghdad. Iraq.Eyes of healthy subjects were examined with the Sirius topography.3 consecutive measurements of central (CCT)and thinnest (TCT) corneal thicknesses were obtain

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Publication Date
Thu Jan 01 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The Effects of Nano-Hydroxyapatite and Casein Phosphopeptide-Amorphous Calcium Phosphate in Preventing Loss of Minerals from Teeth after Exposure to an Acidic Beverage (An In vitro Study)
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Background: To evaluate the effect of antierosive agents (10% Nano-Hydroxyapatite (NHA), 10% Casein Phophopeptide-Amorphous Calcium Phosphate (CPP-ACP), and combination of 10% NHA and 10% CPP-ACP) on loss of minerals from enamel surface of permanent teeth treated with antierosive agents when exposed to an acidic beverage and investigate the morphological changes of treated enamel surface after demineralization with cola based beverage under Scanning Electron Microscope (SEM). Materials and Methods: Sixty maxillary first premolars were randomly divided into four groups, 15 teeth for each group. Group I treated with 10% NHA, Group II treated with 10% CPP-ACP, Group III treated with 10% NHA and 10% CPP-ACP, and Group IV did not treat with any

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Publication Date
Thu Jan 09 2020
Journal Name
Plant Archives
Molecular Study of Two Fungi Millerozyma Farinosa and Candida Orthopsilosis by PCR Using Its Gene and Phylogenetic Structuring Tree Isolated from Diabetic Patient in Baghdad
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Diabetic mellitus is one of the main risk factors of fungal infections because poor glycemic control is associated with a high level of glucose in blood and saliva which could be treated as nutrient to fungi. This study aimed to isolate and identification of pathogenic fungi from diabetic patient. 140 samples were taken from different places of human body from the national center of diabetic patients that related to Mustansiriyah University / college of medicine and Al-yarmuk Hospital in Baghdad. 84 sample (60%) tested positive to fungi and 56 sample (40%) tested negative to fungi. The most frequented fungi isolated have been chosen for molecular identification by PCR (Millerozyma farinosa and Candida orthopsilosis) using specific pri

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Publication Date
Thu Jan 01 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of some mechanical properties of Imprelon® and Duran® thermoplastic Biostar machine sheets in comparison with some types of acrylic resins
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Background: Imprelon® Biostar foils are new alternative tray material that has become increasingly popular because oftheir several advantages. Also, (Duran®) is another type of Biostar foils which is used in splint therapy. This study assessed some mechanical properties of these two types Biostar sheets in comparison with some types of acrylic resins used for construction of trays and splints. Materials and Methods: A total of 150 specimens were prepared, 30 specimens for each test, 10 for each group material in order to assess some mechanical properties of the Imprelon® Biostar foil (dimension stability, surface roughness and shear bond strength of Imprelon® materialto zinc oxide impression material) and compare them to that of the oth

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Publication Date
Fri Jan 01 2021
Journal Name
Journal Of Clinical And Experimental Dentistry
Comparison of the accuracy of intraoral digital impression system and conventional impression techniques for multiple implants in the full-arch edentulous mandible
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Publication Date
Fri Mar 01 2019
Journal Name
Al-khwarizmi Engineering Journal
Study The Influence of Forming Conditions Like Deformation Speed on Void Closure in Open Die Forging
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This paper presents an investigation to the effect of the forming speed on healing voids that inhabit at various size in an ingot. The study was performed by using finite element method with bilinear isotropic material option, circular type voids were considered. The closure index was able to predict the minimum press force necessary to consolidate voids and the reduction. The simulation was carried out, on circular cross-section lead specials containing a central void of different size. At a time with a flat die, different ratio of inside to outside radius was taken with different speed to find the best result of void closure.

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Publication Date
Fri Jul 21 2023
Journal Name
Journal Of Engineering
CATHODIC PROTECTION OF CARBON STEEL IN 0.1N NaCl SOLUTION UNDER FLOW CONDITIONS USING ROTATING CYLINDER ELECTRODE
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The effect of applied current on protection of carbon steel in 0.1N NaCl solution (pH=7) was investigated under flow conditions (0-0.262 m/s) for a range of temperatures (35-55°C) using rotating cylinder electrode. Various values of currents were applied to protect steel from corrosion, these were Iapp.=Icorr., Iapp.=2Icorr. and Iapp.=2.4Icorr. under stationary and flow conditions. Corrosion current was measured by weight loss method. The variation of protection potential with time and rotation velocity at various applied currents was assessed. It is found that the corrosion rate of carbon steel increases with rotation velocity and
has unstable trend with temperature. The protection current required varies with temperature and it inc

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Publication Date
Sun Jan 01 2023
Journal Name
8th Engineering And 2nd International Conference For College Of Engineering – University Of Baghdad: Coec8-2021 Proceedings
Impact of project delivery method on geotechnical site conditions for implementing water treatment plants in Iraq
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