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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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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Publication Date
Tue Jun 01 2021
Journal Name
Al-khwarizmi Engineering Journal
Prediction of Surface Roughness after Turning of Duplex Stainless Steel (DSS)
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Feed Forward Back Propagation artificial neural network (ANN) model utilizing the MATLAB Neural Network Toolbox is designed for the prediction of surface roughness of Duplex Stainless Steel during orthogonal turning with uncoated carbide insert tool. Turning experiments were performed at various process conditions (feed rate, cutting speed, and cutting depth). Utilizing the Taguchi experimental design method, an optimum ANN architecture with the Levenberg-Marquardt training algorithm was obtained. Parametric research was performed with the optimized ANN architecture to report the impact of every turning parameter on the roughness of the surface. The results suggested that machining at a cutting speed of 355 rpm with a feed rate of 0.07 m

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Publication Date
Fri Feb 20 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
Wed Aug 29 2018
Journal Name
Biomedical And Pharmacology Journal
Comparison of Some Mechanical and Physical Properties of three Types of Impression Materials with Different Dental Implant Angulations
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Choosing an appropriate impression material is a challenge for many dentists, yet an essential component to provide an excellent clinical outcome and improve productivity and profit. The purpose of present study was to compare wettability, tear strength and dimensional accuracy of three elastomeric impression materials, with the same consistencies (light-body). Three commercially available light body consistency and regular set 3M ESPE Express polyvinylsiloxane (PVS), 3M ESPE Permadyne polyether (PE), and Identium (ID), impression materials were comparedTear strength test, contact angle test and linear dimensional accuracy were evaluated for three elastic impression material. Among the three experimental groups PE impression materia

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Publication Date
Wed Feb 20 2019
Journal Name
Iraqi Journal Of Physics
A comparison between PCA and some enhancement filters for denoising astronomical images
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This paper includes a comparison between denoising techniques by using statistical approach, principal component analysis with local pixel grouping (PCA-LPG), this procedure is iterated second time to further improve the denoising performance, and other enhancement filters were used. Like adaptive Wiener low pass-filter to a grayscale image that has been degraded by constant power additive noise, based on statistics estimated from a local neighborhood of each pixel. Performs Median filter of the input noisy image, each output pixel contains the Median value in the M-by-N neighborhood around the corresponding pixel in the input image, Gaussian low pass-filter and Order-statistic filter also be used.

Experimental results shows LPG-

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Publication Date
Tue Mar 24 2009
Journal Name
Proceeding Of 3rd Scientific Conference Of The College Of Science, University Of Baghdad.
A Comparison Between Galactic and Large Magellanic Cloud (LMC) Interstellar Extinction Curves
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Average interstellar extinction curves for Galaxy and Large Magellanic Cloud (LMC) over the range of wavelengths (1100 A0 – 3200 A0) were obtained from observations via IUE satellite. The two extinctions of our galaxy and LMC are normalized to Av=0 and E (B-V)=1, to meat standard criteria. It is found that the differences between the two extinction curves appeared obviously at the middle and far ultraviolet regions due to the presence of different populations of small grains, which have very little contribution at longer wavelengths. Using new IUE-Reduction techniques lead to more accurate result.

Publication Date
Tue Jan 01 2013
Journal Name
Iraqi Journal Of Physics
A comparison between PCA and some enhancement filters for denoising astronomical images
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This paper includes a comparison between denoising techniques by using statistical approach, principal component analysis with local pixel grouping (PCA-LPG), this procedure is iterated second time to further improve the denoising performance, and other enhancement filters were used. Like adaptive Wiener low pass-filter to a grayscale image that has been degraded by constant power additive noise, based on statistics estimated from a local neighborhood of each pixel. Performs Median filter of the input noisy image, each output pixel contains the Median value in the M-by-N neighborhood around the corresponding pixel in the input image, Gaussian low pass-filter and Order-statistic filter also be used. Experimental results shows LPG-PCA method

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Publication Date
Thu Jun 01 2017
Journal Name
Journal Of Huazhong University Of Science And Technology [medical Sciences]
New mini dental implant attachments versus O-ring attachment after cyclic aging: Analysis of retention strength and gap space
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Publication Date
Sun Sep 02 2012
Journal Name
Baghdad Science Journal
Study the expression level of beta 2 microglobulin gene on hepatitis C patients before and after treatment with interferon
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This study has been carried out to evaluate the expression level of beta 2 microglobulin gene on patients infected by hepatitis C virus before and after treatment with interferon. The study included 117 hepatitis C patients comprising as 63 pre-treated patients, the range of age was between 20-65 year with a mean age of 48.12 ± 16.1 and 54 post-treated patients with age range was between 23-63 year with the mean of 46.1 ± 18.1. Also it was found that more than half of patients were located within third and fourth decade i.e. 30-49 year, with a percentage of 52.4% and 55.6 % for pre-treatment and post-treatment patients respectively. Moreover , regarding both groups, males are more than females with the ratio of ( 3.2:1) among p

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Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
The natural courses of keratometric, pachymetric and visual acuity outcomes during 1year follow up after corneal collagen cross-linking
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Background: As photochemical reaction that can stiffen the cornea, CXL is the only promising method of preventing progression of keratectasia such as KC and secondary ectasia following refractive surgery. The aim of CXL is to stabilize the underlying condition with a small chance of visual improvement. Objective: To show the sequences of changes in visual acuity and topographic outcomes during 1 year post CXL for patients with progressive Keratoconus.Type of the study: Cross sectional studyMethods: CXL procedure was done for 45 eyes with progressive KC. The following parameters had been monitored pre operatively, 1, 3, 6 and 12 months postoperatively: K apex, K2, corneal thickness at thinnest location, anterior and posterior elevation po

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