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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 18 2018
Journal Name
Mustansiria Dental Journal
The Effect of Pepsi Cola Beverage on Surface Roughness of Two Composite Resins (In Vitro study)
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An acidic environment causes surface changes of resin composites. Filler particlesize and filler distribution also have a direct effect on these surface changes. This invitro study evaluated the influence of Pepsi Cola drink on the surface roughness ofComposan LCM and Composan Ceram over time. Sixteen disc shaped specimens(10mm diameter, 2mm thickness) of each resin composite were fabricated, therebyforming two groups (n= 8). Surface roughness (Ra) was analyzed after 24 hrs beforeexposure to beverage. The specimens were submitted to a five minutes immersion inPepsi Cola three times daily interrupted by immersion in deionized distilled water (37C˚). Surface roughness measurements were done at 10, 30, and 60 days intervals. Datawere

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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
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
Fri Jan 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Between Maximum Likelihood and Bayesian Methods For Estimating The Gamma Regression With Practical Application
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In this paper, we will illustrate a gamma regression model assuming that the dependent variable (Y) is a gamma distribution and that it's mean ( ) is related through a linear predictor with link function which is identity link function g(μ) = μ. It also contains the shape parameter which is not constant and depends on the linear predictor and with link function which is the log link and we will estimate the parameters of gamma regression by using two estimation methods which are The Maximum Likelihood and the Bayesian and a comparison between these methods by using the standard comparison of average squares of error (MSE), where the two methods were applied to real da

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Publication Date
Sun Jan 01 2012
Journal Name
Turkish Journal Of Medical Sciences
Histopathological effects of S. xylosus peptidoglycan in comparison to E. coli lipopolysaccharide in the urinary tract of mice
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he present work, among other previous studies done in our lab, aimed to highlight the histopathological effect of S. xylosus peptidoglycan in comparison to LPS of E. coli. Materials and methods: One hundred and fifty urine specimens were collected from urinary tract infection patients visiting Baghdad hospitals. The histopathological effects of S. xylosus S24 peptidoglycan was studied in the urinary tract of female mice by injecting 5 animal groups at the following concentrations: 1000, 2000, 3000, 4000, and 5000 µg/mL. Another 5 groups were injected with 10, 25, 50, 75, and 100 ng/mL of E. coli (serotype 0128:B12) LPS. Results: Ten isolates were confirmed to be Staphylococcus xylosus. Histopathological study showed different pathological

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Publication Date
Fri Jun 01 2018
Journal Name
Kerbala Journal Of Medicine
Polymerase Chain Reaction Testing in Comparison to Culture of Cerebrospinal Fluid for Diagnosis of Bacterial Meningitis in Children
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Publication Date
Mon Jul 01 2019
Journal Name
Journal Of Engineering
The Characters of the Form in the Vernacular Architecture A comparative study of the form's characters of facades of individual houses and commercial buildings in the City of Baghdad after 2003–Zayoona district as a case study
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The characters of facades' form of the Iraqi building after 2003 have been changed, it has been described by many names. The problem of the research is that what are the features of the characters of the form in the façades of the buildings in Baghdad city after 2003? Are the façade of the individual houses or the commercial buildings is the heaviest in the visual weight? The research aims to answer those questions by choosing the vernacular architecture as a measurement tool. It is the informal image of the architecture, which is built by people informally and spontaneously, without official control and legislation to be organized. This is smellier to what has happened in Baghdad, after 2003 according to previous stud

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Publication Date
Tue Jun 03 2025
Journal Name
Periodicals Of Engineering And Natural Sciences (pen)
Comparison of some artificial neural networks for graduate students
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Artificial Neural Networks (ANN) is one of the important statistical methods that are widely used in a range of applications in various fields, which simulates the work of the human brain in terms of receiving a signal, processing data in a human cell and sending to the next cell. It is a system consisting of a number of modules (layers) linked together (input, hidden, output). A comparison was made between three types of neural networks (Feed Forward Neural Network (FFNN), Back propagation network (BPL), Recurrent Neural Network (RNN). he study found that the lowest false prediction rate was for the recurrentt network architecture and using the Data on graduate students at the College of Administration and Economics, Univer

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