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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
The use of two indicators of market value-added and return on capital invested in measuring the performance of the Iraqi banking sector
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For a long time, the intensification of profit represented a major goal for the company management ,but this goal confirmed a series of restrictions such the constriction on short period, the time rather than on long and medium strategic goal, the relationships with customers ,the supplies, employees , This goal is replaced by another one (intensification of the company's value) ,and the fortune of the share holders itself ,for the purpose  of creating value, the company must generate  great outcomes to cover the operating expense and to insure the a suitable compensation to the invested capital (the market value added) is  the indication used to estimate the company ability to create value –added the development

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Publication Date
Sat Feb 21 2026
Journal Name
Modern Sport
Design and standardization of two scoring tests for the initial selection of people with simple mental disabilities in five-a- Side Soccer
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The five-a- Side Soccer for simple mental disability is as interesting and caring as many other sporting events. Therefore, the researchers believe that their basic skills tests are compatible with then level of the tested individuals in terms of age and mental ability. As a means of selecting those who are qualified to practice this game in a simple way, the problem of research has been identified in the design and standardization of two scoring skills that belong to this category and are approved by the training staff during the initial selection process. The research community is determined by people with mental disabilities who belong to the governmental and private institutes and the Special Olympics Union in Baghdad and for the year 2

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The Iraqi- Kuwaiti relations after 2003
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The Iraqi- Kuwaiti relations had witnessed a lot of problems which had its impact on them, at the fore front is the frontier issue, and the Iraqi invasion of Kuwait in 1990 which led to the severance of relations between them and had strengthened the disagreement and the dispute and raised the animosity and tension.
After 2003, Iraq has witnessed a lot of changes which affected Iraq and the region as a whole.
Under the new political developments in Iraq, a now phase has started in the relations between the two parts. which is based on the emphasis on building new relations based on the mutual respect and non intervention in the internal affairs of both countries, and in accordance with the principles of the international law, and w

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
American - Irani Relations after Nuclear Agreement
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Summary

The fundamental turning point in American policy towards the Iran was the success of the Islamic revolution in Iran 1979 . Since than U S policy has been hostile to Iran . After the events 11 September 2001 , there was an American idea of dialogue with some countries opposed to US policy , including Iran . In 2004 the United States launched the Greater Middle East project , which contain a range of political , economic and cultural proposals for the region , all of which were in the interest of the United States and ( Israel ) , which Iran opposed . The failure of U S projects in region prompted the United States to agree with Iran on the nuclear file . On 8 May 2018 U S President Donald Trump of

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
China's Middle East policy after 2001
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The foreign policy of china is considered an important subject generally, in addition its very significant towards the Middle East specifically. It is the most valued topic, that needs deep academic investigations in order to identify the important factors causes and its consequences, this kind of research provides a proper understanding to the researchers and politicians, it will prove the reasons for China's with the impact to the region, the rivalry with the United States in the coming years

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Publication Date
Fri Dec 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Determination of Implant Primary Stability: A Comparison of the Surgeon’s Tactile Sense and Objective Measurements
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Background: Evaluation and measurement of primary stability could be achieved by several methods, including the resonance frequency analysis (RFA) and implant insertion torque (IT) values. The need for a sufficient primary stability, guaranteed by an adequate insertion torque and implant stability quotient values, increased its importance mainly in one stage implants or in immediate loading protocols. The aims of this study was to find if there is a correlation between the peak insertion torque (PIT) and ISQ values of implants inserted in the jaws of different bone quality which regarded as two important clinical determinant factors for prediction of implant primary stability, and to evaluate and compare whether an experienced clinician cou

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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Comparison of Mercury Intrusion and Nitrogen Adsorption Measurements for the Characterization of Certain Natural Raw Materials Deposits
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The porosity of materials is important in many applications, products and processes, such as electrochemical devices (electrodes, separator, active components in batteries), porous thin film, ceramics, soils, construction materials, ..etc. This can be characterized in many different methods, and the most important methods for industrial purposes are the N2 gas adsorption and mercury porosimetry. In the present paper, both of these techniques have been used to characterize some of Iraqi natural raw materials deposits. These are Glass Sand, Standard Sand, Flint Clay and Bentonite. Data from both analyses on the different types of natural raw materials deposits are critically examined and discussed. The results of specific surface are

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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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