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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Microbiology of active chronic otitis media: in comparison with abroad studies
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Background: Chronic otitis media (COM) of mucosal or squamous type is a common problem in otolaryngology practice, the active form of COM is characterized by discharge of pus and is treated by antibiotics to start with, the appropriate antibiotic should be prescribed to avoid antibiotic abuse and guarantee good outcome. Objectives:The objective of this study is to identify the causative organisms of active chronic active otitis media both (mucosal, squamous) type and test their sensitivity to various anti- microbial agents &compare with abroad studies.Methods:A prospective study was done on eighty patients, different ages and sexes were taken and carful history and examination was done, examination under microscope was done with carf

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Publication Date
Mon Feb 27 2023
Journal Name
Applied Sciences
Comparison of ML/DL Approaches for Detecting DDoS Attacks in SDN
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Software-defined networking (SDN) presents novel security and privacy risks, including distributed denial-of-service (DDoS) attacks. In response to these threats, machine learning (ML) and deep learning (DL) have emerged as effective approaches for quickly identifying and mitigating anomalies. To this end, this research employs various classification methods, including support vector machines (SVMs), K-nearest neighbors (KNNs), decision trees (DTs), multiple layer perceptron (MLP), and convolutional neural networks (CNNs), and compares their performance. CNN exhibits the highest train accuracy at 97.808%, yet the lowest prediction accuracy at 90.08%. In contrast, SVM demonstrates the highest prediction accuracy of 95.5%. As such, an

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Publication Date
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Estimates Nonparametric In Multiple Regression Analysis Function (Gamma ,Beta)
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The use of non-parametric models and subsequent estimation methods requires that many of the initial conditions that must be met to represent those models of society under study are appropriate, prompting researchers to look for more flexible models, which are represented by non-parametric models                  

          In this study, the most important and most widespread estimations of the estimation of the nonlinear regression function were investigated using Nadaraya-Watson and Regression Local Ploynomial, which are one of the types of non-linear

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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 Mar 28 2008
Journal Name
Ama, Agricultural Mechanization In Asia, Africa & Latin America
The Effect of Two Type of Plows With Four Speeds on the Field Capacity and Bulk Density
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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
Mon Nov 17 2025
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
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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