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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Aug 28 2026
Journal Name
Mustansiriya University
Effects Of Some Environmental Growth Conditions On Autoaggregation Of Lactobacillus spp. Isolated From Bacterial Vaginitis Infected Females
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المستودع الرقمي العراقي. مركز المعلومات الرقمية التابع لمكتبة العتبة العباسية المقدسة

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Publication Date
Sun Jan 01 2017
Journal Name
Al–bahith Al–a'alami
The Coverage of Health Topics in Iraqi Press An analytical Study of Two Newspapers entitled 'al-Sabah and al-Mada' from January 1, 2007 to October 31, 2001
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The current study aims to cover  the health topics  in the Iraqi  journalism ,  to know  the concern 's level  of the Iraqi journalism  when  covering  the health subjects and to know the size of its performance  under the diversity of  visual and audio medias. The researcher has discussed his research by wording it with a set of inquiries   that should be answered via the research and study.  He could have determined that by the following:

What is the concern's level of Iraqi journalism over the health subjects?  What are the forms and press arts that are functionalized by the Iraqi journalism as to get the health message to the republics?  What is t

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Publication Date
Wed Jun 01 2016
Journal Name
Nternational Journal Of Mathematics Trends And Technology (ijmtt)
Fuzzy Scheduling Problem on Two Machines
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Publication Date
Mon Jun 30 2003
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Two-Phase Pressure Drop Through Obstructions
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Publication Date
Fri Sep 01 2023
Journal Name
Journal Of Medicine And Life
Potential anti-obesity effects of two-graded doses of Iraqi <i>Hibiscus tiliaceus</i> leaves extract, alone and in combination with orlistat, on high-fat diet-induced obesity in male rats
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Publication Date
Thu Mar 30 2023
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating Nonparametric Binary Logistic Regression
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In this research, the methods of Kernel estimator (nonparametric density estimator) were relied upon in estimating the two-response logistic regression, where the comparison was used between the method of Nadaraya-Watson and the method of Local Scoring algorithm, and optimal Smoothing parameter λ was estimated by the methods of Cross-validation and generalized Cross-validation, bandwidth optimal λ has a clear effect in the estimation process. It also has a key role in smoothing the curve as it approaches the real curve, and the goal of using the Kernel estimator is to modify the observations so that we can obtain estimators with characteristics close to the properties of real parameters, and based on medical data for patients with chro

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Publication Date
Fri Sep 06 2024
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Wavelet Transformations to Estimate Nonparametric Regression Function
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The purpose of this article is to improve and minimize noise from the signal by studying wavelet transforms and showing how to use the most effective ones for processing and analysis. As both the Discrete Wavelet Transformation method was used, we will outline some transformation techniques along with the methodology for applying them to remove noise from the signal. Proceeds based on the threshold value and the threshold functions Lifting Transformation, Wavelet Transformation, and Packet Discrete Wavelet Transformation. Using AMSE, A comparison was made between them , and the best was selected. When the aforementioned techniques were applied to actual data that was represented by each of the prices, it became evident that the lift

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Publication Date
Fri Dec 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of some methods for estimating Poisson-Weibull distribution parameters
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In this paper was discussed the process of compounding two distributions using new compounding procedure which is connect a number of life time distributions ( continuous distribution ) where is the number of these distributions represent random variable distributed according to one of the discrete random distributions . Based on this procedure have been compounding zero – truncated poisson distribution with weibell distribution to produce new life time distribution having three parameter , Advantage of that failure rate function having many cases ( increasing , dicreasing , unimodal , bathtube) , and study the resulting distribution properties such as : expectation , variance , comulative function , reliability function and fa

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Publication Date
Mon Dec 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between some of linear classification models with practical application
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Linear discriminant analysis and logistic regression are the most widely used in multivariate statistical methods for analysis of data with categorical outcome variables .Both of them are appropriate for the development of linear  classification models .linear discriminant analysis has been that the data of explanatory variables must be distributed multivariate normal distribution. While logistic regression no assumptions on the distribution of the explanatory data. Hence ,It is assumed that logistic regression is the more flexible and more robust method in case of violations of these assumptions.

In this paper we have been focus for the comparison between three forms for classification data belongs

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Publication Date
Thu Jan 01 2026
Journal Name
Aip Conference Proceedings
Comparison between methods of solution kepler’s equation for elliptical orbit
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Lagrange series and the Bessel function are two classical methods that were created by series expanding from Taylor series. In this paper, the purpose of those two methods was to find the values of the eccentric anomaly for one period (0–360)°. The Matlab program is used to apply the results, the input parameters were eccentricity (0–1), mean anomaly (0–360)°, and finally the parameter W (1–13). The program does not need a tolerance to obtain a precise value for eccentric anomaly like other iterative and non-iterative methods to stop the program; it will stop after completing the required period from 0° to 360° for a body that is determined by the solver. The output will be the final value of the eccentric anomaly. Furthermore,

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