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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue May 26 2026
Journal Name
Journal Of Engineering
Image Compression Using 3-D Two-Level Techniques
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In this paper three techniques for image compression are implemented. The proposed techniques consist of three dimension (3-D) two level discrete wavelet transform (DWT), 3-D two level discrete multi-wavelet transform (DMWT) and 3-D two level hybrid (wavelet-multiwavelet transform) technique. Daubechies and Haar are used in discrete wavelet transform and Critically Sampled preprocessing is used in discrete multi-wavelet transform. The aim is to maintain to increase the compression ratio (CR) with respect to increase the level of the transformation in case of 3-D transformation, so, the compression ratio is measured for each level. To get a good compression, the image data properties, were measured, such as, image entropy (He), percent root-

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Publication Date
Sat Feb 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of some robust methods to estimate parameters of partial least squares regression (PLSR)
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   The technology of reducing dimensions and choosing variables are very important topics in statistical analysis to multivariate. When two or more of the predictor variables are linked in the complete or incomplete regression relationships, a problem of multicollinearity are occurred which consist of the breach of one basic assumptions of the ordinary least squares method with incorrect estimates results.

 There are several methods proposed to address this problem, including the partial least squares (PLS), used to reduce dimensional regression analysis. By using linear transformations that convert a set of variables associated with a high link to a set of new independent variables and unr

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Publication Date
Tue Jan 26 2021
Journal Name
Plant Archives
THE RESPONSE OF GROWTH OF SOME LAWN PLANTS TO CHEMICAL FERTILIZATION WITH HUMIC ACID UNDER LOW-LIGHT CONDITIONS OF HOUSE GARDEN
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Shade in house gardens is one of the problems that hinder the growth of lawn and its distribution in the soil, where the types of lawns differ in their durability and adaptation to shade. The research aims to know the resistance of some species of lawn plants to shade and to know the appropriate fertilization procedures that can be followed to reduce the negative effects. The study was conducted in the Amiriya district of Baghdad in a house garden. Three varieties of lawn plants Bermuda, Gazon, and Trifoglio were planted. Five fertilization treatments (contained N and P elements) and the control were used. The sunlight density with the temperature of the study field locations were estimated using the AMT-300 and the vegetation coverage perc

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Publication Date
Sun Jun 20 2021
Journal Name
Baghdad Science Journal
Comparison of Some of Estimation methods of Stress-Strength Model: R = P(Y < X < Z)
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In this study, the stress-strength model R = P(Y < X < Z)  is discussed as an important parts of reliability system by assuming that the random variables follow Invers Rayleigh Distribution. Some traditional estimation methods are used    to estimate the parameters  namely; Maximum Likelihood, Moment method, and Uniformly Minimum Variance Unbiased estimator and Shrinkage estimator using three types of shrinkage weight factors. As well as, Monte Carlo simulation are used to compare the estimation methods based on mean squared error criteria.  

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Publication Date
Fri Jan 01 2021
Journal Name
International Journal Of Agricultural And Statistical Sciences
DYNAMIC MODELING FOR DISCRETE SURVIVAL DATA BY USING ARTIFICIAL NEURAL NETWORKS AND ITERATIVELY WEIGHTED KALMAN FILTER SMOOTHING WITH COMPARISON
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Survival analysis is widely applied in data describing for the life time of item until the occurrence of an event of interest such as death or another event of understudy . The purpose of this paper is to use the dynamic approach in the deep learning neural network method, where in this method a dynamic neural network that suits the nature of discrete survival data and time varying effect. This neural network is based on the Levenberg-Marquardt (L-M) algorithm in training, and the method is called Proposed Dynamic Artificial Neural Network (PDANN). Then a comparison was made with another method that depends entirely on the Bayes methodology is called Maximum A Posterior (MAP) method. This method was carried out using numerical algorithms re

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Scopus
Publication Date
Tue Dec 01 2009
Journal Name
Journal Of Economics And Administrative Sciences
Using Artificial Neural Network Models For Forecasting & Comparison
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The Artificial Neural Network methodology is a very important & new subjects that build's the models for Analyzing, Data Evaluation, Forecasting & Controlling without depending on an old model or classic statistic method that describe the behavior of statistic phenomenon, the methodology works by simulating the data to reach a robust optimum model that represent the statistic phenomenon & we can use the model in any time & states, we used the Box-Jenkins (ARMAX) approach for comparing, in this paper depends on the received power to build a robust model for forecasting, analyzing & controlling in the sod power, the received power come from

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Publication Date
Fri Mar 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Comparison for estimation methods for the autoregressive approximations
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Abstract

      In this study, we compare between the autoregressive approximations (Yule-Walker equations, Least Squares , Least Squares ( forward- backword ) and Burg’s (Geometric and Harmonic ) methods, to determine the optimal approximation to the time series generated from the first - order moving Average non-invertible process, and fractionally - integrated noise process, with several values for d (d=0.15,0.25,0.35,0.45) for different sample sizes (small,median,large)for two processes . We depend on figure of merit function which proposed by author Shibata in 1980, to determine the theoretical optimal order according to min

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Publication Date
Tue May 26 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The influence of cavity design for cusp coverage on fracture strength of weakened maxillary first premolars using two esthetic restorative systems (CAD/CAM hybrid ceramic and nanohybrid composite) (An in vitro study)
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Background: Maxillary first premolar with wide MOD cavity more susceptible to fracture. The aim of this study was to assess the influence of cavity design for cusp coverage on the fracture resistance of weakened maxillary first premolar restored with CAD/CAM hybrid ceramic versus nanohybide composite. Materials and Methods: Fifty six intact maxillary first premolars of approximately comparable sizes were divided into seven groups eight for each: Group A: Intact teeth (control group); Group B: teeth prepared for MOD inlay; Group C: teeth prepared for MOD onlay covering the lingual cusp; Group D: teeth prepared for MOD covering buccal and lingual cusps ,the previous three groups indirectly restored with nanohybrid composite (3M ESPE Z 250 X

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Publication Date
Tue Jan 21 2025
Journal Name
Periodicals Of Engineering And Natural Sciences (pen)
A comparison between the hierarchical clustering methods for postgraduate students in Iraqi universities for the year 2019-2020 using the cophenetic and delta correlation coefficients
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The educational sector is one of the important sectors in the world, and it is considered one of the means of community development. In addition, it is one of the means of making the country’s renaissance and devel-opment because it represents the factory of thinking minds that make change. There is no doubt that this sector is the same as any other sector. The deficit in the studied scientific planning has been prolonged, which led to its deterioration, and the problems of education remain diverse and inherited from previous time periods, where the hierarchical cluster analysis was used on postgraduate students in universities in Iraq, except for Kurdistan region, and the number of universities that were included in the study was

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Publication Date
Tue Feb 04 2025
Journal Name
Microbes And Infectious Diseases
A preclinical evaluation of the response of repairing the DNA of MCF7 breast cancer cells after exposure to probiotic bacteria
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