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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2019
Journal Name
Plant Archives
Effect of two harrowing systems on decomposition of organic matter, some soil properties, growth and productivity of sunflower (helianthus annuus l.)
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Publication Date
Thu Jun 01 2017
Journal Name
Journal Of The College Of Languages (jcl)
Plain Language Movement and Legal Translation : An Analytical Study of Two Translations of a Contract of Lease from Arabic into English
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The present paper addresses one of the most challenging topics in translation; namely legal translation in the framework of two different approaches; the classical (formal) and the more recent (functional). The latter approach is the outcome of the process of simplifying legal language known technically as Plain Language Movement. The advent of this movement dates back to the 1950s, in response to the widely-held complain about the awkwardness of the legal register. Within this framework, the salient features of legal language, at the various linguistic and textual levels, underwent reconsideration in favor of more publicly digested expressions. The paper then subjects two translations of a lease contract to analysis in the ligh

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Publication Date
Thu May 31 2012
Journal Name
Journal Of Baghdad College Dentistry
An evaluation of water absorption of Giomer in comparison to other resin-based restorative materials
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Background: Polymeric composites have been widely used as dental restorative materials. A fundamental knowledge and understanding of the behavior of these materials in the oral cavity is essential to improve their properties and performance. The goal of this study was to measure water sorption of four composite resins containing different filler and resin matrix contents. Materials and method: Resin composite specimens giomer (Beautifil II) Filtek™ P90, Filtek™ Z350 XT, and Tetric N Ceram were prepared in a cylindrical mould of 3mm thickness and 6mm diameter (n=10) and light cured . All specimens placed in silica-gel desiccators at 37˚C for seven days, a constant weight was obtained. All samples were immersed in deionized distill

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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Safety Profile of Single Daily Dose of Aminoglycosides in Comparison with Multiple Daily Dose
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To overcome  the  problems  which  associated  with  the standard  multiple  daily  doses (MDD)

of aminoglycosides (AGs) like high incidence of toxicity(nephrotoxicity, ototoxicity)(5-25%) and high cost, an alternative approach was developed which was single daily dose (SDD).This new regimen was designed to maximize bacterial killing by optimizing the peak concentration/minimum inhibitory concentration(MIC)ratio and to reduce the potential for toxicity. The study includes 75 patients selected randomly, 50 of them received SDD regimen of age range of 17-79 years and the remaining received MDD regimen of age range of 13-71 years. The study was designed to evaluate the safety of SDD regim

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Publication Date
Thu Jan 24 2019
Journal Name
Al-kindy College Medical Journal
Clinical and experimental Study to evaluate the effect of Biphasic calcium phosphate collagen composite (cpcc) on healing of bone defects after oral surgical procedures
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Background: A recent discoveries used for reconstruction in maxillofacial surgery is the composite bone graft materials. The availability of collagen I matrix make our choice to use this material in surgery .It is biomaterials that its structure could be modified by simple techniques. Studies to find a new materials use for bone reconstruction is to overcome the disadvantages of autogenous bone and the synthetic resorbable bone substitutes.

Objectives: This study was done to evaluate the effect of biphasic calcium phosphate collagen composite (ccpc) on healing of bone defects after oral surgical procedures.

Type of the study: A cross sectional study.

Method: It involved 60 patients, 35 male and 25 female, age (15-

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Publication Date
Sat Mar 31 2018
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
A Comparison between the Product-Refill and the Equalization Oxygen Pressure Swing Adsorption Processes
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This work presents a design for a pressure swing adsorption process (PSA) to separate oxygen from air with approximately 95% purity, suitable for different numbers of columns and arrangements. The product refill PSA process was found to perform 33% better (weight of zeolite required or productivity) than the pressure equalization process. The design is based on the adsorption equilibrium of a binary mixture of O2 and N2 for two of the most commonly used adsorbents, 5A & 13X, and extension from a single column approach. Zeolite 13X was found to perform 6% better than zeolite 5A. The most effective variables were determined to be the adsorption step time and the operational pressure. Increasing the adsorption step

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Publication Date
Tue Jun 01 2021
Journal Name
Iop Conference Series: Materials Science And Engineering
An Experimental Research on Design and Development Diversified Controllers for Tri-copter Stability Comparison
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Abstract<p>The drones have become the focus of researchers’ attention because they enter into many details of life. The Tri-copter was chosen because it combines the advantages of the quadcopter in stability and manoeuvrability quickly. In this paper, the nonlinear Tri-copter model is entirely derived and applied three controllers; Proportional-Integral-Derivative (PID), Fractional Order PID (FOPID), and Nonlinear PID (NLPID). The tuning process for the controllers’ parameters had been tuned by using the Grey Wolf Optimization (GWO) algorithm. Then the results obtained had been compared. Where the improvement rate for the Tri-copter model of the nonlinear controller (NLPID) if compared with </p> ... Show More
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Publication Date
Tue Jun 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Between Partial Least Square Regression(PLSR) and Tree Regression by Using Simulation(RT).
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This research discussed, the process of comparison between the regression model of partial least squares and tree regression, where these models included two types of statistical methods represented by the first type "parameter statistics" of the partial least squares, which is adopted when the number of variables is greater than the number of observations and also when the number of observations larger than the number of variables, the second type is the "nonparametric statistic" represented by tree regression, which is the division of data in a hierarchical way. The regression models for the two models were estimated, and then the comparison between them, where the comparison between these methods was according to a Mean Square

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Publication Date
Thu Oct 15 2015
Journal Name
Al Mustansyriah Journal Of Science
Comparison between (ARIMA) and (ANNs) models for estimating the relative humidity for Baghdad city
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The aim of the research is to study the comparison between (ARIMA) Auto Regressive Integrated Moving Average and(ANNs) Artificial Neural Networks models and to select the best one for prediction the monthly relative humidity values depending upon the standard errors between estimated and observe values . It has been noted that both can be used for estimation and the best on among is (ANNs) as the values (MAE,RMSE, R2) is )0.036816,0.0466,0.91) respectively for the best formula for model (ARIMA) (6,0,2)(6,0,1) whereas the values of estimates relative to model (ANNs) for the best formula (5,5,1) is (0.0109, 0.0139 ,0.991) respectively. so that model (ANNs) is superior than (ARIMA) in a such evaluation.

Publication Date
Fri Aug 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between the Local Polynomial Kernel and Penalized Spline to Estimating Varying Coefficient Model
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Analysis the economic and financial phenomena and other requires to build the appropriate model, which represents the causal relations between factors. The operation building of the model depends on Imaging conditions and factors surrounding an in mathematical formula and the Researchers target to build that formula appropriately. Classical linear regression models are an important statistical tool, but used in a limited way, where is assumed that the relationship between the variables illustrations and response variables identifiable. To expand the representation of relationships between variables that represent the phenomenon under discussion we used Varying Coefficient Models

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