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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Oct 01 2018
Journal Name
Journal Of Educational And Psychological Researches
The Effectiveness of Two Educational Models in Acquiring Historical Concepts and Orientation of Fourth Grade Students in History
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The study focuses on Kamez model and the Claus Meyer model of instructional design, which are models that provide the learner with educational experiences to suit the logical information of the learner and the variety of instructional models. Research Objective: The present research aims to identify Limitations of the study. The current research is determined by ((fourth grade preparatory students, the book of the date of the fourth preparatory course)) Chapter II includes Arabic and foreign studies on the model of Kemp and Claus Mayer in the acquisition of concepts and direction towards the material. Chapter III Experimental Design: The researcher adopted an experimental design with two experimental groups and a control group. The resea

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Publication Date
Sat Jun 30 2007
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Rise Velocity and Drag Coefficient of Collapsing Two-Phase Bubble Condensing in an Immiscible Liquid
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Collapse of the vapor  bubble condensing  in an immiscible  is investigated for  n-pentane and n-hexane vapors condensing in cold water and n-pentane in two different compositions of glycerin- water mixture. The rise velocity and the drag coefficient of the two-phase bubble are measured.

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Publication Date
Wed Jul 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Experimental and Numerical Comparison of Prestressed Perforated Concrete Rafters of Different Configurations
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Abstract<p>This paper demonstrates an experimental and numerical study aimed to compare the influence of openings of different configurations on the flexural behavior of prestressed concrete rafters. The experimental program consisted of testing six simply supported prestressed concrete rafters; 5 rafters are perforated, and the other one is solid as a reference. All rafters were tested under monotonic midpoint load. The variable which has been investigated in this work was the opening’s configuration (quadrilateral or circular) with the same upper and lower chords depths. The results indicate improvement in the beam flexural behavior using the circular openings compared to the quadrilateral o</p> ... Show More
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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Immunohistochemical Expression of DNMT3B among Oral, Laryngeal and Skin SCC
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Background: Recently epigenetic alterations have received increased attention because of theirimportant role in the process of tumerigenesis. It has been found that more than half of genetic changes were epigenetic. Epigenetic alterations are catalyzed by DNMTs enzymes. Increased knowledge about this molecular event may achieve progress in the war against cancer. The aim of this study was to evaluate and compare the expression of DNMT3B among oral, laryngeal and skin SCC. Materials and Methods: This study was performed on (120) formalin-fixed, paraffin-embedded blocks, histopathologically diagnosed as oral, laryngeal and skin SCC). Immunohistochemical staining of DNMT3B antibody was performed on each case of this study. Results: The immunoh

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Publication Date
Mon Jun 01 2009
Journal Name
Journal Of Economics And Administrative Sciences
Use sensitivity analysis in evaluating projects Investment under the conditions of risk and uncertainty Case study of glass bottles project in Anbar province
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This paper studies the investment project evaluation under the condition of uncertainty. Evaluation of investment project under risk and uncertainty is possible to be carried out through application of various methods and techniques. The best known methods are : Risk-adjusted discount rate , certainty equivalent method , Sensitivity analysis and Simulation method The objective of this study is using the sensitivity analysis in evaluation Glass Bottles project  in Anbar province under the condition of risk and uncertainty.

After applying sensitivity analysis we found that the glass bottles project  sensitive to the following factors (cash flow, the cost of investment, and the pro

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Publication Date
Wed Oct 16 2013
Journal Name
International Journal Of Pharmacy And Pharmaceutical Sciences
Effects of mucoadhesive polymers combination on the properties of lisinpril buccal tablets prepared by wet granulation method
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Publication Date
Fri Mar 31 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Effect of some Variables on the Formulation of Captopril as Tablets Shaymaa Nazar Al – Sammarrai
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Captopril is an angiotensin converting enzyme inhibitor (ACEI) used to treat hypertension,
congestive heart failure, and myocardial infraction.
The only dosage form available for captopril is the plain tablet in strength of 12.5,25,50 and 100mg
tablet.
This investigation is concerned with factors affecting the formulation of captopril as a plain
tablet dosage form of 50mg. Many trials were made to prepare satisfactory tablets for the drug by
using wet – granulation methods with various additives. It was found that poly vinyl pyrrolidone
(P.V.P.) as binder gave the most satisfactory tablets. At the same time a shorter disintegrantion time
and slower dissolution rate were obtained with the addition of starch

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Publication Date
Thu Jun 01 2023
Journal Name
Baghdad Science Journal
Comparison of Faster R-CNN and YOLOv5 for Overlapping Objects Recognition
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Classifying an overlapping object is one of the main challenges faced by researchers who work in object detection and recognition. Most of the available algorithms that have been developed are only able to classify or recognize objects which are either individually separated from each other or a single object in a scene(s), but not overlapping kitchen utensil objects. In this project, Faster R-CNN and YOLOv5 algorithms were proposed to detect and classify an overlapping object in a kitchen area.  The YOLOv5 and Faster R-CNN were applied to overlapping objects where the filter or kernel that are expected to be able to separate the overlapping object in the dedicated layer of applying models. A kitchen utensil benchmark image database and

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Publication Date
Mon Jun 05 2023
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Poisson Regression and Conway Maxwell Poisson Models Using Simulation
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Regression models are one of the most important models used in modern studies, especially research and health studies because of the important results they achieve. Two regression models were used: Poisson Regression Model and Conway-Max Well-  Poisson), where this study aimed to make a comparison between the two models and choose the best one between them using the simulation method and at different sample sizes (n = 25,50,100) and with repetitions (r = 1000). The Matlab program was adopted.) to conduct a simulation experiment, where the results showed the superiority of the Poisson model through the mean square error criterion (MSE) and also through the Akaiki criterion (AIC) for the same distribution.

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Publication Date
Fri Sep 22 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Expermental Comparison For The Performance of Circular And Square Solar Cell
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An    Experimental     comparison     between     the     current-voltage

characteristic and    the  efficiency    conversion from  solar  to  electric energy   were studied  for square  and circular  single crystal  silicon  solar

cell of equal area (35.28  cm2)  . The results show  that the solar shape is

an  important factor  in  calculating the  current-voltage characteristics and  efficiency of  the  solar  cell.  It was  shown   that  the  performance effici

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