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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 20 2023
Journal Name
Bulletin Of The Iraq Natural History Museum
MORPHOLOGICAL DESCRIPTION OF TWO LEECH SPECIES (ANNELIDA, HIRUDINEA) WHICH USED IN SOME ALTERNATIVE MEDICINE CLINICS IN BAGHDAD PROVINCE, IRAQ
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The aim of this study is to describe the leech species that are used in some of the alternative medicine clinics in Baghdad Province based on morphometric measurements and colouring pattern of the body. A collection of twenty leeches was provided from some clinics. All specimens were identified and described based on standard available keys. The morphometric characteristics and colouring patterns were recorded and the indicated that these leeches were Hirudo orientalis Utevsky & Trontelj, 2005 and H. verbana Carena, 1820.

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Publication Date
Thu Jan 16 2020
Journal Name
Periodicals Of Engineering And Natural Sciences
Comparison of some reliability estimation methods for Laplace distribution using simulations
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In this paper, we derived an estimator of reliability function for Laplace distribution with two parameters using Bayes method with square error loss function, Jeffery’s formula and conditional probability random variable of observation. The main objective of this study is to find the efficiency of the derived Bayesian estimator compared to the maximum likelihood of this function and moment method using simulation technique by Monte Carlo method under different Laplace distribution parameters and sample sizes. The consequences have shown that Bayes estimator has been more efficient than the maximum likelihood estimator and moment estimator in all samples sizes

Publication Date
Sat Feb 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
A comparison of the Semiparametric Estimators model smoothing methods different using
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In this paper, we made comparison among different parametric ,nonparametric and semiparametric estimators for partial linear regression model users parametric represented by ols and nonparametric methods represented by cubic smoothing spline estimator and Nadaraya-Watson estimator, we study three nonparametric regression models and samples sizes  n=40,60,100,variances used σ2=0.5,1,1.5 the results  for the first model show that N.W estimator for partial linear regression model(PLM) is the best followed the cubic smoothing spline estimator for (PLM),and the results of the second and the third model show that the best estimator is C.S.S.followed by N.W estimator for (PLM) ,the

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Publication Date
Wed Dec 25 2019
Journal Name
Journal Of Engineering
Comparison of Different DEM Generation Methods based on Open Source Datasets
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Digital Elevation Model (DEM) is one of the developed techniques for relief representation.  The definition of a DEM construction is the modeling technique of earth surface from existing data. DEM plays a role as one of the fundamental information requirement that has been generally utilized in GIS data structures. The main aim of this research is to present a methodology for assessing DEMs generation methods. The DEMs data will be extracted from open source data e.g. Google Earth. The tested data will be compared with data produced from formal institutions such as General Directorate of Surveying. The study area has been chosen in south of Iraq (Al-Gharraf / Dhi Qar governorate. The methods of DEMs creation are kriging, IDW (inver

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Publication Date
Wed Dec 25 2019
Journal Name
Journal Of Engineering
Comparison of Different DEM Generation Methods based on Open Source Datasets
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Digital Elevation Model (DEM) is one of the developed techniques for relief representation.  The definition of a DEM construction is the modeling technique of earth surface from existing data. DEM plays a role as one of the fundamental information requirement that has been generally utilized in GIS data structures. The main aim of this research is to present a methodology for assessing DEMs generation methods. The DEMs data will be extracted from open source data e.g. Google Earth. The tested data will be compared with data produced from formal institutions such as General Directorate of Surveying. The study area has been chosen in south of Iraq (Al-Gharraf / Dhi Qar governorate. The methods of DEMs creation are kri

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Publication Date
Sun Jun 07 2015
Journal Name
Baghdad Science Journal
Optimum conditions for Inulinase production by Aspergillus niger using solid state fermentation
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Thirty local fungal isolates according to Aspergillus niger were screened for Inulinase production on synthetic solid medium depending on inulin hydrolysis appear as clear zone around fungal colony. Semi-quantitative screening was performed to select the most efficient isolate for inulinase production. the most efficient isolate was AN20. The optimum condition for enzyme production from A. niger isolate was determined by busing a medium composed of sugar cane moisten with corn steep liquor 5;5 (v/w) at initial pH 5.0 for 96 hours at 30 0C . Enzyme productivity was tested for each of the yeast Kluyveromyces marxianus, the fungus A. niger AN20 and for a mixed culture of A. niger and K. marxianus. The productivity of A. niger gave the highest

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Publication Date
Tue Oct 01 2024
Journal Name
Journal Of Physics: Conference Series
The operational matrices for Elliptic Partial Differential Equations with mixed boundary conditions
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Abstract<p>The purpose of this research is to implement the orthogonal polynomials associated with operational matrices to get the approximate solutions for solving two-dimensional elliptic partial differential equations (E-PDEs) with mixed boundary conditions. The orthogonal polynomials are based on the Standard polynomial (<italic>x<sup>i</sup> </italic>), Legendre, Chebyshev, Bernoulli, Boubaker, and Genocchi polynomials. This study focuses on constructing quick and precise analytic approximations using a simple, elegant, and potent technique based on an orthogonal polynomial representation of the solution as a double power series. Consequently, a linear </p> ... Show More
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Publication Date
Sun May 24 2026
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparison of the Effectiveness of Reciprocating System with Continuous Rotary Systems in Non-Surgical Endodontic Retreatment (An In vitro study)
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Background: Optimal root canal retreatment was required safe and efficient removal of filling material from root canal. The aim of this in vitro study was to compare the efficacy of reciprocating and continuous motion of four retreatment systems in removal of root canal filling material. Materials and Methods: Forty distal roots of the mandibular first molars teeth were used in this study, these roots were embedded in cold clear acrylic,roots were instrumented using crown down technique and rotary ProTaper systemize Sx to size F2 ,instrumentation were done with copiousirrigation of 2.5% sodium hypochlorite and 17% buffered solution of EDTA was used as final irrigant followed by distilledwater, roots were obturated with AH26 sealer and Prota

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Publication Date
Tue Mar 01 2016
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparison of the Effectiveness of Reciprocating System with Continuous Rotary Systems in Non-Surgical Endodontic Retreatment (An In vitro study)
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Background: Optimal root canal retreatment was required safe and efficient removal of filling material from root canal. The aim of this in vitro study was to compare the efficacy of reciprocating and continuous motion of four retreatment systems in removal of root canal filling material. Materials and Methods: Forty distal roots of the mandibular first molars teeth were used in this study, these roots were embedded in cold clear acrylic,roots were instrumented using crown down technique and rotary ProTaper systemize Sx to size F2 ,instrumentation were done with copiousirrigation of 2.5% sodium hypochlorite and 17% buffered solution of EDTA was used as final irrigant followed by distilledwater, roots were obturated with AH26 sealer and Prota

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Publication Date
Wed Jan 01 2014
Journal Name
Journal Of The College Of Languages (jcl)
The Influence of Manipulating the Virtual Library in Comparison with the Individual Learning via Computer Use in English Language
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The study aims at investigating the effectiveness of the Virtual Library Technology, in developing the achievement of the English Language Skills in the Center of Development and Continuous Education, in comparison with the individual learning via personal computer to investigate the students' attitude towards the use of both approaches. The population of the study includes the participants in the English Language course arranged in the Center. The sample includes 60 students who were randomly chosen from the whole population (participants in English Courses for the year 2009-2010). The sample is randomly chosen and divided into two experimental groups. The first group has learned through classroom technology; while the other group has l

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