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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Jan 10 2018
Journal Name
Al–bahith Al–a'alami
Quality standards and innovation in television production production processes in various fields
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And the necessity for the progress of modern societies Because the scientific and objective characteristics that characterize modern societies and distinguish them from traditional societies, Is represented by the extent of its innovative achievements in the theoretical, applied and material scientific and spiritual fields. It should be noted that quality and innovation in modern societies is based on two main pillars, Standard measures for measuring and evaluating innovations to achieve their high quality, And the dissemination of the culture of innovation to spread awareness of the importance and conditions of success, and this is done by the advanced industrial countries, However, despite the great disparity between developed industri

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Publication Date
Sun Dec 10 2017
Journal Name
Al-academy
Undermining Humanism in Foucault's mind and its implications in the pop art
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The following research has been dealing ( Undermining Humanism in Foucault's thought and its implications in the pop art. meanings and facts which become in the process of the post-modernist.So the research's problem is to ask for undermining Humanism in Foucault's thought and how it formed through the formality of processors and the technical and stylistic and contents in pop art.. How are these technical aspects interact with each other to undermine the humanism in Foucault's mind and with system humanity, intellectual and social relations in the post-modern society . The contents of the first chapter, is the aim of the research, which aims to undermine know humanism in Foucault's mind and its implications in pop art , within the limit

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Publication Date
Thu Jun 30 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
RESPONSE OF FABA BEAN TO PLANTING DISTANCE BETWEEN PLANTS AND SPRAYING WITH NANO AND TRADITIONAL BORON: RESPONSE OF FABA BEAN TO PLANTING DISTANCE BETWEEN PLANTS AND SPRAYING WITH NANO AND TRADITIONAL BORON
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A field experiment was conducted during winter season of 2021 at a research station of college of agricultural engineering sciences, university of Baghdad to determine the response of active fertility percentage and seed yield and its components of faba bean (Vicia faba L. cv. Aguadulce) to distance between plants and spraying of nano and traditional boron. A Randomized Complete Block Design according to split-plots arrangement was used at three replicates. The main plots were three distances between plants (25, 35 and 45 cm), while the sub plots including spraying of distilled water only (control treatment), spraying of boron at a 100 mg L-1 and spraying of nano boron at two concentrations (1

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Publication Date
Tue Jun 30 2015
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Indicators Trends Of Populaion Structure Composition In Iraq And Their Relationship With Dependency Rates For The Period (1986-2010).: Indicators Trends Of Populaion Structure Composition In Iraq And Their Relationship With Dependency Rates For The Period (1986-2010).
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Iraq within the ranks of the fledgling communities characterized by a broad base of the population pyramid, because they pose the age group (under 15 years) of a large proportion of the community, as it exceeded the proportion (40%) during the years of research extended (1986-2010) Despite the relative decline in the rates fertility during that period, but the proportion of young people remained high, especially for groups of at least five years, amounting to about 14% in 2012, a little more than the proportion of what constitutes age group (5-9 above) years, where it was (13%) and this naturally predicts continuing population increases in coming decades, due to the entry of those numbers of individuals in the reproductive stage,

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Publication Date
Thu Dec 01 2022
Journal Name
Iraqi Journal Of Physics
Detection of Physical and Chemical Parameters Using Water Indices (NDWI, MNDWI, NDMI, WRI, and AWEI) for Al-Abbasia River in Al-Najaf Al-Ashraf Governorate Using Remote Sensing and Geographic Information System (GIS) Techniques
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The purpose of this study was to find out the connection between the water parameters that were examined in the laboratory and the water index acquired from the examination of the satellite image of the study area. This was accomplished by analysing the Landsat-8 satellite picture results as well as the geographic information system (GIS). The primary goal of this study is to develop a model for the chemical and physical characteristics of the Al-Abbasia River in Al-Najaf Al-Ashraf Governorate. The water parameters employed in this investigation are as follows: (PH, EC, TDS, TSS, Na, Mg, K, SO4, Cl, and NO3). To collect the samples, ten sampling locations were identified, and the satellite image was obtained on the

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Publication Date
Mon Mar 25 2019
Journal Name
Al-academy
The Aesthetic Discourse of the Pop Artists and its Representations in the Output of Students of the Department of Art Education: هند عبدالله عبد
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The emergence of artistic movements in Western countries was after the period of modernity. They have introduced a great dialectical problem at the level of thought and discourse, which necessitated a change in the course of the aesthetic discourse into new visions. Thus, the present research aims to identify the aesthetic discourse of pop artists' Art and its representations in the outputs of the students of the Department of Art Education. The theoretical framework included two sections: the first one, what is the aesthetic discourse and the second is the educational bases of the students' outputs. The procedures of the current research included the analytical descriptive approach. The research sample consisted of (4) outputs chosen ac

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Publication Date
Thu Mar 05 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The effect of orthodontic relapse on the proliferation of fibroblast and epithelial rests of Malassez in periodontal ligament of rat molars (A histopathological study)
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Background: Relapse of previously moved teeth, is major clinical problem in orthodontics with respect to the goals of successful treatment. This study investigated the effect of orthodontic relapse on the proliferation of fibroblast and epithelial rests of Malassez cells in periodontal ligament of rat molars. Materials and Methods: Sixteen ten-week- old male Wister rats were randomly divided into four groups composed of four animals each: Group I received no orthodontic force (control). In both Group II and Group III, uniform standardized expansive springs were used for moving the maxillary first molars buccally for periods of one and three weeks respectively. The spring initially generated an average expansive force of 20 g on each side.

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Publication Date
Mon Feb 28 2022
Journal Name
Journal Of Educational And Psychological Researches
The Impact of the Strategy of Cooperative Integration of Fragmented Information in the Acquisition of Physical Concepts and Science Processes among Fourth Scientific Students
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The current research aims to reveal the impact of the strategy of cooperative integration of fragmented information in the acquisition of physical concepts and science processes among fourth scientific students through the null hypotheses:

1- There is no statistically significant difference at the level of significance (0.05) between the average grades of female students of the experimental group studying physics according to the strategy of cooperative integration of fragmented information and those who follow the traditional method in the test of acquiring physical concepts.

2-There is no statistically significant difference at the level of indication (0.05) between the average grades of female students of the experimen

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Publication Date
Mon Jun 06 2022
Journal Name
International Journal Of Health Sciences
effect of a training curriculum for the development of some functional variables and the level of achievement in the effectiveness of air rifle shooting
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There are significant differences between the pre and post-tests in favor of the post-test in the tests) stroke volume (S.V), cardiac thrust (C.O.P), left ventricular volume, maximum oxygen consumption Vo2max), which indicates the effect of the proposed training approach.There are significant differences between the pre and post-tests in favor of the post-test in the achievement level test with air rifle shooting for young female shooters, which indicates the effect of the proposed training curriculum.There are no significant differences between the pre and post-tests in the tests (heart rate (HR) before exercise, heart rate (HR) after exercise, systolic blood pressure rate before exercise, systolic blood pressure rate after exercis

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Publication Date
Tue Aug 03 2021
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Standards of creditworthiness of customers and their impact on the liquidity of Iraqi private: Applied research in a sample of Iraqi private commercial banks
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Customers' creditworthiness standards are the key means employed by private commercial banks in assigning a suitable credit assessment for each customer. Accordingly, it had an instrumental role in indicating the degree of solvency of the potential customer before granting the required credit. The research problem reveals the nature of the relationship between the criteria of customer’s creditworthiness and banking liquidity. The most critical objectives of the study shed light on the role of using creditworthiness criteria as a tool for credit analysis of customers by banks that help reducing credit risks and thus increase banking liquidity. The questionnaire that was distributed to bank employees, the research sample, which w

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