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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
The mechanisms of generation of Unemployment in Iraq and its types and calculating the Disguised of it: Analytical Study for the period 2003-2015
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     The objective of this study is to attempt to provide a quantitative analysis to the causes of unemployment  in Iraq and its mechanisms of generation, as well as a review of the most important  types of both visible and invisible unemployment, and an attempt to measure the disguised  unemployment  and analyze the causes. The problem of the research lies in the fact that the Iraqi Economy has been suffered  for  a long time although its characterized by abundant  physical and natural  resources, from the existence of the  phenomenon of unemployment  in the previous two types. Causing a lot of economic problems, represented by the great waste of resources and

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Publication Date
Sat Jul 01 2023
Journal Name
The Egyptian Journal Of Hospital Medicine
Evaluation of the Antibiofilm Activity of Laurus nobilis Leaves Extract and Assessment of Its Effect on fimA and papC genes in Escherichia coli isolates
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Background: The beneficial gut bacterium E. coli can cause blood poisoning, diarrhoea, and other gastrointestinal and systemic disorders. Objective: This study amid to examines the antibiofilm activity of Laurus nobilis leaves extract on E. coli isolates and compares pre- and post-treatment gene expression of fimA and papC genes. Subjects and Methods: Ten isolates of E. coli were obtained from the Genetic Engineering and Biotechnology Institute, University of Baghdad, which was previously collected from Baghdad city hospitals and diagnosed by chemical tests, the diagnosis was confirmed using VITEK-2 System. The preparation of the aqueous and methanolic Laurus nobilis leaves extracts was done by using the maceration method and Soxhlet appara

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Publication Date
Mon Jan 01 2018
Journal Name
Journal Of The College Of Languages (jcl)
‘There is no place like home’: A Comparative Study of the Meaning of Home in The Wonderful Wizard of Oz and Peter and Wendy
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The Wonderful Wizard of Oz and Peter and Wendy present universal ideas that exist in all times, despite being written in the beginning of the 20th century. Among the most significant ones is the concept of “home”. The article discusses the essentiality of the idea of “home” where the identity of an individual shapes, and where one’s spiritual, psychological, and physical being develop. It also studies the attitudes of each protagonist towards the concept of ‘home’ based on their understanding of it and according to their gender differences. The characters in both stories tread on the path of perplexity between leaving their homes and returning to them. Peter’s world is the world of imagination while Doro

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Publication Date
Tue Feb 03 2026
Journal Name
Al–bahith Al–a'alami
SOCIAL MEDIA AND ITS ROLE IN THE PRODUCTION AND NUTRITION OF CRISES: "ANALYTICAL STUDY OF A SAMPLE OF TWITTER DURING THE GULF CRISIS 2017"
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Social networking sites have become very popular since the beginning of the current decade and have become linked to our daily life. We follow the news, Analyses  and opinions on the one issue in a way that attracts millions of users and the number grows every secon On Twitter, one of the most important social networking sites, all social groups rushed from the president to the last citizen to open accounts when they found themselves forced to do so .

During the recent Gulf crisis, Twitter was buzzing with Twitter, which achieved the largest circulation globally. Instead of serving the issue and directing it to serve the Arab interest, most of the publications were on th

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Publication Date
Sat Oct 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
The quality of higher education requirements and its impacts in achieving organizational excellence: The case study of the Universities of Baghdad and AL-Nahrain
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Abstract

This research aims to determine the role of the quality of higher education in achieving organizational excellence at the universities of Baghdad and Al-Nahren, was based on research on the main hypothesis is:First:- There is correlation and between the quality of higher education dimensions (continuous improvement, measurement and analysis, the culture of the organization, optimal use of resources , customer satisfaction) and organizational excellence dimensions (strategic planning, focusing on the market and the customer, information and analysis, the effectiveness of operations, processes and resources), Second:- Second, there is the impact of relationship sig

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Effect of the Aquatic Plant Hydrella vorticellata as a Fertilizer on Seed Germination and some Chemical and Cytogenetics Parameters in the cell of Hordeum vulgare and Vicia faba
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The present study is concerned with studying the effect of aquatic plant Hydrella vorticellata with the concentration of 10 and 20 gm/2 K gm soil on percentage and growth rate of germinating seeds of Hordeum vulgare and Vicia faba. More overs, the quantitative amount of NPK in both tested plants and Hydrella vorticellata, are estimated as an organic fertilizer. It has also been find the total number of root cells, the number of dividing cells, and stages of mitosis. The study reveales, that there are no significant differences between the concentration of hydrella used in germination percentage, growth rate, wet and dry weight. While there are differences in the plants containing NPK. The number of cells dividing stages and number of divid

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Publication Date
Sat Jun 30 2018
Journal Name
Kufa Journal For Agricultural Sciences
Effect of numbers of blades and speed of tillage in the performance of the rotavator plow
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Experiment Factorial conducted with two factor in field texture silt clay loam soil, the first factor were Two Rotavator plow which different in number of rotary blades on flanges, weight, width, made and type, the second factor were four speeds tractor 2.62, 5.10, 7.55, 9.23 km/hr to compare performance two Rotavator under depth 12 cm and knowledge slippage, distance between beat blades, practical productivity, disturbed soil volume, percentage of the soil clods which have diameter less than 5 cm under complete block design with three replications using Least Significant Design 0.05. Results showed Galucho Rotavator recorder the higher practical productivity 0>7089 ha/hr, disturbed soil volume 809.8 m3/hr, percentage of the soil clods 96.1

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Publication Date
Thu Oct 31 2019
Journal Name
Al-kindy College Medical Journal
Assessment of efficacy and safety of dapsone gel 5% in the treatment of acne vulgaris
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ABSTRACTBackground : Acne vulgaris is a
common skin disease, affecting more than 85% of
adolescents and often continuing into adulthood.
People between 11 and 30 years of age and up to
5% of older adults. For most patients acne remains
a nuisance with occasional flares of unsightly
comedones, pustules and nodules. For other less
fortunate persons, the sever inflammatory response
to Propionibacterium acnes (P.acnes) results in
permanent
Methods: Disfiguring scars. (1, 2) Stigmata of sever
acne cane lead to social ostracism, withdrawal
from society and severe psychologic
depression (1-4).
Result Pathogenesis of acne Traditionally, acne
has been thought of as a multifactorial disease of
the fo

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Publication Date
Tue Dec 16 2008
Journal Name
Journal Of Planner And Development
City of Baghdad Analysis of the mechanisms of economic action in the development and development
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The economy of a city has an important role not only in its establishment but also in its development. This is quite clear in the city of Baghdad throughout its history since its building in 762 A.D. In addition, most of its problems that the city is suffering from are basically related to not giving enough importance to the economic factors in the master planning of Baghdad since 1950’s. This may explain the failiars of master plans in dealing with the actual population growth and the city's inability to absorb such increases and interrelated and diverse activities which are negatively reflected on the economic variables particularly the effect on the land values, and the strong competitions amongst the land uses without previ

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Publication Date
Mon Aug 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Using of concepts "conservatism & accrual" and their reflection in enhancing of quality of financial reporting
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The use of Conservatism  significant impacts on the financial statements and thus on financial reporting which is produced by these lists so Rate Some of the professionals that the principle of accounting while Rate of others as a constraint, and brought this category based on the uses of this restriction sometimes used the accountant this restriction and especially with the uncertainties in the Sometimes it may collide with some of the cases in which the accountant may be forced to leave in custody as a result of emergence of economic events that gave rise to rights or future commitments should be disclosed.

The emergence in custody mainly was due to the uncertainty and its essence is to report on a

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