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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 18 2023
Journal Name
Al–bahith Al–a'alami
The Role of Public Relations in Promoting Tourism from the Public Relations officers’ Point of View in Palestinian Travel and Tourism Companies in Gaza
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The aim of the research is to identify the role of public relations in promoting tourism by the Palestinian tourism and travel companies in Gaza from the public relations officer’s point of view in those companies.
The researcher used the descriptive analytical method as the most appropriate for such studies and implemented the questionnaire as a tool to obtain the required data from the respondents.
The Researcher reached several conclusions:
1- There is a low percentage of women working in the field of public relations in Palestinian tourism establishments in the Gaza Strip, where the percentage did not exceed 5%.
2- The interpersonal communication counted as one of the elements of integra

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Publication Date
Tue Dec 31 2019
Journal Name
Journal Of Economics And Administrative Sciences
The Role of Information Technology Competency in Activating of Human Resources Management Practices/ Applied Study in the Informatics and Communications Public Company in Iraq
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This research aims to clarify the role of Information Technology Competency (ITC) with dimensions' (IT Usage, IT Knowledge, and IT Operations) as an independent variable in the activation of Human Resources Management Practices (HRM Practices) as a dependent variable with dimensions' (Training and Development, Recruitment, Job Design, and Performance appraisal). Based on this, the correlation and effect relationships between the independent and dependent variables are determined by formulating two main hypotheses. There are a significant relationship and effect of IT competency with HRM practices within the dimensions. Furthermore, the scope and population of this research are the Informatics and Communications P

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Publication Date
Mon Jan 01 2024
Journal Name
Heliyon
Synthesis and Characterization of Some Metal Ions Complexes with Mixed Ligand of Azo Dye and Metformin and Evaluation of its Effectiveness on the Growth of Some Pathogenic Bacteria Clinically Isolated and Study of its Toxicity on Normal and Cancerous Hepatocytes
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Publication Date
Sun Sep 01 2024
Journal Name
Heliyon
Synthesis and characterization of some Metal ions complexes with mixed ligand of azo dye and Metformin and evaluation of its effectiveness on the growth of some pathogenic bacteria clinically isolated and study of its Toxicity on normal and cancerous Hepatocytes
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Publication Date
Sun Sep 01 2024
Journal Name
Heliyon
Synthesis and characterization of some Metal ions complexes with mixed ligand of azo dye and Metformin and evaluation of its effectiveness on the growth of some pathogenic bacteria clinically isolated and study of its Toxicity on normal and cancerous Hepatocytes
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Four metal compounds mixed ligand of azo dye ligand (L) and metformin.(Met) were produced at aquatic ethanol for (1:1:1) (M:L:Met). The prepared compounds were identified by utilizing atomic absorption flame, FT.IR and UV–Vis spectrum manners as well as conductivity mensuration. These compounds was assayed of the gained datum the octahedral geometry was proposed into whole prepared complexes.Also in this research was studied represented examining the antibacterial and antifungal impact of the azo dye ligand (L), metformin.(Met) and (Co,Ni, Cu and Cd complexes) on four types of pathogenic, clinically isolated bacteria that are resistant to antibiotic, like Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Klebsiella pneu

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Publication Date
Thu Dec 30 2021
Journal Name
College Of Islamic Sciences
The Trilogy of Punishment - The Great, Painful and Humiliating in the Holy Quran An objective study: The Trilogy of Punishment - The Great, Painful and Humiliating in the Holy Quran An objective study
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The study of triples seeks to deal with the comprehensive nature of the Qur’an texts, and the choice fell on the trilogy of great torment, pain, and humiliation in the Noble Qur’an - an objective study, the title of this research, in which I tried to shed light on these terms, and the nuances between them, and in particular torment The eschatological terminology varied, which can be summed up in three terms, namely the great, the painful, and the offensive. The types of torment, the pain is the painful one that is described by the severity of pain and its horror, as for the humiliating punishment, it is that which humiliates the one who has fallen on it, and the diversity of torment is due to the diversity of sins.

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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
The Difficulties of the opening text between changing and collecting reading in poem (city without rain): The Difficulties of the opening text between changing and collecting reading in poem (city without rain)
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Abstract
This research deals with the technical of opening text during the critical
study about the poem of Al- ssiyab which is named ( city with out rain)
We chose this poem also to make connection with the western critical
theories.
Our study aims to explain the act of opening texts and critics and its
methods and directions in modern Arabic poetry.
It also aims to show the differences in the point of view between critics
and poetries.
The research depends on dimension vision of selective, and descriptive.

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The Image of the Soldier in Brendan Behan's The Hostage And Charles Fuller's A Soldiers Play: The Image of the Soldier in Brendan Behan's The Hostage And Charles Fuller's A Soldiers Play
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Abstract
The image of the soldier, as a hero who sacrifices everything to defend his
country and values, is no longer depicted in modern drama. With two World Wars
and many regional wars and civil wars, the soldier becomes a victim, not a hero.
Authors present the character of the soldier as a man who suffers a lot as he is
victimized by his own government and its politics that forces him to be in such a
position. Dramatists express their views about race, oppression and war through
their characters, such as the character of the soldier, as in the two selected plays for
this research: The Hostage by Brendan Behan and A Soldier's Play by Charles
Fuller.
The Hostage depicts, through its events, the Irish oppre

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Publication Date
Mon Dec 31 2018
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
USE OF CLAY MINERAL IN WESTERN ALANBAR DESERT AND USING FOR CRUDE OIL FRACTIONATION (ALQAYAIRA CRUDE): USE OF CLAY MINERAL IN WESTERN ALANBAR DESERT AND USING FOR CRUDE OIL FRACTIONATION (ALQAYAIRA CRUDE)
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In this research, a number of the western al-Anbar clays (red iron clays, Attapulgite) were modified by treating them thermally with a temperature of 650oC. After that, these clays reflux with sodium hydroxide 5% for 1 hour by using microwave as a power supply. The research included fractionation alqayaira crude oil the fractionation included removing the asphaltene by precipitation from the crude using a simple paraffin solvent (normal hexane) as a non-soluble substance. After that it was filtered using the ash-free filter paper 42, the dissolved part, maltinate, was taken, drying a temperature of 75oC and weight, and to find the percentage of the two parts. Malatine was divided into three main parts (paraf

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Publication Date
Thu Feb 16 1995
Journal Name
. مجلة العلوم الزراعية العراقية 26 (1), 84-87
Effect of GA3 and Pollen Extract on Fruit set and Seed Production of Date Palm Cvs. Zahdi and Khaustawi.‏
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