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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 19 2022
Journal Name
International Journal Of Biomaterials
Green Biosynthesis of Silver Nanoparticles from Moringa oleifera Leaves and Its Antimicrobial and Cytotoxicity Activities
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The plant occupied the largest area in the biosynthesis of silver nanoparticles, especially the medicinal plants, and it has shown great potential in biotechnology applications. In this study, green synthesis of silver nanoparticles from Moringa oleifera leaves extract and its antifungal and antitumor activities were investigated. The formation of silver nanoparticles was observed after 1 hour of preparation color changing. The ultraviolet and visible spectrum, Fourier transform infrared spectroscopy, X-ray diffraction, scanning electron microscopy, and transmission electron microscopy techniques were used to characterize synthesis particles. Ultraviolet and visible spectroscopy showed a silver surface plasmon resonance band at 434

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Publication Date
Wed Jan 01 2025
Journal Name
Aip Conference Proceedings
Synthesis and evaluation of chalcone derivatives for antimicrobial and antioxidant activities using microwave-assisted methodology
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Publication Date
Mon Jan 01 2018
Journal Name
Aip Conference Proceedings
Fabricated and investigated the structure and super conductivity properties of Bi2Sr2Can-1CunO2n+4+δ compound
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Publication Date
Sat Feb 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
An open cloud-based platform for the creation and delivery of smart applications and services
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Abstract<p>With the increasing integration of computers and smartphones into our daily lives, in addition to the numerous benefits it offers over traditional paper-based methods of conducting affairs, it has become necessary to incorporate one of the most essential facilities into this integration; namely: colleges. The traditional approach for conducting affairs in colleges is mostly paper-based, which only increases time and workload and is relatively decentralized. This project provides educational and management services for the university environment, targeting the staff, the student body, and the lecturers, on two of the most used platforms: smartphones and reliable web applications by clo</p> ... Show More
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Publication Date
Sun Jun 01 2014
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Suggested Model for The Work of the Certified Fraud Examiner & His Role in Reducing The Incidents of Fraud and Corruption: An Applied Study in The Federal Board of Supreme Audit
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Is hardly day expire without hearing the news either Abuse Managementthe accounting standards or the existence of serious misstatements by someauditors.Which caused the demanding of many companies in the recent republication of the financial statements and the re-announcement of its financialresults. Such acts raise questioning about the role that should be played by theauditors, prompting agencies responsible for setting auditing standards to takeTo throw increasingly responsibility on the auditors in order to interest risksfraud The Risks of Fraud in their review of the financial statements.also The Public Company Accounting Oversight Board in the U.S.called about the need of owning the Certified Public Accountants those whoaudits for

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Publication Date
Wed Jan 05 2022
Journal Name
Journal Of Positive School Psychology
Influence Of Variance In Rest Interval For The Explosive Power Training For The Arms And Legs In The Light Of Some Biochemical Indicators For The Cellular Equilibrium Of The Volleyballers
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Publication Date
Wed Mar 23 2022
Journal Name
Journal Of Educational And Psychological Researches
The Actual Use of Instructional Technology in Teaching History Subject in the Colleges of Education for Humanities from the of the College Staff Members' Perspectives and their Attitudes Towards Them
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The study aims at knowing the actual uses of instructional technology in teaching history subject in the colleges of education for humanities from the college staff members' perspectives and their attitudes towards it. The sample of the study consisted of (24) instructors from the Colleges of Education for the Humanities, the College of Basic Education- Haditha and the College of Education for Women, the study used the descriptive method, and the questionnaire was consisted of (50) items, and the psychometric properties of the instrument of the study were extracted. The researchers used the appropriate statistical means to analyze the data, and the results of the study showed the following: the teaching staff attitudes towards the use of

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Publication Date
Mon Aug 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Job involvement for workers and its influence in Crystallize organizational Identification (An analytical research of the opinions of a sample of workers in the Middle East, the Iraqi Investment Bank)
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Abstract:

     The current research is aimed at analyzing the impact of the dimensions of Job involvement of all of (the enthusiasm, the Devotion, Assimilation ) in the Crystallize organizational Identification across the dimensions of (organizational loyalty, membership, similarities) and was named the Middle East, the Iraqi Investment Bank room to look as the research community of staff adopted in the bank, to be applied to a Random sample of (100) employees working in the said bank, and developed for the purposes of data collection, a questionnaire form included three axes covered (32) paragraph of the measure, which is included adopted Liekrt Quintet for the

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Publication Date
Sun Mar 31 2024
Journal Name
Techhub Journal
The effect of increasing the intensity of specialized endurance training on runners' ability in the advanced 1500-meter run in terms of vital capacity indicators (V.C.) and heart rate (S.V.)
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The 1500m race event is part of the athletics system, and the continuous competition to break records and achieve the highest levels of achievement in athletics events, especially the 1500m race event, is one of the topics that occupies the minds of many people interested in achieving digital development for this event, given the distance of the race and the time it takes to complete it. Because it is unique from other events, it has characteristics that distinguish it from other events, despite it being a middle-distance event, which shares with them that its speed is measured by the step, which consists of the length of the step and its frequency. Increasing any of these two factors while keeping one of them constant or increasing

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Publication Date
Thu Feb 28 2019
Journal Name
The Open Rheumatology Journal
The Value of Soluble Transferrin Receptor and Soluble Transferrin Receptor-ferritin Index in Discriminating Iron Deficiency Anaemia from Anaemia of Chronic Disease in Patients With Rheumatoid Arthritis
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Background:

Anaemia is a common extra-articular manifestation of rheumatoid arthritis (RA) where anaemia of chronic disease (ACD) and iron deficiency anaemia (IDA) are the two most frequent types. The distinction between these two types of anaemia has always been challenging requiring sophisticated techniques. Serum transferrin receptor (sTfR) a truncated soluble form of the transferrin receptor is one of the parameters that is influenced by the Iron content and supply to the erythrons and is not affected by inflammatory status and therefore the use of the sTfR/log ferritin (sTfR-F) index can be a reliable indicator of functional iron deficiency.

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