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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 01 2016
Journal Name
International Journal Of Scientific Research
Anatomical differences of Cerebellar vermismeasurement values in healthy adult men andwomen using MRI images
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Background: e cerebellum is divided into two hemispheres and contains a narrow midline zone called thevermis. A set of large folds are conventionally used to divide the overall structure into ten smaller "lobules". evermis receives fibres from the trunk and proximal portions of limbs, But the question is that does the cerebellum have the same measurementvalues in males and females of the same age?Material and method: e present study used 80 sectional brain MRI images (40: males, 40: females); 35-50 years old as indices of size for thevermian structures of the Cerebellum. is middle age group was taken because as known generally it could be neither an age of growth as inthe young nor of atrophy as in old individuals. e aim rega

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Publication Date
Sat Jul 01 2023
Journal Name
Journal Of Analytical Chemistry
A Spectrophotometric Method for Tetracycline Determination in its Bulk Powder and Pharmaceutical Formulations Using Flow Injection and Batch Procedures: a Comparative Study
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A reliable and environmental analytical method was developed for the direct determination of tetracycline using flow injection analysis (FIA) and batch procedures with spectrophotometric detection. The developed method is based on the reaction between a chromogenic reagent (vanadium (III) solution) and tetracycline at room temperature and in a neutral medium, resulting in the formation of an intense brown product that shows maximum absorption at 395 nm. The analytical conditions were improved by the application of experimental design. The proposed method was successfully used to analyze samples of commercial medications and verified throughout the concentration ranges of 25–250 and 3–25 µg/mL for both FIA and batch procedures, respecti

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Publication Date
Tue May 10 2022
Journal Name
European Scholar Journal (esj)
MODELING AND COMPARISON OF CLOSED-LOOP AND OPENLOOP ADAPTIVE OPTICS SYSTEMS
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Astronomers have known since the invention of the telescope that atmospheric turbulence affects celestial images. So, in order to compensate for the atmospheric aberrations of the observed wavefront, an Adaptive Optics (AO) system has been introduced. The AO can be arranged into two systems: closedloop and open-loop systems. The aim of this paper is to model and compare the performance of both AO loop systems by using one of the most recent Adaptive Optics simulation tools, the Objected-Oriented Matlab Adaptive Optics (OOMAO). Then assess the performance of closed and open loop systems by their capabilities to compensate for wavefront aberrations and improve image quality, also their effect by the observed optical bands (near-infrared band

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Publication Date
Wed Dec 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Expatriate Workers and Its Repercussions on the Economy and Labor Market in Iraq After 2003
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The demand for expatriate labor to Iraq increased after 2003 as a result of the openness that Iraq experienced, but this expatriate labor, which was requested at an increasing rate, has had economic, social, and political effects on the Iraqi economy in general, and the Iraqi labor market in particular. This is due to the high rates of unemployment, as most of these expatriate workers cause competition to local labor, and thus cause repercussions on the Iraqi economy as a whole, except for those expatriate workers coming with companies working in the oil sector. Iraq's GDP

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Publication Date
Thu Jun 25 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Diuretic Effect of Prosopis farcta in Comparison with Spironolactone and Hydrochlorothiazide in Hypertensive Rats
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Prosopis farcta has been used traditionally for several diseases as cardiovascular, kidney, diabetes, bacterial infection and it has diuretic activity. This study was designed to evaluate the diuretic effects of P. farcta extract in comparison with spironolactone and hydrochlorothiazide in normal and hypertensive rats.Forty eight rats, were divided into Two groups. The First group was consist of Twelve normotensive rats, to represent the control group and normal treated group receiving 50 mg/Kg of P. farcta extract; Six rats in each group.

The Second group involved 36 hypertensive rats, were divided into six subgroups, each of six rats. The First subgroups served as a positive control, the Second, Third

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Publication Date
Thu Jan 01 2015
Journal Name
International Journal Of Astronomy And Astrophysics
Determination of Velocity and Radius of Supernova Remnant after 1000 yrs of Explosion
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Supernova explosions are described as very violent events which transfer a significant amount of energy to interstellar media and are responsible for a large variety of physical processes. This study does not discuss the actual explosion mechanisms but follows the behavior of the dynamical evolution of some selected type I and type II supernova remnant and particularly after a thousand years from their explosion and shows how the density of the medium affects the evolution and the lifetime of each remnant. By studying such behaviors, a simplified model has been proposed here for the velocity and radius of the remnant after thousand years of explosion that depends only on the density of the medium and age of the remnant. It has been found th

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Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Physics: Conference Series
Light scattering detector based on light-emitting diodes-Solar cells for a flow analysis of Warfarin in pure form and pharmaceutical formulations
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Abstract<p>Continuous turbidimetric analysis (CTA) for a distinctive analytical application by employing a homemade analyser (NAG Dual & Solo 0-180°) which contained two consecutive detection zones (measuring cells 1 & 2) is described. The analyser works based on light-emitting diodes as a light source and a set of solar cells as a light detector for turbidity measurements without needing further fibres or lenses. Formation of a turbid precipitated product with yellow colour due to the reaction between the warfarin and the precipitation reagent (Potassium dichromate) is what the developed method is based on. The CTA method was applied to determine the warfarin in pure form and pharmaceu</p> ... Show More
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Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Physics: Conference Series
Light scattering detector based on light-emitting diodes-Solar cells for a flow analysis of Warfarin in pure form and pharmaceutical formulations
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Abstract<p>Continuous turbidimetric analysis (CTA) for a distinctive analytical application by employing a homemade analyser (NAG Dual & Solo 0-180°) which contained two consecutive detection zones (measuring cells 1 & 2) is described. The analyser works based on light-emitting diodes as a light source and a set of solar cells as a light detector for turbidity measurements without needing further fibres or lenses. Formation of a turbid precipitated product with yellow colour due to the reaction between the warfarin and the precipitation reagent (Potassium dichromate) is what the developed method is based on. The CTA method was applied to determine the warfarin in pure form and pharmaceu</p> ... Show More
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Crossref (5)
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Publication Date
Sun Jan 01 2023
Journal Name
Aip Conference Proceedings
Histological changes in the uterus and implantation status in pregnant mice after oral administration of Maca powder
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Publication Date
Sun Oct 01 2017
Journal Name
Al–bahith Al–a'alami
Issues of Media Trials in Iraqi after 2003
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The Supreme Judicial Council decided on July 3, 2003, to set up a court to deal with the issues of publication and media. This court tries to solve the problems of media and publishing in both its civil and penal aspects. The decision of establishing the court represents a new and important step to be taken by the Iraqi Judicial Council for the tremendous development witnessed by media sector in general and press in particular especially after 2003.
This study includes two main axes: the first one deals with the most important crimes of publication in the Iraqi legislations such as the crimes of defamation, libel, insult, indecency, and incitement; the second deals with an analytical survey of the completed cases i.e. the issues tha

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