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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Dec 01 2018
Journal Name
Political Sciences Journal
Soft power employment strategy in foreign affairs (Eygpt after Mubarak Regime : An Analytical study)
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(January 25, 2011) represented a real opportunity to bring about fundamental changes in Egyptian foreign policy and to start a new phase that would cut off all the negative and problematic aspects of Egyptian politics in the period before the revolution. Through the employment of Egypt's huge balance and the role of historical is a civilization rooted in the roots of thousands of years and Islamic reference represented over more than a thousand years the Islamic medium of religion in the start of vision and tools to achieve the Egyptian national interest, and safeguarding Egyptian national security in its comprehensive sense. The research attempts to answer a central question: Is there a role for Egyptian soft power in the Islamic world

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Publication Date
Sun Jul 01 2012
Journal Name
Journal Of Educational And Psychological Researches
A comparative study between the emotional responses in patients with blood pressure on a scale of music types characteristics compared with responses to some Healthy patients
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The problem of the study and its significance:

           Due to the increasing pressures of life continually, and constant quest behind materialism necessary and frustrations that confront us daily in general, the greater the emergence of a number of cases of disease organic roots psychological causing them because of severity of a lack of response to conventional treatments (drugs), and this is creating in patients a number of emotional disorders resulting from concern the risk of disease

 

     That is interested psychologists and doctors searchin

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Publication Date
Thu Jun 30 2022
Journal Name
Iraq Journal Of Market Research And Consumer Protection
COMPARISON BETEEEN THE CONSUMPTION OF RED MEAT AND WHITE MEAT FOR ASAMPLE OF CITIZENS OF THE CITY OF BAGHDAD/ AN EXPLORATORY STUDY
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Three hundred Iraqi people participated in demographic and attitudes study about red and white meat consumption. The mean age of the participants was 50 SD ± 11 years (mean 30-72); 51% were females and 49% males, mostly in forties who lived ≥ 5 years in Baghdad. The results showed that 80% of individuals prefer red meat. A 90% of people prefer fresh meat compared to frozen and processed meat. A 60% of people buy meat from popular markets. Nearly 87% of respondents believe the improving of livestock sector is essential and 80% of people confirmed there are obstacles to development this sector. An 80% of participates thought the reasons of the high prices of local fresh meat is the lack of planning and support to livestock sector. A survey

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Publication Date
Sun Jan 01 2017
Journal Name
Iraq Journal Of Agricultural Research
THE COMPARATIVE STUDY OF THE TOTAL COSTS AND NET REVENUE OF DIFFERENT TILLAGE SYSTEMS USING TWO TYPES OF SEEDLINGS IN THE PRODUCTION OF BARLEY GREEN VARIETY SAMEER IN THE GYPSUM SOILS
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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Phytochemical Study of some Flavonoids Present in the Fruits of Two Ammi L. Species Wildly Grown in Iraq
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Ammi species belong to the family Umbellifereae that provide a host of bioactive compounds (mainly coumarins and flavonoids) of important biological activities, like prevention and treatment of heart and vascular disease and some types of cancer. Literature survey revealed that there was no study concerning Ammi flavonoids in Iraq. Ammi majus and Ammi visnaga, which are wildly grown in Iraq, were chosen for this study. This study concerned with extraction, identification, isolation, and purification of some biologically important flavonols quercetin and kaempferol from the fruits of Ammi majus and Ammi visnaga. Extraction of these flavonols was carried out using 85% methanol and 90% e

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Publication Date
Tue Jan 24 2023
Journal Name
Archives Of Razi Institute
PCR-RFLP Analysis of Insulin-Like Growth Factor 2 Gene Polymorphisms in Two Commercial Broiler Chicken Strains (Cobb 500 and Hubbard F-15) and Their Associations with Performance Traits
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The present research aimed to study the polymorphisms of the chicken insulin-like growth factor 2 (IGF2) in two commercial broiler breeds (Cobb 500 and Hubbard F-15). In total, 300 avian blood samples were obtained. The genomic DNA was isolated using a fast salt-extraction technique. Moreover, polymerase chain reaction (PCR) was used to amplify 1146 bp fragments of the gene. The amplified fragments were subjected to restriction enzyme digestion using the HinfI endonuclease enzyme, and the digested products were separated on a 2% agarose gel. The findings indicated that there were two alleles, T and C, for the target locus, with frequencies of 73.3% and 26.7%, respectively. Three distinct genotype variations, TT, TC, and CC, were found, with

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Scopus
Publication Date
Tue Aug 18 2020
Journal Name
Journal Of Mechanics Of Continua And Mathematical Sciences
THE COMPARISON OF THE METHODS ESTIMATING THE FRACTIONAL DIFFERENCES OF PARAMETER AND ITS DEPENDENCE ON ESTIMATION THE BEST LINEAR MODEL OF TIME SERIES IN THE ENVIRONMENTAL FIELD
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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Implementation of Optical Coherent Communication System between Two Computers
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This work represents implementation and investigation of optical coherent communication system between two computers. A single mode optical fiber is selected as transmission medium. The data are sent via the RS-232 standard interface with a bit rate of 9.6 kbps from personal computer (PC1) by line receive to convert the data from electrical levels (-12/+12 V) into TTL level (0/5 V). The modulation of this data was accomplished by internal modulation using laser diode type (HFCT-5208M) 1310 nm wavelength. The optical D-coupler was used to combine the optical signal that come from laser source with optical signal of laser local oscillator (OTS-304XI) at 1310/1550 nm wavelength to obtain coherent (homodyne and heterodyne) detection respective

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Publication Date
Thu Aug 27 2026
Journal Name
Journal Of Engineering
Computational Method for Unsteady Motion of Two-Dimensional Airfoil
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A numerical method is developed for calculation of the wake geometry and aerodynamic forces on two-dimensional airfoil under going an arbitrary unsteady motion in an inviscid incompressible flow (panel method). The method is applied to sudden change in airfoil incidence angle and airfoil oscillations at high reduced frequency. The effect of non-linear wake on the unsteady aerodynamic properties and oscillatory amplitude on wake rollup and aerodynamic forces has been studied. The results of the present method shows good accuracy as compared with flat plate and for unsteady motion with heaving and pitching oscillation the present method also shows good trend with the experimental results taken from published data. The method shows good result

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Publication Date
Sat Jul 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Performance Evaluation of Two Date Palm Frond Cutting Saws
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Abstract<p>Traditional tree management is laborious and costly, thus this work aimed to study the performance of two different types of frond cutting saws (reciprocating saw and vibrating saw) and examine the two saws on five date palm varieties. Four parameters were examined, including cutting time for a single frond, the power needed for cutting a single frond, frond cutting productivity expressed as tree/h, and vibration conveyed to the worker’s hand. A field experiment was designed according to the nested randomized complete block design, including five date palm varieties as the main plot and the type of saw as a sub-plot. Means were compared using the least significant differences (LSD 0</p> ... Show More
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