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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 11 2023
Journal Name
Sport Tk-revista Euroamericana De Ciencias Del Deporte
Analysis of the amount of lost fluids, some blood components and mineral salts in volleyball under hot weather conditions
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The research objective was to study the amount of lost fluids, some blood components and mineral salts in volleyball players under hot weather conditions. The sample of the present study was composed of 12 volleyball players of Al-Sinaa Club (Baghdad, Iraq) in the 2022/2023 season. The variables analyzed in this study were: Heart rate before and after exercise, internal and external body temperature before and after exertion, potassium ion, sodium ion, calcium ion, and the amount of fluid lost (the player's weight) before and after the exercise. The tests were conducted at a temperature between 42-47 degrees Celsius. The maximum anaerobic exercise was performed with volleyball. The results showed that to play volleybal

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Publication Date
Sun Jan 01 2023
Journal Name
Sport Tk - Revista Euro Americana De Ciencias Del Deporte
Analysis of the amount of lost fluids, some blood components and mineral salts in volleyball under hot weather conditions
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Scopus (7)
Scopus
Publication Date
Tue Jul 11 2023
Journal Name
Sport Tk-revista Euroamericana De Ciencias Del Deporte
Analysis of the amount of lost fluids, some blood components and mineral salts in volleyball under hot weather conditions
...Show More Authors

The research objective was to study the amount of lost fluids, some blood components and mineral salts in volleyball players under hot weather conditions. The sample of the present study was composed of 12 volleyball players of Al-Sinaa Club (Baghdad, Iraq) in the 2022/2023 season. The variables analyzed in this study were: Heart rate before and after exercise, internal and external body temperature before and after exertion, potassium ion, sodium ion, calcium ion, and the amount of fluid lost (the player's weight) before and after the exercise. The tests were conducted at a temperature between 42-47 degrees Celsius. The maximum anaerobic exercise was performed with volleyball. The results showed that to play volleybal

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Scopus (7)
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Publication Date
Sun Sep 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
The Economic Conditions of Living in the City of Mosul: Income and Labor Market during the Period 2004-2007
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Abstract

 

This study cares for the economic living conditions in Mosul City. Its importance lies in the critical period that has been covered
(2002-2007), which was dominated by far–reaching events at political economic and social levels.
Among the main results that have been revealed are the following: the rate of economic growth in the City has been the lowest among major urban centers in Iraq. Besides, real income per capita in the City has stayed stagnant during the period of the study. However, the inequality in distribution of income has decreased. The main bulk of the city's population rely on their income from wages and salari

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Publication Date
Fri Mar 31 2017
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Effect of Nanoparticles and Surfactant on Phase Inversion of Two Phases
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In the present study, a pressure drop technique was used to identify the phase inversion point of oil-in-water to water-in-oil flows through a horizontal pipe and to study the effect of additives (nanoparticles, cationic surfactant and blend  nanoparticles-surfactant) on the critical dispersed volume fraction (phase inversion point). The measurements were carried  for mixture velocity ranges from 0.8 m/sec to 2.3 m/sec. The results showed that at low mixture velocity 0.8 and 1 m/sec there is no effect of additives and velocity on phase inversion point, while at high mixture velocities the phase inversion point for nanoparticles and blend (nanoparticles/surfactant) systems was delayed (postponed) to a higher value of the dispers

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Publication Date
Sat Dec 01 2018
Journal Name
Agricultural Engineering
Evaluation of Flat Fan Nozzles Operating Parameters Under Conditions of Accelerated Boundary and Destructive Wear
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Abstract<p>Two tests were carried out to measure the standard flat fan nozzles wear during a specific period of an accelerated wear procedure. The first test aimed at getting 10% increase in the flow rate compared to the nominal flow rate, which is the threshold to replace the nozzles according to the nozzles testing standards. The second test was to wear the nozzles intensively (100 hours of accelerated wear), which represents the use of nozzles beyond the allowed threshold. The results showed that the flow rate reached 1.31 l·min<sup>−1</sup> (equal to 10% increase) for the tested nozzles after 35 hours of the wear test. For the second test, the 10% increase of the flow rate was r</p> ... Show More
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Publication Date
Tue Dec 26 2017
Journal Name
Al-khwarizmi Engineering Journal
FPGA Realization of Two-Dimensional Wavelet and Wavelet Packet Transform
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The Field Programmable Gate Array (FPGA) approach is the most recent category, which takes the place in the implementation of most of the Digital Signal Processing (DSP) applications. It had proved the capability to handle such problems and supports all the necessary needs like scalability, speed, size, cost, and efficiency.

In this paper a new proposed circuit design is implemented for the evaluation of the coefficients of the two-dimensional Wavelet Transform (WT) and Wavelet Packet Transform (WPT) using FPGA is provided.

In this implementation the evaluations of the WT & WPT coefficients are depending upon filter tree decomposition using the 2-D discrete convolution algorithm. This implementation w

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Publication Date
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Spectrophotometric Determination of Nitrofurantoin Drug in its Pharmaceutical Formulations Using MBTH as a Coupling Reagent
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A direct, sensitive and efficient spectrophotometric method for the determination of nitrofurantoin
drug (NIT) in pure as well as in dosage form (capsules) was described. The suggested method was
based on reduction NIT drug using Zn/HCl and then coupling with 3-methyl-2-benzothiazolinone
hydrazone hydrochloride (MBTH) in the presence of ammonium ceric sulfate. Spectrophotometric
measurement was established by recording the absorbance of the green colored product at 610 nm.
Using the optimized reaction conditions, beer’s law was obeyed in the range of 0.5-30 μg/mL, with
good correlation coefficient of 0.9998 and limits of detection and quantitation of 0.163 and 0.544
μg/mL, respectively. The accuracy and

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Publication Date
Sun Aug 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Assessing the Iraqi general budget in light of corruption and fluctuations in oil prices, and their repercussions on unemployment rates after 2003
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The researcher highlighted the general budget in Iraq for the period (2003-2018) facing the challenges of administrative and financial corruption, in addition to the fluctuations in oil prices, the repercussions and many problems suffered and will suffer the Iraqi government in the process of preparing the general budget of the state and weak contribution of the agricultural and industrial sectors and other economic sectors and neglect altogether, oil has become the main supplier in funding Iraq's budget after 2003, and the impact on the unemployment rates in Iraq, which recorded fluctuating rates and then increased during the period (2012-2018) to achieve this, an inductive method was adopted, using theoretical and descriptive a

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Publication Date
Wed Apr 01 2015
Journal Name
Al–bahith Al–a'alami
Methods of US propaganda in Iraq- A Study of Coalition Provisional Authority and US Army Data after 2003
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with an organized propaganda campaign. This military campaign was helped to formulate its speech by many institutions, research centers, and knowledge and intelligence circles in order to mobilize public opinion gain supporters and face the opponents by different means depending on a variety of styles to achieve its required effects. 
          After the US occupation of Iraq, US media fighters sought to influence the Iraqi public opinion and making them convinced them of the important presence of US military forces in Iraq which necessitated finding its justification through the use of persuasive techniques in its intensive propaganda campaigns. 
  This research discusses the most important

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