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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2024
Journal Name
Journal Of The College Of Languages (jcl)
The neology in the Iraqi dialect after the invasion of 2003 and the level of imaginative comprehension: La neología en el dialecto Iraqui tras la invasión de 2003 y el nivel de la comprensión imaginativa
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       The article analyzes the neologisms that arose in the Iraqi dialect after the 2003 US-British invasion and the fall of Saddam Hussein's regime, according to the theory I advocate: "The Basic Outline of Reference," a developed theory of Arab legacy and cognitive theory, which came out in 1987 in America, so we have used the terminology of cognitive grammar. In this theory it is stated that the reference is the interaction between four components: perception, imagination, imaginative comprehension and the linguistic sign or symbolization (the neological word in this article), which are closely related, so that none of them can be lacking, because they constitute a holistic whole that belongs to a deeper level. Let us

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Publication Date
Sat Dec 31 2016
Journal Name
Al-kindy College Medical Journal
A Comparison of Sagittal Sections of Short T1inversion Recovery and T2 Weighted Fast Spin Echo Magnetic Resonance Sequences for Detection of Multiple Sclerosis Spinal Cord Lesions
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Background: Multiple sclerosis is a chronic autoimmune inflammatory demyelinating disease of the central nervous system of unknown etiology. Different techniques and magnetic resonance image sequences are widely used and compared to each other to improve the detection of multiple sclerosis lesions in the spinal cord. Objective: To evaluate the ability of MRI short tau inversion recovery sequences in improvementof multiple sclerosis spinal cord lesion detection when compared to T2 weighted image sequences. Type of the study: A retrospective study. Methods: this study conducted from 15thAugust 2013 to 30thJune 2014 at Baghdad teaching hospital. 22 clinically definite MS patients with clinical features suggestive of spinal cord involvement,

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Publication Date
Thu Feb 02 2012
Journal Name
Wasit Journal For Science And Medicine
Field study for the effect of releasing predator Chrysoperla carnea (Stephens) (Neuroptera:Chrysopidae) in comparison with Deltamethrin in controlling cabbage aphid
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Publication Date
Sat Feb 02 2019
Journal Name
Journal Of The College Of Education For Women
Design of an Electron Gun Using two Electrod Low Aberration Immersion Lens
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Abstract
A two electrode immersion electrostatic lens used in the design
of an electron gun, with small aberration, has been designed using
the finite element method (FEM). By choosing the appropriate
geometrical shape of there electrodes the potential V(r,z) and the
axial potential distribution have been computed using the FEM to
solve Laplace's equation.
The trajectory of the electron beam and the optical properties of
this lens combination of electrodes have been computed under
different magnification conditions (Zero and infinite magnification
conditions) from studying the properties of the designed electron
gun can be supplied with Abeam current of 5.7*10-6 A , electron
gun with half acceptance

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Publication Date
Wed Nov 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Two New Records of Cerceris Latreille, 1802 (Hymenoptera: Apoidea: Crabronidae) from Iraq
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Abstract<p>In a survey of the crabronid fauna of Iraq during June to October 2022; 9species belonging to the genus <italic>Cerceris</italic> Latreille, 1802 were identified. Twospecies are new record of the fauna of Iraq: <italic>C. dorsalis</italic> Eversmann, 1849 and <italic>C. priesneri</italic> Mochi, 1939. Brief description, diagnostic characters, some collecting information, and photographs of each species are provided. As well provides a key to the species depending on many morphological features especially: propodeal enclosure, semicircular plate at base of second gastral sternites and free margin of clypeus. Moreover, this study observed that most collecte</p> ... Show More
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Publication Date
Wed Nov 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Two New Records of Coelioxys Latreille, 1809 (Hymenoptera: Apoidea: Megachilidae) from Iraq
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Abstract<p>Five <italic>Coelioxys</italic> Latreille, 1809 species previously recorded in Iraq; <italic>Coelioxys emargintus</italic> Förster, 1853 and <italic>Coelioxys brevis</italic> Eversmann, 1852 newly recorded species. A brief re-description of each is given, supported by photographs; as well as a provided for their global distribution.</p>
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Publication Date
Sun Dec 11 2022
Journal Name
Journal Of The College Of Basic Education
Rationalization of two strength endurance tests for juniors Ages under (16) years
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Carrying strength is one of the important physical capabilities in the field of competitive sports, which affects the success of the sports training process and helps players to continue to perform skillfully, physically and tactically for as long as possible, and the capacity for endurance varies depending on the type of sports activities, it may sometimes be very short. And with a high level of intensity, such as gymnastics and wrestling movements, and it may be long, and with a medium level of intensity, as in basketball, football and other games. The research community represents a sample of Baghdad players for teams (football, basketball, handball, volleyball, wrestling, weightlifting) and for the sports season (2017-2018 AD) for ages

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Publication Date
Mon Apr 19 2010
Journal Name
Computer And Information Science
Quantitative Detection of Left Ventricular Wall Motion Abnormality by Two-Dimensional Echocardiography
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Echocardiography is a widely used imaging technique to examine various cardiac functions, especially to detect the left ventricular wall motion abnormality. Unfortunately the quality of echocardiograph images and complexities of underlying motion captured, makes it difficult for an in-experienced physicians/ radiologist to describe the motion abnormalities in a crisp way, leading to possible errors in diagnosis. In this study, we present a method to analyze left ventricular wall motion, by using optical flow to estimate velocities of the left ventricular wall segments and find relation between these segments motion. The proposed method will be able to present real clinical help to verify the left ventricular wall motion diagnosis.

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Publication Date
Mon Sep 30 2024
Journal Name
Iraqi Journal Of Computers, Communications, Control And Systems Engineering
Comparative Analysis of Two Robust Strategies for an Angular Velocity Control System
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In this paper, a novel flow control strategy which is the inlet throttled pump was used to design an angular velocity control system for rotary actuator. Inlet throttled systems have good performance in addition to their high efficiency compared to traditional valve controlled systems. The flow in the proposed system is adjusted by a valve that is positioned at the pump inlet with the purpose of reducing the energy loses across the valve. This regulated flow is used then to control the actuator angular velocity. The system was modeled and the open loop stability and performance were studied. In order to improve the system performance, Robust-Proportional-Integral-Derivative (RPID) and structured singular value (M@#@) controllers have been d

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Publication Date
Fri Apr 01 2022
Journal Name
Baghdad Science Journal
Numerical Solutions of Two-Dimensional Vorticity Transport Equation Using Crank-Nicolson Method
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This paper is concerned with the numerical solutions of the vorticity transport equation (VTE) in two-dimensional space with homogenous Dirichlet boundary conditions. Namely, for this problem, the Crank-Nicolson finite difference equation is derived.  In addition, the consistency and stability of the Crank-Nicolson method are studied. Moreover, a numerical experiment is considered to study the convergence of the Crank-Nicolson scheme and to visualize the discrete graphs for the vorticity and stream functions. The analytical result shows that the proposed scheme is consistent, whereas the numerical results show that the solutions are stable with small space-steps and at any time levels.

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