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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
Laplace Distribution And Probabilistic (bi) In Linear Programming Model
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The theory of probabilistic programming  may be conceived in several different ways. As a method of programming it analyses the implications of probabilistic variations in the parameter space of linear or nonlinear programming model. The generating mechanism of such probabilistic variations in the economic models may be due to incomplete information about changes in demand, pro­duction and technology, specification errors about the econometric relations presumed for different economic agents, uncertainty of various sorts and the consequences of imperfect aggregation or disaggregating of economic variables. In this Research we discuss the probabilistic programming problem when the coefficient bi is random variable

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Publication Date
Tue Feb 02 2016
Journal Name
International Journal Of Computer Science And Mobile Computing
Increasing Security in Steganography by Combining LSB and PRGN
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With the increasing rate of unauthorized access and attacks, security of confidential data is of utmost importance. While Cryptography only encrypts the data, but as the communication takes place in presence of third parties, so the encrypted text can be decrypted and can easily be destroyed. Steganography, on the other hand, hides the confidential data in some cover source such that the existence of the data is also hidden which do not arouse suspicion regarding the communication taking place between two parties. This paper presents to provide the transfer of secret data embedded into master file (cover-image) to obtain new image (stego-image), which is practically indistinguishable from the original image, so that other than the indeed us

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Publication Date
Wed Feb 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
(Sustainable Agricultural Development in Iraq ... Solutions and Treatments Obstacles)
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Abstract:

    The achievement of agricultural development provide food security and to form a basis for economic growth and comprehensive social, requires a number of actions to overcome the obstacles and problems facing the development of this economic sector, to make it able to achieve food security and operation of the workforce, and reduce dependence on the outside in the provision of food peripherals, and so it is only available through the highest degree of efficiency and economic mobilization of resources, so most of the developed and developing countries alike seek to achieve sustainable agricultural development tobacco meet the food requirements and good jobs for c

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Publication Date
Mon Jun 01 2020
Journal Name
Journal Of Engineering
Pilot Based Channel Estimation and Synchronization in OFDM System
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Channel estimation and synchronization are considered the most challenging issues in Orthogonal Frequency Division Multiplexing (OFDM) system. OFDM is highly affected by synchronization errors that cause reduction in subcarriers orthogonality, leading to significant performance degradation. The synchronization errors cause two issues: Symbol Time Offset (STO), which produces inter symbol interference (ISI) and Carrier Frequency Offset (CFO), which results in inter carrier interference (ICI). The aim of the research is to simulate Comb type pilot based channel estimation for OFDM system showing the effect of pilot numbers on the channel estimation performance and propose a modified estimation method for STO with less numb

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Publication Date
Mon Oct 01 2018
Journal Name
Journal Of Educational And Psychological Researches
Brain Storming Style and its Singnificance in teaching geography
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                     The current research aims to know the method and strategy of rainstorming for students to open the door towards innovation and creativity in the field of teaching the subject of geography and the importance of brainstorming method and the studies that touched on it. The study also dealt with the steps of teaching the method of brainstorming and the most important (traditional and modern), and the difficulties of using the method of brainstorming in the teaching process, as well as explained the guidance to improve teaching using the method of brainstorming in the teaching p

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Publication Date
Fri May 26 2023
Journal Name
Journal Of Islamic Thought And Civilization
Undermining the Familiar and Embodiment Content in Arabic Calligraphy
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Contrary to deconstruction and its destructive pursuit, the concept of undermining the familiar seeks to refute the constants and its known limitations. It is done through the process of receiving and what is imposed by the formation of the word or text or the structural and design structure in general, along with the Arabic calligraphy in particular. This is based on the recipient's understanding and interpretation of the dual phenomenon and the content's manifestation. More accurately, the disclosure of its reality through its expressive phenomenology; for that sake, the research was devoted to studying “undermining the familiar and embodiment content in Arabic calligraphy” including four chapters. The first chapter comprised

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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Natural gas in Iraq between burning and licensing rounds
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The research aims to shed light on the importance of Natural gas as a National wealth is not being used optimally to be a financial resource is important to Iraq in addition to Oil, as well as could be used as an important Source of Energy, instead of burning gas is a waste of wealth and Contribute to the contamination of the environment. Research Reviews the importance of Natural gas, where is currently about a quarter of global energy consumption. Then deals with the reality of the gas industry in Iraq and winning because of the volume of waste incineration, which reached a rate (45%) of the gas Associated with oil, where Iraq is fourth globally in Terms of the amount of gas Burned. Finally, this paper discusses the future of n

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Publication Date
Mon Sep 01 2008
Journal Name
Journal Of Engineering
GEOTEXTILE AND GEOMEMBRANE USAGE IN AN IRAQI SANDY GEOENVIRONMENT
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The work in this research presents an experimental and a theoretical study to obtain the effect of using a low permeability geosynthetic material on the longitudinal and lateral coefficients of dispersion. This would have its effect on the contaminants migration through an isotropic, homogenous and saturated soil. The first stage of this research involves the study of the geosynthetic material and in calculating the longitudinal and lateral coefficients of dispersion for an Iraqi sandy soil by using an experimental set-up to simulate the processes. To investigate the effect of using a geosynethtic material on the dispersion coefficients, the test was conducted for each velocity that was used in the experimental work and as follows:  with

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Publication Date
Wed Jan 01 2025
Journal Name
Scripta Medica
Correlation between psoriasis severity and dyslipidaemia in Iraqi patients
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Background/Aim: Psoriasis is a persistent systemic disorder characterised by chronic inflammation and linked to multiple comorbidities, including arthritis, cardiometabolic disorders, obesity and hyperlipidaemia. Objective of this study was to identify the relationship of abnormal lipid profiles and psoriasis, as well as to pinpoint factors that correlate with disease severity. Methods: A cross-sectional study was carried out at the dermatology clinic over 6 months from the 1 August 2024 to the 1 February 2025. Patients aged 15 years and above with a diagnosis of psoriasis were enrolled. For each patient two sets of data were collected, demographical characteristics (age, sex, disease duration and the body mass index (BMI)) and the

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Publication Date
Wed Jan 01 2020
Journal Name
Journal Of Southwest Jiaotong University
Integrity and Security in Cloud Computing Environment: A Review
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Cloud computing is a newly developed concept that aims to provide computing resources in the most effective and economical manner. The fundamental idea of cloud computing is to share computing resources among a user group. Cloud computing security is a collection of control-based techniques and strategies that intends to comply with regulatory compliance rules and protect cloud computing-related information, data apps, and infrastructure. On the other hand, data integrity is a guarantee that the digital data are not corrupted, and that only those authorized people can access or modify them (i.e., maintain data consistency, accuracy, and confidence). This review presents an overview of cloud computing concepts, its importance in many

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