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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Oct 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
Analysis the context of Uncertainty (Nature and management) under two school of strategic thinking (theoretical perspective
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Purpose: studying and analyzing the nature of uncertainty as part of strategy formulation, through analyzing the uncertainty faced by managers in the modern business environment characterized by high complexity and dynamism, though developing of an idea about the uncertainty cases and how enable the mind to understand these cases.

Methodology: It was the use of inductive and analytical approach, in order to study the accumulation of knowledge towards development areas that could contribute to strengthening the strategy formulation.

Findings: Mentoring the future will not make the success for business organization but thought business organization ability to developing share mental

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Publication Date
Tue Sep 01 2020
Journal Name
Iraqi Journal Of Physics
Study of the nuclear structure of halo nuclei 23O and 24F using the two-body model
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The nuclear structure included the matter, proton and neutron densities of the ground state, the nuclear root-mean-square (rms) radii and elastic form factors of one neutron 23O and 24F halo nuclei have been studied by the two body model of  within the harmonic oscillator (HO) and Woods-Saxon (WS) radial wave functions. The calculated results show that the two body model within the HO and WS radial wave functions succeed in reproducing neutron halo in these exotic nuclei. Moreover, the Glauber model at high energy has been used to calculated the rms radii and reaction cross section of these nuclei.

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Publication Date
Mon Jan 01 2024
Journal Name
E3s Web Of Conferences
Analytical Comparison of Leading Sustainability Systems in the Iraqi Environment
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Over the last two decades, several sustainability assessment methods have developed as key accelerators for the development and improvement of sustainable industrial buildings. Some of these systems, like as LEED or BREEAM, are considered international, whereas others, such as Pearl Rating Systems (PRS), are local. Although they all share similar goals, they can lead to the construction of green buildings or the improvement of the efficiency of existing conventional buildings. Each technique has its structure, certification process, and weighting norms. The inequalities have prompted various questions about whether global assessment systems appropriately consider the country’s national settings. This study aims to compare the Pear

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Publication Date
Fri Sep 30 2011
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Experimental Study on Carbon Steel Corrosion and its Inhibition Using Sodium Benzoate Under Different Operating Conditions
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Corrosion experiments were carried out to investigate the effect of several operating parameters on the corrosion rate and corrosion potential of carbon steel in turbulent flow conditions in the absence and presence of sodium benzoate inhibitor using electrochemical polarization technique. These parameters were rotational velocity (0 - 1.57 m/s), temperature (30oC – 50oC), and time. The effect of these parameters on the corrosion rate and inhibition efficiency were investigated and discussed. It was found that the corrosion rate represented by limiting current increases considerably with increasing velocity and temperature and that it decreased with time due to the formation of corrosion product layer. The corrosion potential shifted t

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Publication Date
Thu Jan 30 2020
Journal Name
Al-kindy College Medical Journal
Comparison between the Patterns of Common Breast Diseases Presenting as Breast Lumps in Pregnant and Non-Pregnant Married Women
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Background: Breast lump is one of the most common prevalent complaint of patients attending breast clinics.

Objective: To determine if there is any change in the pattern of common breast, diseases presenting as breast lumps between pregnant and non-pregnant women among patients attending Al-Elwiya Breast Clinic.

Methods: This is a cross – sectional study, with convent's patient sampling setting in AL-Elwiya Breast Cancer Early Detection Clinic from 1st Feb. to 1st May 2018, we collected data from patients with breast lumps including the age groups, pregnancy status, parity status, previous breast diseases, hormonal drugs, menstrual cycle, breast fe

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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of Enamel Surface after Debonding of Different Types of Esthetic Brackets (An In Vitro Study)
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Background: Debonding orthodontic brackets and removal of residual bonding material from the enamel surface include critical steps that may cause enamel damage. The aim of the present study was to evaluate and compare the site of bond failure and enamel surface damage after debonding of three types of esthetic brackets (composite, ceramic, sapphire) bonded with light cure composite and resin-modified glass ionomer adhesive. Materials and methods: Seventy two maxillary premolars teeth were divided into three groups each group consisted of 24 teeth according to the type of brackets. Each group was subdivided into two subgroups (12 teeth for each) according to the bonding material that was used. After 7 days of bonding procedure, the brackets

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Publication Date
Fri Nov 11 2022
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Ambidexteritg leadership behaviors in organizational excellence Comparative : applied research in the two public companies, Al-Zawraa and the electrical and electronic industries
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Business organizations strive to reach organizational excellence, in instruction to maintain their position in the market, so the research started from the problem of the weakness of the senior leaders in the two companies investigated in the management and sustainability of work, as well as their inability to face challenges that could affect the work of the two companies in the future, especially the lack of organizational of the future and the prediction of those events, so the two companies seek to explore and invest opportunities to achieve organizational excellence. The research aims to know the role of Ambidexterity  leadership behaviors in organizational excellence in my company .and create ideas that will achieve organizati

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Publication Date
Wed Mar 01 2023
Journal Name
Baghdad Science Journal
Pharmacokinetic Consideration to Formulate Sustained Release Drugs: Understanding the Controlled Drug Diffusion through the Body Compartment of the Systemic Circulation and Tissue Medium-A Caputo Model
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The aim of this study is to provide an overview of various models to study drug diffusion for a sustained period into and within the human body. Emphasized the mathematical compartment models using fractional derivative (Caputo model) approach to investigate the change in sustained drug concentration in different compartments of the human body system through the oral route or the intravenous route. Law of mass action, first-order kinetics, and Fick's perfusion principle were used to develop mathematical compartment models representing sustained drug diffusion throughout the human body. To adequately predict the sustained drug diffusion into various compartments of the human body, consider fractional derivative (Caputo model) to investiga

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Publication Date
Thu Feb 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Estimation of parameters of two-dimensional sinusoidal signal model by employing Deferential Evaluation algorithm and the use of Sequential approach in estimation
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Estimation the unknown parameters of a two-dimensional sinusoidal signal model is an important and a difficult problem , The importance of this model  in modeling Symmetric gray- scale texture image . In this paper, we propose employment Deferential Evaluation algorithm and the use of Sequential approach to estimate the unknown frequencies and amplitudes of the 2-D sinusoidal components when the signal is affected by noise. Numerical simulation are performed for different sample size, and various level of standard deviation to observe the performance of this method in estimate the parameters of 2-D sinusoidal signal model , This model was used for modeling  the Symmetric gray scale texture image and estimating by using

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effect of Some Storage Conditions upon the Survival of Some Fungal Spores
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Folic acid and multivitamin tablets containing Aspergillus flavus Penicillia spp. and Cladosporia spores were prepared at a compression pressure of 148 MN/m2 and stored at 35°C under different relative  humidifies (75,85, and 95)% within air tight containers, to study the effect of storage condition on them, as well as ,the estimation of the microbial level of the raw materials intended to be used in the two kinds of tablets . Result showed that some raw materials derived from natural origin were heavily contaminated with microorganism compared to that of synthetic origin ,the results also indicated the effect of relative humidity , types of fungal spore , and the hygroscopic nature of exicpient upon survival. Multivit

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