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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Sep 01 2021
Journal Name
المجلة السياسية والدولية
Foreign Policy and Asymmetric Threats The United States after 2001 as a model
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يشهد المسرح الدولي قضايا مستجدة ومستحدثة مثل تعدد الفاعلين من الدول ومن غير الدول وتزايد مساحات نفوذهم وتأثيرهم ،ومن جانب اخر أثرت جائحة كورونا على البيئة والمناخ بشكل ملموس على جوانب عدة. فضلا عن ذلك تأثرت جميع المجتمعات البشرية بالإرهاب والهجمات الالكترونية وغيرها ومن بينها دول والمجتمع الدولي بإفراده مؤسسات وكيان اقتصادي وسياسي وقانوني وأمني وامتداد اثاره واسبابه الكثيرة والمتداخلة وما يثيره من خلق حا

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Publication Date
Sun Apr 30 2023
Journal Name
Al-kindy College Medical Journal
Persistent Intraocular Pressure Elevation after Silicon Oil Removal in Patients with Post-Pars Plana Vitrectomy: IOP Level After SO Removal
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Background: It is well-known that silicon oil (SO) injection into the vitreous cavity after pars plana vitrectomy is usually associated with high intraocular pressure.

Objectives: To determine the influence of silicon oil (SO) removal on IOP level after pars plana vitrectomy for spontaneous rhegmatogenous retinal detachment (RRD)

Subjects and Methods: A prospective study was conducted at Ibn Al-Haitham eye teaching hospital, Baghdad- Iraq. Intraocular pressure (IOP) was measured pre and post SO removal in patients who have underwent retinal detachment surgery with SO injection of 1000 centistokes (cSt) viscosity. Baseline IOP was measured for all the patient before the SO

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Publication Date
Tue Mar 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating Parameters of General Linear Model in Presence of Heteroscedastic Problem and High Leverage Points
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Linear regression is one of the most important statistical tools through which it is possible to know the relationship between the response variable and one variable (or more) of the independent variable(s), which is often used in various fields of science. Heteroscedastic is one of the linear regression problems, the effect of which leads to inaccurate conclusions. The problem of heteroscedastic may be accompanied by the presence of extreme outliers in the independent variables (High leverage points) (HLPs), the presence of (HLPs) in the data set result unrealistic estimates and misleading inferences. In this paper, we review some of the robust

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Taxonomical and Comparative morphological study for two wild species of the genus Chaenorhinum (D.C.) Reichb. (Scrophulariaceae) in Iraq.
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Comparative morphological study has been treated for two species of the genus Chaenorhinum (D.C.) Richb., These species were: 1. Chaenorhinum calycinum 2. Chaenorhinum rubrifolium (Robill. & cast. Ex Lam. & DC.) Fourr. The genus belong to the family Scorphulariaceae. Morphological characters has been studies for: root, stem, leaves, flowers (calyx, corolla, androcium including filaments and anthers, gynocium including ovary, style and stigma), fruits and seeds also has been characterized. Key for there two species presented using some quantitative characters. Other characters like shape of fruits and seeds were used too, and they were of a useful taxonomic value

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Publication Date
Tue Dec 30 2025
Journal Name
Journal Of Physical Education
Designing and Standardizing two Dribbling Tests for the Initial selection of Individuals With Simple Mental Disabilities In Futsal
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The game of football is one of the most popular games in the world because of its beauty in the hearts of its fans. From this position, the game of five football for people with simple mental disability has become as much attention to many other sporting events, so the researchers believe that the tests of basic skills match the level of individuals tested In terms of their age and mental ability, the technical aspects were adopted as a means of selecting those who are qualified to practice this game in the simplest form, so the importance of the research problem in designing and standardizing two dribbling skating tests for members of this category and It depends by training their cadres during the selection process. The research community

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Taxonomical and Comparative morphological study for two wild species of the genus Chaenorhinum (D.C.) Reichb. (Scrophulariaceae) in Iraq.
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Comparative morphological study has been treated for two species of the genus Chaenorhinum (D.C.) Richb., These species were: 1. Chaenorhinum calycinum 2. Chaenorhinum rubrifolium (Robill. & cast. Ex Lam. & DC.) Fourr. The genus belong to the family Scorphulariaceae. Morphological characters has been studies for: root, stem, leaves, flowers (calyx, corolla, androcium including filaments and anthers, gynocium including ovary, style and stigma), fruits and seeds also has been characterized. Key for there two species presented using some quantitative characters. Other characters like shape of fruits and seeds were used too, and they were of a useful taxonomic value

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Publication Date
Wed Mar 01 2017
Journal Name
Journal Of Al-nahrain University-science
Cytological Effects of Mutagenic Agents and NaCl on Mitotic Division in Two Iraqi Rice (Oryza sativa L.) Genotypes
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This study was carried out to determine the effects of NaCl (0.00, 50, 100, 150, 180 or 200) mM and two different types of mutagens chemical mutagen ethyl methyl sulphonate (EMS) at 0.5% and physical mutagen UV-B irradiation (40 min time exposure), on mitotic division in two Iraqi rice genotypes Amber 33 (A33) and Amber Baghdad (AB). Different concentrations of NaCl were used. Mitotic index (MI %) was decreased significantly by increasing NaCl concentration, however the highest mitotic index was recorded in mutated genotypes with EMS and UV-B. Different abnormal chromosomes were noticed in mutated plants. Results showed high percentage of abnormal chromosomes in EMS mutated genotypes. In addition no significant differences between genotypes

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Publication Date
Mon Jan 01 2018
Journal Name
Journal Of Physical Education
Designing and Standardizing two Passing tests for the Initial selection of Individuals With Simple Mental Disabilities In Futsal
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The five-a- Side Soccer for people with a minor mental disability has become as important as many other sporting events. Therefore, the researcher considers that the basic skills tests are suited to the level of the tested individuals in terms of their age and mental ability. The technical aspects were adopted as a means of selecting from They are qualified to practice this game in the simplest form, so show the importance of the problem of research through the design and codification of two tests of handling skills belonging to this category and adopted by the training cadres during the selection process. The research community for people with minor mental disabilities determines the male category of the mental and social disability instit

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Cognitive Bias and Organizational Inertia are Two Functions of Strategic Change An Experimental Study in Amman Stock Market
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The research aims at considering the reality of cognitive bias and organizational inertia as determinants of strategic change in a sample of companies listed in Amman Stock Market. To achieve objectives of the research, a model consisting of two independent variables has been designed, namely:

(1) The cognitive bias resulting from (escalating commitment, analogy, previous assumptions, representative generalization, command and control, convergent thinking), and (2) Organizational inertia due to (Icarus discrepancy, power distribution, rooted organizational culture), and a dependent variable, strategic change in (leadership patterns, strategy, the organization per se). 

From the model two main hypotheses were derived;

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Publication Date
Fri Oct 02 2020
Journal Name
Biochem. Cell. Arch.
MORPHOLOGICAL DESCRIPTION AND COMPARATIVE HISTOLOGICAL STUDY OF THE LIVER IN TWO IRAQI MAMMALS : WEASEL (HERPESTES JAVANICUS) AND EASTERN GRAY SQUIRREL (SCIURUS CAROLINENSIS
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The results of the current study showed that the liver of H. javanicus appeared as large lobulated organ divided into six distinct lobes, that filled the cranial region and little extended to the middle region of abdominal cavity. On the other hand, liver of S. carolinensis laid against the diaphragm, occupied the cranial region of the abdominal cavity and consisted of five lobes. The liver is surrounded with a thin capsule of dense regular collagenous connective tissue and few numbers of smooth muscles fibers can be seen in the capsule that covered the squirrel liver. The liver parenchyma divided into a large number of interconnected hepatic lobules marked only by the abundant amount of connective tissue bordered the triads, and within the

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