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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Oct 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Electronic trading system and its refletion in the trading of stock market indices –an analytical study of the Iraqi market for securities–
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The research aims at identify the role of the electronic trading system used in the Iraq stock exchange to promote trading activity for the stocks of listed companies in this market.

To prove the hypothesis of research, it was selected the main trading indicators for the market to be a main field in test the research hypothesis.it was selected as the period of time for (9)years span between the years (2005-2013) because they represent the first two articles of equal time periods represent aperiod that preceded the introduction of electronic trading system  while the second represents the period of time that followed 

The research found a number of conclusions but the mo

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Publication Date
Tue Mar 17 2026
Journal Name
Journal Of Physical Education
The impact of a training field in Lake Al-Razzaza to develop the strength of the legs and arms for young boxers
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Publication Date
Sat Sep 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of Hematocrit Level, Red Blood Cells and White Blood Cells Counts in Blood from Patients with Different Severities of Periodontal Diseases
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Background: Anemia of chronic disease (ACD) occurs in the presence of chronic infection, inflammatory conditions or neoplastic conditions despite of adequate iron and vitamins storage. Gingivitis is the inflammation of the gingiva, periodontitis is the inflammation in the periodontium that extend deeper with loss of connective tissue attachment and supporting bone. The main pathogenesis of periodontal diseases and ACD is immune activation. Aims of study: Determine and compare the clinical periodontal parameters (plaque index (PLI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL)). Evaluate the hematocrit (Hct) level, red blood cells (RBCs) count and white blood cells (WBCs) c

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Publication Date
Sat Jul 20 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Gender Distribution of Coronary Artery Calcium Score and Degree of Stenosis Assessed by Computed Tomography Angiography in Iraqi Patients with Chest Pain
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Background: Sex variations in coronary artery disease (CAD) are well documented. However, sex differences in coronary artery calcium (CAC) and its role in the detection of coronary artery stenosis remain controversial. Objective: To assess the impact of sex variation on coronary artery calcification and its efficacy in predicting coronary artery stenosis. Methods: This is a cross-sectional observational study including 230 consecutive patients with suspected CAD (120 men and 110 women) referred for coronary computed tomography angiography (CCTA). The study analyzed sex-based differences in the sensitivity and specificity of coronary artery calcification (CAC) for detecting moderate to severe stenosis across various coronary arteries

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Publication Date
Wed Sep 27 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Assessment of Serum Levels of Advanced Oxidation Protein Products in Type 2 Diabetic Patients with and without Retinopathy Taking Different Antidiabetic Treatments
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The goal of this study was to investigate the protein peroxidation role by measuring serum levels of advanced oxidation protein products (AOPP) in type 2 diabetic patients with or without retinopathy and comparing them to controls to see if circulating AOPP levels can be used as a detection biomarker for DR. And see which of the two widely used antidiabetic treatment groups had the most impact on this oxidative stress marker. The groups were divided into two subgroups: 1) 70 type 2 diabetic patients (36 male, 34 female), 35 with diabetic retinopathy (DR) and 35 with no evidence of DR, and 2) non-diabetic controls (11 male, 9 female) were chosen from Ibn AL-Haitham Hospital for Ophthalmology and a Specialized Center for Endocrinology and Dia

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Publication Date
Tue Sep 17 2019
Journal Name
Journal Of The College Of Education For Women
The Architectural Heritage of Baghdad in Ibn Al-Faqih Hamadani's Book Baghdad the City of Peace And its impact on Sustainable Development
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This research shows the importance of Baghdad in the field of urban heritage and was demonstrated in the Ibn al-Fiqh al-Hamdani's book Baghdad the City of Peace in which he focused on many urban aspects and reviewing its historical importance by connecting them with modern events and the role they play in cultural and civilized construction which included: mosques, schools and markets etc. and the service providing institutions and other pillars of the Islamic cities through showing the development back then and its importance as an integral part of the urban and cultural heritage of the Islamic cities in general and Baghdad city in particular. 

In his book Baghdad the City of Peace, Ibn al-Faqih Hamadhaani

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Publication Date
Thu Jul 27 2023
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Clinicopathological Features of Colorectal Cancer in the Iraqi Population Focusing on Age and Early-Onset of Malignancy: A Descriptive Cross-Sectional Study
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Background: Colorectal cancer (CRC) is one of the top ten most common cancers worldwide. There are multiple risk factors for CRC, one of which is aging. However, in recent years, CRC has been reported in children. Objective: To describe the main characteristics and symptoms of CRC as well as highlight pathologic data for early-onset CRC. Methods: 79 CRC patients were recruited from the Oncology Teaching Hospital in the period February–December 2022. A questionnaire was used to collect demographic and clinical data. Results: 25 (31.6%) of patients were below 50 years of age. 52 (65.8%) patients had tumors in the colon. The most common symptom is bleeding per rectum in both age groups. There was no significant difference in patholog

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Publication Date
Thu Oct 24 2024
Journal Name
Scientific Reports
Effectiveness of high-frequency vibration, cotton rolls and elastomeric wafers in alleviating debonding pain of orthodontic metal brackets: a randomized clinical trial
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Publication Date
Wed Feb 15 2017
Journal Name
كلية بغداد للعلوم الاقتصادية الجامعة
Competitiveness of business organizations according to the role of knowledge management and customer orientation: a comparative survey study in Iraqi business organizations
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The research aims to reach a set of objectives concerning creation a clear vision about conceptual, philosophical and practical dimension of relations, and effects between knowledge management, costumer orientation and competitiveness to construct a framework of a pragmatic model as a solution to research problem and its questions which the main one is about the role of knowledge management and costumer orientation in competitiveness of business organizations. To achieving this goal, it was necessary to make, in priory, a review and discussion to the theoretical dimension of research variables to have a clear vision about constructing hypostatical research model implying a set of hypotheses which, by proving them in companies studied, repr

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Publication Date
Mon May 01 2023
Journal Name
Journal Of Engineering
Assessment of Climate Change Impact on Water Productivity and Yield of Wheat Cultivated Using Developed Seasonal Schedule Irrigation in the Nineveh Province
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The agricultural lands that depend on supplementary irrigation methods for winter wheat cultivating in wide areas of the Nineveh province are most vulnerable to climate change concerns. Due to frequent rainfall shortages and the temperature increase recently noticed and predicted by the climate scenarios. Hence important to assess the climate effect on the crop response in terms of water consumption during the periods (2021-2040) and (2041-2060) by using high-resolution data extracted from 6 global climate data GCMs under SSP5-8.5 fossil fuel emission scenarios in changing and fixed CO2 concentration. And validate the Aqua-Crop model to estimate the yield and water productivity. And gives the RRSME of 7.1- 4.1

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