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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 01 2020
Journal Name
Al-khwarizmi Engineering Journal
Two-Stage Classification of Breast Tumor Biomarkers for Iraqi Women
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Objective: Breast cancer is regarded as a deadly disease in women causing lots of mortalities. Early diagnosis of breast cancer with appropriate tumor biomarkers may facilitate early treatment of the disease, thus reducing the mortality rate. The purpose of the current study is to improve early diagnosis of breast by proposing a two-stage classification of breast tumor biomarkers fora sample of Iraqi women.

Methods: In this study, a two-stage classification system is proposed and tested with four machine learning classifiers. In the first stage, breast features (demographic, blood and salivary-based attributes) are classified into normal or abnormal cases, while in the second stage the abnormal breast cases are

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Publication Date
Fri Aug 30 2019
Journal Name
Environmental Engineering Research
Numerical modeling of two-dimensional simulation of groundwater protection from lead using different sorbents in permeable barriers
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This study is to investigate the possibility of using activated carbon prepared from Iraqi date-pits (ADP) which are produced from palm trees (Phoenix dactylifera L.) as low-cost reactive material in the permeable reactive barrier (PRB) for treating lead (Pb<sup>+2</sup>) from the contaminated groundwater, and then compare the results experimentally with other common reactive materials such as commercial activated carbon (CAC), zeolite pellets (ZP). Factors influencing sorption such as contact time, initial pH of the solution, sorbent dosage, agitation speed, and initial lead concentration has been studied. Two isotherm models were used for the description of sorption data (Langmuir and Freundlich). The maximum lead sorp

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Publication Date
Fri Dec 31 2021
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
TO WHAT EXTENT THE APPLICATION OF MALCOLM BALDRIGE OF THE COMPREHENSIVE QUALITY STANDARDS IN THE AFTER- SALES SERVICES/ APPLIED RESEARCH IN ONE OF THE PRIVATE SECTOR COMPANIES: TO WHAT EXTENT THE APPLICATION OF MALCOLM BALDRIGE OF THE COMPREHENSIVE QUALITY STANDARDS IN THE AFTER- SALES SERVICES/ APPLIED RESEARCH IN ONE OF THE PRIVATE SECTOR COMPANIES
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The aim of the research is to identify to what extent to which Malcolm Baldrige standards of total quality are applied in the after-sales services of a private sector company for electrical appliances, from the point of view of administrative leaders, in it. To achieve this aim a questionnaire has been used to measure the degree of application of Malcolm’s seven criteria for total quality, namely: (leadership, strategic planning, focus on the customer, measurement and analysis and knowledge management, focus in human resource and operation management and results of the company’s management), the research found that the company achieved a good level of the standard from the de

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Publication Date
Mon Jun 30 2003
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Two-Phase Pressure Drop Through Obstructions
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Publication Date
Wed Jun 01 2016
Journal Name
Nternational Journal Of Mathematics Trends And Technology (ijmtt)
Fuzzy Scheduling Problem on Two Machines
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Publication Date
Mon Mar 13 2017
Journal Name
Journal Of Baghdad College Of Dentistry
The Effects of Enamel Protective Agents on Shear Bond Strength After Rebonding of Stainless Steel Orthodontic Bracket (An in Vitro Study)
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ABSTRACT Background: Bracket rebonding is a common problem in orthodontics which may result in many drawbacks. The aims of this study were to evaluate the effects of application of two enamel protective agents “Icon” and “ProSeal” on shear bond strength before and after rebonding of stainless steel orthodontic brackets using conventional orthodontic adhesive and to assess the site of bond failure. Materials and methods: Fifty sound extracted human upper first premolar teeth were selected and randomly divided into two equal groups; the first time bonding and the rebonding groups (n=30). Each group was subdivided into control, Icon and ProSeal subgroups. The enamel protective agents were applied after etching (precondi

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Publication Date
Sun Jan 01 2017
Journal Name
Al–bahith Al–a'alami
The Coverage of Health Topics in Iraqi Press An analytical Study of Two Newspapers entitled 'al-Sabah and al-Mada' from January 1, 2007 to October 31, 2001
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The current study aims to cover  the health topics  in the Iraqi  journalism ,  to know  the concern 's level  of the Iraqi journalism  when  covering  the health subjects and to know the size of its performance  under the diversity of  visual and audio medias. The researcher has discussed his research by wording it with a set of inquiries   that should be answered via the research and study.  He could have determined that by the following:

What is the concern's level of Iraqi journalism over the health subjects?  What are the forms and press arts that are functionalized by the Iraqi journalism as to get the health message to the republics?  What is t

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Publication Date
Mon May 11 2020
Journal Name
Baghdad Science Journal
On the Growth of Solutions of Second Order Linear Complex Differential Equations whose Coefficients Satisfy Certain Conditions
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In this paper, we study the growth of solutions of the second order linear complex differential equations  insuring that any nontrivial solutions are of infinite order. It is assumed that the coefficients satisfy the extremal condition for Yang’s inequality and the extremal condition for Denjoy’s conjecture. The other condition is that one of the coefficients itself is a solution of the differential equation .

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Publication Date
Thu Jan 22 2026
Journal Name
Mustansiriya University
Effects Of Some Environmental Growth Conditions On Autoaggregation Of Lactobacillus spp. Isolated From Bacterial Vaginitis Infected Females
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المستودع الرقمي العراقي. مركز المعلومات الرقمية التابع لمكتبة العتبة العباسية المقدسة

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Publication Date
Sat Nov 04 2017
Journal Name
Silicon
Optimization of Preparation Conditions to Control Structural Characteristics of Silicon Dioxide Nanostructures Prepared by Magnetron Plasma Sputtering
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