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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 18 2020
Journal Name
College Of Islamic Sciences
Facilitating Tributaries (Supporters) in the Differences between Al Dhadhiya and Al Dhaiya": Dhadhiya and Al Dhaiya"
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   الضاد والظاء موطن تفرد العربية وفخرها ، الفت فيهما العشرات والعشرات من المصنفات الثرّة لكثرة ذرائع تلابسهما والخلط بينهما ، فهما متشابهان في هيكل البناء ، وإخراجهما متداخل على اللسان ، وألفاظهما متناظرة برحابة في الإملاء ، فضلاعن  اشكالهما  إلى حدّ الآن ، مما حثني على التفكير في وسائل تسهل المطروح وتمد جسراً بين أجزائه عسى أن تدنو قطافه في دفع الشبهة ومواراتها ، فتحصلت لي امور ادرتها بكلمتين مف

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Publication Date
Mon Mar 02 2026
Journal Name
Journal Of Baghdad College Of Dentistry
P16 Protein and Human Papillomavirus (HPV16, 18) Expressions in Oral Lichen Planus and Squamous Cell Carcinoma
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Background: Oral carcinogenesis is a molecular and histological multistage process featuring genetic and phenotypic markers for each stage, which involves enhanced function of several oncogenes and/or the deactivation of tumor suppressor genes, resulting in the loss of cell cycle checkpoints. The progression towards malignancy includes sequential histopathological alterations ranging from hyperplasia through dysplasia to carcinoma in situ and invasive carcinoma. The p16 gene produces p16 protein, which in turn inhibits phosphorylation of retinoblastoma, p16 play a significant role in early carcinogenesis. Human papillomavirus is a well established heterogeneous virus and plays an important role in oral cancers. The aims of the study were to

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Publication Date
Mon Mar 02 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Periodontal health status and salivary enzymes level in smokers and non-smokers (comparative, cross sectional study)
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Background: Smoking is considering a major risk factor for development and progression of periodontal disease. Investigations regarding the association between smoking and periodontal disease have consistently demonstrated negative periodontal effects and greater probabilities of established periodontal disease among smokers in comparison with non smokers. The purpose of this study was to evaluate the effects of smoking on periodontal health status and on the salivary levels of alkaline phosphatase (ALP), lactate dehydrogenase (LDH) and creatine kinase (CK), and to correlate the clinical parameters of periodontal health with the biochemical findings in smokers and non-smokers. Materials and methods: Unstimulated saliva sample was collected

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Publication Date
Tue Jan 29 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Liquidity Banking and Its Impact on the Return and Risk: Applied Research in the Rasheed Bank
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The research aims to measure and analyze the reality of liquidity in the Rasheed Bank and determine their impact on risk and return in order to identify the extent of the efficiency of the management of liquidity by the Bank and how to employ them in a profitable investment areas, and analysis of the compatibility of the liquidity gap and gap the balance sheet (sensitive interest rate) and affected net interest Change prices, and through the adoption of style ladder recommended Meritassets and liabilities by the Central Bank of Iraq, as it is an important and vital aspects in commercial banks' management, when there is a commonly used optimizing the resources of the bank available, it means that there is a banking efficient management is

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Publication Date
Sat Oct 01 2016
Journal Name
Journal Of Educational And Psychological Researches
Teaching methods approved in the university and its relationship to classroom discipline and management proposals treated
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The study aims detection teaching modalities adopted relationship in Jerash University exactly the classroom, and to achieve the goal of the study was to develop a questionnaire consisting of (39) items, and was achieving validity and reliability have, then sent to a sample of professors made up the university from (122) university professor of the total (172) professor, and they study population.

     Study found a relationship between the teaching methods of the four their strategies with classroom management, and as a result the overall average level, while Hspt critical thinking at the highest correlation with classroom discipline management relationship strategy, while the relatio

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Publication Date
Sun Jan 06 2019
Journal Name
Arabian Journal Of Geosciences
Iron Content Variations in Sphalerite and Their Effects on Reflectance and Internal Reflections under Reflected Light
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Publication Date
Thu Jun 01 2023
Journal Name
Journal Of Engineering
Integration Building Information Modeling and Lean Construction Technologies in the Iraqi Construction Sector: Benefits and Constraints
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Building Information Modeling (BIM) and Lean Construction (LC) are two quickly growing applied research areas in construction management. This study focuses on identifying the most essential benefits and analyzing the most affecting constraints on the construction sector that construction players face as they attempt to combine BIM-LC in Iraqi construction. Experts assessed 30 benefits and 28 constraints from examining the previous literature, and a two-round Delphi survey formed the responses. Expert consensus analysis was utilized to elaborate and validate responses after descriptive statistical checks had been used for data processing.

According to the study's findings, the benefits include ensuring the most ef

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Publication Date
Fri Jun 26 2020
Journal Name
Clinical And Experimental Dental Research
The oral health and periodontal diseases awareness and knowledge in the Iraqi population: Online‐based survey
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Abstract<sec><title>Objectives

This study aimed to evaluate oral health (OH) and periodontal diseases (PD) awareness in the Iraqi population.

Material and methods

This study was a questionnaire‐based online survey of two weeks duration. The questionnaire was built using a Google platform and was distributed randomly via social media (Facebook and Telegram). The questionnaire consisted of a demographic data section and two other main sections for the evaluation of OH and PD awareness. Each response was marked with “1” for a positive answer and “0” for the other answers. For each respondent, answers were summed to give

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Publication Date
Thu Aug 04 2022
Journal Name
International Journal Of Gynecology &amp; Obstetrics
Are sexual and reproductive health and rights taught in medical school? Results from a global survey
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Abstract<p>Our aim was to investigate the inclusion of sexual and reproductive health and rights (SRHR) topics in medical curricula and the perceived need for, feasibility of, and barriers to teaching SRHR. We distributed a survey with questions on SRHR content, and factors regulating SRHR content, to medical universities worldwide using chain referral. Associations between high SRHR content and independent variables were analyzed using unconditional linear regression or χ<sup>2</sup> test. Text data were analyzed by thematic analysis. We collected data from 219 respondents, 143 universities and 54 countries. Clinical SRHR topics such as safe pregnancy and childbirth (95.7%) and contraceptive methods</p> ... Show More
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Publication Date
Sat Oct 01 2022
Journal Name
Baghdad Science Journal
Absorption and Fluorescence Properties of 3,6-bis(5-bromothiophen-2-yl)-2,5-bis(2-ethylhexyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione. A Covalent Fluorescence in Solution and in the Solid State
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In the cuurent article, the photophysical properties of 3,6-bis(5-bromothiophen-2-yl)-2,5-bis(2-ethylhexyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione were investigated. The visible absorption bands at 527, 558 and 362 nm in propylene carbonate and the compound was found to be fluorescent in solution and in the plastic film with emission wavelengths between 550- 750 nm. The Stokes Shift of P.C., acetonitrile, diethyl ether, Tetrahydrofuran THF, cyclohexane, dibutyl ether, and dichloromethane DCM  are 734, 836, 668, 601, 601, 719, and 804 cm-1 in respectively. The Stokes Shift Δ was less in THF and cyclohexane, than the solvents, which indicates that the energy loss is less between the excitation and fluorescence states. The

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