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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 29 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The Impact of Tax Laws and Decisions in Determining the Tax Base of the Results of the Financial Statements of Companies
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This research aims to measure the discrepancy between the accounting income which is prepared according to generally accepted accounting principles and the tax income that is being prepared according to the rules and tax laws, and find out the most important differences that arise between incomes.The research found the most important to the following conclusions:1.Faces determining the tax base for companies subject to income challenges related to the weakness of the efficiency and the possibility of technical angel tax and its ability to examine the financial statements submitted to the tax administration tax.2.That the tax system in Iraq does not comply with accepted accounting principles generally accepted.The research recommends the

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Publication Date
Mon Feb 01 2021
Journal Name
Indian Journal Of Ecology
Effect of sedimentary source on the properties of sphericity and roundness of feldspar minerals in some soils of the alluvial plain
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This study was conducted on the effect of the sedimentary source (the sediments coming from both the Iraqi-Iranian borderline and the Tigris river) on the optical and textural features, especially sphericity and roundness of feldspar minerals (potassium and plagioclase types) in soils of the southern part of the alluvial plain. Eight pedons were selected to represent the study area, five of them represented sediments coming from the borderline, which included pedons of (Badra, Taj Al-Din, Al-Shihabi, Jassan, and Galati), while two of them represent the sediments of the Tigris River (Essaouira, Al-Dabouni), the pedon of Ali Al-Gharbi was represented the mixing area of sediments of all the floods coming from the borderline and the sediments o

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Publication Date
Fri Sep 15 2023
Journal Name
Al-academy
The aesthetics of abstract expressionism and its representations in the artistic productions of the students of the Department of Art Education
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The research section tagged (Aesthetics of Abstract Expressionism and its Representations in the Artistic Products of Students of the Department of Art Education) into four chapters and it included in..
The first chapter: (the methodological framework) for the research, and the research problem is summarized through the question (what are the aesthetics of abstract expressionism and its representations in the artistic productions of the students of the Department of Art Education). In the products of students of the Department of Art Education).
The aim of the research was (discovering the aesthetics of abstract expressionism and its representations in the artistic products of the students of the Department of Art Education). As we

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Publication Date
Sun Sep 15 2019
Journal Name
Al-academy
Aesthetic and Functional Dimensions of Environmental Waste in the Products of Students of the Department of Art Education: فردوس خضر الجوفي
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The practice of art is an inevitable result imposed by the circumstances surrounding the human being, as he needs some knowledge associated with raw materials, tools and methods to develop skills in the formation of elements of the work of art in new ways that give a decent artistic appearance to the work of art. Through the exploratory study carried out by the researcher, which included asking the following question to the third grade students, Department of Art Education:

What types of materials are used in handicrafts and from which sources are they obtained? Through the answers, the problem of research was founded as follows:

-Are the products of students of the Department of Art Education in the handicraft material d

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Publication Date
Thu Sep 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
Analysis of the indicators of the educational process and scientific levelUsing the analysis of variance of ordered data in repeated measurements
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In this research want to make analysis for some indicators and it's classifications that related with the teaching process and the            scientific level for graduate studies in the university by using analysis of variance for ranked data for repeated measurements instead of the ordinary analysis of variance . We reach many conclusions  for the                         

important classifications for each indicator that has affected on   the teaching process.         &nb

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Publication Date
Mon Mar 01 2021
Journal Name
Journal Of Physics: Conference Series
Annual Behavior of Electron Density and Critical Frequency Parameters During Maximum and Minimum Years of Solar Cycles 22, 23 and 24
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Abstract<p>In this work, the annual behavior of critical frequency and electron density parameters of the ionosphere have been studied for the years (1989, 2001 and 2014) and (1986, 1996 and 2008) which represent the maximum and minimum of years in the solar cycles (22, 23 and 24) respectively. The annual behavior of (Ne, f<sub>o</sub> ) parameters have been investigated for different heights of Ionosphere layer (100 -1000) Km. The dataset was created both of critical frequency and electron density parameters by using the international reference ionosphere model (IRI-2016 model). This study showed result that during the maximum solar cycles the values of the (Ne) parameter change with </p> ... Show More
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Publication Date
Fri Feb 20 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Prediction the widths of maxillary and mandibular canines and premolars from the widths of maxillary incisors and first molars (Iraqi study)
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Background: This study aimed to use the combined mesio-distal crowns widths of maxillary incisors and first molars as predictors to the combined mesio-distal crowns widths of maxillary and mandibular canines and premolars. Materials and methods: The sample included 110 Iraqi Arab subjects with an age ranged between 17-25 years and class I skeletal and dental relations. The crown widths of maxillary teeth and mandibular canines and premolars were measured at the largest mesio-distal dimension on the study casts using digital electronic caliper with 0.01 mm sensitivity. Pearson’s correlation coefficient was used to determine the relation between the combined mesio-distal crowns widths of maxillary incisors and first molars and the combined

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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of Salivary α-amylase and Flow Rate Levels and Their Correlation with Gingivitis and Severity of Chronic Periodontitis (Part: 1)
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Background: Periodontal diseases are bacterial infections of the gingiva, bone and attachment fibers that support the teeth and hold them in the jaw. α-amylase is an enzyme, produced mainly by parotid gland and it seems to play a role in maintaining mucosal immunity. Aims of the study: Determine the salivary levels of α-Amylase and flow rate and their correlations with clinical periodontal parameters(Plaque Index , Gingival Index , Bleeding on Probing , Probing Pocket Depth , and Clinical Attachment Level ) and the correlation between α-Amylase with flow rate of study groups that consist of ( patients had gingivitis and patients had chronic periodontitis with different severities(mild ,moderate ,severe) and control group . Ma

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Publication Date
Sun Jan 01 2017
Journal Name
Biochemical And Cellular Archives
Effect of adding wheat peat and spraying with its extract and organic nutrient vegeamino on growth and yield of red cabbage
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Publication Date
Mon Oct 16 2023
Journal Name
Nano And Medical Materials
Preparation and analysis of silver Nanoparticles (Ag Nps) by plant extract techniques of green tea and study optical and structural properties
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Aqueous root extract has been used to examine the green production of silver nanoparticles (AgNPs) by reducing the Ag+ ions in a silver nitrate solution. UV-Vis spectroscopy, X-ray diffraction, field emission scanning electron microscopy, and Fourier transform infrared spectroscopy (FTIR) were used to analyze the produced AgNPs. The AgNPs that were created had a maximum absorbance at 416 nm, were spherical in form, polydispersed in nature, and were 685 nm in size.The AgNPs demonstrated antibacterial efficacy against Escherichia coli and Staphylococcus. The dengue vector Aedes aegypti's second instar larvae were very susceptible to the AgNPs' powerful larvicidal action.

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