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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Jul 17 2023
Journal Name
Journal Of The Iraqi University
Analysis of the Content of the Physics Textbook of the 3rd Intermediate Grade According to the Criteria for Designing and Producing in Fographics
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In this study, the researcher aims to analyze the content of the physics textbook for the 3rd intermediate grade according to the criteria for designing and producing infographics, and the research community consists of the content of the physics textbook for the 3rd intermediate grade intermediate grade for the academic year 2021-2022. The researcher adopted the analysis instruments with a number of the criteria for designing and producing infographics. The results revealed randomness in the percentage of the criteria included in the content of the physics textbook for the 3rd intermediate grade, and they are not compatible with the proposed criteria by the experts also.

Publication Date
Sun Jan 01 2023
Journal Name
Oncology And Radiotherapy
The role of Modulation Complexity Score (MCS) of the VMAT and IMRT techniques in the treatment planning of left non-small lung cancer
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Background: Lung cancer is a common disease for patients over the age of 50 years, especially males due to smoking habits. This study aimed to compare the modulation complexity score (MCS) for the advanced treatment planning techniques which the intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT). Materials and Methods: Thirty patients who had non-small lung cancerous tumors on their left side participated in this study. The range ages were 68 to 98 years, the heights were between 151 and 182cm and they having weights from 46 to 79 kg. For Each patient will create two plans dial using two different techniques, which will be Intensity Modulated Radiation Therapy (IMRT) and Volumetric Modulated Arc Therapy

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Scopus
Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Simole matimatical technique in leaser cavity design and manufacturing
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In this research design was treated gap laser mathematically and practically Bashaddam model Raasi simple and new and we have found that there is a good match in the practical and theoretical results

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Publication Date
Tue Jan 29 2019
Journal Name
Journal Of The College Of Education For Women
Efforts in cataloging manuscripts some Arab and international libraries
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The Arab Islamic Manuscripts in the science libraries humanly global heritage in different types of knowledge and science, as they were not confined to a particular flag but extended to include all kinds of science, and to facilitate the knowledge of these types of manuscripts has been necessary to operate them indexed in most libraries , because it is important in determining the size of those manuscripts and set them up and facilitate the work of the investigators, as well as the significance of indexing to know printed manuscripts in order to avoid repetition of the publication of the manuscript more than once, especially if the deployment is to be characterized by accurate scientific integrity and following the origins of the scienti

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Publication Date
Wed Dec 06 2023
Journal Name
Journal Of Islamic Thought And Civilization
Artistic Signature's Aesthetic Consistency and Differentiation in Arabic Calligraphy
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The artistic signature of calligraphers has been regarded as a significant aspect of Arabic calligraphy since its inception. As the art form evolved and acquired an aesthetic dimension, the artistic signature became an integral part of this dimension. The calligrapher failed to include his name on the frames, a practice that has become customary among calligraphers nowadays. This tradition allowed to trace the evolution of Arabic calligraphy and identify certain gaps in the calligraphy composition. Additionally, the inclusion of calligrapher's name contributes to the achievement of visual balance within the calligraphy composition, signifying consistency or formal separation. The current study concentrated to investigate the aesthet

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Publication Date
Sat Jun 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
NONPARAMETRIC And Semiparametric Bayesian Estimators in survival function analysis
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 Most statistical research generally relies on the study of the behaviour of different phenomena during specific time periods and the use of the results of these studies in the development of appropriate recommendations and decision-making and for the purpose of statistical inference on the parameters of the statistical distribution of life times in  The technical staff of most of the manufacturers in the research units of these companies deals with censored data, the main objective of the study of survival is the need to provide information that is the basis for decision making and must clarify the problem and then the goals and limitations of this study and that  It may have different possibilities to perform the

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Publication Date
Sat Feb 02 2019
Journal Name
Journal Of The College Of Education For Women
Jamal Basha: His Administrative and Political Effort in Baghdad
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Jamal Basha: His Administrative and Political Effort in Baghdad

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Publication Date
Sun Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
An Introduction to Gender in Feminine Literature and Criticism
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The Gender study is consider one of the concepts which the Postmodernism reached
after the end of Modernism, where the first one has limited the criticism study choices before
the second after closed many doors of subjects which was enriched by researches.
It is pretty clear that the root of this concept belongs to the Linguistics which provided
the Criticism with a countable reasons of it is growth.
The attention in the study of gender in Feminine Literature and Criticism increased in
Arabic studies since the early years of twenty one century, so this research is presented to be
an introduction to this subject which could pave the way to more studies.
In addition to the Gender studies this research deals with ano

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Publication Date
Wed Jun 14 2023
Journal Name
Al-academy
fashion and Contrasting in the contemporary Iraqi theater show
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Since its inception, the theatrical performance has been based on the principle of permanence, continuity, renewal and innovation in the structure of its visual elements. These innovations and the effectiveness of continuity cannot be achieved without searching for everything that is new and different at the level (form and content) in order to create an image with innovative and effective features in the theatrical discourse, and from Among the elements of the theatrical performance (theatrical costumes) that have been subject to variation since the beginning of the theater until now, and for this purpose, the current research was conducted with the question of the research problem: What are the variations of costumes in the contemporar

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Publication Date
Tue Jan 29 2019
Journal Name
Journal Of The College Of Education For Women
Suggestibility in Kindergarteners and its relation to some variables
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The childhood of the most important stages throughout the human and which have been more vulnerable to various factors surrounding it and with the scientific and cognitive development in all fields surfaced many psychological phenomena that play a large role in influencing children and their behavior trends is the susceptibility of the lure of psychological phenomena which plays a major role in the social attitudes of individuals it may not be predictable so that individuals vary in between them in terms of vulnerability Balasthoa You do this only _bl that the same individual at different influenced Balasthoa different depending on the positions and this was research to achieve its objectives and that are known:
_ alasthoa The childre

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