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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jul 01 2012
Journal Name
Eastern Mediterranean Health Journal
Knowledge and practices of women in Iraqi universities on breast self examination
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This study evaluated the knowledge and practice of breast self-examination (BSE), among a sample of educated Iraqi women. The study sample comprised 858 women aged 18–62 years affiliated to 6 major Iraqi universities, categorized according to occupation as teaching staff (11.5%), administrative staff (18.0%) and students (70.5%). Data were collected by a self-completed questionnaire. In all, 93.9% of the women had heard about BSE, the main source of information was television (39.9%), doctors (18.4%) and the awareness campaign of the Iraqi National Breast Cancer Research Programme (11.6%). Only 53.9% of the women practised BSE; the most common excuses by those that did not were lack of knowledge of the significance of BSE (42.0%) and lack

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Publication Date
Thu Jun 15 2017
Journal Name
Arab World English Journal
An Assessment of Iraqi EFL Learners’ Performance in Using Synonymy and Antonymy
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The knowledge related with lexical items can be realized as including relations of meaning a cross words. Words that share a similarity of meaning are called to be synonymous, and words that share a contrary of meaning are called to be antonymous. Both of them are universal linguistic phenomenon that exist in terms of linguistic system of every language. The present study aims at finding out areas of difficulty that Iraqi EFL learners encounter in the use of synonymy and antonymy, both on the recognition and production levels. Also tries to detect the main reasons behind such difficulties. A diagnostic test of two parts, namely, recognition and production, is designed. The test is built to include two linguistic phenomenon which are: synony

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Publication Date
Fri Sep 24 2021
Journal Name
Arab World English Journal
A Pragma- Stylistic Analysis of Formal Congratulatory Letters in English and Arabic
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Politeness strategies are of significant importance to maintain the face of the addressee. Senders of formal congratulatory letters seek to create a positive image in the minds of their addresses by performing particular illocutionary acts and face-saving acts (FSAs) in the form of written texts. To the best knowledge of the researcher, this topic received little attention from linguistic researchers, especially on the pragma-stylistic level. The importance of this study arises from the fact that congratulatory formal letters are an effective tool in the successful performance of foreign relations and thus deserve investigation. The current study investigates the pragmastylistic aspects of illocutionary acts and FSA Politeness Stra

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Publication Date
Wed Dec 30 2015
Journal Name
College Of Islamic Sciences
Electonic management   And its role in the development of the Zakat Foundation
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The world is witnessing a remarkable development in the use of technology, which has made it an essential means of investment, especially in the field of management, which provided many of the facilities experienced by the institutions, including improving revenues, shortening time and saving labor. Islamic investment technology as a successful means of management and we touched on the Zakat Foundation as an application model.

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Publication Date
Sun Jun 21 2020
Journal Name
Baghdad Science Journal
Structural and Thermal Unusual Properties in Invar Behavior of Ni-Mn Alloys
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The Invar effect in 3D transition metal such as Ni and Mn, were prepared on a series composition of binary Ni1-xMnx system with x=0.3, 0.5, 0.8 by using powder metallurgy technique. In this work, the characterization of structural and thermal properties have been investigated experimentally by X-ray diffraction, thermal expansion coefficient and vibrating sample magnetometer (VSM) techniques. The results show that anonymously negative thermal expansion coefficient are changeable in the structure. The results were explained due to the instability relation between magnetic spins with lattice distortion on some of ferromagnetic metals.    

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Publication Date
Thu Dec 01 2016
Journal Name
Journal Of Engineering
A Laboratory Study Attempt of Flow and Energy Dissipation in Stepped Spillways
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A new laboratory study conducted on stepped spillways in order to investigate their efficiency of dissipating flow energy. All previous study on stepped spillway indicated that the flow energy dissipation decreased as increasing in discharge. Increasing in the step numbers and the spillway slope led to energy dissipation decrease. In this study, an experimental attempt to increase energy dissipation at variable discharges was performed on stepped spillway and that leads to decreasing the cost of initiating the stilling basin or may be ignoring it. Five spillways were constructed from concrete and tested to investigate and compare among them. Three were roughed by gravel with different size for each one, one of them was s

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Publication Date
Tue Sep 19 2017
Journal Name
Al-academy
The Soul and Body Dichotomy in the Performance of the Iraqi Actors
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The body of the actor and its expressive significance is an essential topic in studying acting . it is not only confined to the study of soul and body from philosophical aesthetic perspective , but also to study the conception and mechanism of such a dichotomy followed by theatre directors and theorists , who are highly concerned with the creativity of actors . The researchers believe that such a study would be of benefit for actors as well as others working in theatre .                             

     The study falls into two sections . the first deals with the phi

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Publication Date
Mon Jan 01 2018
Journal Name
Plant Archives
The morphological and pollen grains study of Tropaeolum L. (Tropaeolaceae) in Iraq
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The current study included a detail morphological study of all parts of the two species of the genus Tropaeolum L. (Tropaeolumceae) cultivated in different gardens, the roots, stems, leaves, flowers and fruit were studied in detail, also the pollen grains were studied, and there are photographs for all that parts were putted. A specimens of that taxa were studied in some Iraqi herbaria. The study found that there are many characters were used in differentiation of two species under study.

Scopus
Publication Date
Mon Jan 01 2018
Journal Name
Journal Of Global Pharma Technology
Detection of HBME-1 and galectin-3 by immunohistochemistry in follicular lesions
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The main problem established by a discovery of a thyroid nodule is to discriminate between a benign and malignant lesion. Differential diagnosis between follicular thyroid cancer (FTC) and benign follicular thyroid adenoma (FTA) is a great challenge for even an experienced pathologist and requires special effort. A developing number of some encouraging IHC markers for the differential diagnosis of thyroid lesions have emerged, including, Hector Battifora mesothelial (HBME-1) and galectin-3 (Gal-3). There was significant positive correlation between Galectin-3 and HBME-1 in follicular carcinoma and follicular variant of papillary carcinoma (r= 0.380, P= 0.041) and (r= 0.315, P=0.047) respectively. There was no significant correlation between

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Publication Date
Mon Aug 01 2016
Journal Name
2016 3rd International Conference On Computer And Information Sciences (iccoins)
Measurement model of e-SQ dimensions and users' satisfaction in Malaysia IHL
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