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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Oct 11 2023
Journal Name
Journal Of Educational And Psychological Researches
The Association between Emotional Intelligence and Academic Adaptation among a Sample of Gifted Students in the Intermediate and Secondary Schools in Jeddah
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This study aims to examine the relationship between emotional intelligence and academic adaptation among a sample of gifted students in intermediate and high schools in Jeddah, Saudi Arabia. The study also seeks to examine the differences between group means in emotional intelligence and academic adaptation due to demographic variables (gender and school level). In addition, the study aims to examine the role of emotional intelligence in predicting the level of academic adaptation. The researcher performed the descriptive, correlational, predictive, and comparative approaches to collect the data from a sample comprised of (309) gifted students using the emotional intelligence scale developed by Bar-on (2000), whi

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Publication Date
Wed Apr 01 2020
Journal Name
Biochemical & Cellular Archives
INVESTIGATION OF VITAMIN D, ESTRADIOL AND C-REACTIVE PROTEIN LEVELS IN PRE AND POST-MENOPAUSAL IRAQI TYPE 2 DIABETES MELLITUS IN WOMEN.
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Diabetes mellitus is a metabolic chronic disease, with global estimation increase in patient (around 100 million in 2030).The aim of the current study is to investigate vitamin D, C-reactive protein and estradiol levels in pre and postmenopausal Iraqi women with type 2 diabetes (T2MD).A total of 176 female distributed into two groups: the first included 90 women withT2MD (43 pre and 47 post-menopausal); the second group included 86 healthy subjects (41 pre and 45 postmenopausal) considered as control. This study has shown that women in premenopausal (20-40 years) had highly significant difference in the estradiol and vitamin D levels in diabetes subjects (62.192 ± 17.643pg/ml, 10.522 ± 1.958ng/ml) compared with healthy (131.793 ± 1

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Publication Date
Mon Mar 08 2021
Journal Name
Baghdad Science Journal
The pathological changes of the digestive system for Anas platyrhychos in Baghdad and Kut in Iraq which infectel with platyhelminthes and nematodes
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A total of 247 Mallard ( Anas platyrhynchos platyrhynchos L.) from Baghdad and Kut were examined for the Cestodes Diorchis stefanskii Sobolevicanthes gracilis; Hymenolepis mastigopraditae and the Nematode Amidostomum acutum in the first time in Iraq . Among these , 151 birds were found infected by these helminthes It has been found small nodules on the external surface of the intestine , Ulceration of mucosa inflammatory infiltrate , Oedemats changes and hyperplasia in the section of infected intestine were noticed.

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Publication Date
Mon Feb 28 2022
Journal Name
Journal Of Educational And Psychological Researches
Social Support and Its Relationship to Psychological Rigidity in a Sample of Breast Cancer Patients In the Ramallah and Al-Bireh Governorate
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This study aims to identify the impact of social support on breast cancer patients’ psychological rigidity using a sample in Ramallah and al-Bireh. A descriptive correlative approach was adopted to fulfill the goals of the study and a questionnaire consisted of two criteria: social support and psychological rigidity, which was adopted as a tool for data collection for the study. In order to achieve the goals of the study, the researcher selected a convenient sample that consisted of 123 female breast cancer patients in Ramallah and al-Bireh. This sample represented 50% of the original patient population. The study showed that the average estimated percentage of social support and psychological rigidity for women with breast cancer, in

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Publication Date
Mon Aug 19 2024
Journal Name
Chemical Papers
In vitro and in silico evaluation of 4'-hydroxy-[1,1'-biphenyl]-4-carbohydrazide Schiff base and oxadiazole derivatives targeting EGFR allosteric site
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Publication Date
Sat Oct 20 2018
Journal Name
Journal Of Economics And Administrative Sciences
Analysis of the causes of poverty and progress strategy to combat in sudan
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Abstract:

   The problem of poverty is one of the most important development challenges facing developing countries including Sudan for several decades. Although many efforts have been made to reduce poverty, however, its rates are increasing, and public policies adopted by the government in this regard remain elusive in achievinging its main objectives or making any significant progress. The purpose of the present study is to analyse poverty in Sudan by identifying its measurement, causes and the factors that have contributed to the increasing poverty rates over the past two decades. Also this study aims at investigating the interim poverty reduction strategy in Sudan as well as evaluates that strategy throug

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Publication Date
Mon Feb 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Problematic of Non Performing Banking Loans in Iraq and the Methods of Treatment
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The banking system considered as one of the most important intermediate circle between creditor and debtors it is mean the most important funding rings in economic activity, whether finance takes the a consumer or investment form and therefore it is the main base to stimulate economic activity both on the demand side, both consumption and investment and therefore of the main motivating factors for economic growth.

The banking system depends in achieve its goals on the grants and loan recovery, or what is known credit process and according to what the importance referred to the role of the banking system, it is important to ensure the safety and efficiency of the mechanisms of banking device and safety is

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Publication Date
Sun Jan 05 2014
Journal Name
Journal Of Educational And Psychological Researches
The role of educational curricula and teaching methods in the development of environmental
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Described the Arabic language being of genius sets by top models of eloquence , rhetoric and clarity of sounds and developments Moreover , it is an important element of our existence and our identity and our survival . That my methods and best in teaching Arabic language what has pursued the easiest ways to learning and teaching and helped learners to be aware of the function linguistic information , and they need it and its impact on their lives , and contributed to unleashing the potential of activism and led them to make the effort to apply them in the form of examples and uses of new life , as well as fits are the capabilities and tendencies of different learners , so the goal of current research into the importance of the curriculum

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Publication Date
Mon Jan 01 2024
Journal Name
Journal Of Research In Pharmacy
Preparation and in-vitro evaluation of Carbopol hydrogel of clobetasol-loaded ethylcellulose microsponges
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: Clobetasol propionate (CP) is a potent corticosteroid used for skin conditions but often causes side effects due its systemic absorption. To improve its solubility and reduce it side effects (like skin irritation, skin atrophy, hypopigmentation and steroidal acne), Microsponge (Msg) has been employed as a unique three-dimensional particle that can encapsulate hydrophilic and lipophilic drugs. This study aims to develop and evaluate CP Msg-loaded hydrogels. Two Clobetasol-loaded ethylcellulose-based Msg formulas were prepared using the quasi-emulsion solvent diffusion method, then they were incorporated into Carbopol hydrogel. Two ratios of Carbopol 940 (1% and 1.5% w/w) were used. The prepared hydrogel were assessed for appearance, pH, dr

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Publication Date
Wed Mar 15 2023
Journal Name
Al-academy
The Relationship of Aesthetics in the Art of Interior Architecture and Architectural Criticism
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The concept of aesthetics is one of the postmodern propositions, and it is one of the branches of philosophy that examines beauty, its standards and theories, and it is a holistic concept that includes several concepts, including the beautiful, the ugly, and the sublime.
The concept of aesthetics dealt with several studies in general (and in the field of architecture in particular), and the problem of aesthetics is in the blurring of the relationship between aesthetics and architectural criticism, based on the research hypothesis which states that there is a relationship between aesthetics and architectural criticism. The importance of the research in accommodating aesthetic standards and bases of evaluation that increases the possi

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