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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 15 2020
Journal Name
Al-academy
The Philosophy of Beauty and Aesthetic Tasting in the Story of Yusuf, peace be upon him, with the Al-Azeez’s Wife in light of the sayings of Ancient Philosophers and Modernists: نزار بن صالح أحمد عبد الحفيظ
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This study aimed to review the aesthetic miracle in the story of Yusuf, peace be upon him, with the Al-Azeez’s wife, using the historical, descriptive and analytical approaches. The study sample was determined in the verses (30-34) of the Holy Quran. The study found that the beauty of Yusuf, peace be upon him, went beyond the four stages and steps of the aesthetic judgment that Feldman set, in which Yusuf’s beauty is nothing but a divine miracle that cannot be described, analyzed, and interpreted. Also despite the various concepts of beauty dealt with by ancient Greek philosophers such as the Pythagoreans, Socrates, Plato and Aristotle; and modern philosophers such as Descartes, Diderot, Kant, Hegel, and Schopenhauer are embodied in

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Publication Date
Thu Sep 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
The use of the methods of the lower squares and the smaller squares weighted in the estimation of the parameters and design of the sample acceptance schemesFor general exponential distribution
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The acceptance sampling plans for generalized exponential distribution, when life time experiment is truncated at a pre-determined time are provided in this article. The two parameters (α, λ), (Scale parameters and Shape parameters) are estimated by LSE, WLSE and the Best Estimator’s for various samples sizes are used to find the ratio of true mean time to a pre-determined, and are used to find the smallest possible sample size required to ensure the producer’s risks, with a pre-fixed probability (1 - P*). The result of estimations and of sampling plans is provided in tables.

Key words: Generalized Exponential Distribution, Acceptance Sampling Plan, and Consumer’s and Producer Risks

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Publication Date
Thu Mar 20 2025
Journal Name
Tikrit Journal Of Engineering Sciences
Effect of Different Compressor Speeds on the Energy and Exergy of an Automobile Air-Conditioner Using R134a in the Absence and Presence of a Liquid-Suction Heat Exchanger
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Refrigerant R134a has been widely utilized in automotive air conditioning systems (AACSs); R134a has a high global warming potential (GWP) of 1430 despite having zero ozone depletion potential (ODP). Coming refrigeration systems must include refrigerants with low GWP and zero ODP. The aim of this experimental study is to evaluate the thermal performance of an (AAC) with different values of compressor speeds, i.e., (1000, 1700, and 2400 rpm) and two thermal loads, i.e., (500 and 1000 Watt) with the absence and presence of liquid suction heat exchanger (LSHX) using R134a. The results showed that adding LSHX enhanced the COP cycle by 7.18%, 10.7%, and 3.09% for the first, second, and third speed, respectively, at 500 Watt, while the en

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Publication Date
Sun Feb 15 2026
Journal Name
Al–bahith Al–a'alami
"THE COMMUNICATOR AND THE FACTORS INFLUENCING HIS JOB IN UNIVERSITY PRESS": " A survey study of the managers of administrative departments of public relations and media at Iraqi Universities. "
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The research problem lies in the lack of accurate scientific perceptions concerning the reality of the communicator and the factors influencing his job. The research is aimed at introducing the communicator in the university press, clarifying the obstacles facing him, and uncovering the level of his job satisfaction and his visions of developing his work.

The researcher adopted the survey method in the collection, analysis, and interpretation of the data using a questionnaire.

 A set of results and conclusions has been reached, most importantly are:

 

*The communicator performs multiple missions including writing, editing, and collecting info

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Publication Date
Thu Sep 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
360 degree reverse feedback / comparative analytical study for a sample of managers and heads of departments in the Central Electricity DepartmentAnd the General Directorate of Water and Sewage
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يسعى البحث إلى الاهتمام بإحدى الوظائف المهمة في إدارة الموارد البشرية وهي تقويم الأداء التي تواجه مجموعة من الانتقادات والآراء السلبية، اذ ظهر في الأّونة الأخيرة أنموذج جديد يمكن إن يتجاوز تلك السلبيات وهو أنموذج التغذية العكسية المتعدد المصادر درجة .وقد حاول الباحثان توظيف هذا المفهوم في اثنتين من المنظمات العامة العراقية هما (دائرة كهرباء الوسط) التابعة لوزارة الكهرباء
و (دائرة الماء والمجاري) ال

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Publication Date
Sat Dec 28 2024
Journal Name
Journal Of Physical Education
The effect of rehabilitation exercises with body weight and rubber resistance on the range of motion and the strength of the sprained ankle muscles in female rugby players
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The study aimed to prepare a set of qualifying exercises to improve the muscular strength of the muscles surrounding the ankle joint by applying different resistances according to the nature of the movement of this joint, which is one of the second moving joints (flexion, extension and rotation of the right and left) in order to increase the efficiency of all muscles working on this joint according to those movements and identification On the impact of these exercises and assume that there will be statistical differences between the two tests of the research sample. The researcher used the semi-articulated experimental method with a pre- and post-test for one group. The injury was evaluated on the women's national team players durin

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Publication Date
Thu Jun 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Prevalence and localization of the posterior superior alveolar artery in relation to the floor of the maxillary sinus and alveolar crest among sample of Iraqis using computed tomography
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Background: Posterior superior alveolar artery (PSAA) is branch of the maxillary artery. It usually supplies the lateral wall of the sinus and overlying membrane. Evaluation and awareness of the anatomy of maxillary sinus before surgery is crucial to avoid surgical complications. The aim of this study is to examine the prevalence, location of the (PSAA) in relation to the floor of the maxillary sinus and alveolar crest using computerized tomography (CT) scans. Materials and Methods: This study included 180 Iraqi subjects (99 males and 81 females) with age more than 16 years old. CT scans for (right and left) Maxillary sinuses were done for each patient. The information obtained was assessed in a coronal multi planar reconstructions images (

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Publication Date
Wed Oct 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
The impact properties of strategic thinking in the stages of the application Business process re-engineering: A survey Study of the consultant of a sample of managers and their assistants and consultants in the General Company for Cotton Industries
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Need organizations today to move towards strategic thinking which means analyzing situations faced by particular challenges of change in the external environment, which makes it imperative for The Organization That to reconsider their strategies and orientations and operations, a so-called re-engineering to meet those challenges and pressures, to try to achieve improvement root in the installation of the organization and methodscompletion of its work towards achieving high levels of performance and that is reflected to achieve its objectives, and this is what aims to Current search to deal with implications characteristics of strategic thinking in the stages of application re-engineering business of the company General Industries

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Publication Date
Tue Nov 30 2021
Journal Name
Iraqi Geological Journal
Natural Radioactivity in Soil and Bitumen in Al-Marj Spring and Abu-Jir Village, Anbar, Western Iraq
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The aim of the present research is to illustrate γ-ray levels emitting from soil and bitumen producing from 238U, 232Th, and 40K along Abu-Jir Fault Zone. in the area extended from Al-Marj valley to Abu-Jir village using scintillometer device. Such study is important in environmental assessment to buildup data base about radioactivity. The concentration of natural radionuclides in the study area was determined to be occurring mostly in the clay minerals and organic matter. A high purity germanium spectrometer was used to detect the activity of these elements which ranged between 00.6±18.1- 1526±102, 0- 8.4±1.4, and 70.1±10.9- 328.2±73 in soil, and 28.2±5.6- 94±22.1, 0- 2.2±0.5, and 38.4±7.9- 70.1±10.9 in bitumen for 226Ra

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Publication Date
Fri Jan 15 2021
Journal Name
Psychology And Education Journal
Property and Possession in Gayl Jones’s Novel Corregidora: A Study in African American Literature and Literary Theory
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the traumatic memory of their ancestors. The novel navigates sites of trauma, memory, and blues music while resisting the bourgeoisie-capitalist relationships that permeated not only white society but also African American communities. Jones’s novel presents the plight of an African American woman, Ursa, caught between the memory of her enslaved foremothers and her life in an emancipated world. The physical and spiritual exploitation of African American women who bear witness to the history of slavery in Corregidora materializes black women’s individuality. This article is framed by trauma studies as well as the Marxists’ concepts of commodification, accumulation, and production. Ursa, one of the Corregidora women, represents

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