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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2025
Journal Name
Scripta Medica
Correlation between psoriasis severity and dyslipidaemia in Iraqi patients
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Background/Aim: Psoriasis is a persistent systemic disorder characterised by chronic inflammation and linked to multiple comorbidities, including arthritis, cardiometabolic disorders, obesity and hyperlipidaemia. Objective of this study was to identify the relationship of abnormal lipid profiles and psoriasis, as well as to pinpoint factors that correlate with disease severity. Methods: A cross-sectional study was carried out at the dermatology clinic over 6 months from the 1 August 2024 to the 1 February 2025. Patients aged 15 years and above with a diagnosis of psoriasis were enrolled. For each patient two sets of data were collected, demographical characteristics (age, sex, disease duration and the body mass index (BMI)) and the

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Publication Date
Wed Jan 01 2020
Journal Name
Journal Of Southwest Jiaotong University
Integrity and Security in Cloud Computing Environment: A Review
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Cloud computing is a newly developed concept that aims to provide computing resources in the most effective and economical manner. The fundamental idea of cloud computing is to share computing resources among a user group. Cloud computing security is a collection of control-based techniques and strategies that intends to comply with regulatory compliance rules and protect cloud computing-related information, data apps, and infrastructure. On the other hand, data integrity is a guarantee that the digital data are not corrupted, and that only those authorized people can access or modify them (i.e., maintain data consistency, accuracy, and confidence). This review presents an overview of cloud computing concepts, its importance in many

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Publication Date
Thu Jun 01 2023
Journal Name
Baghdad Science Journal
Gogny interaction and nuclear charge distribution in 48Ca Nucleus
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Charge multipole Coulomb scattering form factors in 48Ca nucleus have been reproduced utilizing the theory of nuclear shell. The efficient two-body nuclear potential fpbm is considered to construct the-spin orbit term LS vectors with Harmonic Oscillator HO potential as a wave function of single particle in Fp shell. Discarded spaces ( core + higher configuration) are taken into account through the Core polarization effect by model space with accurate two-body potential of Gogny to  interact the LS operating particles with the discarded space pair ( particle-hole) with energy of excitation equal to 2ћω. Gogny interaction has been selected as it had succeeded in nuclear shell theory. The computed results were compared with th

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Publication Date
Wed Jan 01 2020
Journal Name
International Journal Of Innovation, Creativity And Change
Responsible accounting and its role in achieving competitive advantage
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One of the management accounting tools is responsible accounting. In this system, the organisation is divided into responsibility centres that help to connect an individual performance responsible to perform through a combined system of reports according to the implementation of the mechanism of exception tools which gives assistance in planning. The exploitation of the organisation's available resources is achieved through the application of responsible accounting. Also, the best exploitation will lead to the provision of low-cost products through the disposal of all types of waste or loss during the cost centres. By providing products at a lower cost and satisfying the wishes of the needs of customers, the result reflects the competitive

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Publication Date
Sat Jun 29 2019
Journal Name
Journal Of The College Of Education For Women
Parenthetical Constructions in English and Arabic: A Contrastive Study
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The present study attempts to give a detailed discussion and analysis of parenthetical constructions in English and Arabic, the aim being to pinpoint the points of similarity and difference between the two languages in this particular linguistic area.The study claims that various types of constructions in English and Arabic could be considered parenthetical; these include non-restrictive relative clauses, non-restrictive appositives, comment clauses, vocatives, interjections, among others. These are going to be identified, classified, and analyzed according to the Quirk grammar - the approach to grammatical description pioneered by Randolph Quirk and his associates, and published in a series of reference grammars during the 1970

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Publication Date
Thu Feb 02 2023
Journal Name
Journal Of The College Of Basic Education
Context and conveying meaning in the Iraqi theatrical show
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يشكل السياق جانبا مهماً في فهم الخطاب والمقصود هنا العرض المسرحي، من خلال ما يمده السياق للمتلقي من مؤشرات، يتم الاعتماد عليها في استكمال المعنى الظاهر بالمعنى المستتر، فالسياق يعتمد في الاصل على المحيط المادي الاجتماعي الذي يتم فيه التواصل وفيه يتعرف المرسل والمتلقي أحدهما على الآخر وتتبلور الصورة التي يحملها الطرفان أحدهما عن الآخر، الى جانب كونه يمثل الاحداث التي سبق لهما أن عاشاها والتبادل القولي

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Publication Date
Tue Apr 22 2025
Journal Name
Passer Journal Of Basic And Applied Sciences
Searching Elastic and Inelastic Coulomb Transitions in Chromium-54
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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The paradise in surat al-rahman and its preparation
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Our life is a test and the eternal life in the afterlife. So we must work well in our life even win paradise, must always remember the death and there is a life after this death and we will be responsible for everything we've done in our life. God did not create us vain but for reward, punishment, for this we must have to well prepare for this great day and we have to think about what to do in order to win the paradise.
Keywords: paradise, surat al-rahman, preparation.

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Publication Date
Thu Dec 31 2020
Journal Name
Political Sciences Journal
Public Policy Education in Iraq / Reality Challenges and Proposed
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The policy issue in all countries of the world is concerned with government and research because it has the ability to reveal many of the problems facing the state and its organizational and scientific capabilities in the development of solutions and appropriate treatments that go beyond random and improvisational reactions, As a result of this interest, many studies have attempted to conceptualize and academicism it. The concept of public policy has been linked to various aspects of social life such as social, economic, educational, agricultural or other aspects. Public policy, regardless of its meaning or its relation to aspects of life, refers to the systematic thinking that directs the behavior and actions of the state, organization

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Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
Financial corruption and investment opportunities in the Iraqi economy
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Corruption is one of the barriers to economic growth and investment opportunities, and after the most serious security and stability, that corruption plagued the Iraqi economy is striking and has roots since the eighties of the last century to the present day.

The study aimed to identify practical impact of corruption on investment in the Iraqi economy and revealed the possibilities and obstacles to investment in Iraq and clarify the investment opportunities at the level of Iraq and the impact of corruption on investments.

The focus will be on the statement of the extent of corruption and investment in Iraq and the adoption of the style of economic measurement using cross-section

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