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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 28 2022
Journal Name
Journal Of Educational And Psychological Researches
The Effect of Using the Strategy of Roundhouse in the Achievement of Fourth Grade Students of Computer and Their Attitudes towards It
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The research aims to identify the effect of using the strategy of Roundhouse on the achievement of fourth-grade students of computer and their Attitudes towards it. The research sample consisted of (61) fourth-grade secondary school students distributed into the experimental group consisted of (31) students study computer according to the Roundhouse strategy, and the control group consisted of (30) students follow the traditional method. The researcher designed an achievement test consisting of (30) items of multiple choice. To measure the attitudes of students towards the computer, a questionnaire of (32) paragraphs with three alternatives was designed by the researcher. The results showed that there is a statistically significant diffe

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Publication Date
Thu Jan 04 2024
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The impact of performance based costing technology in measuring the cost of consulting services : (an applied study in the Office of Scientific and Consulting Services - University of Technology
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             This research aims to apply the Performance Focused Activity Based Costing System in the offices of scientific and advisory services at the University of Technology for the purpose of measuring the cost of services provided by these offices in order to reduce costs. To test the hypothesis of the research, the research was applied in the consulting offices of the University of Technology through the financial statements for the year ending 12/31/2017 of the Scientific and Consulting Services Office of the University of Technology, because the data of these years were issued and audited by the Federal Office of Financial Supervision.

A number of

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Publication Date
Sun May 04 2014
Journal Name
Journal Of Physical Education
The effect of developing the strength of the muscles of the arms and shoulders in developing the performance of some floor movements skills in artistic gymnastics for women
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Publication Date
Mon Jul 01 2019
Journal Name
Journal Of Educational And Psychological Researches
The Level of Academic Achievement and its Relationship with Some Characteristics of Female Students at College of Education for Girls in Baghdad University: The Level of Academic Achievement and its Relationship with Some Characteristics of Female Students at College of Education for Girls in Baghdad University
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Abstract

Personality is one of the most important elements that should be developed in university student. Thus, we have to develop the positive traits and neutralize the negative traits of students as well as we have to pay attention to the level of student achievement at the same time, the researcher designed a scale to measure the traits of study sample. The research come out with a number of recommendations and proposals, the most important of which Enhancing the positive characteristics of university students in order to reach them to the level of mature personality with mental health. Enhancing the positive role of the high level of achievement by motivating the stude

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Publication Date
Sun Jun 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
The Organizational Climate Development in the Light of Job Stress Treatment: A Field Study in Governmental Sheltered Accommodation Houses in the Ministry of Labour and Social Affairs
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        Job stress is considered one of the most important obstacles that may appear in the work field. In order to deal with the obstacles and challenges , the idea to deal with job stress has come to address job stress as one of the most important trends that enable organizations to face those challenges through focusing on the role of job stress and the organizational climate of the organization.

       The research deals with two variables: the job stress as an independent variable, and the organizational climate as a dependent one. Each variable includes five sub-dimensions. These dimensions have been involved in an interaction to form

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Publication Date
Mon Jan 02 2017
Journal Name
Journal Of Educational And Psychological Researches
The impact of the proposed strategy in accordance with the objectives of science in achievement and some science operations at the second-grade middle students in chemistry
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It aim current researchs֬ to identify the impact of a proposed strategy in accordance with the objectives of science in the achievement and some science processes, where the experimental method was adopted, and define the research community was students second grade averag in Education Bagdad / Rusafa third, research sample intentionally chosen as school Radwan, and (30) students experimental group and (29) of control group, research tools were achievement test and the test of science operations and use the appropriate statistical tools to process information and data, showing results, the experimental group surpassed the control group in the collection and operations science, and light it, the researcher recommended several recommendat

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Publication Date
Mon Jan 07 2013
Journal Name
Journal Of Educational And Psychological Researches
The effective of utilization Blending learning on academic achievement in Biology course of second class students in secondary special schools in Omdurman Locality and attitudes towards it.
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This research aimed to definite Blending learning (BL) technique, and to know the impact of its use onacademic achievement in Biology course of second class students in secondary special schools in Omdurman Locality and attitudes towards it, to achieve this; researcher adopted the experimental method. The sample was selected of (41) students, chosen from Atabiyah school, were divided into two equals groups: one experimental group reached (26) students studied by using the  BL technique, and the second control group (25) students have been taught in the traditional method.

   Data has collected by using two tools: achievement test and a questionnaire for measuring the attitudes towards Blend

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Publication Date
Thu Apr 25 2019
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
STUDY THE ANTIBACTERIAL ACTIVITY AND INHIBITION EFFECT OF REACTIVE RED (31) DYE FOR THE CORROSION OF CARBON STEEL IN CORROSIVE MEDIA: STUDY THE ANTIBACTERIAL ACTIVITY AND INHIBITION EFFECT OF REACTIVE RED (31) DYE FOR THE CORROSION OF CARBON STEEL IN CORROSIVE MEDIA
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The inhibitive action of Reactive Red (RR31) dye against corrosion of carbon steel in 1M acetic acid solution has been studied using gravimetric method at temperature ranged (288-318)K. The antibacterial activity for the different concentrations of RR31 dye against different bacterial species was studied. The experimental data indicates that this dye acts as a potential inhibitor for carbon-steel in acetic acid medium and the protection efficiency increase with increasing (RR31) dye. The adsorption of (RR31) dye on the carbon steel surface was found to follow Langmuir adsorption isotherm. Thermodynamic data for the adsorption process such as Gibbs free energy change ∆Gads, enthalpy change ∆Hads, and entropy change ∆Sads were estima

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Publication Date
Mon Mar 07 2022
Journal Name
Journal Of Educational And Psychological Researches
The Degree of Focus of The Science Curriculum for the First Intermediate Grade on National, Health, Environmental And Economic Values in Light of the Education Policy in The Kingdom of Saudi Arabia and a Suggested Scenario for a Mechanism to Be Strengthe
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The study aimed to reveal the extent of the first intermediate grade science curriculum focus on the national values, health, environmental, economic values, in the light of the education policy in the Kingdom of Saudi Arabia, in addition to present a proposed vision to strengthen it in the science curriculum for the first intermediate grade. The study was applied to the two books student and the two books of activity on the first-second semesters for the academic year 1441 AH. To analyze the curriculum content, the study used a verified card prepared by the researchers and a criterion for interpreting percentages. The study reached the following results: environmental values ranked first with a concentration of (43%), i.e. with an avera

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Publication Date
Fri Feb 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
"The relationship between the profits management and profits quality and their impact on users of accounting information (A comparative study of a sample of banks listed in the Iraqi market for securities)
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The aim of the research is to determine the impact of profit management practices on the quality of profits through the use of flexibility in determining accounting methods and practices profit information is one of the most important information that concerns current users in general and observing users in particular. Some corporations managements manipulate the results of the company's profit or loss (income statement) and financial position statement with multiple reasons, including capital market motivations to raise their share prices in the stock market and attract investors, and on the other hand the motives of funding and borrowing loans, and the use of the flexibility in accounting policies and estimates to change the in

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