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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 May 18 2016
Journal Name
Al-academy
Abstraction and exaggeration formalism and its reflection in the industrial product: نور عباس حسين
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This study deals with the reality of the design of a washing machine automation available in the markets Mahlah.otata importance of this issue is through the development of technological and technical exploited for the benefit of the consumer and always seeking perfection in industrial product through providing comfort to the user and reduce fatigue and the effort and time-saving as well. On this basis, the research aims of this study put the foundations for the development of design automation washer. The boundaries of the study were products company LG producing Sna2012.uahtot this study on five chapters included Allvsal first importance of research and the need for a mechanism in addition to Alchuklh research objectives and Hdodh.ama

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Publication Date
Tue Nov 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Financial and administrative corruption: concept, causes, types and ways to address them in Iraq
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Abstract:-

The phenomenon of financial and administrative corruption is not the result today, but not tied to time or designated place, he is the scourge is rampant in all countries of the world, without exception, those developed and developing, a phenomenon that crossed national boundaries and become withstand a global character, and corruption is limited to communities of particular economic systems without the other, but suffered Throughout history most societies to varying degrees, Iraq is one of the countries that suffered and continues to suffer from corruption, which has become, B grumble in most of the Iraqi state institutions, especially after the occupation in 2003 as administrative corruption in Iraq arrived i

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Publication Date
Fri Apr 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
The political changes and economic developments in contemporary Turkish Backgrounds, manifestations and future possibilities
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         The research entitled "The political changes and economic developments in contemporary Turkish Backgrounds, manifestations and future possibilities" consists of the introduction, four sections and conclusions. The background details, its developments, and the transformation in the economic   sector in Turkey were reviewed. The first section concentrated on the brief introduction about the political developments which happened since the independence of Turkey at 1923 with the highlight on the years after the receipt of the Freedom and Justice Party (Ak PARTi) the Turkish Government rule. The second section demonstrated the reality of Turkish economy before 2002, while the

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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
Places between vanishing and appearing compass and sense in the Iraqi Kurdish poetry translator
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Longer Kurdish poetry translator important tributary of the tributaries of the Iraqi culture contemporary , and a wealth of knowledge rich experiences of an important segment of the Iraqi people , nicked culturally with the languages and cultures of the neighboring nations have , however, much of this potery under depends on the effect of the Arab form and complex , but suffered marginalization and loss as a result of repression by the governments of the country by successive throughout history , and tried to search that offers a vision on the theme of the place and its implications in the Kurdish poetry translator, through the election of a collection of poems and chisels, vertical than that of quantum poetic enormous , but thenature of

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
Aljdhiran incision and rip and derivatives in the Qur'an: A statistical study morphological tag
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It is more beneficial science and created and the highest honor is the Koran Sciences, God has honored research in this fun science, came this research that shed the light on the radical incision, and Naughty derivatives as contained in the Koran, and illustrate the diversity of Saghma morphological, and fork them from derivatives what it entailed connotations, as well as the evacuation of cryptic in some of these verses from the biological secrets take minds newly exposed Anitrjt science under the name of scientific miracles.
The research methodology is revenue verse which included the word, and revenue lexical meaning and its meaning in the context of the Qur'an, and reflect the views of the commentators of the verse, and then the r

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Publication Date
Mon Jun 19 2023
Journal Name
Journal Of Engineering
MIXED CONVECTIVE AND RADIATIVE HEAT TRANSFER IN A HORIZONTAL CONCENTRIC AND ECCENTRIC CYLINDRICAL ANNULI
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A numerical investigation has been performed to study the effect of eccentricity on unsteady state, laminar aiding mixed convection in a horizontal concentric and eccentric cylindrical annulus. The outer cylinder was kept at a constant temperature
while the inner cylinder was heated with constant heat flux. The study involved numerical solution of transient momentum (Navier-Stokes) and energy equation using finite difference method (FDM), where the body fitted coordinate system (BFC) was
used to generate the grid mesh for computational plane. The governing equations were transformed to the vorticity-stream function formula as for momentum equations and to the temperature and stream function for energy equation.
A computer progra

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Publication Date
Mon Feb 25 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Planning and implementation of the audit process by using the styles of time management and its impact on the quality of the audit process: Applied Research in the Federal Board of Supreme Audit
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Witnessing the global arena many changes in the political, economic, social, scientific and technological have left their mark on the world as a whole, these changes require necessarily Advancement of the profession of auditing, and improve their performance, especially after the mixer skepticism the health of approach and the method followed by a check in the major audit firms global view as for the external audit of an active role in providing services to members of the community in various sectors, were to be provide these services to the highest level of quality.To ensure the quality of the audit process to be a proper planning is based on a scientific basis to be the substrate a strong underlying different audit works, and if planni

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Publication Date
Tue Jul 11 2023
Journal Name
Journal Of Educational And Psychological Researches
Future Teachers' Attitudes Towards Cloud Computing in the Kingdom of Saudi Arabia: Assistant Professor of Education Techniques, Department of Curriculum and Teaching Techniques Faculty of Education and Literature, Northern Border University Saudi Arabia
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The research aims to identify the future teachers' attitudes toward cloud computing in the Kingdom of Saudi Arabia from their point of view. The research adopted the descriptive approach, and a questionnaire was applied to a random sample of (370) male and female teachers in governmental and private general education schools in the Al-Jouf region, Saudi Arabia. The results of the research concluded that the reality of future teachers' attitudes towards cloud computing in the Kingdom of Saudi Arabia from their point of view is very high and that most areas of using computing are in the field of assessment, then teaching, and activities. The challenges of future teachers' attitudes toward cloud computing are recorded at a high level, parti

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Publication Date
Sun Sep 07 2008
Journal Name
Baghdad Science Journal
The Extent of Homogeneity in the Distribution of Petrophysical Properties that Affecting the Primary and Enhanced Oil Recoveries of Reservoir Rocks in Zubair Formation of South Iraq
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Records of two regionalized variables were processed for each of porosity and permeability of reservoir rocks in Zubair Formation (Zb-109) south Iraq as an indication of the most important reservoir property which is the homogeneity,considering their important results in criterion most needed for primary and enhanced oil reservoirs.The results of dispersion treatment,the statistical incorporeal indications,boxes plots,rhombus style and tangents angles of intersected circles indicated by confidence interval of porosity and permeability data, have shown that the reservoir rocks of Zubair units (LS),(1L) and (DJ) have reservoir properties of high quality,in contrast to that of Zubair units (MS) and (AB)which have reservoir properties of less q

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Publication Date
Fri Apr 12 2019
Journal Name
Journal Of Economics And Administrative Sciences
Measuring and analysis of the impact of public budget deficit on external debt in lraq with in the framework of joint integration of the period (1990 – 2016 )
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The concept of deficit in public budget becomes a chronic economic phenomenon in most of the world, whether the advanced countries or developing countries. Despite  the difference in the visions of the economic schools to accept or reject the deficit in public budget but the opinion that prevailed is the necessity of the state to reduce the public spending which led to a continuous deficits in the public budget which consequently increased the government borrowing ,increase income taxes and wealth, consequently this weakened the in motivation in private investment which contributed to the increase of in factionary stagnation , so that governments have to cover the lack of local funding sources which become difficult to be eq

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