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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 20 2018
Journal Name
Al-academy
Simulation and its applications in contemporary graphic design
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   The simulation is the oldest theory in art, since it appeared in the Greek aesthetic thought of the philosopher Plato, as we find in many of the thinkers and philosophers over a wide period of time to reach our world today. Our fascination with art in general and design art in particular is due to the creativity and innovations of the artist through the simulation, as well as the peculiarities in this simulation, which give objects signs and signals that may have an echo that sometimes does not exist in their physical reality.

   The real representation of life and design construction, descriptions of the expression of each of them in the form of intellectual construction and the ideas of producti

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Crossref
Publication Date
Sun Apr 02 2017
Journal Name
Journal Of Educational And Psychological Researches
Educational values and their role in some religions
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 The Islamic religion approach Rabbani urges and seeks to bring happiness to people, as Allah says: ((We sent thee not all people glad tidings and a warner, but most people do not know)) Spa: State 28
   Islam looks at the concept of educational values ​​through positive behavior derived emerging through formal and informal education. The Islamic approach works on the basis of a systematic and clear rule in the form of an integrated system includes multiple areas. As the lead actor role as the desired position.
  Although 

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Publication Date
Tue Oct 31 2023
Journal Name
College Of Islamic Sciences
Heretic rulings And related words in Islamic jurisprudence
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How I was eager to research the ruling on three of the most dangerous types to Islam and Muslims (the heretic, the sorcerer, the innovator, and related terms).
Because it is the most dangerous deadly disease that destroys the hearts of Muslims, and may even expel a Muslim from the circle of Islam, and how many Muslims have done or committed such a thing without knowing it. Indeed, how many Muslims have left Islam and whose wife has abandoned him without realizing it, and among them are those who have committed it without knowing it. As well as related words associated with heresy.( )
Because people debated such matters between extremists and lenient ones, most of whom were extremists, and they did not reach a conclusion. So I decid

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Publication Date
Thu Oct 01 2009
Journal Name
Ipmj
Perniosis: Clinical and epidemiological study in Iraqi patient
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A Al-Nuaimy, B Fadheel…, IPMJ, 2009 - Cited by 1

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Publication Date
Thu Oct 01 2009
Journal Name
Journal
Perniosis: clinical and epidemiological study in Iraqi patients
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AN Adil A, F Basman M, 2009

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Publication Date
Sun Oct 01 2023
Journal Name
Bionatura
Geological and Plant Diversity in Hawizeh Marshes, Iraq
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Scopus
Publication Date
Sat Feb 02 2019
Journal Name
Journal Of The College Of Education For Women
The Haughtiness and the Humility in Al Koran
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Abstract
What the research come to:
1- The presentation of the image of the proud person in this
mortal life appeared in several styles such as (conversation)
arousing the insert once and convincing in other time,
(confirmation) in all its types، (argument) scolding with the
gradual progress of time of the discourse .Interview and
parallelism are two of these styles with the presences of the
repetition style especially in the topics that has a reference to
the theme of (pride) being implied not directly stated. The
Koran discourse varied in its reference to the theme of pride
according to the context which is mentioned directly
(eighteen times) which formed one third of the number of

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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
Social Work and Social Policies in Iraqi Society
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Through the study of social work and social policy ( problems of marginalization and empowerment opportunities ) and taken a theoretically descriptive and analytical and highliyhed the role of social work in social policy its achieved only through community intraction and paamong all parties and according to social policies include of material resources and haman and integrated in to the planning and development framework with the aim of providing social services for allsegments of society and become the study in social work that include the introducation / and five chapters each chapter in cludes several detectives and each complements the other .
1 – The absence of social development projects on social policy .
2 – social pol

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Publication Date
Fri Jun 01 2018
Journal Name
Journal Of The College Of Languages (jcl)
In-betweenness and Liminal Selfin Amiri Baraka's Dutchman
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This study deals with the thems of "in-betweeness" in the modern Afro-American Drama, drawing upon the accumulated literature of the colonial and postcolonial studies. In-betweeness appears in these studies under the canopy of the terms mimicry, hybridity and liminality which refer to a transformative, in-between state of being. It also refers to themutual relations holdingbetween man and his cultural space.

This concept is fitting the Afro-American playwright Amiri Baraka's plays and his violent, revolutionary theatre. In his play Dutchman (1964), Clay, the protagonist, is a good example of the two-ness or in-betweeness. He finds difficulty choosing between the ethnocentric white culture and the black culture.He allows

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Publication Date
Sun Jun 01 2008
Journal Name
Al-khwarizmi Engineering Journal
Hydrodynamics, Mass and Heat Transfer in Reactive Distillation
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      The ethyl acetate synthesis via heterogeneous reactive distillation is studied experimentally using ethanol and acetic acid. Three types of cation exchanging resins were used as catalysts: Zerolit 225, Zerolit 226 and Ambylite 400. Experiments were carried out in two units of the same dimensions. Each unit consisted of three sections: rectifying, reactive and stripping sections of heights (60+25+20) cm respectively and 2.5cm column diameter. The first unit (column-A-) was a fractionation type and the second unit (column-B-) was packed column. The packing type was hollow glass cylinders with 10 mm height, and 4, 5 mm inner and outer diameter respectively.

      The experiment

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