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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 04 2004
Journal Name
5th Scientific Conference Of Engineering College In University Of Baghdad, 25th -27th Of February, Baghdad, Iraq
Technology and lighting in interior Design.
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Publication Date
Thu Jun 03 2004
Journal Name
Journal Of Engineering
Heritage and Art Creativity in architecture
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Publication Date
Thu Dec 30 2021
Journal Name
Al-kindy College Medical Journal
Melatonin in male and female fertility
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Melatonin, a hormone synthesized mainly by the pineal gland, has been found in extra-pineal organs as well. It’s known as an organizer of circadian rhythms and more recently as an anti-oxidant. In addition to its role in maintaining immunity, pathophysiology of cardiovascular and neurological diseases, and as an anti-cancer agent, evidence has demonstrated that melatonin exerts a positive impact on male and female fertility primarily through oxygen scavenging effects. In In Vitro Fertilization (IVF) programs, supplementation of melatonin may be associated with better outcomes in terms of sperm quality, oocyte quality, embryo quality and pregnancy rates. This review summarizes various actions of melatonin on the body focusing on ma

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Publication Date
Wed Dec 15 2021
Journal Name
Al-academy
Shorthand and Implicit in Graphic Design
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 Reduction represents a form of artistic abstraction to express things with formal symbols that suggest the content of the idea, as the beauty of the design artwork cannot be unique in the form only, but in revealing its meaning as well. He resorts to shorthand to express the content of his idea related to design necessities and needs to achieve a specific function whose role is crystallized through the form that follows the function. The importance of the research was also represented in: Benefiting workers and scholars in the field of design with regard to shorthand and implicit in graphic design. The aim of the research: to identify the relationship between implicit meaning and reduced forms in graphic design. And the aesthetic of fo

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Publication Date
Thu Dec 30 2021
Journal Name
Al-kindy College Medical Journal
Melatonin in male and female fertility
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Melatonin, a hormone synthesized mainly by the pineal gland, has been found in extra-pineal organs as well. It’s known as an organizer of circadian rhythms and more recently as an anti-oxidant. In addition to its role in maintaining immunity, pathophysiology of cardiovascular and neurological diseases, and as an anti-cancer agent, evidence has demonstrated that melatonin exerts a positive impact on male and female fertility primarily through oxygen scavenging effects. In In Vitro Fertilization (IVF) programs, supplementation of melatonin may be associated with better outcomes in terms of sperm quality, oocyte quality, embryo quality and pregnancy rates. This review summarizes various actions of melatonin on the body focusing on male an

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Publication Date
Thu Jan 31 2019
Journal Name
Journal Of The College Of Education For Women
Urbanization and urban growth in Iraq
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The development issue is considered as one of the most important matters of concern to governments, intellectuals and specialists in the contemporary world, especially in developing countries that are trying hard to move out of the afflicting underdevelopment domain to a brighter future and achieve the aspirations of those countries through organized planning which take advantage of available resources, whether material or humanitarian, in the best way possible.
The development process are taking place at multiple levels ranging from national to regional to local where the community is stimulated and excited for the cooperation, participation and preparation to perform planned change in the methods of thinking, acting and production.<

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Publication Date
Wed May 17 2023
Journal Name
College Of Islamic Sciences
Time in (what and whatever) conditionals
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This is a research in which I studied the opinions of Arab scholars, in their studies
For (what) and (whatever) the two conditionals and their indication of time, and its name
B (time in (what) and (whatever) the two conditions), and I mentioned their opinions in it
This issue was discussed and discussed, and in this study it relied on the sources of the Arabic language.
Especially the books of grammar, interpretation, and the opinions of the scholars of the principles of jurisprudence are mentioned,
I also mentioned the opinion of the scholars of jurisprudence, and how they likened (whatever) to (everything).
In its indication of repetition, and as long as it indicates repetition, it indicates
time Because repetitio

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The Babis and Baha’is in Iran
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The person who wants to learn. The history of Bab’is will notice a very
starnge phenomenon that they (Babis and Baha’is) resort to visions to prove their
delusion.
The believers usually reach to each other by their visions. This phenomenon
are shared among them from Al- Ahsa’ai time till the last phase of their propaganda
which is the Baha’is propaganda, and this is due to their ignorance and under
development in doctrine of islam which was widespread in Iran and the Islamic world.
The whole secrets of Babis and Baha’is movement were restricted among
particular group, most of them were Al- Rashti’s students and knew the basic
principles of their movement which deperding or (the principles) declarati

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Publication Date
Sat Oct 01 2022
Journal Name
Al–bahith Al–a'alami
Approaches in media, role and mobilization
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There is a natural problem raised by the issue of media performance. As a separate activity and express its own capabilities. This problem can be framed in the form of a question: Is media performance merely a reflection of the activity of other sectors of society, especially political and economic, and what links them to other societal sectors of interrelated relations? Is the media limited to mere transfer, or is it an industry with its own mechanisms and rules? The answer may seem somewhat complicated if we handle media with research and study in general, but the issue may be less complicated when it comes to Arab media, because its data may add another setback to the overall Arab setbacks.

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Publication Date
Wed Jan 01 2014
Journal Name
Journal Of The College Of Languages (jcl)
Hedges in Male and Female Language
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Hedging is a linguistic phenomenon used to convey interpersonal messages in spoken interaction. It is a communicative strategy which enables speakers to soften the force of utterances or moderate the assertive force of  utterances. It is resulted from different features such as uncertainty, doubt, tentativeness, ambiguity, neutrality, mitigation, and subjectivity. Hedging is used widely in  TV debates to make utterances more acceptable to the interlocutors. Hedges are expressions used to communicate the speaker's  weak commitment to information conveyed. The utterances in debates are often hedged because in an unhedged form  might sound threatening to the addressees, and, therefore, be likely to be rejected.

&

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