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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Jan 05 2024
Journal Name
Al-academy
metaphor and their transformations in surrealist painting
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The problem of research tagged: (metaphor and its transformations in the surreal drawing) dealt with the nature of the concept of metaphor and the mechanisms of its work in the contemporary global achievement. The research came in four chapters: The first chapter was concerned with the systematic framework for the research represented by the problem of the research, as it was manifested through this study by metaphor and its transformations, which were associated with the Surreal drawing papers in Europe. The goal of the study has been crystallized with the following:

Exposing metaphor and its transformations in the visual system of the surreal drawing.
As for the limits of the research, I was interested in analyzing video mod

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Publication Date
Thu May 30 2019
Journal Name
لارك
Approaches to Lexicography in English and Arabic
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Lexicography, the art and craft of dictionary-making, is as old as writing. Since its very early stages several thousands of years ago, it has helped to serve basically the every-day needs of written communication among individuals in communities speaking different languages or different varieties of the same language. Two general approaches are distinguished in the craft of dictionary-making: the semasiological and the onomasiological. The former is represented by usually-alphabetical dictionaries as such, i.e. their being inventories of the lexicon, while the latter is manifested in thesauruses. English and Arabic have made use of both approaches in the preparation of their dictionaries, each having a distinct aim ahead. Wit

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Publication Date
Wed May 24 2023
Journal Name
College Of Islamic Sciences
The wife's alimony in Sharia and law
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Praise be to God, we praise Him, we seek His help, we seek His forgiveness, and we seek refuge in God from the evils of ourselves and our bad deeds. . The marriage contract, like other contracts, gives rise to reciprocal rights and duties that bind both the husband and the wife, pursuant to the principle of balance, equivalence, and the equality of the parties to the contract on which every contract is based. . That is, women have rights over men similar to what men have over women, or that the basis for estimating these rights and duties is custom based on the nature of both men and women. The Iraqi Personal Status Law stipulates all the financial rights that the wife is entitled to from her husband: namely, the dowry and alimony. As fo

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Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
Leptin and Insulin Resistance in Obese Children
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Background: Insulin resistance (IR) is the primary metabolic disorder associated with obesity. Obesity is a growing worldwide health problem affecting both adults and children. Objectives: To determine the association between leptin and IR, and to identify the ratio of fasting glucose/leptin (G/L) and insulin/leptin (I/L) as a new simple method for the detection of IR in obese children.Methods: This study was done in the National DiabeticCenter/ AL-Mustansiriya University during the period fromMay 2013 until the end of October 2013. Fasting bloodglucose (FBG), serum insulin, leptin, and lipid profile weremeasured in 52 obese children (24 children with IR and 28without IR); their age range was (5-15) years, they werecompared with 38 healt

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Publication Date
Sat Jan 01 2011
Journal Name
Journal Of Computer Sciences
Connectedness in Graphs and Gm-Closure Spaces
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This paper is devoted to the discussion the relationships of connectedness between some types of graphs (resp. digraph) and Gm-closure spaces by using graph closure operators.

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Publication Date
Sun Oct 15 2023
Journal Name
Bionatura
Nanohydroxyapatite in enamel remineralization and tooth hypersensitivity
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This study evaluates the advantages of employing nano-hydroxyapatite in dentistry, particularly for preventive treatment applications. Only electronically published papers were searched within this review. Sources: "PubMed" website was the only source used to search for data. 92 most relevant papers to the topic were selected, especially the original articles and review papers, from 1990 till the 1st of April 2022. The morphology of nano-hydroxyapatite, as well as the structure of its crystals, are close to that of dental enamel. As a result, hydroxyapatite can biomimetically replace the natural enamel mineral element. Keywords: remineralization of enamel, nanotechnology, nanohydroxyapatite, hypersensitivity.

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Publication Date
Wed Oct 02 2019
Journal Name
Alanbar Journal
Precarity and Gender Performitivity in Morrison’s Home
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Precarity means the lack of social and economic networks; a considerable exposure to danger and harm. Minority groups are precariat for they lack rights and full citizenship. Precarity is related, states Judith Butler, with the individual’s performativity, and his ability to perform his gender role. Toni Morrison continually goes to past to retell the history of African Americans. The issues of race, gender and national identity are recurrent in her work. Reading her book Home (2012) evokes the idea of precarity and performativity since the two main characters, Frank and Cee are precarious characters that fail to perform their gender role properly, and eventually are exposed to hazard and harm. This research displays how African American

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Publication Date
Wed May 24 2023
Journal Name
College Of Islamic Sciences
Proof and its inferences in the Qur'an
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And after:

There are many aspects of inference in the Holy Qur’an, whether it is evidence, evidence, argument, authority, or proof.
These expressions or expressions are close in meaning to each other in appearance, but the Qur’an used them all in their exact place, so every word in the Qur’an has its own use that was set for it, and no other word can replace it even if it is close in meaning to it. And these aspects that the Qur’an mentioned as evidence for the aspects of inference in it may come to be mental, textual, or tactile evidence.
The Qur’an exalted the importance of evidence and proof in its religion, and entrusted it with confirming and rejecting the plaintiff’s claim, regardless of its subject matter

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Publication Date
Tue Mar 31 2020
Journal Name
College Of Islamic Sciences
Ruling on abortion in Sharia and law
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Research title: Ruling on abortion in Sharia and law.

The importance of research: Projection is of great importance because it touches the life of a living being who enjoys human qualities. However, this organism often wastes its rights and does not protect its human beings. These souls are lost in millions by the sake of casual desire or hidden desire.

The research plan: The research dealt with an introductory topic, four topics, and in each topic there are demands, branches, and a conclusion.

The most important findings of the study: The ruling on aborting the fetus in the Sharia is only permissible (and the necessity is valued at its va

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Publication Date
Thu Oct 18 2018
Journal Name
Al–bahith Al–a'alami
Modalities and Methodological Techniques in Media Studies
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There have been many writings and discussions that dealt with the details and interpretation of the research methods and the identification of the methods and methodological methods used by researchers and writers as they deal with research topics and problems in all fields of natural and human sciences. But we noticed that the movement of science and its knowledge and development requires the identification of suitable tools and methodological methods appropriate for each type of science. In other words, attempts should be established to build appropriate methodological tools for human and cognitive activity that can be referred to as a specific science that sets out certain paths of the human sciences which is certainly the ori

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