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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Nov 26 2017
Journal Name
Journal Of Engineering
Reservoir Characterizations and Reservoir Performance of Mishrif Formation in Amara Oil Field
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Mishrif Formation is the main reservoir in Amara Oil Field. It is divided into three units (MA, TZ1, and MB12). Geological model is important to build reservoir model that was built by Petrel -2009. FZI method was used to determine relationship between porosity and permeability for core data and permeability values for the uncored interval for Mishrif formation. A reservoir simulation model was adopted in this study using Eclipse 100. In this model, production history matching executed by production data for (AM1, AM4) wells since 2001 to 2015. Four different prediction cases have been suggested in the future performance of Mishrif reservoir for ten years extending from June 2015 to June 2025. The comparison has been mad

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Publication Date
Tue Jun 30 2015
Journal Name
College Of Islamic Sciences
The Logic of Freezers and Animals in the Holy Quran: (Objective study
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The Logic of Freezers and Animals in the Holy Quran

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Publication Date
Wed Dec 30 2015
Journal Name
College Of Islamic Sciences
Medical evidence in matters of proof between Sharia and law: A model
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Praise be to God, prayer, and peace be upon the Messenger of Allah and his God and his companions. The field of the judiciary to prove or invalidate some cases in the field of proof of descent and attachment to the plaintiff or exile, and other legal and judicial issues, especially in this era where the spread of previously unknown evidence, such as DNA, which was discovered in 1953, and the genetic fingerprint discovered 1984, blood analysis and a Saliva, sweat, poetry, etc. in the field of forensic evidence, in forensic medicine or medical expertise, it can be used to identify the killer, or verify his identity, using all the evidence in the scene, such as a point of blood or sweat, and the like So, as well as to prove the lineage is u

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Publication Date
Wed Mar 29 2023
Journal Name
Journal Of The College Of Education For Women
Blindness and the Critique of Society: Dystopia in “Blindness” by José Saramago""
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This paper addresses the new coloring in the concept of dystopian society as represented by the positive role of one of the characters vs. the passive role of the government and its mutual effect on the people of the society. In addition, it describes how all men in the dystopian society victimize and degrade the other through unlawful acts, like: stealing, rape, and fear, which are the lowest points in a moral decay. However, it offers hope by illustrating a positive sense, as exemplified by the doctor's wife out of Saramago's optimistic view that men may be descended from good women. Accordingly, the paper aims to examine the effect of the government’s role in the lives of the people who have later turned into blind in a dystopi

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Publication Date
Wed Jun 01 2022
Journal Name
Res Militaris
Relationship marketing and its role in the success of industrial project management
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The research aims to identify the role determined by the dimensions of marketing in the relationship represented by (trust in the relationship, commitment to the relationship, communication during the relationship) in how to contribute to the success of the industrial project management in Iraq as a case study in the General Directorate of Industrial Development. Their number is (50) workers, where the research problem centered on knowing the impact and importance of relationship marketing on the success of industrial project management. The descriptive analytical approach. Using SPSS and Amos, the researcher tested and analysed hypotheses about the relationship and the influence between the research variables through a questionnaire . Test

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Publication Date
Tue Feb 28 2023
Journal Name
Iraqi Journal Of Science
Gentamicin Upregulates the Gene Expression of hla and nuc in Staphylococcus aureus
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The current study aimed to detect the effect of gentamicin stress on the expression of hla (encodes hemolysin) and nuc (encodes nuclease) genes of Staphylococcus aureus. Fifty-eight isolates identified as S. aureus were isolated locally from different clinical specimens. Disk diffusion method was used to detect the resistance to S. aureus. The minimum inhibitory concentration (MIC) of gentamicin was estimated by broth microdilution method. hla and nuc genes were determined by polymerase chain reaction technique. The biofilm was evaluated using the microtiter plate method in the presence and absence of gentamicin at sub-MIC. The results showed that 18 (31%) and 40 (69%) S. aureus isolates were sensitive and resistant to gentamicin, respectiv

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Calcium, Magnesium and Phosphorous Levels in Serum of Iraqi Women with Fibromyalgia
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         Fibromyalgia (FM) is a common, debilitating, and chronic pain syndrome. The women are more likely to have more tender points on examination than are their male counterparts. Iraqi study showed that FM occur in 1.5% among adolescents of Iraqi population. In compare to normal healthy women, present study was revealed that Iraqi women with FM have significant elevation of calcium (p = 0.003) with significant reduction of magnesium (p = 0.001), whereas the inorganic phosphorous was not differs (p = 0.31). In conclusion, magnesium and calcium would play a crucial role in etiopathogenesis of fibromyalgia.

Key words: calcium, magnesium, phosphorous, Fibromyalgia.

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Publication Date
Wed Mar 15 2023
Journal Name
Bionatura
Study the antioxidant of Matricaria chamomilla (Chamomile) powder: In vitro and vivo
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Oxidative stress is oxidative damage caused by free radicals and reactive oxygen species (ROS). These ROS can cause oxidative damage to cellular components, including membrane lipids, receptors, enzymes, proteins, and nucleic acids. It would eventually lead to cell apoptosis and the appearance of certain pathological conditions. This work investigates the antioxidant potentials of chamomile extract in vitro by evaluating the extract activity to scavenge 2,2-Diphenyl-1-picrylhydrazyl (DPPH), also in vivo by investigating its effects on oxidative stress-induced rats by assessing the total oxidant status (TOS) and total antioxidant capacity in the radiation exposed rats with and without the treatment with chamomile extract. The results

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Publication Date
Thu Aug 01 2024
Journal Name
Journal Of Engineering Research
Design, analysis and development of a proton exchange membrane in fuel cell
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Publication Date
Sun Nov 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Isolation and identification of polyhydroxyalkanoates producing bacteria from biopolymers waste in soil
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Abstract<p>The production of polyhydroxyalkanoates PHAs from biopolymer degrading bacteria was examined <italic>in situ</italic> by screening isolates using Sudan B Black staining process as potential PHAs detecting, and Nile Blue staining as a proof method detection. Five bacterial strains isolated from biopolymer waste buried in a garden soil were able to produce high rate of PHA. <italic>AK1P</italic> and <italic>AK2P</italic> strains demonstrated high productivity of biopolymer by converting 5% (w/v) lactose as the only carbon source to PHA during fermentation. <italic>AY2P</italic> strain converted 5% (w/v) of glucose with less PHA accumulation. The f</p> ... Show More
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