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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 30 2014
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Adsorption of Methyl Green Dye onto Bamboo in Batch and Continuous System
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Adsorption techniques are widely used to remove certain classes of pollutants from waters, especially those that are not easily biodegradable. Dyes represent one of the problematic groups. The removal of methyl green from waste water using bamboo was studied in batch and continuous system. In batch system equilibrium time and adsorption isotherm was studied at different concentrations (5, 10, 15, 20, 25 and 30 ppm) and 50 mg weight of adsorbent.
Langmuir and Freundlich equations were applied for adsorption isotherm data. Langmiur equation was fitted better than Freundlich equation (R2=0.984 for Langmuir equation).The maximum percentage dye removal obtained 79.4% and adsorption capacity was 15.5 mg/g. For continuous system the breakthr

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Publication Date
Mon Feb 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Audit strategies and their role in the quality of the business audit
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Increased the need to promote the profession of auditing, and improving the performance of the audit process, which comes through the effective implementation of its tasks, where the auditor collects the necessary data about the nature of client activity, and any other information it deems necessary to carry out the planning and development of the strategy for how to determine the procedures for implementing the audit process and the scope and timing for evidence clues in order to form an opinion technician neutral about the fairness of the financial statements, as required by the standards of the field work of the planning and supervision of the internal control and evidence to prove, but the failure of the auditor whether in th

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Publication Date
Tue Mar 15 2022
Journal Name
Al-academy
The human self and its representations in the works of Salvador Dali
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The products of the surrealist school since its inception to this day have greatly influenced art in the world, so we find many artists around the world invested in their visual texts the forms generated by surrealism, and here the researcher raises several questions: What are the formal vocabulary that directly or indirectly refers to Self-used by the surrealist painter? Was the surrealist form understood as intended by the movement? In these questions, the research problem is summarized. The importance of it lies in identifying the references to the form of the human self, which are related to the psychological field in the works of the surrealists, especially Salvador Dali. Then the researcher chose his research community from the wor

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Publication Date
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Detection and isolation of flavonoids from Calendula officinalis (F.Asteraceae) cultivated in Iraq
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Calendula officinalis L. (Asteraceae) known as marigold is known to have several pharmacological activities and used for the treatment of several diseases as measles, jaundice, constipation and several inflammations. Marigold flowers contain several chemical constituents mainly flavonoids, triterpenoids and essential oil. In this study marigold flowers cultivated in Iraq had been investigated for its flavonoids content. The study revealed the presence of quercetin and kaempferol glycosides and the absence of myricetin glycosides. The flowers were extracted with ethanol 70% fractionated with different solvent and the flavonoids were isolated by preparative HPLC. The isolated flavonoids were identified by measuring melting points, UV, IR,

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Publication Date
Wed Sep 30 2015
Journal Name
College Of Islamic Sciences
Break in the bond And its impact on the difference of scholars
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Break in the bond and its impact on the difference of scholars

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Publication Date
Sat Jan 13 2018
Journal Name
Journal Of Engineering
Statistical Analysis of Mortality and Morbidity Due to Traffic Accidents in Iraq
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Undoubtedly, Road Traffic Accidents (RTAs) are a major dilemma in term of mortality and morbidity facing the road users as well as the traffic and road authorities. Since 2002, the population in Iraq has increased by 49 percent and the number of vehicles by three folds. Consequently, these increases were unfortunately combined with rising the RTAs number, mortality and morbidity. Alongside the humanitarian tragedies, every year, there are considerable economic losses in Iraq lost due to the epidemic of RTAs. Given the necessity of understanding the contributory factors related to RTAs for the implementation by traffic and road authorities to improve the road safety, the necessity have been a rise for this research which focuses into

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Publication Date
Fri Apr 01 2016
Journal Name
Communications In Nonlinear Science And Numerical Simulation
Simultaneous determination of time and space-dependent coefficients in a parabolic equation
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Publication Date
Thu Oct 06 2022
Journal Name
Advances In Systems Science And Applications
Stability and Bifurcation of a Delay Cancer Model in the Polluted Environment
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It is well known that the spread of cancer or tumor growth increases in polluted environments. In this paper, the dynamic behavior of the cancer model in the polluted environment is studied taking into consideration the delay in clearance of the environment from their contamination. The set of differential equations that simulates this epidemic model is formulated. The existence, uniqueness, and the bound of the solution are discussed. The local and global stability conditions of disease-free and endemic equilibrium points are investigated. The occurrence of the Hopf bifurcation around the endemic equilibrium point is proved. The stability and direction of the periodic dynamics are studied. Finally, the paper is ended with a numerical simul

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Publication Date
Mon Mar 30 2020
Journal Name
International Journal Of Language And Literary Studies
Examination of ‘Pause’ in Pinter's The Homecoming and Baker's Circle Mirror Transformation
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Pauses as pragmatic markers are considered important devices that help readers to gain a better and deeper understanding of certain texts as well as speech, promoting effectively language communication. They can help both the speaker and the hearer, due to the functions they have in a text. Their occurrence in speech has a value that they make it more understandable. In this regard, the present study aims to examine the forms and functions of pauses in literary texts, more specifically, in selected extracts from two dramas, namely, Pinter's The Homecoming and Baker's Circle Mirror Transformation and to compare how the two writers use pauses in these two dramas. To do so, the sequential production approach of turn-taking by Sacks, Sc

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Publication Date
Fri Mar 15 2019
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of Dental Calculus, Plaque and GingivalInflammation in Patients with Urinary Stone
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Background: Dental calculus is mineralized dental plaque formed on teeth and dental prosthesis surfaces in the oral cavity. Urinary stone is a crystal aggregation formed in urinary system due to minerals saturation present in urine. The structure of dental calculus is similar to that of urinary stone. Objective: To assess oral hygiene and gingival status in patients with urinary stone. And compared with healthy subjects. Patients and Methods: Sixty participants, 25-40 years, were involved in this study who were divided into study and control group. The study group involved patients with urinary stone while the control group involved healthy subjects. Clinical parameters including plaque, calculus and gingival indices were recorded for al

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