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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 30 2019
Journal Name
Journal Of Global Pharma Technology
Morphometric Assessment of the Cerebellum of the Pre-implanted albino Rats Embryos after Maternal Exposure to AgNPs
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Cerebellum (cb) is the most important and sensitive part of the central nervous system (CNS) after cerebrum. The exposure to any infection during embryogenesis produces abnormalities in the cerebellum function and morphology that effect on behavioral of offspring later. In the present study we used 30 mature female pregnant albino rats divided in to three groups, each group contain 10 females: G1 was considered the control group received D.W only, while G2 group treated orally with (2mg/kg /day) suspension of silver nanoparticles (AgNPs) and G3 group treated orally with (20mg/kg/day) AgNPs. The embryos retrieved in different embryonic days from ED12 to ED21. In this study morphometric analysis was measured in the developing albino rats cere

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Publication Date
Fri Mar 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Robust Two-Step Estimation and Approximation Local Polynomial Kernel For Time-Varying Coefficient Model With Balance Longitudinal Data
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      In this research, the nonparametric technique has been presented to estimate the time-varying coefficients functions for the longitudinal balanced data that characterized by observations obtained through (n) from the independent subjects, each one of them is measured repeatedly by group of  specific time points (m). Although the measurements are independent among the different subjects; they are mostly connected within each subject and the applied techniques is the Local Linear kernel LLPK technique. To avoid the problems of dimensionality, and thick computation, the two-steps method has been used to estimate the coefficients functions by using the two former technique. Since, the two-

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Publication Date
Tue May 01 2012
Journal Name
Engineering Analysis With Boundary Elements
Radial integration boundary integral and integro-differential equation methods for two-dimensional heat conduction problems with variable coefficients
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Publication Date
Tue May 16 2023
Journal Name
Political Sciences Journal
The New Russian Orientation towards the Eastern European Region after 2021
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The arrival of Russian President Vladimir Putin to power in the Russian Federation is an important factor in delineating a new approach to Russian policy towards regions that have great strategic importance affecting its national security. Therefore, NATO's progress eastward towards these regions prompts Russia to delineate a new strategy to confront this progress as well as preserving its control in the near neighboring regions represented by the countries of Eastern Europe, especially after the changes that occurred in those regions following the color revolutions that swept the region, such as the first application of this Russian policy in 2014, through the annexation of Crimea, and the latest military operations in Ukraine i

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Publication Date
Tue Jul 26 2022
Journal Name
International Journal Of Pharmacy Practice
What might COVID-19 patients experience after recovery? A comprehensive review
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Abstract<sec> <title>Objectives

The objective of this review was to describe the COVID-19 complications after recovery.

Methods

The researchers systematically reviewed studies that reported post-COVID-19 complications from three databases: PubMed, Google Scholar and the World Health Organization (WHO) COVID-19 database. The search was conducted between 21 November 2020 and 14 January 2021. Inclusion criteria were articles written in English, with primary data, reporting complications of COVID-19 after full

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Publication Date
Sun Jun 03 2012
Journal Name
Baghdad Science Journal
Approximate Solution of Some Classes of Integral Equations Using Bernstein Polynomials of Two-Variables
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The research aims to find approximate solutions for two dimensions Fredholm linear integral equation. Using the two-variables of the Bernstein polynomials we find a solution to the approximate linear integral equation of the type two dimensions. Two examples have been discussed in detail.

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Publication Date
Sun Jun 07 2015
Journal Name
Baghdad Science Journal
A comparative study to determine the nature of the eye lens protein in the two types of birds Iraqi
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The study showed significant differences between the average weight lens and the average amount protein in the lens between that Kestrel Falco tinnunculus L. and the Collared Dove Streptopelia decaocto F. , also the study electrical migration of lens proteins having one bundle of crystalline –? in Kestrel compared with three bundles in Collared Dove, two bundles of crystalline – ? in both , and crystalline – ? appeared as one bundle in both birds.

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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
Study of Naidid worms community associated with two species of aquatic plants in River Tigris inside Baghdad City / Iraq
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The present study is concern with the interaction between the naidid worms diversity and the species of aquatic plant within which the worms found . For this purpose, two species of aquatic plant were used, Ceratophyllum demersum and Eichhornia crassipes. 12 samples of aquatic plants were collected , as one sample monthly for a period from September 2012 to September 2013 from different site on Tigris river within Baghdad City. From C. demersum, 1428 individuals, were sorted during the study period, related to 17 species. 12 species of subfamily Naidinae which are Chaetogaster limnaei , C. diastrophus , Ophidonais serpentine , Dero ( Dero) digitata. , D.(D.) evelinae , Nais pseudobtosa , N.simplex, N.stolci , N.Paradalis , N.elingiu

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Publication Date
Sat Dec 03 2022
Journal Name
Iraqi Journal Of Science
Detection of Spectral Reflective Changes for Temporal Resolution of Land Cover (LC) for Two Different Seasons in central Iraq
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The purpose of the study is the city of Baghdad, the capital of Iraq, was chosen to study the spectral reflection of the land cover and to determine the changes taking place in the areas of the main features of the city using the temporal resolution of multispectral bands of the satellite Landsat 5 and 8 for MSS and OLI sensors respectively belonging to NASA and for the period 1999-2021, and calculating the increase and decrease in the basic features of Baghdad. The main conclusions of the study were, This study from 1999 to 2021 and in two different seasons: the Spring of the growing season and Summer the dry season. When using the supervised classification method to determine the differences, the results showed remarkable changes. Where h

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Publication Date
Sat Dec 31 2022
Journal Name
International Journal Of Dentistry
Bond Strength Survival of a Novel Calcium Phosphate-Enriched Orthodontic Self-Etching System after Various Ageing Protocols: An In Vitro Study
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Objective. This study aimed to evaluate the orthodontic bond strength and enamel-preserving ability of a hydroxyapatite nanoparticles-containingself-etch system following exposure to various ageing methods. Materials and Methods. Hydroxyapatite nanoparticles (nHAp) were incorporated into an orthodontic self-etch primer (SEP, Transbond™ plus) in three different concentrations (5%, 7%, and 9% wt) and tested versus the plain SEP (control) for shear bond strength (SBS), adhesive remnant index (ARI) scores, and enamel damage in range-finding experiments using premolar teeth. The best-performing formulation was further exposed to the following four artificial ageing methods: initial debonding, 24 h water storage, one-month water stora

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