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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Mar 01 2018
Journal Name
2018 International Conference On Computing Sciences And Engineering (iccse)
Comparison between Epsilon Normalized Least Means Square (ϵ-NLMS) and Recursive Least Squares (RLS) Adaptive Algorithms
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There is an evidence that channel estimation in communication systems plays a crucial issue in recovering the transmitted data. In recent years, there has been an increasing interest to solve problems due to channel estimation and equalization especially when the channel impulse response is fast time varying Rician fading distribution that means channel impulse response change rapidly. Therefore, there must be an optimal channel estimation and equalization to recover transmitted data. However. this paper attempt to compare epsilon normalized least mean square (ε-NLMS) and recursive least squares (RLS) algorithms by computing their performance ability to track multiple fast time varying Rician fading channel with different values of Doppler

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Publication Date
Fri Apr 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
A Comparison Between Classic Local Least Estimatop And Bayesian Methoid For Estimating Semiparametric Logistic Regression Model
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Semi-parametric models analysis is one of the most interesting subjects in recent studies due to give an efficient model estimation. The problem when the response variable has one of two values either 0 ( no response) or one – with response which is called the logistic regression model.

We compare two methods Bayesian and . Then the results were compared using MSe criteria.

A simulation had been used to study the empirical behavior for the Logistic model , with  different sample sizes and variances. The results using represent that the Bayesian method is better than the   at small samples sizes.

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Publication Date
Sun Jul 09 2023
Journal Name
Journal Of Engineering
Comparison between Linear and Non-linear ANN Models for Predicting Water Quality Parameters at Tigris River
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In this research, Artificial Neural Networks (ANNs) technique was applied in an attempt to predict the water levels and some of the water quality parameters at Tigris River in Wasit Government for five different sites. These predictions are useful in the planning, management, evaluation of the water resources in the area. Spatial data along a river system or area at different locations in a catchment area usually have missing measurements, hence an accurate prediction. model to fill these missing values is essential.
The selected sites for water quality data prediction were Sewera, Numania , Kut u/s, Kut d/s, Garaf observation sites. In these five sites models were built for prediction of the water level and water quality parameters.

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Publication Date
Mon Jan 01 2024
Journal Name
Aip Conference Proceedings
A comparison between banana peel powder and gel for removing methylene blue dye from aqueous solution
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This research aims to removes dyes from waste water by adsorption using banana peels. The conduct experiment done by banana powder and banana gel to compare between them and find out which one is the most efficient in adsorption. Studying the effects different factors on adsorption material and calculate the best removal efficiency to get rid of the methylene blue dye (MB).

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Publication Date
Sat Jan 01 2022
Journal Name
The 2nd Universitas Lampung International Conference On Science, Technology, And Environment (ulicoste) 2021
A comparison between IRI-2016 and ASAPS models for predicting foF2 ionospheric parameter over Baghdad city
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Publication Date
Thu Feb 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Phytochemical Screening of Petroleum Ether Fractions by GC/MS and Isolation of Lupeol from Two Different Parts of Iraqi Leucaena leuco-cephala. (Conference Paper )#
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Abstract

This work is considered the first study for the components of the Iraqi Leucaena leucocephala plant, where the different phytochemical compounds that present in the aerial parts were identified by using the gas chromatography/mass spectrometry technique (GC/MS). The type of the components and their concentration will differ according to the part of the plant used and the method of extraction (hot and cold). This study made a comparison in lupeol concentration that was identified and isolated from petroleum ether fractions of Leucaena leucocephala by using Gas Chromatography/Mass Spectrometry (GC/MS), High-performance thin-layer chromatography (HPTLC), and Preparative High-Performance Li

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Publication Date
Wed Nov 01 2023
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
After Introducing Artificial Intelligence, can Pharmacists Still Find a Job?
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Publication Date
Thu Sep 12 2019
Journal Name
Al-kindy College Medical Journal
Minimal sternotomy surgery in comparison to standard sternotomy in the coronary bypass Surgery
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Background Median sternotomy is the gold standard incision for most cardiac operations. However, with the advent of minimal invasive surgery, a new approach emerged in cardiac surgery named mini-sternotomy and has been successfully used to perform a variety of operations.

 The aim of this paper is to present our experience of using mini-sternotomy to harvest the left internal mammary artery (LIMA) for off-pump revascularization of the left anterior descending artery (LAD)

 Methodology Over a 2-year period (October 2012-October 2014), 100 patients underwent coronary artery bypass grafting (CABG) via conventional median sternotomy (CMS) (n=80) and mini-sternotomy (MS) (n=20). The

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Publication Date
Mon Sep 30 2002
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Effect of using Two Binders on the Agglomeration of Zeolite Type 4A
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Publication Date
Tue Mar 01 2016
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparison of the Effectiveness of Reciprocating System with Continuous Rotary Systems in Non-Surgical Endodontic Retreatment
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Background: Optimal root canal retreatment was required safe and efficient removal of filling material from root canal. The aim of this in vitro study was to compare the efficacy of reciprocating and continuous motion of four retreatment systems in removal of root canal filling material. Materials and Methods: Forty distal roots of the mandibular first molars teeth were used in this study, these roots were embedded in cold clear acrylic,roots were instrumented using crown down technique and rotary ProTaper systemize Sx to size F2 ,instrumentation were done with copiousirrigation of 2.5% sodium hypochlorite and 17% buffered solution of EDTA was used as final irrigant followed by distilledwater, roots were obturated with AH26 sealer and Prota

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