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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 2024
Journal Name
Iraqi Journal Of Science
Efficient Computational Methods for Solving the One-Dimensional Parabolic Equation with Nonlocal Initial and Boundary Conditions
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     The primary objective of the current paper is to suggest and implement effective computational methods (DECMs) to calculate analytic and approximate solutions to the nonlocal one-dimensional parabolic equation which is utilized to model specific real-world applications. The powerful and elegant methods that are used orthogonal basis functions to describe the solution as a double power series have been developed, namely the Bernstein, Legendre, Chebyshev, Hermite, and Bernoulli polynomials. Hence, a specified partial differential equation is reduced to a system of linear algebraic equations that can be solved by using Mathematica®12. The techniques of effective computational methods (DECMs) have been applied to solve some s

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Publication Date
Fri May 01 2015
Journal Name
Journal Of Nuclear Medicine
Comparison of in vivo uptake of radioactive gold nanoparticles formulated using phytochemicals
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1267 Objectives Aim to evaluate 198Au nanoparticles (AuNP) biodistribution and uptake in a human prostate model for treatment. Many phytochemicals are known to have anti-tumor properties but have short half-lives in vivo. We hypothesized that using these phytochemicals to formulate and coat AuNP would inhibit enzyme cleavage and enhance their anti-tumor properties. Initial evaluations were performed in SCID mice bearing PC3 tumors. Methods : 198AuNP were formulated with the following gum Arabic, epigalocatechin gallate (EGCg) pomegranate extract and mangiferin extract. The resultant nanoparticles were evaluated in normal mice and in human prostate bearing SCID mice. The tumor bearing mice were injected intratumorally with 3-5 uCi of 198A

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Publication Date
Thu Dec 30 2004
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
History of a Two-Phase Bubble Condensing in an immiscible Liquid
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Publication Date
Sat Feb 01 2020
Journal Name
Journal Of Economics And Administrative Sciences
Economic policies and their ability to reform the investment climate Case Study Iraq after 2003
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The investment climate is the main engine of economic development. If an appropriate and attractive investment climate is created that takes into account economic, administrative, political and environmental issues, it will contribute to the development of industry, transfer of technology, diversification of agricultural production, increased productivity, the promotion of a green economy and support for sustainable and inclusive growth. Thus, analyzing the investment climate of a country can provide reasons and roots for the complexity of the problems in the economy. In the Iraqi economy, the problem has not been rooted in the economy, but the roots of the problem are deeper and inherent in the management of the economy. Investm

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Publication Date
Tue Mar 03 2009
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of repetitive estimation methodsSelf-data
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In this study, we review the ARIMA (p, d, q), the EWMA and the DLM (dynamic linear moodelling) procedures in brief in order to accomdate the ac(autocorrelation)  structure of data .We consider the recursive estimation and prediction algorithms based on Bayes and KF (Kalman filtering) techniques for correlated observations.We investigate the effect on the MSE of  these procedures and compare them using generated data.

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Publication Date
Tue Jun 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
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Publication Date
Wed Jun 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
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Through recent years many researchers have developed methods to estimate the self-similarity and long memory parameter that is best known as the Hurst parameter. In this paper, we set a comparison between nine different methods. Most of them use the deviations slope to find an estimate for the Hurst parameter like Rescaled range (R/S), Aggregate Variance (AV), and Absolute moments (AM), and some depend on filtration technique like Discrete Variations (DV), Variance versus level using wavelets (VVL) and Second-order discrete derivative using wavelets (SODDW) were the comparison set by a simulation study to find the most efficient method through MASE. The results of simulation experiments were shown that the performance of the meth

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Publication Date
Mon Jun 01 2015
Journal Name
International Journal Of Advanced Research In Computer Science And Software Engineering
Performance Comparison of Transport Layer Protocols
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Transport layer is responsible for delivering data to the appropriate application process on the host computers. The two most popular transport layer protocols are Transmission Control Protocol (TCP) and User Datagram Protocol (UDP). TCP is considered one of the most important protocols in the Internet. UDP is a minimal message-oriented Transport Layer protocol. In this paper we have compared the performance of TCP and UDP on the wired network. Network Simulator (NS2) has been used for performance Comparison since it is preferred by the networking research community. Constant bit rate (CBR) traffic used for both TCP and UDP protocols.

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Publication Date
Tue Jun 01 2021
Journal Name
Al-khwarizmi Engineering Journal
Prediction of Surface Roughness after Turning of Duplex Stainless Steel (DSS)
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Feed Forward Back Propagation artificial neural network (ANN) model utilizing the MATLAB Neural Network Toolbox is designed for the prediction of surface roughness of Duplex Stainless Steel during orthogonal turning with uncoated carbide insert tool. Turning experiments were performed at various process conditions (feed rate, cutting speed, and cutting depth). Utilizing the Taguchi experimental design method, an optimum ANN architecture with the Levenberg-Marquardt training algorithm was obtained. Parametric research was performed with the optimized ANN architecture to report the impact of every turning parameter on the roughness of the surface. The results suggested that machining at a cutting speed of 355 rpm with a feed rate of 0.07 m

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Publication Date
Tue Jan 01 2019
Journal Name
Indian Journal Of Public Health Research & Development
Anticardiolipin Antibodies in Comparison to B-HCG Titer and Serum Progesterone as Indicator for Ectopic Pregnancies
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