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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Jan 01 2021
Journal Name
International Journal Of Agricultural And Statistical Sciences
DYNAMIC MODELING FOR DISCRETE SURVIVAL DATA BY USING ARTIFICIAL NEURAL NETWORKS AND ITERATIVELY WEIGHTED KALMAN FILTER SMOOTHING WITH COMPARISON
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Survival analysis is widely applied in data describing for the life time of item until the occurrence of an event of interest such as death or another event of understudy . The purpose of this paper is to use the dynamic approach in the deep learning neural network method, where in this method a dynamic neural network that suits the nature of discrete survival data and time varying effect. This neural network is based on the Levenberg-Marquardt (L-M) algorithm in training, and the method is called Proposed Dynamic Artificial Neural Network (PDANN). Then a comparison was made with another method that depends entirely on the Bayes methodology is called Maximum A Posterior (MAP) method. This method was carried out using numerical algorithms re

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Publication Date
Sun May 26 2019
Journal Name
Iraqi Journal Of Science
Bayesian Estimation for Two Parameters of Gamma Distribution under Generalized Weighted Loss Function
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This paper deals with, Bayesian estimation of the parameters of Gamma distribution under Generalized Weighted loss function, based on Gamma and Exponential priors for the shape and scale parameters, respectively. Moment, Maximum likelihood estimators and Lindley’s approximation have been used effectively in Bayesian estimation. Based on Monte Carlo simulation method, those estimators are compared in terms of the mean squared errors (MSE’s).

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Publication Date
Tue Oct 08 2002
Journal Name
Iraqi Journal Of Laser
Cross-focusing Effect of Two Intense Laser Beams on Electron Plasma Wave Excitation
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This paper presents the effect of relativistic and ponderomotive nonlinearity on cross-focusing of two intense laser beams in a collisionless and unmagnetized plasma. It should be noted here that while considering the self-focusing due to relativistic electron mass variation, the electron ponderomotive density depression in the channel may also be important. Therefore/these two nonlinearties may simultaneously affect the self-focusing process. These nonlinearities depend not only on the intensity of one laser but also on the second laser. Therefore, one laser beam affects the dynamics of the second beam and hence the process of cross-focusing takes place. The electric field amplitude of the excited electron plasma wave (EPW) has been cal

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Publication Date
Sat Jan 01 2022
Journal Name
International Journal Of Nonlinear Analysis And Applications
A general solution of some linear partial differential equations via two integral transforms
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In this paper, a new analytical method is introduced to find the general solution of linear partial differential equations. In this method, each Laplace transform (LT) and Sumudu transform (ST) is used independently along with canonical coordinates. The strength of this method is that it is easy to implement and does not require initial conditions.

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Clarivate
Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Calculate the one – expectation to electronic charge of atomic system contiun two electron
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The aim of this work is to calculate the one- electron expectation value of the electronic charge of atomic system Z=2,3….7 and we compare with He atom . the electronic density function D(r1) of He atom and like ions are evaluated . using Hartree –Fock wave.

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Publication Date
Fri Dec 30 2011
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Extraction of Valuable Metals From Spent Hydrodesulfurization Catalyst By Two Stage Leaching Method
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Spent hydrodesulfurization (Co-Mo/γ-Al2O3) catalyst generally contains valuable metals like molybdenum (Mo), cobalt (Co), aluminium (Al) on a supporting material, such as γ-Al2O3. In the present study, a two stages alkali/acid leaching process was conducted to study leaching of cobalt, molybdenum and aluminium from Co-Mo/γ-Al2O3 catalyst. The acid leaching of spent catalyst, previously treated by alkali solution to remove molybdenum, yielded a solution rich in cobalt and aluminium.

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Publication Date
Sun Jul 09 2023
Journal Name
Journal Of Engineering
Two-Phase Partitioning Bioreactor for the Treatment of Crude Oil- Contaminated Aqueous Solution
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A new application of a combined solvent extraction and two-phase biodegradation processes using two-liquid phase partitioning bioreactor (TLPPB) technique was proposed and developed to enhance the cleanup of high concentration of crude oil from aqueous phase using acclimated mixed culture in an anaerobic environment. Silicone oil was used as the organic extractive phase for being a water-immiscible, biocompatible and non-biodegradable. Acclimation, cell growth of mixed cultures, and biodegradation of crude oil in aqueous samples were experimentally studied at 30±2ºC. Anaerobic biodegradation of crude oil was examined at four different initial concentrations of crude oil including 500, 1000, 2000, and 5000 mg/L. Complete removal of crud

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Publication Date
Sun Feb 05 2017
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
STUDY THE OPTIMUM CONDITIONS FOR THE REMOVAL OF HEAVY METAL ELEMENTS FROM AQUEOUS SOLUTIONS USING CONTAMINATED BACTERIA Bacillus subtilis LOCALLY ISOLATED: STUDY THE OPTIMUM CONDITIONS FOR THE REMOVAL OF HEAVY METAL ELEMENTS FROM AQUEOUS SOLUTIONS USING CONTAMINATED BACTERIA Bacillus subtilis LOCALLY ISOLATED
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We studied the effect of certain environmental conditions for removing heavy metal elements from contaminated aqueous solutions (Cd, Cu, Pb, Fe, Zn, Ni, Cr) using the bacterium Bacillus subtilis to appoint the optimal conditions for removal ,The best optimum temperature range for two isolate was 30-35○C while the hydrogen number for the maximum mineral removal range was 6-7. The best primary mineral removal was 100 mg/L, while the maximum removal for all minerals was obtained after 6 hrs of Cu element time and the maximum removal efficiency was obtained after 24 hrs of Cu element. The results have proved that the best aeration for maximum removal was obtained at rotation speed of 150 rpm/minute. Inoculums of 5ml/100ml which contained 1

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Publication Date
Tue Feb 04 2025
Journal Name
Microbes And Infectious Diseases
A preclinical evaluation of the response of repairing the DNA of MCF7 breast cancer cells after exposure to probiotic bacteria
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Publication Date
Sat Feb 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of some robust methods to estimate parameters of partial least squares regression (PLSR)
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   The technology of reducing dimensions and choosing variables are very important topics in statistical analysis to multivariate. When two or more of the predictor variables are linked in the complete or incomplete regression relationships, a problem of multicollinearity are occurred which consist of the breach of one basic assumptions of the ordinary least squares method with incorrect estimates results.

 There are several methods proposed to address this problem, including the partial least squares (PLS), used to reduce dimensional regression analysis. By using linear transformations that convert a set of variables associated with a high link to a set of new independent variables and unr

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