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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Sep 26 2018
Journal Name
Journal Of Research In Ecology
Study of changes using biochemical markers in albino mice after acute exposure to acetamiprid
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The present study aimed to investigate the acetamiprid effects on biochemical aspects in albino mice. Thirty albino mice at the age of 6-8 weeks and average weight 25±5 g were divided into three groups each having ten (10) healthy mice. The first group was orally administrated with distilled water while the second and third groups were orally administrated with 50 mg/mL and 100 mg/mL respectively of acetamprid (0.1 mL) daily for one week. LD50 of acetamiprid was measured and found to be 200 mg/kg. The parameters of evaluations included liver function using Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP). Lipid profile was anal

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Publication Date
Sat Apr 01 2017
Journal Name
Al–bahith Al–a'alami
Stereotypical Frames if the Image of Women in the Iraqi TV Drama after 2003
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This study aims to deliver the woman’s image and to unveil on how to be introduced in the TV series. The research is based on the survey method-using content analysis tool. The research sample represented in the TV series produced by the IMN, which were displayed in 2014 and used the pattern of Margaret Gallagher to analyze the content of the series in accordance with the frame analysis theory.
The study came up with declination of the woman’s representation compared with man in Iraqi TV drama, also the study finds that the series introduced the woman according to the personal, social, political, and economic frames in a standardizing method. It focuses on the characteristics always attributed to it as showing her obedient of the

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Publication Date
Thu Jan 30 2020
Journal Name
Journal Of Engineering
Calculation of Pressure Loss of Two Drilling Muds in Noor Oil Field
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In this work, calculation of pressure losses in circulating system for two drilling muds is evaluated in Noor oil field. Two types of drilling muds that were used for drilling section 12 1/4" and 8 3/4" which are Salt saturated mud and Ferro Chrome Lignosulfonate-Chrome Lignite mud. These calculations are based on field data that were gathered from the drilling site of well Noor-15, which are included, rheological data, flow data and specification of drill string. Based on the obtained results, the best rheological model that fit their data is the Herschel-Bulkley model according to correlation coefficient value for their two drilling mud. Also, the difference between the calculated pressure lo

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Publication Date
Thu Feb 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
The Comparison between the BEKK and DVECH Models of Multivariate GARCH Models with Practical Application
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The Purpose of this research is a comparison between two types of multivariate GARCH models BEKK and DVECH to forecast using financial time series which are the series of daily Iraqi dinar exchange rate with dollar, the global daily of Oil price with dollar and the global daily of gold price with dollar for the period from 01/01/2014 till 01/01/2016.The estimation, testing and forecasting process has been computed through the program RATS. Three time series have been transferred to the three asset returns to get the Stationarity, some tests were conducted including Ljung- Box, Multivariate Q and Multivariate ARCH to Returns Series and Residuals Series for both models with comparison between the estimation and for

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Publication Date
Sun Dec 01 2019
Journal Name
Baghdad Science Journal
Comparison between Biological Activities of Commercial and Synthesized Carbon Nanotubes by Flame Fragments Deposition Technique
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Carbon nanotubes (CNTs) were synthesized via liquefied petroleum gas (LPG) as precursor using flame fragments deposition (FFD) technique. In vitro, biological activates of carbon nanotubes (CNTs) synthesized by FFD technique were investigated. The physiochemical characterizations of synthesized CNTs are similar to other synthesized CNTs and to the standard sample. Pharmaceutical application of synthesized CNTs was studied via conjugation and adsorption with different types of medicines as promote groups. The conjugation of CNTs was performed by adsorption the drugs such as sulfamethoxazole (SMX) and trimethoprim (TMP) on CNTs depending on physical properties of both bonded parts. The synthesized CNTs almost have the same performance in a

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Publication Date
Tue Jan 01 2019
Journal Name
Cogent Engineering
IEC 60909 and ANSI standards comparison with ASCC based fault calculations of Iraqi power system
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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 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
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
Tue Jun 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
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