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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Some Estimation Methods Of GM(1,1) Model With Missing Data and Practical Application
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This paper presents a grey model GM(1,1) of the first rank and a variable one and is the basis of the grey system theory , This research dealt  properties of grey model and a set of methods to estimate parameters of the grey model GM(1,1)  is the least square Method (LS) , weighted least square method (WLS), total least square method (TLS) and gradient descent method  (DS). These methods were compared based on two types of standards: Mean square error (MSE), mean absolute percentage error (MAPE), and after comparison using simulation the best method was applied to real data represented by the rate of consumption of the two types of oils a Heavy fuel (HFO) and diesel fuel (D.O) and has been applied several tests to

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Publication Date
Fri Dec 30 2022
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Comparison of Estimation Sonic Shear Wave Time Using Empirical Correlations and Artificial Neural Network
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Wellbore instability and sand production onset modeling are very affected by Sonic Shear Wave Time (SSW). In any field, SSW is not available for all wells due to the high cost of measuring. Many authors developed empirical correlations using information from selected worldwide fields for SSW prediction. Recently, researchers have used different Artificial Intelligence methods for estimating SSW. Three existing empirical correlations of Carroll, Freund, and Brocher are used to estimate SSW in this paper, while a fourth new empirical correlation is established. For comparing with the empirical correlation results, another study's Artificial Neural Network (ANN) was used. The same data t

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
A comparison of cross sections for Selenium -73 radioisotopes produced by accelerators and reactors
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Background: Selenium-73 with half- life of 7.15 hour emits β+ in nature and has six stable isotopes which are ( 74Se,76Se,77Se,78Se,80Se and 82Se ). Selenium-73 has many applications in technology and radioselenium compounds of metallic have found various applications in medicine.

Objective:  To make a comparison between different reactions that produced cross sections of Se-73 radioisotopes.

Subjects and methods: The feasibility of the production of Selenium -73 via various nuclear reactions was investigated. Excitation functions of 73Se production by the re

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Publication Date
Wed Nov 24 2021
Journal Name
International Journal Of Drug Delivery Technology
Comparison among the Synthesis of Some Azomethine Derivatives by Classical and Non-classical Methods
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الوصف In this time, most researchers toward about preparation of compounds according to green chemistry. This research describes the preparation of 2-fluoro-5-(substituted benzylideneamino) benzonitrile under reflux and microwave methods. Six azomethine compounds (B1-6) were synthesized by two methods under reflux and assisted microwave with the comparison between the two methods. Reflux method was prepared of azomethine (B1-6) by reaction of 5-amino-2-fluorobenzonitrile with some aldehyde derivatives with (50–100) mL of absolute ethanol and some quantity of GAA and time is limited between (2–5) hours with a yield between (60–70) percent with recrystallization for appropriate solvents. But the microwave-assisted method was synthe

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Publication Date
Fri Apr 22 2022
Journal Name
Asian Journal Of Water, Environment And Pollution
An Ecological Comparison of Benthic Invertebrate Communities Between Sewage and Tigris River Water – Baghdad
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In the current study, two sites were selected from the city of Adhamiya, central Baghdad. The first site is the Adhamiya Corniche, which includes a sample of river water and the second includes domestic sewage in the same area. The total density of benthic invertebrates was 775 ind/m2, which is divided into 15 taxa. Biological indices were found, such as the stability index, the abundance index, the biodiversity index (Shannon’s index), the homogeneity index, and the invader’s guide. The result showed an increase in the density of benthic invertebrates, as well as an increase in the diversity of these organisms.

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Publication Date
Thu Jun 30 2011
Journal Name
Fac Med Baghdad
Prevalence of Anemia among Iraqi Patients after Renal Transplantation
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Background: Although the issue of anemia after renal transplantation (RT) has received increasing attention lately, the data on the exact prevalence of post-transplantation anemia (PTA) in the Iraqi patients are limited. Objective: In this study we sought to determine the prevalence of PTA among Iraqi patients and to correlate the renal allograft function measurements and the use of immunosuppressant with the prevalence of anemia. Patients and Methods: One hundred and twelve (74 male, 38 female) kidney transplant recipients (KTR) attending the kidney transplant center at surgical specialties hospital were studied. All patients were on maintenance, combined immunosuppressive therapy. The renal function tests [blood urea, serum cre

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Flammability action of tires material after adding flame inhibitor
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Magnesium hydroxide was used as flame inhibitor to increased flame resistance for tires .Magnesium hydroxide was adding with (5%,10%) weight percents to rubber master batch of tire and then exposed the resulting material to a flame generated from gas torch with (10 mm) exposure distance . Method of measuring the surface temperature opposite to the flame was used to determine the heat transferred through tire material. The results were obtained shows enhanced flame resistance for tire by added magnesium hydroxide and this resistance increased by increasing hydroxide Percentage .

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Publication Date
Sat Mar 23 2024
Journal Name
Irish Journal Of Medical Science (1971 -)
Validity of galactin-3 in acromegaly: comparison with traditional markers
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Publication Date
Mon Jan 01 2024
Journal Name
E3s Web Of Conferences
Analytical Comparison of Leading Sustainability Systems in the Iraqi Environment
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Over the last two decades, several sustainability assessment methods have developed as key accelerators for the development and improvement of sustainable industrial buildings. Some of these systems, like as LEED or BREEAM, are considered international, whereas others, such as Pearl Rating Systems (PRS), are local. Although they all share similar goals, they can lead to the construction of green buildings or the improvement of the efficiency of existing conventional buildings. Each technique has its structure, certification process, and weighting norms. The inequalities have prompted various questions about whether global assessment systems appropriately consider the country’s national settings. This study aims to compare the Pear

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Publication Date
Wed Jul 01 2020
Journal Name
Journal Of Physics: Conference Series
A Multilevel Approach for Stability Conditions in Fractional Time Diffusion Problems
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Abstract<p>The Caputo definition of fractional derivatives introduces solution to the difficulties appears in the numerical treatment of differential equations due its consistency in differentiating constant functions. In the same time the memory and hereditary behaviors of the time fractional order derivatives (TFODE) still common in all definitions of fractional derivatives. The use of properties of companion matrices appears in reformulating multilevel schemes as generalized two level schemes is employed with the Gerschgorin disc theorems to prove stability condition. Caputo fractional derivatives with finite difference representations is considered. Moreover the effect of using the inverse operator which tr</p> ... Show More
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