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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 13 2011
Journal Name
Baghdad Science Journal
Phytoplankton primary production in southern Iraqi marshes after restoration
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Primary productivity and chlorophyll-a were used in this study to monitor the restoration process of southern Iraqi marshes (Al-Hewaizeh, central marshes, and Al-Hammar). The phytoplankton primary productivity was based on oxygen light/dark bottle method. Two different depths samples were taken monthly from six studied marshes stations (two stations for each marsh) during November 2005 to October 2006, while chlorophyll-a samples taken from surface water. The phytoplankton primary productivity values ranged 9.38 – 249.79 mg C/m3.hr for all marshes, its values for surface water sample ranged 11.71 – 256.24 mg C/m3.hr, while for 1m depth ranged 9.38 – 142.5 mg C/m3.hr. Chlorophyll-a values ranged between (1.1 – 21.26) µg/l indicating

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Publication Date
Sun Jan 01 2017
Journal Name
Advances In Animal And Veterinary Sciences
Dogs' hormonal levels drop after surgical gonadectomy in Iraq
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Publication Date
Tue Jan 01 2013
Journal Name
International Journal Of Advance Biological Research
SOME BIOCHEMICAL CHANGES AFTER TREATMENT IN IRAQIS ACROMEGALIC PATIENTS
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Acromegaly is a rare disease produce generalize and serious alteration in the patient with active disease. Many of these patients are also diabetic. Many analytes, hormones, markers are change in these disease. The objective of study is to assess the modification in a number of parameters that changed during the acromegaly as a result of excess in GH and IGF1 levels. The study included 36 patients and 38 healthy controls, paired by sex and age and BMI. Serum concentration of GH and the other parameters including (insulin, glucose, lipid profile, uric acid ) were determined by biochemical method .Compared to controls, acromegalic patients had increased levels of GH, insulin, glucose, triglyceride, very low density lipoprotein(VLDL) (p<0.05)

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Publication Date
Sat Jul 03 2021
Journal Name
Periodicals Of Engineering And Natural Sciences (pen)
Comparison between VG-levy and Kernel function estimation with application
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Publication Date
Wed Sep 30 2020
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Performance Comparison between Recycled Single Stage and Double Stage Hydrocyclones
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   This research presents a comparison of performance between recycled single stage and double stage hydrocyclones in separating water from water/kerosene emulsion. The comparison included several factors such as: inlet flow rate (3,5,7,9, and 11 L/min), water feed concentration (5% and 15% by volume), and split ratio (0.1 and 0.9). The comparison extended to include the recycle operation; once and twice recycles. The results showed that increasing flow rate as well as the split ratio enhancing the separation efficiency for the two modes of operation. On the contrary, reducing the feed concentration gave high efficiencies for the modes. The operation with two cycles was more efficient than one cycle. The maximum obtained effici

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Publication Date
Tue Jun 20 2023
Journal Name
Baghdad Science Journal
Comparison between Modified Weighted Pareto Distribution and Many other Distributions
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In 2020 one of the researchers in this paper, in his first research, tried to find out the Modified Weighted Pareto Distribution of Type I by using the Azzalini method for weighted distributions, which contain three parameters, two of them for scale while the third for shape.This research compared the distribution with two other distributions from the same family; the Standard Pareto Distribution of Type I and the Generalized Pareto Distribution by using the Maximum likelihood estimator which was derived by the researchers for Modified Weighted Pareto Distribution of Type I, then the Mont Carlo method was used–that is one of the simulation manners for generating random samples data in different sizes ( n= 10,30,50), and in di

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Publication Date
Sat Jan 01 2005
Journal Name
Iraqi Journal Of Science
Comparison between Zernike moment and central moments for matching problem
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Moment invariants have wide applications in image recognition since they were proposed.

Publication Date
Fri Oct 02 2020
Journal Name
Biochem. Cell. Arch.
MORPHOLOGICAL DESCRIPTION AND COMPARATIVE HISTOLOGICAL STUDY OF THE LIVER IN TWO IRAQI MAMMALS : WEASEL (HERPESTES JAVANICUS) AND EASTERN GRAY SQUIRREL (SCIURUS CAROLINENSIS
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The results of the current study showed that the liver of H. javanicus appeared as large lobulated organ divided into six distinct lobes, that filled the cranial region and little extended to the middle region of abdominal cavity. On the other hand, liver of S. carolinensis laid against the diaphragm, occupied the cranial region of the abdominal cavity and consisted of five lobes. The liver is surrounded with a thin capsule of dense regular collagenous connective tissue and few numbers of smooth muscles fibers can be seen in the capsule that covered the squirrel liver. The liver parenchyma divided into a large number of interconnected hepatic lobules marked only by the abundant amount of connective tissue bordered the triads, and within the

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Publication Date
Sat Nov 15 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Retentive forces, tensile strength and deflection fatigue of Acetal thermoplastic clasp material in comparison with cobalt-chromium alloy
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Background: Nowadays there is an increasing of the emphasis on aesthetic, dentist have been concerned about providing aesthetics and functional removable partial dentures to their patients and this was make the mission more difficult because of the goal now is achieving optimal aesthetic of the denture - while maintaining retentive, stable, and conservative to the health of supporting tooth and supporting tissue. The traditional use of metal clasp like cobalt-chromium, gold, stainless-steel and titanium hampers esthetics because of its obvious display conflicts with patient’s prosthetic confidentiality. Acetal resin (poly oxy methylene) may be used as alternative denture clasp material. This material was promoted primarily on the basis of

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Publication Date
Fri Oct 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between method penalized quasi- likelihood and Marginal quasi-likelihood in estimating parameters of the multilevel binary model
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Multilevel models are among the most important models widely used in the application and analysis of data that are characterized by the fact that observations take a hierarchical form, In our research we examined the multilevel logistic regression model (intercept random and slope random model) , here the importance of the research highlights that the usual regression models calculate the total variance of the model and its inability to read variance and variations between levels ,however in the case of multi-level regression models, the calculation of  the total variance is inaccurate and therefore these models calculate the variations for each level of the model, Where the research aims to estimate the parameters of this m

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