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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 30 2011
Journal Name
Al-kindy College Medical Journal
Comparison Between Mechanical and Non Mechanical Bowel Preparation Prior To Elective Colorectal Surgery
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Background: Bowel preparation prior to
colonic surgery usually includes antibiotic
therapy together with mechanical bowel
preparation which may cause discomfort to the
patients, prolonged hospitalization and water
& electrolyte imbalance.
Objective: to assess whether elective colon
and rectal surgery may be safely performed
without preoperative mechanical bowel
preparation.
Method: the study includes all patients who
had elective large bowel resection at Medical
City – Baghdad Teaching Hospital between
Feb, 2007 to Jan, 2010. Emergency operations
were not included. The patients were randomly
assigned to the 2 study groups (with or without
mechanical bowel preparation.
Results: A to

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Publication Date
Mon May 01 2023
Journal Name
Journal Of Engineering
Design Comparison between the Gravity and Pressure Sand Filters for Water Treatment, Review
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Hygienic engineering has dedicated a lot of time and energy to studying water filtration because of how important it is to human health. Thorough familiarity with the filtration process is essential for the design engineer to keep up with and profit from advances in filtering technology and equipment as the properties of raw water continue to change. Because it removes sediment, chemicals, odors, and microbes, filtration is an integral part of the water purification process. The most popular technique for treating surface water for municipal water supply is considered fast sand filtration, which can be achieved using either gravity or pressure sand filters. Predicting the performance of units in water treatment plants is a basic pri

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Publication Date
Tue Oct 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Some Parametric and Non –parametric Methods To Estimate Median Effective Dose ( ED5
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            In this paper the research represents an attempt of expansion in using the parametric and non-parametric estimators to estimate the median effective dose ( ED50 ) in the quintal bioassay and comparing between  these methods . We have Chosen three estimators for Comparison. The first estimator is
( Spearman-Karber )  and the second estimator is ( Moving Average ) and The Third estimator  is ( Extreme Effective Dose ) .
We used a minimize Chi-square as a parametric method. We made a Comparison for these estimators by calculating the mean square error of (ED50) for each one of them and comparing it with the optimal the mean square

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Publication Date
Tue Mar 28 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Comparison between Rowatinex and Tamsulosin as a Medical Expulsion Therapy for Ureteral Stone
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The objective of this study is to evaluate the efficacy and safety of rowatinex and tamsulosin in the treatment of patients with ureteric stone.

Forty patients with ureteric stone ranged (4- 12) mm, were included in this study. They were randomized into two groups where the first group includes twenty patients treated with Rowatinex three times daily (Group 1), and the second group includes twenty patients treated with tamsulosin 0.4mg/day (Group 2). All patients were randomly assigned to receive the designed standard medical therapy for a maximum of 3 weeks.

Each group was given an antibiotic as prophylaxis and an injectable non-steroidal anti-inflammatory drug used on demand. At the outpatient clinic all subjects were a

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Publication Date
Thu Apr 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Between Tree regression (TR), and Negative binomial regression (NBR) by Using Simulation.
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            In this paper, the process of comparison between the tree regression model and the negative binomial regression. As these models included two types of statistical methods represented by the first type "non parameter statistic" which is the tree regression that aims to divide the data set into subgroups, and the second type is the "parameter statistic" of negative binomial regression, which is usually used when dealing with medical data, especially when dealing with large sample sizes. Comparison of these methods according to the average mean squares error (MSE) and using the simulation of the experiment and taking different sample

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Publication Date
Sun Feb 05 2017
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
STUDY OF OPTIMUM CONDITIONS FOR REMOVAL OF HEAVY METAL ELEMENTS BY LOCALLY ISOLATED FUNGI Aspergillus niger.: STUDY OF OPTIMUM CONDITIONS FOR REMOVAL OF HEAVY METAL ELEMENTS BY LOCALLY ISOLATED FUNGI Aspergillus niger.
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The best optimum temperature for the isolate was 30○C while the pH for the maximum mineral removal was 6. The best primary mineral removal was 100mg/L, while the maximum removal for all minerals was obtained after 8 hrs, and the maximum removal efficiency was obtained after 24 hrs. 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 106 cell/ ml showed maximum removal for the isolate.

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Publication Date
Wed Dec 14 2011
Journal Name
Journal Of Faculty Of Medicine Baghdad
The correlation between FEV1/ FVC with Arm span to height or chest to waist ratio as an index of pulmonary function in healthy subject.
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Abstract

Publication Date
Fri May 22 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of marginal gap at the composite/enamel interface in Class II composite resin restoration by SEM after thermal and mechanical load cycling (An in vitro comparative study)
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Background: This study compared in vitro the marginal adaptation of three different, low shrink, direct posterior composites Filtekâ„¢ P60 (packable composite), Filtekâ„¢ P90 (Silorane-based composite) and Sonic fillâ„¢ (nanohybrid composite) at three different composite/enamel interface regions (occlusal, proximal and gingival regions) of a standardized Class II MO cavity after thermal changes and mechanical load cycling by scanning electron microscopy. Materials and methods:Thirty six sound human maxillary first premolars of approximately comparable sizes were divided into three main groups of (12 teeth) in each according to the type of restorative material that was used: group (A) the teeth were restored with Filtekâ„¢ P6

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Publication Date
Wed Jun 30 2021
Journal Name
College Of Islamic Sciences
Phonological, dialectical and semantic explanation of the two phenomena of substitution and compulsion in the book of translation Thirty surahs from the Noble Qur’an by Ibn Khallouh d. 370 AH
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This research aims to find out the phonemic, dialect and semantic ailments that were interrogated by the book of the parsing of thirty surahs of the Noble Qur’an by Ibn Khalawiyeh, by examining some phonemic phenomena of Qur’anic expressions and their explanatory relationships that resulted in their occurrence, such as substitution and compression, as the sounds in a word are affected by one another, especially during performance and composition. This influence and influence is the tendency of the human being to the law of ease, facilitation, and the reduction of muscular effort in speech often, all for the purpose of obtaining phonemic harmony for the compound letters; To facilitate pronunciation; And get rid of the muscular effort

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Publication Date
Thu Jun 30 2011
Journal Name
Al-khwarizmi Engineering Journal
Extraction of Zn (II) and Cu (II) Ions Using PEG (300) - KCl Salt Aqueous Two-Phase Systems
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In this paper the process of metal ions extraction (Zn(II) and Cu(II)) was studied in PEG-KCl aqueous two phase system was investigated without using an extracting agent. The experimental runs were performance at constant temperature (25 oC), constant mixing time (30 min), and constant PH of the solution (about 3). The effect of KCl salt concentration (from 10% to 25%), volumetric phase ratio of PEG solution to KCl solution (from 0.5 to 2), and the initial metal ion concentration (from 0.25 ml to 2 ml of 1 gm/L solution) were investigated on the percent extraction of Zn(II) and Cu(II). The results indicated that the percent extraction of metal ions increase with increasing of salt concentration and phase ratio, and slightly de

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