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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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

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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 between Process Control Charts and Fuzzy Multinomial Control Charts with Practical Appliance
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     The control charts are one of the scientific technical statistics tools that will be used to control of production and always contained from three lines  central line and upper, lower lines to control quality of production and represents set of numbers so finally the operating productivity under control or nor than depending on the actual observations. Some times to calculating the control charts are not accurate and not confirming, therefore the Fuzzy Control Charts are using instead of Process Control Charts so this method is more sensitive, accurate and economically for assisting decision maker to control the operation system as early time. In this project will be used set data fr

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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
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
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
Sun Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
The Egyptian-Ethiopian Relations after the Change
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Egypt and Ethiopia have connected in a strong relation as there are historical facts that
deepen these relations, one of these is Egypt's cooperation in establishing the first economic
and financial banking system in Ethiopia.
Beside the religious relation between The Egyptian and Ethiopian churches the Nile River is
considered one of the effective connections
That strong then the relations as it leads to some tension between the two countries because
Ethiopia believes that Egypt seeks to control the river tries to build its project over the Blue
Nile means a threat to the Ethiopian national security.
The tension continues even after the revolution of 25th of January 2011because the Nahda
dam which is a clear t

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Publication Date
Fri Dec 01 2023
Journal Name
Political Sciences Journal
Nation-Building in The Fragile States: Iraq After 2003 as a Model
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The nation-building process in fragile states is complex, often involving multifaceted challenges and opportunities. A pertinent example is Iraq post-2003, which serves as a model to study the intricacies of rebuilding a nation in the aftermath of conflict. During this period, we witnessed a significant international intervention aimed at establishing democratic governance, fostering economic development, and restoring social stability. Iraq’s nation-building journey showcases both successes and shortcomings. Establishing a representative government marked a step towards inclusivity and political participation, yet sectarian tensions persisted, hindering cohesive national identity. Economic initiatives aimed to harness Iraq's oil resou

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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
Wed Jun 01 2022
Journal Name
Jordan Journal Of Biological Sciences
Comparison of the Folate and Homocysteine Levels with A80G -RFC1 Gene Polymorphism between the Sample of Iraqi Children with and without Down Syndrome
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Many international studies indicated that the polymorphisms of some genes disturbed the folate homocysteine (Hcy) metabolism and increased the vulnerability to Down syndrome (DS). We aimed to measure the serum levels of folate and Hcy in DS children and compare the levels with age and sex-matched apparently normal healthy children. We also aimed to study the A80G polymorphism of the gene reduced folate carrier (RFC1) in the DS children as a risk factor. Forty children with DS (24 were boys, and 16 were girls) with the age range between 5-13 years, and 26 normal healthy children (16 boys and ten girls) were included in this study. The results show that the highest genotype in the control group was AG (53.85%) followed by AA and GG (30.

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