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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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
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
Thu Oct 01 2009
Journal Name
Jssdds
Topical 10% lactic acid solution in the treatment of pityriasis versicolor in comparison with topical 1% clotrimazol solution (single-blind, comparative and therapeutic study)
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KE Sharquie, AA Noaimi, AM Oweid, JSSDDS, 2009 - Cited by 2

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Publication Date
Wed Oct 17 2018
Journal Name
Iraqi Journal Of Laser
The Effect of using 940 nm Diode Laser in Comparison with Endoactivator on Radicular Dentin Permeability and Smear Layer Removal (An in Vitro Study)
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Abstract: The aim of this study is to assess the effectiveness of 940 nm diode laser in comparison to Endoactivator in elimination of smear layer in terms of radicular dentin permeability and ultra-structural changes of root canal walls by SEM evaluation. Twenty-eight single-rooted extracted lower premolars were instrumented up to size X4 (protaper Next, Dentsaply) and divided into two experimental groups according to the irrigation system, G1; activated by EndoActivator and G2; activated by Diode laser 940 nm, CW mode, 1.7 W. Afterward, the roots were made externally impermeable, filled with 2%methylene blue dye, divided horizontally into three segments representing the apical, middle, and coronal thirds then examined under stereo- micr

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Publication Date
Sat Dec 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Development of Sinusitis After Sinus Floor Elevation Surgery: A Systematic Review
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Background: Maxillary sinusitis can arise after sinus floor elevation surgery and should be treated immediately to prevent further complications which included dental implants failure, graft lost, and oro-antral fistula. This is the first systematic review to assess the incidence, causes, and treatment of sinusitis after sinus lift surgery. Materials and methods: An electronic search included MEDLINE (PUBMED) data base site was carried out for articles involving development of sinusitis after sinus lift surgery from September 1997 up to April, 8, 2017. The search was done and reviewed by two independent authors. Results: The total results of electronic search were (182) abstracts and articles, the extracted articles which involved develo

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Publication Date
Wed Feb 27 2019
Journal Name
Political Sciences Journal
Effects of Neighboring Countries on the Iraqi Parliament Performance after 2003
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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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Publication Date
Thu Dec 21 2017
Journal Name
International Journal Of Engineering & Technology
Determination of liquefaction potential for two selected sites in Kerbala city- middle of Iraq
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Geotechnical characterization of the sites has been investigated with the collection of borehole data from different sources. Using the data, grain size distribution curves have been developed to understand the particle size distribution of the alluvium present. These curves were further used for preliminary assessment of liquefiable areas. From geotechnical characterization, it has been observed that the soil profile in the two sites is dominated by sand and silty sand.Seed and Idriss (1971) approachhas been usedevaluatethe liquefaction potentialbydeterminationof the relation between the maximum ground acceleration (a max/g) valuesdue to an earthquake and the relative density of a sand deposit in the field. The results reveal that

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Publication Date
Sat Dec 24 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Possible protective effects of two different doses of cyanocobalamin against methotrexate nephrotoxicity in rats
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Abstract

   Nephrotoxicity is defined as rapid deterioration in kidney functions. It arises from direct exposure to drugs or their metabolites. Methotrexate is a famous chemotherapeutic drug with anti-inflammatory and immunosuppressive properties. A high-dose methotrexate-induced renal dysfunction can be life threatening. Cyanocobalamin, one of the forms of vitamin B12, acts as a coenzyme in the conversion of homocysteine to methionine in the cytosol, and the conversion of methylmalonyl-CoA to succinyl-CoA in the mitochondrion. This study is designed to examine the effect of cyanocobalamin in two different doses each co-administered with methotrexate at 20 mg/kg induced nephrotoxicity in rat

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