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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 May 13 2021
Journal Name
Al-kindy College Medical Journal
Vitamin D deficiency/ insufficiency and some of its related factors in a sample of Iraqi pregnant women and their neonates at Al-Elwiya Maternity Teaching Hospital during 2019
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Background: Vitamin D deficiency/ insufficiency is common in different age groups in both genders especially among pregnant women and neonates where it is associated with several adverse outcomes including preeclampsia and preterm delivery.   Objectives: To assess the extent of vitamin D deficiency/ insufficiency among mothers and their neonates and some factors related to it and identify some adverse outcomes of the deficiency/ insufficiency on neonates (preterm birth and low birth weight). Subject and Methods: A cross-sectional study was conducted on 88 Iraqi pregnant women and neonates admitted to “Al-Elwiya teaching hospital for maternity” in Baghdad- Al-Rusafah from 1st of June 2019 to 31st of August 2019. Dat

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Publication Date
Wed Jan 31 2024
Journal Name
Journal Of The Faculty Of Medicine Baghdad (jfacmed Baghdad)
The Role of Activin A levels, Body Mass Index and Beta-Human Chorionic Gonadotropin in Ectopic Pregnancies and Missed Abortions – A Study on a Group of Iraqi Women
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Publication Date
Thu May 13 2021
Journal Name
Al-kindy College Medical Journal
Vitamin D deficiency/ insufficiency and some of its related factors in a sample of Iraqi pregnant women and their neonates at Al-Elwiya Maternity Teaching Hospital during 2019
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Background: Vitamin D deficiency/ insufficiency is common in different age groups in both genders especially among pregnant women and neonates where it is associated with several adverse outcomes including preeclampsia and preterm delivery.  

Objectives: To assess the extent of vitamin D deficiency/ insufficiency among mothers and their neonates and some factors related to it and identify some adverse outcomes of the deficiency/ insufficiency on neonates (preterm birth and low birth weight).

Subject and Methods: A cross-sectional study was conducted on 88 Iraqi pregnant women and neonates admitted to “Al-Elwiya teaching hospital for maternity” in Baghdad- Al

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Publication Date
Wed Jan 01 2014
Journal Name
Department Of Bioengineering And Sciences
1 T.R. KAHRAMANMARAŞ SÜTÇÜ İMAM UNIVERSITY GRADUATE SCHOOL OF NATURAL AND APPLIED SCIENCE Cloning and overexpression of Lactobacillus acidophilus bile salt hydrolase A gene (bshA) in Escherichia coli
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The bile salt hydrolase gene (bshA), encoding bile salt hydrolase enzyme (EC 3.5.1.24) from probiotic isolate Lactobacillus acidophilus Ar strain which is responsible for assimilation cholesterol were studied in the present work. About 801 bp in length DNA fragment of Lb. acidophilus Ar strain was amplified by PCR techniques. Two restriction sites (PstI/SacI) were added to each end of that fragment for manipulation of DNA during cloning. Amplified fragment inserted into pJET1.2\blunt end vector and pMG36e vector respectively. pJET1.2\blunt end vector is overexpression plasmid for E. coli MC1022, and pMG36e vector is a shuttle vector which is able to replicate in both E. coli and lactic acid bacteria. The resulted constructs were named as pJ

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Publication Date
Fri Feb 20 2026
Journal Name
Journal Of Studies And Researches Of Sport Education
Design and rationing test compound to assess the performance of the attack straight in terms of power characteristic speed And vital capacity for young players duel weapon Blinds
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Publication Date
Sat Jan 01 2022
Journal Name
Revista Iberoamericana De Psicologia Del Ejercicio Y El Deporte
THE EFFECT OF A PROPOSED TRAINING PROGRAM USING INTERMITTENT TRAINING TO DEVELOP SOME PHYSICAL AND BIO-KINEMATIC VARIABLES AND ACCURACY OF THE JUMP SPIKE SERVE SKILL IN VOLLEYBALL
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The purpose of this paper is to identifying the values of some physical and Bio- Kinematic variables during the performance of the jump spike serve skill, and identifying the effect of the proposed training program using intermittent training to develop some physical and Bio- Kinematic variables and accuracy of the jump spike serve skill among the research sample. The experimental method was used and the research was conducted on a deliberately chosen sample of the players of the Army Club, who were primarily advanced in volleyball, and the number of the sample was (10) players. The conclusions were reached that the proposed training program using intermittent training has a positive effect on some of the physical and Bio- Kinematic variabl

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Publication Date
Thu Dec 30 2021
Journal Name
Al-kindy College Medical Journal
Vitamin D deficiency/ insufficiency and some of its related factors in a sample of Iraqi pregnant women and their neonates at Al-Elwiya Maternity Teaching Hospital during 2019
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In their cross-sectional study, Al-Rubaye et al studied the extent of vitamin D (VD) deficiency/ insufficiency, factors affecting its degree, and the adverse outcomes of the altered VD status among a group of mothers and their neonates from Baghdad, Iraq. They found that 96.6% of the mothers had VD deficiency/ insufficiency compared to 86.4% in their neonates. Maternal VD levels and neonatal weights were significantly correlated with neonatal VD levels. We believe that the study results need to be revised. This is based  two points listed in this letter to editor

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Publication Date
Sun Dec 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Evaluate the effectiveness of internal control systems and their role in providing an effective governance framework in Sudanese banks
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   The study aimed to find out the relationship between the dimensions of internal control systems and the availability of an effective governance framework in the Sudanese banks. The study used descriptive and analytical method for collecting and analyzing the study data using SPSS program. The questionnaire was used as an analysis tool. The target sample of Sudanese bank employees, the study found several results, including that the bank avoids methods that lead to the rational use of available resources, and identifies and separation of tasks among employees, in addition to rapid response to reports The study found several recommendations, including the need for a list of banks that are sufficiently flexible and comp

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Publication Date
Fri May 11 2018
Journal Name
Biomedical And Pharmacology Journal
Molecular and Phylogenetic Analysis of Human Papillomavirus Using L1 Gene in Oral Squamous Cell Carcinoma Patients in Baghdad, Iraq
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Oral squamous cell carcinoma (OSCC) is the most common malignant neoplasm of the oral mucosa. Human papillomavirus (HPV) virus cause a broad scope of diseases from benign to invasive tumors, types 16 and 18 classified as carcinogenic to humans. This study aimed to provide the first molecular characterization of HPV types in Iraq. Thirty-five unstimulated whole saliva samples were collected from histopathologically confirmed patients with oral cancer were enrolled in this study. Genomic DNA was extracted from exfoliating cells to amplify HPV-DNA using HPV-L1 gene sequence primers by polymerase chain reaction method (PCR), the viral genotyping was performed using direct sequencing method. HPV genotypes identified were deposited in Gen

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Publication Date
Thu Feb 01 2018
Journal Name
European Journal Of Internal Medicine
On the use of substandard medicines in hematology: An emerging concern in the Middle East and North Africa region
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