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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Jan 01 2020
Journal Name
Says Rev Pharm
Healing of apical periodontitis after minimally invasive endodontics therapy using Er,Cr:YSGG laser: A prospective clinical study
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Publication Date
Wed Oct 17 2018
Journal Name
Iraqi Journal Of Laser
Thermal Effects of 940 nm Diode Laser on Dental Socket Blood after Teeth Extraction for Diabetic Patients
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Abstract: Background: High percentage of diabetes patients complain from post extraction hemorrhage. Many types of hemostatic materials are used to stop bleeding after teeth extraction: diode lasers are good hemostatic agents owing to their highly absorption by hemoglobin therefore they are used in soft tissue procedures with relatively no effects on dental hard tissues due to their poorly absorption by water and hydroxyapatite. Objectives: The aim of this study is to evaluate the efficiency of diode laser to assist the clot formation after tooth extraction for type II diabetes patients with minimum temperature elevation to prevent periodontal destruction. Materials and methods: From 12 type II diabetes patients (7 males and 5 females wi

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Publication Date
Sun Jun 20 2021
Journal Name
Baghdad Science Journal
Comparison of Some of Estimation methods of Stress-Strength Model: R = P(Y < X < Z)
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In this study, the stress-strength model R = P(Y < X < Z)  is discussed as an important parts of reliability system by assuming that the random variables follow Invers Rayleigh Distribution. Some traditional estimation methods are used    to estimate the parameters  namely; Maximum Likelihood, Moment method, and Uniformly Minimum Variance Unbiased estimator and Shrinkage estimator using three types of shrinkage weight factors. As well as, Monte Carlo simulation are used to compare the estimation methods based on mean squared error criteria.  

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Publication Date
Wed Jun 29 2022
Journal Name
College Of Islamic Sciences
term of the first difference between the Imam of the Two Holy Mosques, Imam Taj Al-Din al-Subki and its impact on the doctrine of Al-Shafeiyah
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Praise be to Allah, the Lord of the Worlds, the best prayer and the best prayer, on our master Muhammad, and on his pure God, and his companions and the faithful, and who followed them by charity to the day of religion. This relationship between emphasis, is a sincere, and this harmony, such as the relationship between water, and the green, but it is good, but, with greenery, it is better, and as well as alone, is a beautiful view, but the most beautiful, with the most beautiful. From here he was starting on myself in writing the fundamentalist research of jurisprudence, to show the depth of this interconnection. The doctrine as a new term, then the taj al-Din al-Suobki came after three centuries, and a

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Publication Date
Tue Jan 21 2025
Journal Name
Periodicals Of Engineering And Natural Sciences (pen)
A comparison between the hierarchical clustering methods for postgraduate students in Iraqi universities for the year 2019-2020 using the cophenetic and delta correlation coefficients
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The educational sector is one of the important sectors in the world, and it is considered one of the means of community development. In addition, it is one of the means of making the country’s renaissance and devel-opment because it represents the factory of thinking minds that make change. There is no doubt that this sector is the same as any other sector. The deficit in the studied scientific planning has been prolonged, which led to its deterioration, and the problems of education remain diverse and inherited from previous time periods, where the hierarchical cluster analysis was used on postgraduate students in universities in Iraq, except for Kurdistan region, and the number of universities that were included in the study was

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Publication Date
Thu Dec 24 2020
Journal Name
Psychology And Education
The Use of Ergative Verbs to Background the Role of the Agent in two Selected Short Stories: A Syntactico-Semantic Study
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The study explores the use of ergative verbs in constructing clauses and their impact on the backgrounding of the agent's role in two selected short stories. Contrary to hypothesis No. 1, the research indicates that changes in sentence patterns don't affect the meaning of the process. Additionally, hypothesis No. 2 is refuted as the middle structure is found to highlight the agent's role in the science fiction short story, Terra Infirmum, rather than concealing it as hypothesized for "The Invisible Man." The analysis uncovers that writers utilize ergative processes to narrate stories in various ways, including transitive/active voice, intransitive/active voice, and transitive/passive voice. Furthermore, the findings suggest that writers emp

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Publication Date
Fri Jan 23 2026
Journal Name
Mustansiriya Medical Journal
The Pattern Of Skin Diseases Among Kindergarten Children In Baghdad. A Comparative Study Between Two Surveys Five Years Apart
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Publication Date
Tue Jul 01 2008
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
FIRST RECORD IN IRAQ OF TWO NEMATODE PARASITES FROM THE BLUE-CHEEKED BEE-EATER MEROPS SUPERCILIOSUS PERSICUS PALLAS, 1773
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Thirty three specimens of the blue-cheeked bee-eater were collected at central and southern Iraq from April 1997 to October 2000. Two nematodes Hadjelia truncata and Syphaciella capensis, were recovered from the alimentary tract. Reporting these two nematodes represents the first record for Iraq as well as a new host record.

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Publication Date
Thu Jan 01 2009
Journal Name
J. Of University Of Anbar For Pure Science
Estimation of the Normalized Difference Vegetation Index (NDVI) Variation for Selected Regions in Iraq for two Years 1990 & 2001
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The Normalized Difference Vegetation Index (NDVI) is commonly used as a measure of land surface greenness based on the assumption that NDVI value is positively proportional to the amount of green vegetation in an image pixel area. The Normalized Difference Vegetation Index data set of Landsat based on the remote sensing information is used to estimate the area of plant cover in region west of Baghdad during 1990-2001. The results show that in the period of 1990 and 2001 the plant area in region of Baghdad increased from (44760.25) hectare to (75410.67) hectare. The vegetation area increased during the period 1990-2001, and decreases the exposed area.

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Publication Date
Tue May 28 2019
Journal Name
Al-khwarizmi Engineering Journal
Heuristic D* Algorithm Based on Particle Swarm Optimization for Path Planning of Two-Link Robot Arm in Dynamic Environment
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 Finding a path solution in a dynamic environment represents a challenge for the robotics researchers, furthermore, it is the main issue for autonomous robots and manipulators since nowadays the world is looking forward to this challenge. The collision free path for robot in an environment with moving obstacles such as different objects, humans, animals or other robots is considered as an actual problem that needs to be solved.  In addition, the local minima and sharp edges are the most common problems in all path planning algorithms. The main objective of this work is to overcome these problems by demonstrating the robot path planning and obstacle avoidance using D star (D*) algorithm based on Particle Swarm Optimization (PSO)

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