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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Jun 30 2020
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
FACTORY OF SORTING AND RECYCLING OF WASTE IN THE DISTRICT OF AL-MAHMOUDIYAH BETWEEN THE ECONOMIC AND ENVIRONMENTAL IMPACT: FACTORY OF SORTING AND RECYCLING OF WASTE IN THE DISTRICT OF AL-MAHMOUDIYAH BETWEEN THE ECONOMIC AND ENVIRONMENTAL IMPACT
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The waste sorting and recycling plant in the district of al- Mahmudiya (Yusufiya) is the only laboratory in Baghdad governorate. It is the only one in Iraq that collects and recycles waste. After sorting, we have packages of raw materials (aluminum cans, glass bottles, plastic bottles, Nylon bags) as well as natural fertilizers (food residues and others) and a sanitary landfill with specifications that meet international standards; However, the absence of a structure for the management of the plant (manager, assistant manager, accountant, etc.) in addition to the non-supply of waste on a daily and continuous basis and the lack of cooperation of the Municipality of Baghdad with the management of the plant led to delay in the work

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Publication Date
Sat Mar 01 2025
Journal Name
Radiology Case Reports
Intradural extra-medullary spinal cord tumor after dorso-lumbar spine fixation following 12th dorsal vertebra burst fracture: A case report with literature review
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Publication Date
Wed Jun 29 2022
Journal Name
College Of Islamic Sciences
Evidence for monotheism in Islam and the Qur’an and the meaning of the names and attributes and their unification
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This topic is considered to be of a high degree of importance to every Muslim, and its importance is due to the fact that monotheism is:

Prove that God Almighty is the God who created everything and everything opposite to monotheism is polytheism, and it is taking other than God Almighty as a deity.

Therefore, we have to know the concept of God. If he is known, then he knows the concept of monotheism and the concept of polytheism

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Publication Date
Tue Oct 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Robust M Estimate With Cubic Smoothing Splines For Time-Varying Coefficient Model For Balance Longitudinal Data
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In this research، a comparison has been made between the robust estimators of (M) for the Cubic Smoothing Splines technique، to avoid the problem of abnormality in data or contamination of error، and the traditional estimation method of Cubic Smoothing Splines technique by using two criteria of differentiation which are (MADE، WASE) for different sample sizes and disparity levels to estimate the chronologically different coefficients functions for the balanced longitudinal data which are characterized by observations obtained through (n) from the independent subjects، each one of them is measured repeatedly by group of  specific time points (m)،since the frequent measurements within the subjects are almost connected an

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Publication Date
Sun Oct 02 2011
Journal Name
The Iraqi Journal Of Agricultural Sciences
AN ECONOMIC ANALYSIS OF PRODUCTION AND CONSUMPTION OF SUGAR CANE AND SUGAR BEET IN IRAQ
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In spite of economic importance of sugar cane and sugar beet as they described as industrial crops they still face decreasing rates of production and productivity in Iraq , and their production was not able to satisfy the local industrial demands for sugar . Thus this study aimed at studying and analyzing, production and productivity of sugar cane and sugar beet in Iraq and this has been done by using non serial data that can be obtained from official offices in Iraq . The area and production of sugar cane in Iraq recorded positive annual growth rates during 1970- 1978 which were 6% and 5% consequently , while the productivity of sugar cane recorded at the same duration of time negative annual growth rate which was 1% , while they recorded

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Publication Date
Tue Jan 09 2024
Journal Name
Psychology And Education
Longevity of hope, its causes, effects, and treatments in light of the Qur'n and Hadith
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This study came to show the importance of long hope and its extent on human life, and I found that through the research, the majority of the scholars did not address this topic separately, and did not explain the travails of this situation and the worldly problems it causes to its owner, and the consequences that fall upon it in the hereafter. Most of the studies inside of the books consisted of a simple presentation of this problem and an explanation of the remedies that came to us from the Qur'an and the hadiths and the Sunnah, and on the sayings of the imams of guidance (may the best prayers and peace be upon them), and on the chosen companions and followers, may God be pleased with them, but the length of hope does not stop At a certain

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Publication Date
Thu Jul 21 2022
Journal Name
Journal Of Advanced Biotechnology And Experimental Therapeutics,
Effect of gentamicin and doxycycline on expression of relB and relE genes in Klebsiella pneumonia
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Publication Date
Mon Jan 26 2026
Journal Name
Journal Of Baghdad College Of Dentistry
An Evaluation of Serum and Salivary Adipokines (Leptin and Resistin) Levels in Periodontal Health and Disease
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Background: With the start of the current century, increased the interest in the role of the adipose tissue derived substances that named adipokines in the inflammatory diseases of the human being including the inflammatory periodontal disease, but scientific evidences were not clearly demonstrate the association between these adipokines and periodontal pathologies. Materials and Methods: Forty two subjects male only with normal body mass index were selected for the study with an age ranged (30-39 years). Samples were divided into three groups of 14 subjects in each group based on clinical periodontal parameters; clinically healthy gingiva (group I), gingivitis group (group II) and chronic periodontitis patients group (group III), from whom

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Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
The Role Of Intellectual Capital In The Performance Of Small And Medium Enterprises Research filed In Small And Medium Enterprises In Baghdad
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The Research aims to determine role of The Intellectual capital in the performance of small and medium enterprises , to achieve this goal through a researcher from the theoretical literature and studies related to the construction of the scheme shows the hypothetical relationship between the variables, which was adopted by the independent variable intellectual capital, distributed four variable are:( human  capital, structure capital ,customer capital, innovation capital) as well as four variable (the financial perspective, the customer perspective, process perspective ,the learning & growth perspective) The  study were getting to  many results as bellow :the intellectual capital in the small and intermediate p

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Publication Date
Wed Dec 15 2021
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of Cytotoxicity and Biocompatibility of Ti2AlC in Rabbits
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Background: The Titanium and its alloys are suitable for dental implant and medical applications. Biocompatibility of the materials is a major factor in determining the success of the implant and has a great impact on their rate of osseointegration. The aim of this study was to evaluate the biocompatibility and cytotoxicity of Ti2AlC in comparison to CPTi & Ti6Al7Nb in rabbits. Materials and Methods: 10 male New Zealand White rabbits, weighing (2-2.5 kg), aged (10-12 months) were used in this study. Cylindrical implants were prepared from the study materials (CPTi, Ti6Al7Nb and Ti2AlC) with (8mm) height and (3mm) diameter for the evaluation of tissue response and disc specimens were prepared with (6 mm) diameter and (2 mm) thickness for ev

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