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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jan 01 2017
Journal Name
Transportation Research Procedia
The importance of intelligent transport systems in the preservation of the environment and reduction of harmful gases
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Publication Date
Sat Jun 06 2020
Journal Name
International Journal Of Psychosocial Rehabilitation
Job Enrichment and Its Influence in Organizational Cynicism among Workers in Iraqi Youth and Sport Forums
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This study aims to (1) identify the level of job enrichment and organizational cynicism among workers in some youth and sport forums, and (2) identify the influence the job enrichment in the organizational cynicism from their perspective. A descriptive survey was used to guide this study. The study included 478 workers who were randomly selected from the youth and sport forums in Baghdad City in 2019. The Job Enrichment Scale and the Organizational Cynicism Scale were used. Data were analyzed using the statistical package for social science, version 26. The study results revealed that the level of job enrichment and organizational cynicism among workers were unsatisfactory. This calls for paying more attention to these phenomena and improve

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Publication Date
Sun Sep 27 2020
Journal Name
Journal Of The College Of Education For Women
Spatial Variation in Date Production and its Spatial Relationship to Climate in Central and Southern Iraq
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The climate is one of the natural factors affecting agriculture, and the success of the cultivation of any agricultural crop depends on the nature of the prevailing climate in the area of its ​​cultivation. If the main elements of climate: temperature, rain and humidity, affect the various agricultural activities that can be practiced, and the stages of growth of agricultural crops and also determine the areas of spread. When the climatic requirements of any crop are well available, its cultivation is successful and comfortable. The research starts from the problem of spatial variation of date production spatially in the study area and the reason for choosing dates because of its economic importance, so the research will be based on

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Publication Date
Thu Jun 29 2017
Journal Name
College Of Islamic Sciences
Balance and moderation in dealing with the oppressor and the oppressed in the Sunnah - "Applied models")
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Research Summary

In The Name of Allah Most Gracious Most Merciful

The word injustice and its derivatives were repeated in the Holy Qur’an in several places, approximately (154) times. This is due to the severity of its danger, and that the most dangerous thing that our Islamic nation suffers from in our time is; It is injustice in all its forms and types, so we should all have an honest review of the sincere change in the right direction, and uncover cases of injustice and explain their causes and causes, and work to treat them and rid the wrongdoers of their injustice, and help them to correct their condition. To reveal their grievances and explain their causes and causes, and work to remedy them, and support them and mi

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Publication Date
Fri Mar 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Emotional Trends, and Emotional Exhaustion in organizations: (Developing foundations the philosophy and thinking in organizational behavior)
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Emotional exhaustion considered one of the critical factors in the formation and composition of organizational behavior of individuals within organizations, as well as social behavior and psychological, and emotional exhaustion is one of the three components of burnout, as well as depersonalization (cynicism) and low achievement, the emergence of research relevant to this concept began at the beginning of the seventies of the twentieth century, then started to become clear features in the eighties it. This research aims to build intellectual framework for draining emotional exhaustion through highlight on most important philosophical contents, as well as review and analysis of some models associated with this concept, and then a

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Publication Date
Sat Dec 31 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
SYNTHESIS AND CHARACTERIZATION OF NEW DEMULSIFIER FROM NATURAL AND SYNTHETIC POLYMER: SYNTHESIS AND CHARACTERIZATION OF NEW DEMULSIFIER FROM NATURAL AND SYNTHETIC POLYMER
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ABSTRACT

This research included the preparation and characterization of new demulsifies from natural and synthetic polymers of chitosan and polyvinyl alcohol that are environmentally friendly and at the same time have high efficacy comparable to emulsifiers. imported foreign. The prepared compounds were examined using infrared spectroscopy and nuclear magnetic resonance spectroscopy, and all the spectral signals of the polymers were in good agreement with the chemical composition of the polymers. And the melting and decomposition that occur on polymers at high temperatures. The effect of the length and type of side chain in the compositions of polymers on the process of water separation of oil emulsions w

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Publication Date
Sun Sep 02 2012
Journal Name
Baghdad Science Journal
Metarhizium anisopliae (Metchnikoff)SorokinEffect of fungus Metarhizum anisopliae (Metchnikoff) Sorokin and actelic insecticide in pupa ages of 24 and 120 hours of Callosobruchus maculatus Fab. (Coleoptera : Bruchidae)
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This study was perform to defined the effect of fungus Metarhizium anisopliae Sorokin with concentrations 5x101, 5x103 and 5x105 spore/ ml and Actelic insecticide with concentration 0.001% in pupa stages of Callosobruchus maculatus in pupa ages of 24 and 120 hours the results of the study showed the following: the highest killing rate of treated pupa in age 120 hours 100% at concentration 105 spore/ ml. observation for distortions in the adult insects from the pupa that treated with fungal concentration like wings and abdominal distortion , the concentration of fungal effect on the number of eggs that production from adults and percentage of hatching.

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Publication Date
Thu Feb 12 2026
Journal Name
Revista Iberoamericana De Psicología Del Ejercicio Y El Deporte, Issn 1886-8576, Vol. 16, Nº. 3, 2021
The effect of a rehabilitation program using a tens device for the treatment of pain and impaired mobility of the wrist and limbs joint in basketball players
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Autorías: Hadeer Idan Ghanim, Ishraq Mahmood. Localización: Revista iberoamericana de psicología del ejercicio y el deporte. Nº. 3, 2021. Artículo de Revista en Dialnet.

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Scopus
Publication Date
Tue Jun 20 2023
Journal Name
Baghdad Science Journal
Assessing the Activity of Renin and GST in the Serum of Ladies Suffering from Polycystic Ovary Syndrome and COVID-19 to Predict the Danger of Cardiac Disease
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The coronavirus-pandemic has a major impact on women's-mental and physical-health. Polycystic-ovary-syndrome (PCOS) has a high-predisposition to many cardiometabolic-risk factors that increase susceptibility to severe complications of COVID-19 and also exhibit an increased likelihood of subfertility. The study includes the extent of the effect of COVID-19-virus on renin-levels, glutathione-s-transferase-activity and other biochemical parameters in PCOS-women. The study included 120 samples of ladies that involved: 80 PCOS-patients, and 40 healthy-ladies. Both main groups were divided into subgroups based on COVID-19 infected or not. Blood-samples were collected from PCOS-patients in Kamal-Al-Samara Hospital, at the period between Decembe

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Publication Date
Wed Oct 11 2023
Journal Name
Journal Of Educational And Psychological Researches
Designing a Proposed Educational Program Based on Augmented Reality Technology and Measuring Its Effectiveness in Developing the Skills of Research and Historical Imagination Among Students of the Humanities Track in The Secondary Stage in the City of Mak
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The current study aims to develop a proposed educational program based on augmented reality (AR) technology, in addition to assessing its effectiveness in developing research and historical imagination skills of the Humanities Track's female students at the secondary stage, as well as assessing the correlative and predictive relationships between the amount of growth for the two dependent variables. To achieve this, a secondary school in the city of Makkah Al-Mukarramah was chosen, and an available random sample of (30) female students from the study population was selected. The quasi-experimental approach was followed by this study, particularly one group design. In addition, two tools were used to collect study data, namely: a test of

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