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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2013
Journal Name
Asian Journal Of Management Research
The influence of human resources management practices, and government’s role in the organizational performance of small businesses in Malaysia
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This study tries to examine a model involving human resources management practices, employees’ outcomes, governmental support, and organizational performance of small businesses in Malaysia. It was hypothesized that HRM practices will be positively related to the organizational performance (financial and operational), and that employees’ outcomes would serve as a mediator in the relationship between HRM practices and performance. Also it was hypothesized that the governmental support will be positively related to organizational performance. The statistical results on data gathered from a sample of 265 small manufacturing businesses will demonstrate the nature of relationships among the study variables. Theoretical and practical

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Publication Date
Wed Dec 30 2015
Journal Name
College Of Islamic Sciences
Weightings of Imam Ibn al-Mundhir               In his middle book in Sunan, unanimity and difference - the book of prayer
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The Imam Ibn al-Mundhir is likely in Shafi'i school. He has outlined some issues and disagreed with his doctrine. And that the vocabulary on which he relied on the weighting is correct and correct and I choose which I say. One of the most likely issues is the delay of Isha prayer to the darkness. And other issues simplified in the folds of research and study.

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Publication Date
Wed Apr 01 2015
Journal Name
Journal Of Educational And Psychological Researches
The reality of the colleges of education in quality assurance for professors teaching methods in educational and psychological science
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     That achieve a level of excellence for the quality of university education cannot be achieved only by uniting the efforts of all employees at the university and active participation by students and by alumni and the labor market and society, however we can say that the administrative and academic  university staff play an active role and the largest in achieving equivalent quality of higher education, It should unite the efforts of all employees in the educational institution in order to achieve quality education. It is the concept of quality of education, quality assurance and overall management of the quality of the basic pillars on which it is based university education. That highlight the need fo

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Publication Date
Sun Dec 30 2012
Journal Name
Al-kindy College Medical Journal
Evaluation of Fludarabine, and granulocyte colony stimulating factor in treatment of efractory/Relapsed Acute Leukemias in adult Iraqi patients
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Background: Refractory/relapsed acute leukemia has always been a challenging problem for hematologist. Over the past decade emphasis has been made in the development of regimens containing fludarabine, combined with cytosine arabinoside for the treatment of refractory/relapsed acute leukemias. The aim of this study is to evaluate the efficacy and toxicity of the combination of fludarabine, high dose cytarabine, and granulocyte colony stimulating factor in refractory relapsed cases of acute leukaemia,
Methods: a prospective study is being conducted at the national center of hematology and hematology unit /Baghdad teaching hospital from July 2008 to July 2010.Twenty Patients with refractory/relapsed acute leukemia were treated with flud

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Publication Date
Mon Mar 07 2022
Journal Name
Journal Of Educational And Psychological Researches
The Integration of international issues in Saudi social studies and citizenship books in the light of international education principles
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The study aimed to reveal the level to which the international issues are integrated into the books of Saudi public education social studies and citizenship in the light of the principles of international education, and to know the level of continuity and integration of these issues in the books, to build a range and sequence matrix of international issues through it. The study followed the descriptive and analytical method that used the content analysis card as a tool for study when the tool achieved the necessary validity and reliability characteristics. The data of this study has been processed using the SPSS statistical program according to a set of appropriate methods of descriptive and inferential statistics.

 The resu

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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
Detection of RAF fusion transcripts in FFPE samples of Medullablastoma and Ependymom in Iraqi children with RT-RQPCR assays
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Medulloblastomas and ependymomas are the most common malignant brain tumors in children. However genetic abnormalities associated with their development and prognosis remain unclear. Recently two gene fusions, KIAA1549–BRAF and SRGAP3–RAF1 have been detected in a number of brain tumours. We report here our development and validation of RT-RQPCR assays to detect various isoforms of these two fusion genes in formalin fixed paraffin embedded (FFPE) tissues of medulloblastoma and ependymoma. We examined these fusion genes in 44 paediatric brain tumours, 33 medulloblastomas and 11 ependymomas. We detected both fusion transcripts in 8/33, 5/33 SRGAP3 ex10/RAF1 ex10, and 3/33 KIAA1549 ex16/BRAF ex9, meduloblastomas but none in the 11 ep

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Publication Date
Wed Jun 01 2022
Journal Name
Political Sciences Journal
Terrorism and its impact on the right of Human in development - A study case of ISIS (Daesh) in Iraq
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       Iraq is one of the most important countries in the world that has received its share of terrorist acts by the terrorist organization the Islamic State of Iraq and al-Sham (ISIS), which has caused instability, especially during the period of ISIS's control of seven Iraqi provinces (2014-2017). This stage has caused a decline in the levels of human and economic development and its inconsistency with the capabilities and needs of the Iraqi population. Therefore, this study aims to investigate the hypothesis that there is a close relationship between the decline in development in Iraq and the brutal practices of ISIS that it committed during his period of control over many Iraqi cities and regions. This study used several method

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Publication Date
Thu Feb 28 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The Role of Job Enrichment in Building Differentiation Strategy Service: Analytical Exploratory Study of the Views of a Sample of the General Managers and Heads of Departments and Officials of the People in the General Establishment of Civil Aviation
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According to the importance of the subject of research, and the importance of the surveyed organization as a dynamic sector of the country in general , The research attempts to suggest to service organizations in general reconsidering the currently adopted mechanisms in the redesign of its functions , and in the services provided industry . The data was collected from (98) Director Mangers , head of department and head of division . The research tool is the questionnaire , which included (50) items . The results show Significant Effect & Correlation relationship between the two variables due to their dimensions . These lead to he application of job enrichment technology will increase the organization's ability to possess efficient hu

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Publication Date
Thu Nov 09 2023
Journal Name
Biomedicine
Role of immunological and biochemical markers in bone turnover in type I diabetic patients in Karbala province, Iraq
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Introduction & Aim: Long-term diabetes mellitus (DM) is known to have a deleterious impact on bone health, resulting in change in bone mineral density, bone turnover, and bone quality, all of which increase the risk of fractures. The aim of. this study was to link immunological and pro-inflammatory cytokine (I.L-6, I.L-1, and TNF-alpha) markers in patients.with type 1 diabetes to Their connection to bones formation (sPINP) and bone resorption parameters (sCTX).   Materials & Methods: This study included 80 patients suffering from T1DM in the age range of 20-45 years. The patients were assayed for their biochemical (Vitamin D and HbA1c), Immunological (IL-6, IL-1 and TNF-alpha) parameters, as well as bone formation and resor

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Publication Date
Tue Jun 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
The Interactive Role of Organizational Elegance between Organizational Anomaly and Planned Human Resource Behavior A survey of a sample of workers in the Ministry of Construction and Housing
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This study attempts to test the interactive role played by organizational agility in enhancing the effect of organizational anomie on the behavior of planned human resources. The study of organizational anomie has increased because of the moral and legal pressures facing the organization by the external environment within its framework. To adapt to all external developments faced by these organizations, the behavior of human resources planned reflects the ability of individuals to control their behavior in different situations and situations that face them in the work.

The problem of the research indicates that there is a clear lack of understanding of what is meant by the variables studied in the sample

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