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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Plant Archives J.
Evaluation of the performance of triple, single crosses and their inbred in bred lines of maize under two plant population
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Scopus
Publication Date
Wed Sep 01 2021
Journal Name
المجلة السياسية والدولية
Foreign Policy and Asymmetric Threats The United States after 2001 as a model
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يشهد المسرح الدولي قضايا مستجدة ومستحدثة مثل تعدد الفاعلين من الدول ومن غير الدول وتزايد مساحات نفوذهم وتأثيرهم ،ومن جانب اخر أثرت جائحة كورونا على البيئة والمناخ بشكل ملموس على جوانب عدة. فضلا عن ذلك تأثرت جميع المجتمعات البشرية بالإرهاب والهجمات الالكترونية وغيرها ومن بينها دول والمجتمع الدولي بإفراده مؤسسات وكيان اقتصادي وسياسي وقانوني وأمني وامتداد اثاره واسبابه الكثيرة والمتداخلة وما يثيره من خلق حا

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Publication Date
Sun Jan 01 2017
Journal Name
Advances In Animal And Veterinary Sciences
Dogs' hormonal levels drop after surgical gonadectomy in Iraq
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Scopus (4)
Scopus
Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Phytoplankton primary production in southern Iraqi marshes after restoration
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Primary productivity and chlorophyll-a were used in this study to monitor the restoration process of southern Iraqi marshes (Al-Hewaizeh, central marshes, and Al-Hammar). The phytoplankton primary productivity was based on oxygen light/dark bottle method. Two different depths samples were taken monthly from six studied marshes stations (two stations for each marsh) during November 2005 to October 2006, while chlorophyll-a samples taken from surface water. The phytoplankton primary productivity values ranged 9.38 – 249.79 mg C/m3.hr for all marshes, its values for surface water sample ranged 11.71 – 256.24 mg C/m3.hr, while for 1m depth ranged 9.38 – 142.5 mg C/m3.hr. Chlorophyll-a values ranged between (1.1 – 21.26) µg/l indicating

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
Iraqi Woman Political situation in Quota Framework after 2003
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Abstract Since 2003. Iraq has begun a new phase in its modern history, which was after a long period of tyranny, repression of freedom of expression, and women were no better off than men; they suffered marginalization and exclusion, but after the fall of the former regime and the adoption of a parliamentary system of government, The level of participation in the government; where it approved the share of women in the legislative authority called "quota" which reflects the legislative level of a certain proportion of the seats in Parliament, amounting to 25%, and this is approved by the Iraqi constitution for 2005. But it is noticeable that women in parliament did not work within the quota; in other words they belonged to the pol

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Publication Date
Wed Jun 03 2020
Journal Name
Political Sciences Journal
Obstacles to achieving societal peace in Iraq after 2018
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    Community peace is achieved in law-based states Constitutional institutions with competence and powers, and otherwise that peace is shaken and begins to collapse. The movement of individuals and groups in the State is regulated by law The law and its proper application without selectivity or exception, and then the sense of equal opportunity and equal rights grows every citizen looks at his spouse, what he has, and when he is unbalanced, a sense of frustration and stealing of rights is generated Societal peace suffers from the shocks of instability and what is reflected in the surrounding environment. Instead of production, demolition takes place, which impedes the achievement of the required peace.  

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Publication Date
Tue Jan 01 2013
Journal Name
International Journal Of Advance Biological Research
SOME BIOCHEMICAL CHANGES AFTER TREATMENT IN IRAQIS ACROMEGALIC PATIENTS
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Acromegaly is a rare disease produce generalize and serious alteration in the patient with active disease. Many of these patients are also diabetic. Many analytes, hormones, markers are change in these disease. The objective of study is to assess the modification in a number of parameters that changed during the acromegaly as a result of excess in GH and IGF1 levels. The study included 36 patients and 38 healthy controls, paired by sex and age and BMI. Serum concentration of GH and the other parameters including (insulin, glucose, lipid profile, uric acid ) were determined by biochemical method .Compared to controls, acromegalic patients had increased levels of GH, insulin, glucose, triglyceride, very low density lipoprotein(VLDL) (p<0.05)

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Publication Date
Tue Aug 20 2019
Journal Name
Political Sciences Journal
Israeli foreign policy towards Iraq after occupation in 2003
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Summery of the Study: The Israeli interest in Iraq was not the result of the 2003 US war, which ended with its occupation, but Iraq was still at the top of Israeli concerns, as it was due to its interest and desire to occupy the Zionist movement for a number of reasons, most importantly its religious position in the Jews and control It is a sacred religious duty, so Israel has employed all its organs, institutions, relations and espionage networks in order to penetrate it and perpetuate its existence, and succeeded in achieving its foreign policy objectives at a time when the area was open to it without opposition or competition thanks to its strategic alliance with the states Of the United States of America, which has been able to penet

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Publication Date
Thu Jan 31 2019
Journal Name
Journal Of Engineering
Experimental Study of Solar Still Under Influence of Various Conditions
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In the present work, experimental tests was done to explain the effect of insulation and water level on the yield output. Linear basin, single slope solar still used to do this purpose. The test was done from May to August 2017 in Mosul City-Iraq (Latitude: Longitude: Elevation: 200 m, and  South-East face). Experimental results showed that the yield output of the still increased by 20.785% and 19.864% in case of using thermal insulation at 4cm and 5cm respectively, also the yield output decrease by 15.134% as the water level increase from 4 to 5cm, with the presence of insulation and 14.147% without it. It has been conclude that the insulation and water level play important role in the process of passive

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Publication Date
Tue Mar 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating Parameters of General Linear Model in Presence of Heteroscedastic Problem and High Leverage Points
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Linear regression is one of the most important statistical tools through which it is possible to know the relationship between the response variable and one variable (or more) of the independent variable(s), which is often used in various fields of science. Heteroscedastic is one of the linear regression problems, the effect of which leads to inaccurate conclusions. The problem of heteroscedastic may be accompanied by the presence of extreme outliers in the independent variables (High leverage points) (HLPs), the presence of (HLPs) in the data set result unrealistic estimates and misleading inferences. In this paper, we review some of the robust

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