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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 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
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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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
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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Publication Date
Fri Mar 15 2019
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison between diode laser and scalpel for lip lengthening in patients with gummy smile
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Background: lip lengthening procedure is one of the surgical options for the correction of gummy smile in patients with short upper lip. Methods: A comparative clinical study was conducted on 15 patients requiring lip lengthening procedure for the esthetic correction of excessive gingival exposure with gummy smile. Scalpel was used in seven patients and diode laser in the remaining eight patients. Under infiltration anesthesia, about one cm strip of mucosa was excised at the vestibular depth and the mucosa of the lip was sutured to the alveolar mucosa. Results: The diode laser group demonstrated less postoperative pain and swelling. Regarding postoperative ecchymosis, three patients in the scalpel group developed ecchymosis and no cases

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Publication Date
Mon Dec 10 2018
Journal Name
Day 3 Wed, December 12, 2018
Experimental Comparison between WASP and LSASF in Bartlesville Sandstone Reservoir Cores Bearing Heavy Oil
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Low salinity (LS) water flooding is a promising EOR method which has been examined by many experimental studies and field pilots for a variety of reservoirs and oils. This paper investigates applying LS flooding to a heavy oil. Increasing the LS water temperature improves heavy oil recovery by achieving higher sweep efficiency and improving oil mobility by lowering its viscosity. Steam flooding projects have reported many problems such as steam gravity override, but override can be lessened if the steam is is alternated with hot LS water. In this study, a series of reservoir sandstone cores were obtained from Bartlesville Sandstone (in Eastern Kansas) and aged with heavy crude oil (from the same reservoir) at 95°C for 45 days. Five reservo

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Publication Date
Thu Feb 01 2024
Journal Name
Infrastructures
Strength and Deformation of Concrete-Encased Grouting-Filled Steel Tubes Columns Exposed to Monotonic Quasi-Static Loading Conditions
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This study aimed to evaluate the effectiveness of a novel concrete-encased column (CE) using small circular steel tubes filled with cementitious grouting material (GFST) as the primary reinforcement instead of traditional steel bars. The research involved three different types of reinforcement: conventional steel bars, concrete-filled steel tubes with 30% of the reinforcement ratio of steel bars, and concrete-filled steel tubes with the same reinforcement ratio as steel bars. Twenty-four circular concrete columns were tested and categorized into six groups based on the type of reinforcement employed. Each group comprised four columns, with one subjected to concentric axial load, two subjected to eccentric axial load (with eccentrici

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Publication Date
Mon Jun 01 2009
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of the Shapiro-Wilk test Jureckova test using simulation and multiple distributions
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 إن المقصود باختبارات حسن المطابقة هو التحقق من فرضية العدم القائمة على تطابق مشاهدات أية عينة تحت الدراسة لتوزيع احتمالي معين وترد مثل هكذا حالات في التطبيق العملي بكثرة وفي كافة المجالات وعلى الأخص بحوث علم الوراثة والبحوث الطبية والبحوث الحياتية ,عندما اقترح كلا من   Shapiro والعالم Wilk  عام 1965 اختبار حسن المطابقة الحدسي مع معالم القياس
(

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Publication Date
Sun Dec 15 2019
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison between the effects of Aloe vera and chlorhexidine on clinical periodontal parameters
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Background: Periodontal diseases are one of the major dental pathologies that affect human populations worldwide at high prevalence rates The term periodontal disease usually refers only to plaque related inflammatory disease of the dental supporting tissues. Mouth rinses which act as an anti-plaque agents mostly used as adjuncts to oral hygiene. Aims of the study: To Estimate and compare the effects of Aloe vera relative to chlorhexidine on the clinical periodontal parameters (plaque index, gingival index, bleeding on probing). Material and method: A total of 44 subjects with plaque-induced gingivitis, baseline of data were collected for (PLI, GI, and BOP) and underwent oral hygiene instruction, scaling and polishing, then divided into:

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