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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Aug 06 2021
Journal Name
Research Journal Of Pharmacy And Technology
Molecular Detection and Genotyping of Human Herpes Virus 8 in a sample of Iraqi Blood Donors
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Human herpes virus-8 (HHV-8) infection has increased recently in Arabic countries. HHV-8 in healthy persons does not necessarily cause life-threatening infection, and however, it causes a more severe infection among immunocompromised patients. The distribution of HHV-8 genotypes varies according to ethnicity and depends on the geographic region prior rapid development of global travel. A cross sectional prospective study included a hundred healthy blood donor samples with a mean age of (36.60±10.381), 81% were positive for molecular detection of HHV-8 DNA. PCR results for HHV-8 were strongly related with risk factors such as the number of sexual relations, previous surgeries, blood transfusion, dental operation, and the number of b

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Publication Date
Sun Sep 06 2009
Journal Name
Baghdad Science Journal
Study of Malondialdehyde Levels in sera, RBCs and Tissues homogenate of Iraqi Women With Breast Tumors
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Breast tumors patients generally have more oxidative stress than normal females. This was clear from a highly significant elevation (P<0.05) in malondialdehyde level in RBCs, serum and tissue of all patients groups with breast cancer as compared with control group. In this study we had found that free radicals in malignant breast tumors were higher than benign tumors, therefore the MDA might be used as a marker for prognosis of the disease.

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Publication Date
Sun Apr 06 2014
Journal Name
Journal Of Educational And Psychological Researches
Effectiveness of cooperative learning in at the implementation of floral material for celli graph and decoration
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The purpose of this resesrh know (the effectiveness of cooperative lerarning implementation of floral material for calligraphy and ornamentation) To achieve the aim of the research scholar put the two zeros hypotheses: in light of the findings of the present research the researcher concluded a number of conclusions, including: -
1 - Sum strategy helps the learner to be positive in all the information and regulations, monitoring and evaluation during the learning process.
2 - This strategy helps the learner to use information and knowledge and their use in various educational positions, and to achieve better education to increase its ability to develop thinking skills and positive trends towards the article.
In light of this, the

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Publication Date
Wed Nov 08 2023
Journal Name
Aip Conf. Proc.
Correlation of Mercury With Some Biochemical Parameters in Serum of Mothers and Their New Born Children
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Publication Date
Sun Jan 01 2023
Journal Name
Rawal Medical Journal
Knowledge and Attitude of students about Varicella Infection in AL-Kindy College of Medicine, Baghdad, Iraq
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Objectives: To highlight the knowledge of Al-Kindy medical students regarding varicella infection and to assess their knowledge and attitude toward its prevention. Methodology: This descriptive cross-sectional study enrolled academic year 2020/2021 students at Al-Kindy College of Medicine from first to final year. We used an online questionnaire by Google forms to collect data, which were analyzed with SPSS 26. Results: A total of 208 students participated with 126 in the preclinical and 82 in the clinical grades. Generally, most clinical students were more aware about epidemiology, clinical manifestations, and complications of varicella infection than the preclinical students. Conclusion: Educational stage is a significant variab

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Publication Date
Sat Sep 30 2023
Journal Name
Journal Of The College Of Education For Women
The Problem of Paradox and its Manifestations: A Study in the Titles of Najm Wali's Novels
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The irony pushes us to inquire about what is in the text of contradiction, irony, suspense, and other acts of paradox, as well as a departure from what is logical, or familiar, that attracts the attention of the addressee, and this is what drives us to introspect the text and interrogate it in order to get to know the intended product of the text or its real or metaphorical intent. On the other hand, the irony is more in the literary text than in the scientific texts. Therefore, critics add the word literature to it in their definition.

 As it is represented by the paradox, we will seek to study the paradox of the title and the problematic that it may pose as the beginning of the text, and i

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Publication Date
Wed Mar 18 2020
Journal Name
Baghdad Science Journal
Mixed Micelles of Binary Mixtures of Sodium Dodecylbenzene Sulfate and Tween 80 Surfactants in Aqueous Solutions
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In the present work, the surface properties of mixed binary surfactants containing sodium dodecylbenzene sulfate (SDBS) and Tween 80 (TW80) surfactants in aqueous solutions were studied at temperature 293 K using surface tension measurements. The critical micelle concentration (cmc) magnitude for both individual surfactants and their mixtures were established the obtained results revealed  that the magnitude of cmc of the mixtures are less than the magnitude of individual surfactants and decrease with the increase in Tween 80 percent in solution which indicate the nonideal  mixing of the two surfactants. The values of molecular interaction parameters  and the mole fraction of surfactants in the micelle (X1) were calculated

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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
Study the role of auxins and sytoknins on in vitro propagation of Spilanthes acmella (L.) Murr
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The technique of plant tissue culture has been used to In vitro micropropagation of Spilanthes acmella (L.) Murr. It is an ornamental and medicinal plant not cultivated in Iraq. Seeds were sterilized and cultuared on full strength Murashige and Skoog medium(1962)(MS). Naphthalene acetic acid (NAA), 6- furfuryl aminopurine (Kin.) growth regulators were used at the Initiation stage.The combination between IAA and Kin. was used in multiplication stage. IAA was used for rooting the shoots. Results showed that 1.5% sodium hypochlorite for 15 min was very effective for disinfecting and survival. Nodes exhibited relatively highest response as compared with apical meristems and leaflets culture. Supplying the culture medium with 1 mg/L.

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Publication Date
Tue Apr 04 2017
Journal Name
International Journal Of Science And Research
Effect of Coriandrumsativum Leaves Aqueous Extract on Structure and Function of Kidney in Male Albino Mice
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Abstract: Coriandrum sativum leaves are used in folk medicine to treat several diseases such as digestive system disorder, diabetes, and hyperlipidemia. This study was designed to investigate the effect of aqueous extract of Coriandrum sativum on the structure and function of kidney, 30 males of white Swiss mice Mus musculus were divided randomly to three groups with 10 mice in each group. Animals of first group (control group) had been given orally 0.1 ml of tap water, animals in the second group had been treated orally with 0.1 of single dose (125 mg/Kg b. w./day) of C. sativum leaves extract and animals in the third group has been treated orally with 0.1 ml (250mg/Kg. b. w./day) of the same extract for 30 days. At the end of experiment,

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Publication Date
Mon Jun 01 2009
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Accounting Measurement of Environmental Effects and isclosure it: Applicatiory research in one of Iraqi manufacturing state
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This research aims to Presented model can be applicable – in the frame of current accounting implementations - to measure environmental effects and disclosure then in the financial statements of economic entities after determined the environmental performance scopes of environmental activities that is works by this entities , because of importance of accounting information which presentation by accounting systems which's effectiveness tool on hand of decision maker about site plans and goals and drawing policies aims protection environment sustainable the represented of naturalism wealth elements . The researcher could be able to application his suggested model which's proof the ability to environmental accounting measurement and discl

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