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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 30 2013
Journal Name
Al-kindy College Medical Journal
Community and Individual Causes of Students Failure in Al Kindy College of Medicine 2012
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Bac kground:
Failure is the state or condition of not meeting a desirable or intended objective, and may be viewed as the opposite of success; students always have a question "Why did I get this grade. On the contrary success leads towards new sources of earning, in fact there are a lot of interacting factors play such extrinsic and extrinsic to reach success.
Objec t i ves :
To explore internal and external factors causing students failure in medical college and to reconnoiter factors improve academic performance.
Methods: A cross-sectional study, conducted in Al Kindy College of Medicine, for the period from November 8th 2012 to May 1st 2013. Formal ethical considerations were obtained about participation and methodology. A

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Publication Date
Thu Sep 02 2021
Journal Name
International Journal Of Drug Delivery Technology
Role of Lactobacillus plantarum and Lactobacillus acidophilus as a Treatment of Cryptosporidiosis in Mice
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Objective: To evaluate the therapeutic activity of probiotics mixture of Lactobacillus plantarum and Lactobacillus acidophilus towards Cryptosporidium infection in experimentally infected mice. Oocysts of Cryptosporidium were separated from the stool of humans to infect mice. Methods: Forty male albino mice were split equally into four groups, every group contained 10 mice, the group I (early treated group), were treated from the 1st day from infection to the 11th post-infection, group II (late treated group), were treated from the 4th day from infection to the 15th post-infection, and group (III) (untreated group), were mice considered as a positive control group. Results: It was showed that daily application of a mixture of L. plantarum w

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Publication Date
Wed Jan 01 2020
Journal Name
Biochem. Cell. Arch.
ANATOMICAL AND CHEMICAL STUDY OF ALTHEAE OFFICINALIS L. SPREAD IN THE NORTH OF IRAQ
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Publication Date
Thu Dec 02 2021
Journal Name
Indian Journal Of Forensic Medicine & Toxicology
Study of Prevalence of Placenta Previa and Circumstances among Pregnant Women in Fallujah Hospital
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Placenta previa refers to placenta which is totally or partly implanted in lower segment of the uterus. Mortality and morbidity of mother increase with placenta previa due to the increase in the incidence of bleeding during pregnancy. This study aims to define placenta previa prevalence among pregnant women at AL-Fallujah teaching hospital and to determine the risk factors and their association with placenta previa incidence in al-Fallujah city population. This retrospective cohort study investigated medical registry of 6339 gravid women in al-Fallujah teaching Hospital in Iraq. We find 13 cases of placenta previa (0.21%) amongst the 6339 cases registered. The risk factors that strongly appeared to affect the complication of pregnancy with

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Publication Date
Wed Mar 18 2020
Journal Name
Baghdad Science Journal
Biomarker Significance of Serum CXCL8, CXCL10 and CXCL16 in Breast Tumors of Iraqi Patients
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The biomarker significance of three chemokines (CXCL8, CXCL10 and CXCL16) was evaluated in sera of 45 breast cancer (BC) and 28 benign breast lesion (BBL) patients, as well as 20 control women. Clinical stage and tumor expression of estrogen (ER), progesterone (PgR) and human epidermal growth factor receptor-2 (HER-2) receptors were considered in this evaluation. The results demonstrated that CXCL8, CXCL10 and CXCL16 showed a significant increased median in BC and BBL patients compared to control (CXCL8: 47.3 and 25.7 vs. 15.0; CXCL10: 37.6 and 30.7 vs. 13.1; CXCL16; 27.9 and 25.2 vs. 19.2 pg/ml, respectively). The increased levels of CXCL8 and CXCL16 were more pronounced in triple-negative and HER-2 positive p

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Publication Date
Mon Mar 01 2010
Journal Name
Al-khwarizmi Engineering Journal
Estimation of Extract Yield and Mass Transfer Coefficient in Solvent Extraction of Lubricating Oil
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An investigation was conducted to suggest relations for estimating yield and properties of the improved light lubricating oil fraction produced from furfural extraction process by using specified regression.

Mass transfer in mixer-settler has been studied. Mass transfer coefficient of continuous phase, mass transfer coefficient of dispersed phase and the overall mass transfer coefficient extraction of light lubes oil distillate fraction by furfural are calculated in addition to all physical properties of individual components and the extraction mixtures.

The effect of extraction variables were studied such as extraction temperature which ranges from 70 to 110°C and solvent to oil ratio which ranges from 1:1 to 4:1 (wt/wt

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Publication Date
Tue Aug 20 2019
Journal Name
Political Sciences Journal
Moved movement the dynamics of conflict and the restructuring of balance maps in Syria
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This study deals with the absence of state control over the whole of the Syrian geography in creating an environment conducive to the emergence of a new force represented by armed groups and organizations that point to fundamental changes in the conflict and to transform competition for control over the land into a struggle for influence. Which in itself represents the prospects of change in the Syrian scene, and that understanding their interests requires shedding light on the extent of the continuation of this competition and the conflict on land and expansion at the expense of the other, and thus contribute to complicate the Syrian scene, especially after attempts to bite Of land and annexation to each party's areas of influence, espe

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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
The Role of University in Awareness of Social and Cultural Human Rights to Students
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The role of university in awareness of Social and Cultural Human Rights to Students
still at the beginnings . the irritable secure of Iraqi environment is the most challenges that
cease any work that may raise the human rights in university . in spite of obstacles the same
society of university like conferences and meetings that related to this subject . as well as the
luck of professional teachers.
This study raises a group of important questions, perhaps the most :
The contribution of university in educates their students of the social and cultural human
rights? What are the most challenges that facing these students? Does the university
responsible of this luck of understanding these human rights?
This Study

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Publication Date
Thu Jul 01 1999
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
Records of some leaf miners of Anthomylidae, (Diptera) and their host plants in Iraq
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The leaf miners Pegoinya terbrans (Rondani) and P. bicolor (Wiedemann) (Diptera; Anthomyiidae) were newly recorded in Iraq. Host plants of these leaf miners and P. cunicularia (Rondani) were identified: P. bicolor was found to be monophagous, whereas P. terbrans and P. cunicularia were oligophagous . It was found that Cirsixim syriaca and Silybum marianum were more susceptible to P. terbrans than the other ones. Infectivity and severity of infestation were estimated for most susceptible weeds against P. terbrans and P.bicolor. These leaf miners. Have two generations a year.

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Publication Date
Sun Sep 01 2019
Journal Name
Baghdad Science Journal
Evaluation of Physical Chemical and Biological Characteristics of Underground Wells in Badra City, Iraq
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The quality of groundwater should be improved by keeping safe water sources from contaminants in protective way by doing regular measuring and checkup before it supplied for usage. Private Wells do not receive the same services that wells supplying the public do. Well owners are responsible for protecting their drinking water. This work was carried out in Badra city, Iraq from December 2017 to May 2018, six wells water were investigated to determine the general characteristics of wells as well as studying the effect of environmental factors on the quality of water. The average of six wells were eleven parameters that is out of permissible limits were EC, Sal., Alk., TH, TDS, Na, Ca, Cl, SO4, Fe, Zn (4402-5183 /cm, 2.76-3.9 ppt

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