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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jun 01 2017
Journal Name
Journal Of The College Of Languages (jcl)
Formal and Functional Perspectives in the Analysis of Hyperboles in Obama's Speeches
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     Hyperbole is an obvious and intentional exaggeration in the sense that it takes things to such an extreme that the audience goes too far and then pulls itself back to a more reasonable position, i.e. it is an extravagant statement or figure of speech not intended to be taken literally. This paper focuses on the formal and functional perspectives in the analysis of hyperbole which American candidates produce in their speeches in electoral campaigns, for it is hypothesized that candidates in their electoral campaigns use hyperbolic expressions excessively to persuade voters of the objectives of their electoral campaign programs. Hence, it aims to analyze hyperbole in context to determine the range of pragmatic func

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Publication Date
Sun Mar 15 2020
Journal Name
Journal Of The College Of Education For Women
The Role of Supervisory and Training Practices in The Field Education Programmes in Achieving the Course Objectivesfrom the Perspective of the Student Teachers in the Faculty of Science and Arts in Sharourah
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The present study aimed at identifying the role of supervisory and training practices in the field   education program in achieving course objectives from the perspective of the student teachers in the Faculty of Science and Arts in sharourah, and its relationship to some variables (gender, specialization,estimation). To achieve this, the researcher used the descriptive-analytical method, and the study tool was designed, which consists of (24) items distributed on two axes: the objectives of field education and supervisory and training practices.Then, the study tool was applied to the research sample represented in the entire study community, which consists of (65) male and female students in the Faculty of Sciences and Arts in

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Publication Date
Sun Jun 03 2012
Journal Name
Baghdad Science Journal
Study the effect of the mixture aquatic extract of Peganum harmala seeds and Pericarp of Punica granutum on viability of protoscolices of Echinococcus granulosus in vitro and in vivo
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This study included the preparation of the mixture aquatic extracts of Peganum harmala seeds and Pericarp of Punica granutum at concentration (10+50) ?(15+55)? (20+60) mgml .To study the influence of the mixture on the percentage of vitality of the protoscolices of E. granulosus In vitro, as the vitality of protoscolices had caused complete death when the using concentration at time 120,90,60 minute respectively. Also study the effect of mixture in white mice with infectious protoscolices In vivo and study the change occurred in the averages of the weights of the liver and spleen and the averages of its distension In vivo in processed group with mixture at concentration (15+55) , (10+50)mgml ,as which was approach to the negative gro

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Publication Date
Mon May 31 2021
Journal Name
Indian Journal Of Ecology
Identification and Antimicrobial Susceptibility Profiles of Salmonella spp. Isolated from Chicken Flocks and their Feed and Water in Karbala, Iraq
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The objective of study was determining the most prevalent Salmonella spp. and their antimicrobial susceptibility in broilers and laying chickens and their feed and drinking water in five chicken farms in Karbala, Iraq over the period from August to October 2020. A total of 289 samples, including 217 cloaca swabs, 46 water and 26 feed samples were collected. Salmonella spp. was identified firstly by routine diagnostic methods, followed by applying the API 20E kit, the Vitek2 system, and serology. There was significant differences in Salmonella prevalence among different types of samples, mainly cloaca swabs reported a high isolation rate (21.7%). In contrast, feed samples were completely free of contamination. The highest rate of isolation w

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Publication Date
Tue Jan 01 2013
Journal Name
Advances In Physics Theories And Applications
Tracing and Analysis of Manganese, Nickel, Cadmium ,Copper, zinc , Lead And Aluminum Concentration and PH Values In Iraqi Chewing Gums
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Evaluation of trace elements in Iraqi chewing gums are unavailable, particularly pollution of toxic elements, materials which change the values of PH in the Oral. Atomic Absorption Spectroscopy (AAS) were successfully employed to determine the concentration of 7 trace elements (essentially toxic and nonessential) and the PH, in thirteen different brands of chewing gum generally consumed in Iraq. Combined wet and dry digestion procedures were applied. Two types of heated graphite tubes were used, coated and uncoated tubes treated with tungsten solution. Result showed that Cu, Al and Zn were at very high levels in almost all brands whereas Mn was found to be high in brands A and O only.

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Publication Date
Mon Jan 01 2018
Journal Name
Journal Of The College Of Languages (jcl)
Images of Woman, She-Camel and Horse and Their Manifestations in Tarafah-ibnulAbd's Poetry between Symbolic Reference and Poetic Function
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This paper tries to understand the poetic reference in the images of woman, she-camel, horse and their manifestations in Tarafah-ibnulAbd's poetry. There has got my attention the fact that these three images have their own distinct taste which is characterised by a clear rhythm, let alone the  lively nature that is filled with liveliness and activity to be in harmony with the poet's youth. For these three images represented the best manifestations of his psychological and artistic poetics. The paper adopts an artistic analysis to arrive at the psychological aspects of these experiences-the woman, the she-camel, and the horse- and to understand the functions of their images and symbolic reference.

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Publication Date
Thu Dec 28 2023
Journal Name
Al–bahith Al–a'alami
The Self and the Other in the Dogmatic Discourse: The Cognitive and Emotional Structure of the Authoritarian and Destructive Personality
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The philosopher and social psychologist Erich Fromm (1900-1980), in his book "Escape from Freedom" highlighted the distinction between the "I" of the authoritarian personality and the "I" of the destructive personality based on their stance towards "the other." The former (the authoritarian self) relies on a submissive, enslaving formula, where the "I" is the master/dominator/controller/strong, while "the other" is the servant/submissive/controlled/weak, essential for perpetuating this formula. In contrast, the latter (the destructive self) relies on an annihilating, negating formula, where the "I" is existence/killer/destroyer/pe

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Publication Date
Fri May 17 2024
Journal Name
Annals Of Applied Sport Science
Psychological Well-being and Its Relationship with the Functional Creativity of Female Professors of Gymnastics in the Colleges of Physical Education and Sports Sciences in Iraq
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Background. Teaching quality in gymnastics is influenced by teachers' performance and attitudes, leading to increased functional creativity and psychological well-being. This, in turn, contributes to the success of the sports institution by enhancing the overall performance and overall well-being of the students. Objectives. The research aims to assess the psychological well-being and functional creativity of female gymnastics professors in Iraqi colleges of physical education and sports sciences, focusing on their level of well-being and the relationship between these factors. Methods. The researchers used a descriptive survey method to survey female gymnastics professors at 16 colleges in Iraq's physical education and sports science

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Publication Date
Thu Jan 01 2015
Journal Name
Journal Of Traumatic Stress Disorders & Treatment
Randomised Controlled Study Comparing Two Psychological Therapies for Posttraumatic Stress Disorder (PTSD): Emotional Freedom Techniques (EFT) vs. Narrative Exposure Therapy (NET)
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Publication Date
Sun Dec 06 2015
Journal Name
Baghdad Science Journal
Find the concentration of radon gas emitted naturally from the bones and skin of some kinds of birds and local and imported chicken available in the City of Baghdad
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In the present research we the study the deposition of radioactive elements naturally and particularly radioactive radon gas in parts of the body of organisms which are of direct relevance to human life in the city of Baghdad as the samples which were collected from the bones and skin of some kinds of birds and chicken based on the principle that radioactive elements are concentrated always on the bones. We use of this as the exercise detector impact nuclear (CR-39), using the technology Cylindrical diffusion , the results indicated that the largest concentration of radon found in the bone bird Seagull tapered as it was (625 ± 37) Bq.cm-3, and less concentration of radon gas in the chicken bones of Al-kafeel as it was (105 ± 10) Bq.c

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