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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 26 2022
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The role of banking effort tests in the face of monetary credit risk and its impact on the profits and adequacy of the bank’s capital : / a case study of Sumer Commercial Bank for the period from 2015 to 2020
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The research seeks to identify the proposed scenarios to predict and ward off monetary credit risks that the bank is exposed to in the future, using the banking stress tests model, and showing their impact on capital adequacy and profitability ratio,To achieve this purpose, Sumer Commercial Bank was taken as a case study, and mathematical equations were used to extract the results. Low percentage of profits and returns, strictness in the process of granting credit and financing operations in order to reduce credit risks.

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Publication Date
Thu Dec 20 2018
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
ANTIMICROBIAL ACTIVITY OF EDIBLE FILM FROM WHEY PROTIEN ISOLATE INCORPORTED WITH GREEN TEA EXTRACT AND ITS USE IN CHEESE COATIN: ANTIMICROBIAL ACTIVITY OF EDIBLE FILM FROM WHEY PROTIEN ISOLATE INCORPORTED WITH GREEN TEA EXTRACT AND ITS USE IN CHEESE COATIN
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The aim of the current research is to study the effect of adding green tea to the edible film prepared from the whey protein isolate on the effectiveness of microorganisms and evaluating the of antimicrobial effectiveness of these films on Iraqi soft cheese packaging during the nine days of storage as an alternative to commercial packaging. At the beginning of the study, the minimum inhibitory concentration was measured by calculate the diameter of the zone of inhibition on growth of the bacteria and it's included the group of Gram negative bacteria (Escherichia coli, Salmonella spp, Pseudomonas Aeruginosa) and the group of Gram positive bacteria (Staphylococcus Aureus, Bacillus spp) and a yeast (Candida Albican). Where the diameter of t

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Publication Date
Thu Apr 25 2019
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
The Correlation between the Dimensions of Organizational Silence and the F Function Life an Exploratory Study of the Views of a Sample of Workers in the Health Center / Sulaykh: The Correlation between the Dimensions of Organizational Silence and the F Function Life an Exploratory Study of the Views of a Sample of Workers in the Health Center / Sulaykh
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The research aims to test the effect of the behavioral factors (intangible) represented by an explanatory variable represented by organizational silence and a responsive variable of quality of Function life. The problem was the negative effects of the organizational silence on the morale of the employees and consequently their performance and the quality of function life. To collect the data and information needed to measure the two variables of research conducted in the health center / Sulaikh by taking a sample of (40) employees to test the hypotheses of research through the survey of their views, using statistical tools non parametric using the program. The most important recommendations were the establishment of training workshops fo

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Publication Date
Thu Dec 15 2022
Journal Name
Journal Of Inorganic And Organometallic Polymers And Materials
Ultrasound-Assisted and One-Pot Synthesis of New Fe3O4/Mo-MOF Magnetic Nano Polymer as a Strong Antimicrobial Agent and Efficient Nanocatalyst in the Multicomponent Synthesis of Novel Pyrano[2,3-d]pyrimidines Derivatives
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Publication Date
Mon Mar 07 2022
Journal Name
Journal Of Educational And Psychological Researches
Awareness of Students at Imam Muhammad bin Saud Islamic University of the Requirements of Married Life in the Light of Social Changes and Methods of Deepening It in Accordance with an Islamic Educational Vision
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This study aims to identify the level of students’ awareness at Imam Muhammad bin Saud University of the requirements of married life in the light of social changes and suggested methods to deepen this awareness (according to the Islamic educational vision) from their own perspective. In this study, the researcher used the descriptive approach with a survey research method, depending on questionnaires to collect data, which he applied to students of College of Sharia in Imam Muhammad bin Saud Islamic University, as well as, students in the fields of Sociology, Social Work, and Psychology in the College of Social Sciences. The findings of the study revealed that students are aware of the requirements of married life concerning mutual ri

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Publication Date
Wed Jun 29 2022
Journal Name
Journal Of The College Of Education For Women
The Reality of Teachers’ Use of Modern Technologies in Teaching Arabic as a Second Language in Terms of Objectives and Selection Foundations at the Institute of Arabic Language in Umm Al-qura University Mamoun Eltigani Hassan Eldali
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This study aims to know the degree of importance and the availability of the enhancing specifications of the educational process, and the way its objectives are achieved. Such a step involves using educational techniques, laying the selection foundations, knowing the methods of their employment and tracking the obstacles that limit this employment in teaching Arabic to non-native speakers. To achieve these objectives, the study followed a descriptive approach, and collected the necessary data through an integrated questionnaire prepared for the purpose of describing the phenomenon or topic. This approach was adopted, as it is characterized by being comprehensive, focuses on collecting data related and necessary to the topic under study.

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Publication Date
Wed Jan 03 2024
Journal Name
Eximia
The reality of the organizational brilliance of physical Educators in the college of Physical Education and Sports Sciences / University of Baghdad from female students point of view
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Achieving goals effectively reflects the success of the institution. However, unless this indicator is coupled with efficiency when achieving goals, the institution will be equal in its achievements, and distinction will remain unachieved. Perhaps the role of the teaching staff in pushing the institution or college towards brilliance focuses on their ability to motivate people on the one hand and their interest in achieving brilliance for the institution. On the other hand, the importance of the research lies in the institution’s reaching a prominent position through the brilliance and creativity of teaching and achieving competition between institutions that make it more brilliance. The study seeks to achieve the goal of the real

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Publication Date
Wed Nov 03 2021
Journal Name
Al-ghary Journal Of Economic And Administrative Sciences
The Role of Marketing Vigilance in Analyzing the Strategic Position of Tourism Organization: A Survey Study of the Opinions of a Sample of Travel and Tourism Companies
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The study aims at studying and analyzing the subject of marketing vigilance as it is one of the modern approaches in the marketing field that can be used to face changes in the competitive and strategic environment and that represents quick reactions on the part of the institution to ensure its survival and distinctiveness other aims are: Consolidating the strength of the marketing organization and its success continuously, represented by changes in the market share, awareness of the institution's position in the market and its relations with competing tourism companies, diversification of tourism services, as well as an analysis of the competitive strategic position of tourism institutions for the purpose of conducting a r

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Publication Date
Wed Jun 22 2022
Journal Name
Journal Of Medicinal And Chemical Sciences
Organo-Clay Composites of Intercalated 4-Methylaniline and Its Schiff Base Derivative: Preparation and Characterization
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4-methylaniline and its Schiff base derivative were intercalated into the Bentonite clay interlayers in a solid state reaction followed by a condensation reaction to produce two organo-clay composites. X-ray diffraction was used to identify the changes in basal spacing of montmorillonite layers which exhibited noticeable alteration before and after the formation of the composites. FT-IR spectra, on the other hand, were utilized for identifying the structural compositions of the prepared materials as well as the formation of the intercalated Schiff base derivative. The surface morphology of the composites was examined by Scanning Electron Microscopy SEM and Atomic Force Microscope AFM, which reflected some differences in the surface of prepa

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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Synthesis, Characterization and study biologicalactivity of several 1-cyclopentene-1,2-dicarboxylimidyl Containing oxadiazole and Benzothiazole
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In this work involved prepared of several new 1-cyclopentene-1,2-dicarboxylimide linked to oxadiazole and benzothiazole moiety were synthesized by two steps: The first step 2-amino-substituted-1,3,4-oxadiazoles and substituted-2-aminobenzothiazole were reaction with 1-cyclopentene-1,2-dicarboxyl anhydride producing N-( 5- substituted-1,3,4-oxadiazole-2-yl)-1-cyclopentene-1,2-dicarboxyl amic acids and N-(Substitutedbenzothiazole-2-yl)-1-cyclopentene-1,2-dicarboxyl amic acids which in turn were dehydrated in the second step via fusion method to afford he desirable N-(5-substituted-1,3,4-oxadiazole-2-yl)-1-cyclopentene-1,2-dicarboxylimides and N-(Substituted benzothiazole-2-yl)1-cyclopentene-1,2-dicarboxylimides respectively. Struct

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