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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Jun 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Maximizing competitive strategies in the general framework of the critical success factors and the risk management process: applied research in a sample of Iraqi private banks
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Discussion dealt with the independent factors critical  such us success factors and the risk management process, and dependent factor of the general competitive strategies, and began searching the dilemma of thought, as crystallized his problem in the light of the need for organizations to philosophy and deeper vision of a more comprehensive understanding of the concept of risk management, assessment and management to maximize the competitive strategies of public, and on this basis, Search queries formulated problem of the gap between the knowledge-based intellectual propositions farcical for the purposes of interpretation of the relationship between the critical success factors and the risk

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Publication Date
Sun Dec 05 2004
Journal Name
Journal Of Physical Education
The evaluate of usage educational method for jump shooting and it effect on speed strength in basketball for specialized students in College Sport of Dayla University
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The research aim to the usage educational method for jump shooting and it effect on speed strength in basketball for the specialist students in College Sport of Dayla University, which used the following statistic treatment (The T.test for compatible specimens), so after statistic treatment which appears theres a tow moral differences in speed strength and jump shooting tests results to (legs & arms) for the before and after tests, and after that the conclusions we positive and the second the special drills effect immaterial speed strength to legs and arms, so the tow researches recommended to looking after the best for educational methods that used in our sport colleges in Iraq.

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Publication Date
Tue Mar 10 2020
Journal Name
Journal Of Research On The Lepidoptera
Study of the Association of Glucagon like Peptide-1 Receptors (GLP-1R) Gene Polymorphism and GLP-1 Hormone Levels in Type 2 Diabetics Patients in Iraq
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Publication Date
Thu Feb 07 2019
Journal Name
Iraqi Journal Of Laser
The Effect of 532 nm Diode Pumped Solid State (DPSS) Laser in Combination with Safranin on the Growth of Pseudomonas aeruginosa and Staphylococcus aureus in Vitro
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The effect of 532nm Diode Pumped Solid State (DPSS) laser at power density of 5.234 W/cm2 on the growth of Gram-negative Pseudomonas aeruginosa and Gram-positive Staphylococcus aureus was evaluated. These bacteria were isolated from samples taken from burn and infected wound areas of 55 patients admitted to the burn-wound unit in Al-Kindy teaching hospital in Baghdad during the period from October 2012 to March 2013. Each isolate was identified using microscopic, cultural and biochemical methods. A standard bacterial suspension was prepared for each isolate. Serial dilutions were then prepared and a dilution of 10-5 was selected. Irradiation experiments included four groups: (L-P-) bacterial suspension in saline solution, (L-P+) bacteria

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Publication Date
Thu Jun 15 2023
Journal Name
Journal Of Population Therapeutics And Clinical Pharmacology
Detection the Phylogenetic groups of E. coli that isolated from diarrheal in children under five years and study their relationship of common serotypes in Baghdad hospitals.
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Publication Date
Sun Mar 08 2026
Journal Name
Revista Iberoamericana De Psicología Del Ejercicio Y El Deporte, Issn 1886-8576, Vol. 17, Nº. 4, 2022, Págs. 221-223
An Analytical Study of the Offensive Aspect of the Iraqi National Team Players in the 2015 Arabian Gulf Championships and the 2018 Asian Nations in Football
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Autorías: Naji Kadhim Ali, Saleh Radhi Amish, Wameedh Shamil Kamil. Localización: Revista iberoamericana de psicología del ejercicio y el deporte. Nº. 4, 2022. Artículo de Revista en Dialnet.

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Publication Date
Thu Jan 04 2024
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Creative accounting practices for supply contracts and the role of internal audit in reducing them: An exploratory study on a sample of industrial companies in Iraq
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Abstract:

                The internal control is the tool through which it is possible to verify and ensure the implementation of tasks in accordance with the established plans and programs and to evaluate the level of performance that is implemented within the different companies.

A guarantee from the supplier with the absence of a specialized technical committee that follows up the stages of implementing the contract and disbursing all amounts of financial dues to the supplier before completing the implementation of the contract and overlooking the non-implementation of some clauses of the contract by the committee in charge of

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Publication Date
Sun Feb 28 2021
Journal Name
Journal Of Economics And Administrative Sciences
The effect of innovation and modernization as an approach to strategic change in the efficiency of organizational performance Field research in the Oil Projects Company (SCOP(
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The purpose of this research is to improve the organizational performance of the Oil Projects Company by adopting an approach to strategic change، and finding appropriate solutions to the problems facing the company. The researcher adopted in designing his research by conducting a survey of previous literature that dealt with approaches to strategic change، as the results of the survey showed that most researchers agree on the approach of renewal and modernization، Which formed a starting point for the researcher to identify the extent of the company's management interest in renewal and modernization to improve its level of performance، and the quality of the procedures followed on the ground that is related to

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Publication Date
Sat Dec 31 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
EFFECT OF ORGANIC FERTILIZER SOURCRS AND CHEMICL FERTILIZATION ON SOME SOIL PHYSICL TRAITS AND YIELD OF SUMMER SQUASH (Cucurbta Pepo L.): EFFECT OF ORGANIC FERTILIZER SOURCRS AND CHEMICL FERTILIZATION ON SOME SOIL PHYSICL TRAITS AND YIELD OF SUMMER SQUASH (Cucurbta Pepo L.)
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ABSTRACT

            The results showed that the organic fertilizer mixture (1:1) 30 tons/ha with chemical fertilization recorded the lowest level of bulk density of 1.2 g/cm3, the organic fertilizer mixture (1:1) 30 tons/ha with chemical fertilization recorded the highest percentage of aggregation stability amounting to 16.17%, the organic fertilizer palm fronds recorded the highest level of ready water with an average of 5.50 cm3/cm3 and the organic fertilizer mixture (1:1) 30 tons/ha without chemical fertilization recorded the highest level of ready water as it reached 6.93%, the or

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Publication Date
Fri Jan 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Role of Strategic Leadership in Achieving University Governance Requirements: A Survey of a Sample of Teaching Staff at College of Administration and Economics/University of Mosul
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Aim of the Study: The paper aims at identifying the extent of the role of strategic leadership represented by its four dimensions (administrative, transformational, political, moral) in fulfilling the requirements of university governance (Context, message and Goal, Management orientation, Independence, Issue, Sharing)

Methodology: A survey is applied to (107) members of the teaching staff at the college of Administration and Economics/ University of Mosul.  To achieve the goals of the study, the researcher makes use of a number of tools such as:  questionnaire, statistical tools and methods (repetitions, perce

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