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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 27 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Prevalence of Smoking among Health Workers and Effectiveness of Instructional Booklet concerning Risks of Smoking on Health Workers′ Knowledge in Baghdad Teaching Hospital
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Objective(s): The present study aims at assessing the prevalence of smoking among health workers in Baghdad Teaching Hospital and to find out the effectiveness of instructional booklet concerning risk of smoking on health workers′ knowledge in hospital.

Methodology: A pre-experimental design study was conducted from 1st of October 2019 to 17th of March 2020. A non-probability sample consists of (500) participant (343 non-smokers and 157 smokers) from (1500) health workers in Baghdad Teaching Hospital, they included the physicians, nurses, pharmacists, physiotherapists, Laboratory Technicians, Medical Assistants. A questionnaire is constructed to evaluate the effectiveness of instructional booklet on health workers’ knowledge

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Publication Date
Mon Dec 03 2018
Journal Name
The Iraqi Postgraduate Medical Journal
Operative Treatment by Plate and Screws Versus Conservative Treatment of Closed Displaced Fracture of the Mid Third of Clavicle in Adults: Comparative Study
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BACKGROUND: Clavicle fractures are common injuries in young active individuals, the mid third of the clavicle is most commonly fractured part(80% of clavicle fracture) OBJECTIVE: To compare the outcomes of operative and non operative management of displaced and or comminuted closed fracture of the mid third of clavicle in young adults PATIENTS AND METHODS: This prospective observational study of 24 patients of fracture of the mid third of the clavicle was conducted in Alkindy teaching hospital from July 2015 to January 2017 and divided into two groups; one managed by operative treatment with plate and screws and the other by non operative sling immobilization after taking the consent and the patients were seen at 2, 4, 6 weeks,3, 6, and 9 m

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Publication Date
Tue Aug 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Sustainability of Agricultural Productivity of Potato Crop in Desert Soils and Evaluation of Water Productivity Under Drip Irrigation System with Future Climate Changes
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A field experiment was conducted during the spring season 2020 in Karbala proving/ Al-Sharia Distrit, located at latitude N 32° 42' 13.8" and longitude E 43° 54' 36.6" and at an altitude of 27 m above sea level. The experiment included a study of two factors: the first, Irrigation Interval, three treatments were used: irrigation treatment every 2 days, Irrigation treatment every 4 days, and Irrigation treatment every 6 days. The second factor is the addition of soil conditioners, in which four treatments were used: the control treatment without any addition, the treatment of adding bio-organic fertilizers, the treatment of adding water-conserving technology (polymer), and the treatment of adding water-conserving technology + fertilizers O

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Publication Date
Sun Dec 31 2023
Journal Name
Lark
Digital and pedagogical practices of French as a foreign language in a post-COVID-19 context (The case of the University of Baghdad)
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Publication Date
Sat Oct 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Strategic planning of human resources and its impact on the stages of a career path :A field research in the Ministry of Health
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Abstract

The objective of this research is to analyze the relationship between the strategic planning for human resources and career path, and I have tested Search the Ministry of  Health and some health centers headquarters in the Karkh district, that is applied in sample Consist of (45) Deputy Director, Head of Depts, Departmental Manager, and health center Manager.

Find interested in studying the two subjects are important and vital, at the level of organizations at the present time, namely the strategic planning of human resources and career path. To achieve the objectives of the research was designed Qusestionnair (31) items to collect  Primary data. and collected t

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Publication Date
Sun Aug 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
The role of organizational symmetry in improving the quality of work life an applied research at the University of Information and Communications Technology
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"The aim of the research is to identify the availability of the dimensions of the research variables represented by organizational symmetry and the quality of work-life at the University of Information and Communications Technology, which is one of the formations of the Ministry of Higher Education and Scientific Research in Baghdad, in addition to knowing the relationship and influence between them. The research relied on the descriptive analytical approach based on peer description. The research was analyzed and the research sample consisted of (148) individuals, the sample was chosen using the comprehensive inventory method, data was obtained by relying on the questionnaire which was prepared from ready-made m

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Publication Date
Thu Feb 21 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The Reality of Environmental Pollution and The Use of Environmental Taxes to Limit It: Analytical Search for Diesel Generators in Governorate of Baghdad
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The research depth and dimensions of the problem of environmental pollution resulting from the combustion of fuel used in electric power generators, especially in the summer and you are the national electric power supplied by almost non-existent state where this problem is a local phenomenon that has serious dimensions to human health, as well as the possibility of using a the tax system tools of b (environmental taxes) to reduce these pollutants, so the search is aimed at the types of gases emitted from burning fuel electric generators operating in the province of Baghdad and then measure the amount of environmental pollution as well as compared to the amount of some of these gases, which is more risk to humans with permitted by the Wor

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Publication Date
Tue Mar 01 2011
Journal Name
Iraqi Journal Of Science
EVALUATION OF THE TOXICITY OF DIFFERENT NICOTINE SULFATE CONCENTRATIONS IN CONTROLLING NYMPHAL INSTARS AND ADULTS OF CABBAGE APHID BREVICORYNE BRASSICAE (L.)(HOMOPTERA: APHIDIDAE)
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Publication Date
Thu Jun 25 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluating the Effects of Different Doses of Vitamin B2 and Single Dose of Vitamin B12 Against Myelosuppression Induced by Cyclophosphamide in Experimental Rats
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Cyclophosphamide is chemotherapeutic agent that utilized for the treatment of different malignancies; however its’ used associated with numerous adverse effects. Vitamin B2 and vitamin B12 suggested having myeloprotective effect. This work is designed to investigate the myeloprotective effect of both vitamins against cyclophosphamide induced myelosuppression. One hundred adult rats of both sexes were used in this study. The animals were randomly enrolled into ten groups of 10 rats each. Group I: Control group. Group II: Cyclophosphamide-treated. Group III and Group IV Orally-administered vitamin B2 (10, and 40 mg/kg/day), respectively alone for 7 days. Group V:

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Publication Date
Sun Jun 30 2019
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Evaluation the Effect of Velocity and Temperature on the Corrosion Rate of Crude Oil Pipeline in the Presence of CO2/H2S Dissolved Gases
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In this paper investigate the influences of dissolved CO2/H2S gases, crude oil velocity and temperature on the rate of corrosion of crude oil transmission pipelines of Maysan oil fields southern Iraq. The Potentiostatic corrosion test technique was conducted into two types of carbon steel pipeline (materials API 5L X60 and API 5L X80). The computer software ECE electronic corrosion engineer was used to predict the influences of CO2 partial pressure, the composition of crude oil, flow velocity of crude oil and percentage of material elements of carbon steel on the rate of corrosion. As a result, the carbon steel API 5L X80 indicates good and appropriate resistance to corrosion compared to carbon steel API

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