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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Jun 15 2021
Journal Name
Al-academy
The directing vision and two display technologies in the Iraqi Child Theater: عباس قاسم كاظم
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  The current research contains four chapters. The first topic included the methodological framework that included the problem of research and the need for it, and then the importance of the research, and then the aim of the research, its limits and the definition of terms linguistically, conventionally and procedurally. The second chapter (the theoretical framework) contained two topics, the topic The first is titled: The Outward Vision in Child Theater Performances, while the second topic was titled: Presentation Technology in Child Theater, Chapter Four (Research Procedures), which organized the research community and analyzed its sample, and the fourth chapter contained research results, conclusions and recommendations. The prop

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Publication Date
Fri Jan 01 2021
Journal Name
International Journal Of Agriculture And Statistical Science
COMPARISON OF FORECASTING OF THE RISK OF CORONAVIRUS (COVID-19) IN HIGH-QUALITY AND LOW-QUALITY HEALTHCARE SYSTEMS, USING ANN MODELS
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COVID-19 is a disease that has abnormal over 170 nations worldwide. The number of infected people (either sick or dead) has been growing at a worrying ratio in virtually all the affected countries. Forecasting procedures can be instructed so helping in scheming well plans and in captivating creative conclusions. These procedures measure the conditions of the previous thus allowing well forecasts around the state to arise in the future. These predictions strength helps to make contradiction of likely pressures and significances. Forecasting procedures production a very main character in elastic precise predictions. In this case study used two models in order to diagnose optimal approach by compared the outputs. This study was introduce

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Publication Date
Wed Jan 01 2020
Journal Name
Medico -legal Update
Histological changes in liver tissue resulting from Hydatid cyst infection: Comparison between sheep and cattle in iraq
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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
Efficiency and Safety of Desferioxamine Chelation Therapy in Paediatric Patients with Transfusion-Dependent Anaemia: Experience of two Centres from Sudan
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Background: Repeated blood transfusion   is   the main   therapeutic option for transfusion-dependent anaemias with consequent iron overload and organ damage .Therefore iron chelating agents are important protective measures for these patients. The aim of this study was  to investigate  the efficiency and safety of Desferroxamine  in paediatrics population subjected  to iron overload as a consequence  of repeated transfusion in a group of  Sudanese children  

Subjects & Methods: This was a descriptive cross-sectional hospital based study.  Conducted in two main paediatric reference hospitals   in, Su

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Publication Date
Fri Nov 01 2019
Journal Name
Journal Of Engineering
A Comparison Study of Brine Desalination using Direct Contact and Air Gap Membrane Distillation
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Membrane distillation (MD) is a hopeful desalination technique for brine (salty) water. In this research, Direct Contact Membrane Distillation (DCMD) and  Air Gap Membrane Distillation (AGMD) will be used. The sample used is from Shat Al –Arab water (TDS=2430 mg/l). A polyvinylidene fluoride (PVDF) flat sheet membrane was used as a flat sheet form with a plate and frame cell. Several parameters were studied, such as; operation time, feed temperature, permeate temperature, feed flow rate. The results showed that with time, the flux decreases because of the accumulated fouling and scaling on the membrane surface. Feed temperature and feed flow rate had a positive effect on the permeate flux, while permeate temperatu

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Publication Date
Sun May 01 2016
Journal Name
2016 Al-sadeq International Conference On Multidisciplinary In It And Communication Science And Applications (aic-mitcsa)
Review and performance comparison of VANET protocols: AODV, DSR, OLSR, DYMO, DSDV & ZRP
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Publication Date
Fri Dec 30 2022
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Comparison of Estimation Sonic Shear Wave Time Using Empirical Correlations and Artificial Neural Network
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Wellbore instability and sand production onset modeling are very affected by Sonic Shear Wave Time (SSW). In any field, SSW is not available for all wells due to the high cost of measuring. Many authors developed empirical correlations using information from selected worldwide fields for SSW prediction. Recently, researchers have used different Artificial Intelligence methods for estimating SSW. Three existing empirical correlations of Carroll, Freund, and Brocher are used to estimate SSW in this paper, while a fourth new empirical correlation is established. For comparing with the empirical correlation results, another study's Artificial Neural Network (ANN) was used. The same data t

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Publication Date
Thu Jun 30 2022
Journal Name
International Journal Of Drug Delivery Technology
Comparison among the Synthesis of Some Azomethine Derivatives by Classical and Non-classical Methods
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Publication Date
Fri Jun 25 2021
Journal Name
International Journal Of Drug Delivery Technology
Comparison among the Synthesis of Some Azomethine Derivatives by Classical and Non-classical Methods
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In this time, most researchers toward about preparation of compounds according to green chemistry. This research describes the preparation of 2-fluoro-5-(substituted benzylideneamino) benzonitrile under reflux and microwave methods. Six azomethine compounds (B1-6) were synthesized by two methods under reflux and assisted microwave with the comparison between the two methods. Reflux method was prepared of azomethine (B1-6) by reaction of 5-amino-2-fluorobenzonitrile with some aldehyde derivatives with (50–100) mL of absolute ethanol and some quantity of GAA and time is limited between (2–5) hours with a yield between (60–70) percent with recrystallization for appropriate solvents. But the microwave-assisted method was synthesized of co

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
A comparison of cross sections for Selenium -73 radioisotopes produced by accelerators and reactors
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Background: Selenium-73 with half- life of 7.15 hour emits β+ in nature and has six stable isotopes which are ( 74Se,76Se,77Se,78Se,80Se and 82Se ). Selenium-73 has many applications in technology and radioselenium compounds of metallic have found various applications in medicine. Objective:  To make a comparison between different reactions that produced cross sections of Se-73 radioisotopes. Subjects and methods: The feasibility of the production of Selenium -73 via various nuclear reactions was investigated. Excitation functions of 73Se production by the reactions of 75As (p,3n), 169Tm( d,x), 74Se, natSe, natBr (p,x) , 75As (d,4n), natGe (3He,x), 70Ge (α, n), and 72Ge (α, 3n) and neutron capture were calculated using the avail

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