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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Estimation of parameters of two-dimensional sinusoidal signal model by employing Deferential Evaluation algorithm and the use of Sequential approach in estimation
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Estimation the unknown parameters of a two-dimensional sinusoidal signal model is an important and a difficult problem , The importance of this model  in modeling Symmetric gray- scale texture image . In this paper, we propose employment Deferential Evaluation algorithm and the use of Sequential approach to estimate the unknown frequencies and amplitudes of the 2-D sinusoidal components when the signal is affected by noise. Numerical simulation are performed for different sample size, and various level of standard deviation to observe the performance of this method in estimate the parameters of 2-D sinusoidal signal model , This model was used for modeling  the Symmetric gray scale texture image and estimating by using

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effect of Some Storage Conditions upon the Survival of Some Fungal Spores
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Folic acid and multivitamin tablets containing Aspergillus flavus Penicillia spp. and Cladosporia spores were prepared at a compression pressure of 148 MN/m2 and stored at 35°C under different relative  humidifies (75,85, and 95)% within air tight containers, to study the effect of storage condition on them, as well as ,the estimation of the microbial level of the raw materials intended to be used in the two kinds of tablets . Result showed that some raw materials derived from natural origin were heavily contaminated with microorganism compared to that of synthetic origin ,the results also indicated the effect of relative humidity , types of fungal spore , and the hygroscopic nature of exicpient upon survival. Multivit

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Publication Date
Fri Nov 11 2022
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Ambidexteritg leadership behaviors in organizational excellence Comparative : applied research in the two public companies, Al-Zawraa and the electrical and electronic industries
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Business organizations strive to reach organizational excellence, in instruction to maintain their position in the market, so the research started from the problem of the weakness of the senior leaders in the two companies investigated in the management and sustainability of work, as well as their inability to face challenges that could affect the work of the two companies in the future, especially the lack of organizational of the future and the prediction of those events, so the two companies seek to explore and invest opportunities to achieve organizational excellence. The research aims to know the role of Ambidexterity  leadership behaviors in organizational excellence in my company .and create ideas that will achieve organizati

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Publication Date
Mon Oct 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Beran estimator using Nadaraya-Waston and Prestley-chao weights in estimating the conditional survival function of breast cancer patients
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This study includes the application of non-parametric methods in estimating the conditional survival function of the Beran method using both the Nadaraya-Waston and the Priestley-chao weights and using data for Interval censored and Right censored of breast cancer and two types of treatment, Chemotherapy and radiation therapy Considering age is continuous variable, through using (MATLAB)  use of the (MSE) To compare weights The results showed a superior weight (Nadaraya-Waston) in estimating the survival function and condition of Both for chemotherapy and radiation therapy.

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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of Enamel Surface after Debonding of Different Types of Esthetic Brackets (An In Vitro Study)
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Background: Debonding orthodontic brackets and removal of residual bonding material from the enamel surface include critical steps that may cause enamel damage. The aim of the present study was to evaluate and compare the site of bond failure and enamel surface damage after debonding of three types of esthetic brackets (composite, ceramic, sapphire) bonded with light cure composite and resin-modified glass ionomer adhesive. Materials and methods: Seventy two maxillary premolars teeth were divided into three groups each group consisted of 24 teeth according to the type of brackets. Each group was subdivided into two subgroups (12 teeth for each) according to the bonding material that was used. After 7 days of bonding procedure, the brackets

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Publication Date
Mon Feb 25 2019
Journal Name
Iraqi Journal Of Physics
Comparison study of CC and CH vibration frequencies and eelectronic properties for mono, Di, Tri, and tetra-rings layer of arm chair (SWCNTs)
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Semi-empirical methods were applied for calculating the vibration frequencies and IR absorption intensities for normal coordinates of the {mono (C56H28), di (C84H28), tri (C112H28) and tetra (C140H28)} -rings layer for (7,7) armchair single wall carbon nanotube at their equilibrium geometries which were all found to have D7d symmetry point group.

Assignment of the modes of vibration (3N-6) was done depending on the pictures of their modes by applying (Gaussian 03) program. Comparison of the vibration frequencies of (mono, di, tri and tetra) rings layer which are active in IR, and inactive in Ramman spectra. For C-H stretching vibrat

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Publication Date
Mon Jul 01 1996
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
TWO PRIMITIVE ORIBATIDS: FIRST RECORD IN IRAQ
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Cosmochthonius reticulatus Grandjean, 1947 (Acari: Oribatei: Cosmochthoniidae) and Rhysotritia ardua ardua C. L. Koch, 1841 ( Acari : Oribate : Euphthiracari¬dae), are two species of oribatids mites first recorded in Iraq from a woodland in the central part of Iraq. The two species are described and illustrated.

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Publication Date
Sun Sep 30 2001
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Two Phase Flow in Large Diameter Pipe
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Publication Date
Mon May 01 2023
Journal Name
Journal Of Engineering
Measuring the Attribute Accuracy and Completeness for the OpenStreetMap Roads Networks for Two Regions in Iraq
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The OpenStreetMap (OSM) project aims to establish a free geospatial database for the entire world which is editable by international volunteers. The OSM database contains a wide range of different types of geographical data and characteristics, including highways, buildings, and land use regions. The varying scientific backgrounds of the volunteers can affect the quality of the spatial data that is produced and shared on the internet as an OSM dataset. This study aims to compare the completeness and attribute accuracy of the OSM road networks with the data supplied by a digitizing process for areas in the Baghdad and Thi-Qar governorates. The analyses are primarily based on calculating the portion of the commission (extr

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Publication Date
Mon May 01 2023
Journal Name
Journal Of Engineering
Measuring the Attribute Accuracy and Completeness for the OpenStreetMap Roads Networks for Two Regions in Iraq
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The OpenStreetMap (OSM) project aims to establish a free geospatial database for the entire world which is editable by international volunteers. The OSM database contains a wide range of different types of geographical data and characteristics, including highways, buildings, and land use regions. The varying scientific backgrounds of the volunteers can affect the quality of the spatial data that is produced and shared on the internet as an OSM dataset. This study aims to compare the completeness and attribute accuracy of the OSM road networks with the data supplied by a digitizing process for areas in the Baghdad and Thi-Qar governorates. The analyses are primarily based on calculating the portion of the commission (extra road) and

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