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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Microbiology of active chronic otitis media: in comparison with abroad studies
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Background: Chronic otitis media (COM) of mucosal or squamous type is a common problem in otolaryngology practice, the active form of COM is characterized by discharge of pus and is treated by antibiotics to start with, the appropriate antibiotic should be prescribed to avoid antibiotic abuse and guarantee good outcome. Objectives:The objective of this study is to identify the causative organisms of active chronic active otitis media both (mucosal, squamous) type and test their sensitivity to various anti- microbial agents &compare with abroad studies.Methods:A prospective study was done on eighty patients, different ages and sexes were taken and carful history and examination was done, examination under microscope was done with carf

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Publication Date
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Estimates Nonparametric In Multiple Regression Analysis Function (Gamma ,Beta)
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The use of non-parametric models and subsequent estimation methods requires that many of the initial conditions that must be met to represent those models of society under study are appropriate, prompting researchers to look for more flexible models, which are represented by non-parametric models                  

          In this study, the most important and most widespread estimations of the estimation of the nonlinear regression function were investigated using Nadaraya-Watson and Regression Local Ploynomial, which are one of the types of non-linear

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Publication Date
Mon Feb 27 2023
Journal Name
Applied Sciences
Comparison of ML/DL Approaches for Detecting DDoS Attacks in SDN
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Software-defined networking (SDN) presents novel security and privacy risks, including distributed denial-of-service (DDoS) attacks. In response to these threats, machine learning (ML) and deep learning (DL) have emerged as effective approaches for quickly identifying and mitigating anomalies. To this end, this research employs various classification methods, including support vector machines (SVMs), K-nearest neighbors (KNNs), decision trees (DTs), multiple layer perceptron (MLP), and convolutional neural networks (CNNs), and compares their performance. CNN exhibits the highest train accuracy at 97.808%, yet the lowest prediction accuracy at 90.08%. In contrast, SVM demonstrates the highest prediction accuracy of 95.5%. As such, an

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Publication Date
Thu Jun 01 2017
Journal Name
Journal Of Huazhong University Of Science And Technology [medical Sciences]
New mini dental implant attachments versus O-ring attachment after cyclic aging: Analysis of retention strength and gap space
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Publication Date
Sun Sep 02 2012
Journal Name
Baghdad Science Journal
Study the expression level of beta 2 microglobulin gene on hepatitis C patients before and after treatment with interferon
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This study has been carried out to evaluate the expression level of beta 2 microglobulin gene on patients infected by hepatitis C virus before and after treatment with interferon. The study included 117 hepatitis C patients comprising as 63 pre-treated patients, the range of age was between 20-65 year with a mean age of 48.12 ± 16.1 and 54 post-treated patients with age range was between 23-63 year with the mean of 46.1 ± 18.1. Also it was found that more than half of patients were located within third and fourth decade i.e. 30-49 year, with a percentage of 52.4% and 55.6 % for pre-treatment and post-treatment patients respectively. Moreover , regarding both groups, males are more than females with the ratio of ( 3.2:1) among p

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Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
The natural courses of keratometric, pachymetric and visual acuity outcomes during 1year follow up after corneal collagen cross-linking
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Background: As photochemical reaction that can stiffen the cornea, CXL is the only promising method of preventing progression of keratectasia such as KC and secondary ectasia following refractive surgery. The aim of CXL is to stabilize the underlying condition with a small chance of visual improvement. Objective: To show the sequences of changes in visual acuity and topographic outcomes during 1 year post CXL for patients with progressive Keratoconus.Type of the study: Cross sectional studyMethods: CXL procedure was done for 45 eyes with progressive KC. The following parameters had been monitored pre operatively, 1, 3, 6 and 12 months postoperatively: K apex, K2, corneal thickness at thinnest location, anterior and posterior elevation po

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Publication Date
Sun Mar 06 2016
Journal Name
Baghdad Science Journal
Comparison Between Conventional and Microwave Methods For Extraction Pectin and Degree of Esterification from Orange (Citrus sinesis) and Grapefruit (Citrus paradisi) Peels
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In this study Microwave and conventional methods have been used to extract and estimate pectin and its degree of esterification from dried grapefruit and orange peels. Acidified solution water with nitric acid in pH (1.5) was used. In conventional method, different temperature degrees for extraction pectin from grape fruit and orange(85 ,90 , 95 and 100?C) for 1 h were used The results showed grapefruit peels contained 12.82, 17.05, 18.47, 15.89% respectively, while the corresponding values were 5.96, 6.74, 7.41 and 8.00 %, respectively in orange peels. In microwave method, times were 90, 100, 110 and 120 seconds. Grapefruit peels contain 13.86, 16.57, 18.69, and 17.87%, respectively, while the corresponding values were of 6.53, 6.68, 7.2

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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Comparison of Mercury Intrusion and Nitrogen Adsorption Measurements for the Characterization of Certain Natural Raw Materials Deposits
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The porosity of materials is important in many applications, products and processes, such as electrochemical devices (electrodes, separator, active components in batteries), porous thin film, ceramics, soils, construction materials, ..etc. This can be characterized in many different methods, and the most important methods for industrial purposes are the N2 gas adsorption and mercury porosimetry. In the present paper, both of these techniques have been used to characterize some of Iraqi natural raw materials deposits. These are Glass Sand, Standard Sand, Flint Clay and Bentonite. Data from both analyses on the different types of natural raw materials deposits are critically examined and discussed. The results of specific surface are

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Publication Date
Fri Dec 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Determination of Implant Primary Stability: A Comparison of the Surgeon’s Tactile Sense and Objective Measurements
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Background: Evaluation and measurement of primary stability could be achieved by several methods, including the resonance frequency analysis (RFA) and implant insertion torque (IT) values. The need for a sufficient primary stability, guaranteed by an adequate insertion torque and implant stability quotient values, increased its importance mainly in one stage implants or in immediate loading protocols. The aims of this study was to find if there is a correlation between the peak insertion torque (PIT) and ISQ values of implants inserted in the jaws of different bone quality which regarded as two important clinical determinant factors for prediction of implant primary stability, and to evaluate and compare whether an experienced clinician cou

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Publication Date
Mon Oct 14 2019
Journal Name
Open Access Macedonian Journal Of Medical Sciences
Comparison of Clinico-Pathological Presentations of Triple-Negative versus Triple-Positive and HER2 Iraqi Breast Cancer Patients
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BACKGROUND: Breast cancer remains the most common malignancy among the Iraqi population. Affected patients exhibit different clinical behaviours according to the molecular subtypes of the tumour. AIM: To identify the clinical and pathological presentations of the Iraqi breast cancer subtypes identified by Estrogen receptors (ER), Progesterone receptors (PR) and HER2 expressions. PATIENTS AND METHODS: The present study comprised 486 Iraqi female patients diagnosed with breast cancer. ER, PR and HER2 contents of the primary tumours were assessed through immunohistochemical staining; classifying the patients into five different groups: Triple Negative (ER/PR negative/HER2 negative), Triple Positive (ER/PR positive/HER2 positive), Luminal A (ER

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