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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Dec 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Non-Parametric Quality Control Methods
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    Multivariate Non-Parametric control charts were used to monitoring the data that generated by using the simulation, whether they are within control limits or not. Since that non-parametric methods do not require any assumptions about the distribution of the data.  This research aims to apply the multivariate non-parametric quality control methods, which are Multivariate Wilcoxon Signed-Rank ( ) , kernel principal component analysis (KPCA) and k-nearest neighbor (

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Publication Date
Fri Nov 02 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Impact of Maternal Risk Factors on Birth Weight of Newborn in Two Maternity Hospitals in Baghdad City
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Objectives: A cross sectional analytic study was carried out to identify the maternal risk factors which
contribute to occurrence of low birth weight, and to determine the statistical significant differences between low
birth weight and maternal risk factors.
Methodology: A purposive sample of (400) woman was selected from AL-Elwyia Maternity Teaching Hospital
and Fatima Al-Zaharia Maternity and Pediatric Teaching Hospital. Data was collected through the interview of
mothers. Questionnaire format was designed and consisted seven parts, demographic variables, and reproductive
variables , Reproductive health variables, complications during the current pregnancy, the mother newborn
variables nutritional status for the m

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Publication Date
Sun Apr 30 2023
Journal Name
Al-kindy College Medical Journal
Comparison between Reference Infliximab (Remicade) and its Biosimilar (Remsima) in Patients with Ankylosing Spondylitis: A Field-based Pharmacoeconomic Study
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Background: Ankylosing spondylitis is a chronic inflammatory disease that mostly involves the spine and sacroiliac joints. It is associated with a decreased quality of life. Biological medicines such as infliximab and its biosimilar are the mainstay treatments for active ankylosing spondylitis.

Objective: The study objective was to conduct a pharmacoeconomic study comparing the cost-effectiveness of the reference infliximab with its biosimilar in ankylosing spondylitis patients visiting public hospitals.

Subjects and Method: This is a two-center pharmacoeconomic study performed at two large teaching governmental hospitals in Baghdad, Iraq, which s

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Publication Date
Sun Dec 01 2013
Journal Name
Baghdad Science Journal
Study the Effect of Plant Pathogenic Fungi in solid media in comparison with common Fungicide
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A study carried out for study effect of furfural that extracted from corn cobs by using specialized reaction system laboratory on phytopathogenic fungi: Pythium aphanidermatum, Rhizoctonia solani, Macrophomina phaseolina and Fusarium solani in addition to biocontrol fungus Trichoderma viride were isolated from infected plants and from their rhizosphere . The preparation results of different concentrations from stock solution in concentration 1% of furflural showed that The concentration was 100 ppm of furfural was inhibited the growth of P. aphanidermatum46.7 % and the was in concentration 400 ppm. while the concentration 500 ppm caused inhibition 50% and 41.1% of R. solani and F. solani respectively. Whereas the concentration 500 pp

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Publication Date
Sat Aug 23 2025
Journal Name
Journal Of Baghdad College Of Dentistry
An Antimicrobial Activity of Moringa Oleifera Extract in Comparison to Chlorhexidene Gluconate (In vitro study)
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Background: Oral diseases persist to be a major health problem all over the world. Various bacteria and fungi are found to be the possible pathogensresponsible for the oral diseases. Moringa oleifera it is an extraordinary nutritious vegetable tree with many different uses. These leaves have high medicinal value. In the present study, antibacterial and antifungal activities of aqueous extracts of plant Moringa oleifera in comparison to chlorohexidene gluconate and deionized water were determined. Materials and methods: The leaves of plant of Moringa oleifera were collected from College of Pharmacy; Baghdad, Iraq. Tested microorganism (bacterial and fungal) was isolated from different clinical specimens. In-vitroantimicrobial activity was pe

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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Efficacy of Papacarie in Reduction Total Bacterial Count in Comparison with the Conventional Rotary Method
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Background: The change in the concepts of cavity preparation and the development of reliable adhesive materials lead to the development of alternative methods of caries removal. Chemo-mechanical caries removal (CMCR) involves the chemical softening of carious dentin, followed by its removal with manual excavation. The present study was conducted to evaluate clinically the efficiency of caries removal using a new chemo-mechanical agent (Papacarie) compared to the conventional drilling method in reduction of total bacterial count. Material and methods: The study is a split mouth design. The sample composes from sixty mandibular deciduous molars teeth in thirty children, between six to nine years of age with bilateral class I deep occlusal car

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Publication Date
Wed Jan 01 2020
Journal Name
Plant Archives
The effect of adding nano concentrations of hydrogen peroxide to the diluted semen of iraqi local roosters on some laboratory characteristics after cooling and cryopreservation
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This study was conducted at the poultry farm located in the College of Agricultural Engineering Sciences, University of Baghdad, Abu Gharib (the old site), and laboratories of the Animal Production Department, Jadriya, to investigate the effect of adding hydrogen peroxide H2O2 at nanoscale levels to semen diluents of local roosters sperm in a number of semen characteristics. In this study, 80 roosters local Iraqi chickens were used, the roosters were trained three times a week, to collect semen, until the largest number of them responded. Then the best 40 of the roosters were elected for the purpose of collecting the semen with a pooled sample, and then the samples were diluted and divided equally into four parts. The concentrations of 0, 1

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Scopus
Publication Date
Tue Jun 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Between Partial Least Square Regression(PLSR) and Tree Regression by Using Simulation(RT).
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This research discussed, the process of comparison between the regression model of partial least squares and tree regression, where these models included two types of statistical methods represented by the first type "parameter statistics" of the partial least squares, which is adopted when the number of variables is greater than the number of observations and also when the number of observations larger than the number of variables, the second type is the "nonparametric statistic" represented by tree regression, which is the division of data in a hierarchical way. The regression models for the two models were estimated, and then the comparison between them, where the comparison between these methods was according to a Mean Square

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Publication Date
Thu Oct 15 2015
Journal Name
Al Mustansyriah Journal Of Science
Comparison between (ARIMA) and (ANNs) models for estimating the relative humidity for Baghdad city
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The aim of the research is to study the comparison between (ARIMA) Auto Regressive Integrated Moving Average and(ANNs) Artificial Neural Networks models and to select the best one for prediction the monthly relative humidity values depending upon the standard errors between estimated and observe values . It has been noted that both can be used for estimation and the best on among is (ANNs) as the values (MAE,RMSE, R2) is )0.036816,0.0466,0.91) respectively for the best formula for model (ARIMA) (6,0,2)(6,0,1) whereas the values of estimates relative to model (ANNs) for the best formula (5,5,1) is (0.0109, 0.0139 ,0.991) respectively. so that model (ANNs) is superior than (ARIMA) in a such evaluation.

Publication Date
Tue Jun 01 2021
Journal Name
Iop Conference Series: Materials Science And Engineering
An Experimental Research on Design and Development Diversified Controllers for Tri-copter Stability Comparison
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Abstract<p>The drones have become the focus of researchers’ attention because they enter into many details of life. The Tri-copter was chosen because it combines the advantages of the quadcopter in stability and manoeuvrability quickly. In this paper, the nonlinear Tri-copter model is entirely derived and applied three controllers; Proportional-Integral-Derivative (PID), Fractional Order PID (FOPID), and Nonlinear PID (NLPID). The tuning process for the controllers’ parameters had been tuned by using the Grey Wolf Optimization (GWO) algorithm. Then the results obtained had been compared. Where the improvement rate for the Tri-copter model of the nonlinear controller (NLPID) if compared with </p> ... Show More
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