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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Jul 01 2022
Journal Name
Operative Dentistry
Interfacial Bond Strength and Morphology of Sound and Caries-affected Dentin Surfaces Bonded to Two Resin-modified Glass Ionomer Cements
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SUMMARY<sec> <title>Objective

To evaluate the shear bond strength and interfacial morphology of sound and caries-affected dentin (CAD) bonded to two resin-modified glass ionomer cements (RMGICs) after 24 hours and two months of storage in simulated body fluid at 37°C.

Methods and Materials

Sixty-four permanent human mandibular first molars (32 sound and 32 with occlusal caries, following the International Caries Detection and Assessment System) were selected. Each prepared substrate (sound and CAD) was co

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Publication Date
Wed Feb 20 2019
Journal Name
Iraqi Journal Of Physics
A comparison between PCA and some enhancement filters for denoising astronomical images
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This paper includes a comparison between denoising techniques by using statistical approach, principal component analysis with local pixel grouping (PCA-LPG), this procedure is iterated second time to further improve the denoising performance, and other enhancement filters were used. Like adaptive Wiener low pass-filter to a grayscale image that has been degraded by constant power additive noise, based on statistics estimated from a local neighborhood of each pixel. Performs Median filter of the input noisy image, each output pixel contains the Median value in the M-by-N neighborhood around the corresponding pixel in the input image, Gaussian low pass-filter and Order-statistic filter also be used.

Experimental results shows LPG-

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Publication Date
Tue Mar 24 2009
Journal Name
Proceeding Of 3rd Scientific Conference Of The College Of Science, University Of Baghdad.
A Comparison Between Galactic and Large Magellanic Cloud (LMC) Interstellar Extinction Curves
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Average interstellar extinction curves for Galaxy and Large Magellanic Cloud (LMC) over the range of wavelengths (1100 A0 – 3200 A0) were obtained from observations via IUE satellite. The two extinctions of our galaxy and LMC are normalized to Av=0 and E (B-V)=1, to meat standard criteria. It is found that the differences between the two extinction curves appeared obviously at the middle and far ultraviolet regions due to the presence of different populations of small grains, which have very little contribution at longer wavelengths. Using new IUE-Reduction techniques lead to more accurate result.

Publication Date
Tue Jan 01 2013
Journal Name
Iraqi Journal Of Physics
A comparison between PCA and some enhancement filters for denoising astronomical images
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This paper includes a comparison between denoising techniques by using statistical approach, principal component analysis with local pixel grouping (PCA-LPG), this procedure is iterated second time to further improve the denoising performance, and other enhancement filters were used. Like adaptive Wiener low pass-filter to a grayscale image that has been degraded by constant power additive noise, based on statistics estimated from a local neighborhood of each pixel. Performs Median filter of the input noisy image, each output pixel contains the Median value in the M-by-N neighborhood around the corresponding pixel in the input image, Gaussian low pass-filter and Order-statistic filter also be used. Experimental results shows LPG-PCA method

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Publication Date
Sat May 01 2021
Journal Name
Materials Today: Proceedings
WITHDRAWN: Analyzing and measuring the impact of trade openness on the gross domestic product growth of the Iraqi economy after 2003
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Publication Date
Thu Mar 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
The Surface Hardness Measurement of Stone and Improved Die Stone After the Addition of a Mixture of Chemical Additives with Different Proportion
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Background: Incorporation of chemical additives has long been a technique used to improve properties of the gypsum products. The purpose of this work was to study the effects of adding a combination of gum Arabic and calcium hydroxide to a type III dental stone and type IV improved die stone with different proportion. The effect on water/powder ratio, and surface hardness was determined. Material and method: Both material stone and die stone were blended with two proportion of additives so that each material was mixed twice but with different proportion of gum Arabic (0.1% and 0.2%) and calcium hydroxide (0.5 % and 0.3%). Data for hardness were subjected to two-way analysis of variance. Results: The results revealed that the chemical additi

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Publication Date
Sat Jul 13 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
The Effect of Systemic Proteolytic Enzymes on Postoperative Inflammatory Response and Quality of Life after Surgical Extraction of Impacted Mandibular Third Molar
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Background: The surgical extraction of impacted third molar usually results in postoperative inflammation manifested as pain, facial swelling and trismus which may cause deterioration in the patient’s quality of life. Methods: This randomized controlled study included 56 patients indicated for surgical extraction of IMTM under local anesthesia. These patients were randomly assigned into two groups: a study group that included patients who received Tibrolin® postoperatively and a control group that did not. The predictor variable was whether to use SET or not. Pain measured by the pain numerical rating scale (NRS), facial swelling, and the degree of trismus were the outcome variables. The Arabic version of the Oral Health Impact P

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Publication Date
Fri Dec 01 2023
Journal Name
Political Sciences Journal
The Future of the Russian- Ukrainian War and the Extent of its Reflection on the Security of Eastern European Countries after 2022
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Wars represent one of the most serious threats to the world order; It is considered a violation of international laws and norms, and humanitarian principles. From this point comes the study of the importance of the topic entitled (The Future of the Russian-Ukrainian war and the extent of its Reflection on the security of Eastern European countries after the year 2022). This study is based on reviewing future possibilities (scenarios) of war. The Russian-Ukrainian war, which was launched by the Russian government led by Russian President Vladimir Putin in February 2022, is still ongoing at the time of writing this research. This chapter includes three possibilities (scenarios). The first possibility deals with the development of the war t

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Publication Date
Fri Jan 02 2026
Journal Name
Research On Crops
Effect of organic acid, amino acids and nano-fertilizer on growth, yield and nitrate concentration of lettuce plant under two farming systems
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Publication Date
Tue Dec 20 2022
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
FIRST RECORD OF TWO PARASITOID WASPS OF THE FAMILY CHALCIDIDAE (HYMENOPTERA) IN IRAQ
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The family Chalcididae (Order: Hymenoptera) is known as one of the large chalcidoid wasps with some distinct morphological characters. The first occurrence of two parasitoid species belonging to this family was reported in the Al-Husayniya district Karbala Province, Iraq; which are: Brachymeria podagrica (Fabricius, 1787) and Chalcis myrifex (Sulzer, 1776). Both species were collected by using the sweeping net from orchards during July 2020.

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