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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Feb 03 2018
Journal Name
Chinese Journal Of Physics
A true random number generator based on the photon arrival time registered in a coincidence window between two single-photon counting modules
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True random number generators are essential components for communications to be conconfidentially secured. In this paper a new method is proposed to generate random sequences of numbers based on the difference of the arrival times of photons detected in a coincidence window between two single-photon counting modules

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Publication Date
Sun Jan 02 2022
Journal Name
Journal Of The College Of Languages (jcl)
Comparison between Ghassan Kanafani's Novel " Ma tabaqa lakom" and William Faulkner's "The Sound and the Fury" from the Perspective of the American School (the methodology of the novelistic theme and style): مقایسة دو رمان "ماتبقّي لكم"کنفانی و " خشم و هياهو"ی فاکنر بر اساس مكتب آمريكا (بررسی روش شناختی محتوایی و سبکی )
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     Being the meeting points of the world different languages and out of a scholarly perspective, comparative literature represents a cultural leap as well as an artistic and intellectual development or a global literary movement of both prose and poetry. Such homogenous literary structure requires a systematic and coherent study of the literary output of the people different cultures and civilizations. It also represents the theoretical approach of the present study that debates a systematic comparison between Ghassan Kanafani’s All That's Left to You and William Faulkner’s. The Sound and the Fury.  Within the perspective of the descriptive analysis approach, the present paper discusses th

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Publication Date
Mon Jan 01 2018
Journal Name
International Journal Of Chemtech Research
Liquid Chromatographic and validation study in separation and determination of benzidines and phenols in the main discharge point of wastewater
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Publication Date
Sat Apr 29 2023
Journal Name
International Journal Of Biomaterials
The Influence of the Hyaluronic Acid Gel on the Postoperative Sequelae following Surgical Removal of the Impacted Mandibular Third Molar in Comparison with the A-PRF: A Randomized Controlled Trial
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One of the most common procedures in oral surgery is the removal of impacted mandibular third molars, often followed by pain, swelling, alveolitis, and trismus. Purpose. To compare the outcomes of the intrasocket application of 1% hyaluronic acid oral gel (HA) and advanced platelet-rich fibrin (A-PRF) on the expected postoperative complications, pain, swelling, and trismus follow the surgical extraction of the impacted mandibular third molar. Material and Methods. A randomized controlled trial was conducted at the Oral and Maxillofacial Surgery Unit, Dental Teaching Hospital. Healthy patients who required surgical removal of the impacted mandibular third molar were divided randomly into three groups. The extraction site of the group

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Publication Date
Tue Mar 04 2008
Journal Name
Journal Of Baghdad College Of Dentistry
Twelve months clinical comparison between modified Widman flap with or without enamel matrix derivative for the treatment of infrabony defects
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Publication Date
Sun May 07 2017
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
DETECTION OF MINERAL AND MICROBIAL CONTAMINATION IN CEREAL AND IT,S PRODUCTS: DETECTION OF MINERAL AND MICROBIAL CONTAMINATION IN CEREAL AND IT,S PRODUCTS
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The results shows existence of metals such as copper, iron, Cadmium, lead and zinc in most of examined samples , the highest concentration are up to (2.26, 40.82, 282.5, 31.02, 19.26, 4.34) Part per million) ppm) in pasta hot (Zer brand), Indomie with chicken, granule (Zer brand), brand (Zer brand), and rice (mahmood brand) respectively, with presence nickel in spaghetti( Zer brand), granule, Zer brand with concentration reached to 4.34 ppm and 1.06 ppm respectively.
The results of cereals group and its products show that two kinds of fungi, Aspergillus spp. and Penicillin spp. were found in rice (Mahmood brand) with numbers got to 1.5×103 Colony Forming Unit/ gram (c.f.u./g),while Bacillus cereus and Staphylococcus aureus were isola

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Publication Date
Sun Feb 25 2024
Journal Name
Baghdad Science Journal
Prioritized Text Detergent: Comparing Two Judgment Scales of Analytic Hierarchy Process on Prioritizing Pre-Processing Techniques on Social Media Sentiment Analysis
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Most companies use social media data for business. Sentiment analysis automatically gathers analyses and summarizes this type of data. Managing unstructured social media data is difficult. Noisy data is a challenge to sentiment analysis. Since over 50% of the sentiment analysis process is data pre-processing, processing big social media data is challenging too. If pre-processing is carried out correctly, data accuracy may improve. Also, sentiment analysis workflow is highly dependent. Because no pre-processing technique works well in all situations or with all data sources, choosing the most important ones is crucial. Prioritization is an excellent technique for choosing the most important ones. As one of many Multi-Criteria Decision Mak

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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Ecological and Geographical distribution of species and genera of Primulaceae in Iraq
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The present research deal with ecological and geographical distribution of species and genera of Primulaceae in Iraq. The results were revealed that species distributed in the north , north-east and west of Iraq. Anagallis arvensis L. is the most prevalent species tolerant to different environmental conditions, while the species of Primula L. characterized as less widespread and limited in one District. In addition, the districts Rawanduz (MRO) and Sulaymaniyah (MSU) have ranked first in distribution of the species on geographical districts with (75%), while the districts southern desert (DSD) and Basra (LBA) in last place with (16.7%). Maps for geographical distribution for all species were illustrated.

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Publication Date
Wed Jan 22 2020
Journal Name
Molecules
In Vivo and In Vitro Evaluation of the Protective Effects of Hesperidin in Lipopolysaccharide-Induced Inflammation and Cytotoxicity of Cell
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(1) Background: Plant flavonoids are efficient in preventing and treating various diseases. This study aimed to evaluate the ability of hesperidin, a flavonoid found in citrus fruits, in inhibiting lipopolysaccharide (LPS) induced inflammation, which induced lethal toxicity in vivo, and to evaluate its importance as an antitumor agent in breast cancer. The in vivo experiments revealed the protective effects of hesperidin against the negative LPS effects on the liver and spleen of male mice. (2) Methods: In the liver, the antioxidant activity was measured by estimating the concentration of glutathione (GSH) and catalase (CAT), whereas in spleen, the concentration of cytokines including IL-33 and TNF-α was measured. The in vitro expe

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Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
Kinds of Food and Drinks in Morocco in the Period of Al-Murabteen and Al-Moahideen
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Cooking was of great importance in the Islamic Arabic culture and the
people of Morocco have shown great interest in this aspect and also in the
variety in the making of food. They used all kinds of meat of and have shown
interest in preserving and distributing it .The people of Morocco used the
additives in their cooking such as salt, saffron and many other kinds to add
special flavor and taste and their cooking a distinctive flavor.
Sweet and pastry, in addition to the drinks, represented another aspect of the
Moroccan kitchen. At that time women were brought as slaves from Sudan
and as a result they brought their experience in the making of sweets and
pastry with them to Morocco, they used sugar, fat, wheat

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