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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Feb 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Partial Least Squares and Principal Components Methods by Simulation
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Abstract                                                                                              

The methods of the Principal Components and Partial Least Squares can be regard very important methods  in the regression analysis, whe

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Publication Date
Thu Jun 01 2023
Journal Name
Baghdad Science Journal
Comparison of Faster R-CNN and YOLOv5 for Overlapping Objects Recognition
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Classifying an overlapping object is one of the main challenges faced by researchers who work in object detection and recognition. Most of the available algorithms that have been developed are only able to classify or recognize objects which are either individually separated from each other or a single object in a scene(s), but not overlapping kitchen utensil objects. In this project, Faster R-CNN and YOLOv5 algorithms were proposed to detect and classify an overlapping object in a kitchen area.  The YOLOv5 and Faster R-CNN were applied to overlapping objects where the filter or kernel that are expected to be able to separate the overlapping object in the dedicated layer of applying models. A kitchen utensil benchmark image database and

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Publication Date
Wed Jan 01 2025
Journal Name
Lecture Notes In Networks And Systems
Comparison Between the Performance of Human Translators and AI-Supported Applications
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This study aims to conduct an exhaustive comparison between the performance of human translators and artificial intelligence-powered machine translation systems, specifically examining the top three systems: Spider-AI, Metacate, and DeepL. A variety of texts from distinct categories were evaluated to gain a profound understanding of the qualitative differences, as well as the strengths and weaknesses, between human and machine translations. The results demonstrated that human translation significantly outperforms machine translation, with larger gaps in literary texts and texts characterized by high linguistic complexity. However, the performance of machine translation systems, particularly DeepL, has improved and in some contexts

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Publication Date
Mon Jun 01 2015
Journal Name
Journal Of The College Of Languages (jcl)
A Stylistic Analysis of Two Selected, English and Arabic, War Poems
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War as a human phenomenon, has its own literature. Poetry is a major genre in this literature. This paper is an attempt to investigate and analyse some stylistic features in two selected, English and Arabic, war poems. These poems share the same theme.Both promote the principle of sacrificing one’s own life for the sake of homeland.  This paper limits itself to analyse, thecontent words, tenses, semantic grouping of vocabulary and foregrounding in the two poems. The areas of analysis show great similarities in distributing the general content words (nouns, verbs, adjectives, and adverbs). In the analysis of the semantic areas of each content word, these poems reveal some similarities and some differences in their frequency rates.

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Publication Date
Sun Jun 27 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessment of Women’s Knowledge about Health Promotion after Cesarean Delivery at Maternity and Pediatric Hospital in Al-Samawa City
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Objective(s): To assess women’s knowledge about health promotion after a cesarean delivery and to determine the association between women’s knowledge and their demographic data of age, level of education, and monthly income.
Methodology: A descriptive design is carried out to assess women’s knowledge about health promotion after cesarean delivery at Maternity and Pediatric Hospital in Al-Samawa City. This study starts from 26th of September 2020 up to 16th March 2021. Sample of (100) woman who are at reproductive age, pregnant (prime or multipara) who have planned to have birth by elective cesarean section or had previous elective caesarian section without medical indication or women who had cesarean section with medical indicat

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Publication Date
Fri Jan 01 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessment of Women’s Knowledge about Health Promotion after Cesarean Delivery at Maternity and Pediatric Hospital in Al-Samawa City
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Objective(s): To assess women’s knowledge about health promotion after a cesarean delivery and to determine the association between women’s knowledge and their demographic data of age, level of education, and monthly income. Methodology: A descriptive design is carried out to assess women’s knowledge about health promotion after cesarean delivery at Maternity and Pediatric Hospital in Al-Samawa City. This study starts from 26th of September 2020 up to 16th March 2021. Sample of (100) woman who are at reproductive age, pregnant (prime or multipara) who have planned to have birth by elective cesarean section or had previous elective caesarian section without medical indication or women who had cesarean section with medical indication or

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Publication Date
Sat Dec 04 2021
Journal Name
International Journal Of Drug Delivery Technology
Evaluation of the Anti-inflammatory and Anti-oxidant Activity of Crab Components and Crab Shell in Experimental Rats in Comparison with Dexamethasone and Diclofenac Sodium
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Crabs belong to the crustacean family (Decapods crustacean), and their shells contain natural ingredients from which the bioactive compounds are derived. It has been used as folklore medicine in cancer treatment. We investigate the possible anti-inflammatory and anti-oxidant effects for crab shells and whole crabs. Thirty-six rats (150–200 gm) from both sexes were used, divided into six groups, the anti-inflammatory and anti-oxidant activity measured using cotton pellet induce granuloma model. Detection of tumor necrosis factor alpha (TNF α), Interleukin 1 beta (IL-1β), superoxide (SOD), and malondialdehyde (MDA) levels using ELISA Kits. The data analysis by one-way ANOVA followed by the Tukey test. Values are significant at (p < 0.05).

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Publication Date
Sun Sep 15 2024
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of surface microhardness of enamel surface treated with Nano- HAP serum before and after bleaching
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Background: Although bleaching is typically considered a safe procedure, various investigations have found minor negative effects and changes in mineral composition. The aim was to Evaluate and compare the efficacy of using Nanohydroxyapatite serum on surface microhardness of enamel surface before and after bleaching with chemically cured Boost bleaching. Material and methods: ten sound human permanent upper and lower premolar teeth were used and their roots were removed 2 mm apically to the cementoenamel junction, the crowns were sectioned mesiodistally into two halves buccal and lingual/palatal, the buccal surface was further subdivided into two halves. The samples were embeded in an acrylic resin, resulting in 30 specimens divide

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Publication Date
Tue Aug 05 2025
Journal Name
Al–bahith Al–a'alami
SPECIALIZED JOURNALISM IN IRAQ : (After The Events of 09-04-2003)
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The specialized Journalism plays an important role in our daily lives using all of its different ways, including news, caricature, commentary and dialogue. The specialized Journalism deserves vigilance and interest for it is caring about having a new media system. It is meant by “specialization”, first: identifying the areas of work in which the person concerned possesses great knowledge in the specialty resulting from a long experience, it also means being able to continuously develop required skills in that specialty. The specialization is not only a feature of the press, but also a feature of human development; thousands of years ago, the primitive society consisted of people from different specializations: fishermen, farmers, her

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Publication Date
Mon Apr 01 2024
Journal Name
Medical Journal Of Babylon
Clinical Evaluation and Comparison between Effects of Rituximab and Prednisolone with Imuran to Neutrophils and Platelet Counts in Pemphigus Vulgaris Patients
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Background: Pemphigus vulgaris (PV) is an autoimmune vesiculobullous mucocutaneous disease with life-threatening consequences. Rituximab (RTX) has recently emerged as an effective treatment for PV. Objectives: This study aims to determine changes in neutrophil and platelet counts for PV patients treated with RTX or corticosteroids combined with Imuran (azathioprine). Materials and Methods: The present cross-sectional study was conducted in the Department of Dermatology at Baghdad Teaching Hospital, Baghdad, Iraq. Thirty PV patients received two types of treatment: 15 patients were administered RTX and 15 patients took corticosteroids with Imuran (azathioprine). Neutrophil and platelet counts were detected at the hospital laboratory. Results

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