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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2024
Journal Name
Bio Web Of Conferences
Species diversity of <i>Fusarim</i> fungi on grain crops in the conditions of the foothill zone of the Central Caucasus
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The article presents the results of studies of the species composition of phytopathogens of winter soft wheat grain affected by ear fusarium. For the first time, studies were conducted using a complex of electron microscopic, molecular genetics, and mycological methods. The species F. graminearum dominated in all samples (frequency of occurrence 42.8%). The species F. avenaceum (23.3%), F. sporotrichioides and F. equiseti (8.8% each) were noted with high frequency. Next in descending order of frequency of occurrence: F. oxysporum, F. boothii, F. poae, F. proliferatum, F. accumatum, F. incarnatum, F. vorosii, F. tricinctum, F. cerealis, F. sambuticum. For the first time, 7 species were found for the plain zone of the Pre-Caucasus: F.

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Publication Date
Sun Dec 30 2012
Journal Name
Al-kindy College Medical Journal
Factors Influence the Development of Dysrhythmia after Acute Myocardial Infarction in Patients Admitted to CCU of Alkindy Teaching Hospital
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Objective The incidence of rhythm and conduction abnormalities during acute myocardial infarction may approaches 100%; most are seen during the pre-hospital and coronary care unit phases, leading to deleterious effect on morbidity and mortality, this study conducted to find important persistent dysrhythmia found during CCU admission of acute myocardial infarction patients.Method A retrospective observational study of 553 patients who were admitted to the Coronary Care Unit of Alkindy Teaching Hospital during Year 2011 with diagnosis of acute myocardial infarction, Information and data extracted from case sheets and associated 12 leads daily ECGsResults only 25% of our patients had dysrhythmia on examining the present 12 leads ECGs , the

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Publication Date
Sun Jun 07 2026
Journal Name
International Journal Of Arabic-english Studies (ijaes
The Apocalyptic Voice of Nature: An Ecocritical Analysis of Climate Change in Whitley Strieber’s The Day After Tomorrow (2004)
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Abstract: This study analyzes the depiction of environmental catastrophes and social response as humanity confronts consequences of human induced climate change climate change in Strieber’s The Day After Tomorrow (2004). It aims to examine ecological degradation, and human-nature relationships. To achieve the study's purpose, a qualitative methodology, specifically thematic analysis, has been employed to investigate the representation of climate change in The Day After Tomorrow by Whitley Strieber. The study examines themes and their interaction with the ecological dimensions of climate change using an ecocriticism theory by Garrard’s 2004, particularly the concept of apocalypse. It has been observed that Strieber’s The Day Aft

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Publication Date
Mon Jul 30 2018
Journal Name
Journal Of Pharmacy And Biological Sciences
Histological study of the embryogenesis of metencephalon in pre-implantation of albino rat's embryos after maternal treated with silver nanoparticles
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Cerebellum is the most important and critical part of the central nervous system, cerebellum is very sensitive to the abnormal changes during the embryological development in its histological structure, the exposure to any infection during embryogenesis produce abnormalities in the cerebellum and behavioral of offspring. In this study we tried to study the ontogenesis of the cerebellum in the embryos of the albino rats and detection the effect of the AgNPs on the ontogenesis of the rat cerebellum after exposure of AgNPs during pregnancy. we used 60 female pregnant rats divided in to three group, each contain 20 female, (G1) treated with 2mg/kg /day suspension of silver nanoparticles (Ag NPs) (G2) treated with 20mg/kg/day AgNPs from first da

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Publication Date
Tue Apr 02 2024
Journal Name
Engineering, Technology &amp; Applied Science Research
Two Proposed Models for Face Recognition: Achieving High Accuracy and Speed with Artificial Intelligence
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In light of the development in computer science and modern technologies, the impersonation crime rate has increased. Consequently, face recognition technology and biometric systems have been employed for security purposes in a variety of applications including human-computer interaction, surveillance systems, etc. Building an advanced sophisticated model to tackle impersonation-related crimes is essential. This study proposes classification Machine Learning (ML) and Deep Learning (DL) models, utilizing Viola-Jones, Linear Discriminant Analysis (LDA), Mutual Information (MI), and Analysis of Variance (ANOVA) techniques. The two proposed facial classification systems are J48 with LDA feature extraction method as input, and a one-dimen

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Publication Date
Thu Aug 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Some Estimation methods for the two models SPSEM and SPSAR for spatially dependent data
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ABSTRUCT

In This Paper, some semi- parametric spatial models were estimated, these models are, the semi – parametric spatial error model (SPSEM), which suffer from the problem of spatial errors dependence, and the semi – parametric spatial auto regressive model (SPSAR). Where the method of maximum likelihood was used in estimating the parameter of spatial error          ( λ ) in the model (SPSEM), estimated  the parameter of spatial dependence ( ρ ) in the model ( SPSAR ), and using the non-parametric method in estimating the smoothing function m(x) for these two models, these non-parametric methods are; the local linear estimator (LLE) which require finding the smoo

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Publication Date
Tue Jan 01 2019
Journal Name
Association Of Arab Universities Journal Of Engineering Sciences
Experimental and numerical investigation on the behavior of reinforced reactive powder concrete two-way slabs under static load
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This paper studied the behaviour of reinforced reactive powder concrete (RPC) two-way slabs under static load. The experimental program included testing three simply supported slabs of 1000 mm length, 1000 mm width, and 70 mm thickness. Tested specimens were of identical properties except their steel fibers volume ratio (0.5 %, 1 %, and 1.5 %). Static test results revealed that, increasing steel fibers volume ratio from 0.5% to 1% and from 1% to 1.5%, led to an increase in: first crack load by (32.2 % and 52.3 %), ultimate load by (36.1 % and 17.0 %), ultimate deflection by (33.6 % and 3.4 %), absorbed energy by (128 % and 20.2 %), and the ultimate strain by (1.1 % and 6.73 %). The stiffness and ductility of the specimens also increased. A

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Publication Date
Sat Jan 01 2022
Journal Name
Journal Of Clinical And Experimental Dentistry
Cusp deflection and fracture strength of root canal filled premolars with two access cavities designs (Conservative vs Traditional)
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Publication Date
Sat Oct 01 2011
Journal Name
Iraqi Journal Of Physics
Two dimensional grating and efficiency enhancement of Si photovoltaic cells by surface texturing using UV femtosecond laser pulses
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A fast laser texturing technique has been utilized to produce micro/nano surface textures in Silicon by means of UV femtosecond laser. We have prepared good absorber surface for photovoltaic cells. The textured Silicon surface absorbs the incident light greater than the non-textured surface. The results show a photovoltaic current increase about 21.3% for photovoltaic cell with two-dimensional pattern as compared to the same cell without texturing.

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Publication Date
Tue Jan 01 2019
Journal Name
Molecular Biology Research Communications
Association study of two single nucleotide polymorphisms rs10757278 and rs1333049 with atherosclerosis, a case-control study from Iraq
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