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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 01 2023
Journal Name
Baghdad Science Journal
COVID-19 Diagnosis Using Spectral and Statistical Analysis of Cough Recordings Based on the Combination of SVD and DWT
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Healthcare professionals routinely use audio signals, generated by the human body, to help diagnose disease or assess its progression. With new technologies, it is now possible to collect human-generated sounds, such as coughing. Audio-based machine learning technologies can be adopted for automatic analysis of collected data. Valuable and rich information can be obtained from the cough signal and extracting effective characteristics from a finite duration time interval that changes as a function of time. This article presents a proposed approach to the detection and diagnosis of COVID-19 through the processing of cough collected from patients suffering from the most common symptoms of this pandemic. The proposed method is based on adopt

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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Synthesis and Polymerization of Poly Acryl Imide and One of Their Derivatives Then Curing the Product with Alkyl Halide
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The present work involved four steps: First step include reaction of acrylamide ,N-?-Methylen-bis(acryl amide) and N-tert Butyl acryl amide with poly acryloyl chloride in the presence of triethyl amine (Et3N) as catalyst, the second step include homopolymerization of all products of the first step by using benzoyl peroxide(BPO) as initiator in (80-90)Co in the presence of Nitrogen gas(N2). In the third step the poly acrylimide which prepare in second step was convert into potassium salt by using alcoholic potassium hydroxide solution. Fourth step include Alkylation of the prepared polymeric salts in third step by react it with different alkyl halides(benzyl chloride, allylbromide , methyl iodide) by using DMF as solvent for(10-12) hours.

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Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Effect of some plant extracts on germination and seeding of Raphanus sativus and effect on surface growth ofRhizoctonia solani
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The experiment was conducted to study the effect of leaves extract of Salvia sclarea , Rosmarinus officinalis and Thymus vulgaris with 10% and 30% concentration on germination of seeds and growth of seedlings . The effect of these extracts on infection percentage of seeds decay and surface growth of Rhizoctonia solani . The results showed that the three extracts effected significantly to reduced percentage of seeds germination, acceleration of germination , promoter indicator , infection percentage of seeds decay and surface growth of R. solani especially in 30% concentration .

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Publication Date
Sun Jan 01 2012
Journal Name
Karbala University The 2nd Scientific Conference
Effect of budding autumn date, rootstock and cultivars on budtake and some growth characteristics of japanese plum prunus salicina
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Publication Date
Mon May 23 2022
Journal Name
The International Journal Of Artificial Organs
Quantitative analysis and control of the torque profile of the upper limb using a kinetic model and motion measurements
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This paper investigates a new approach to the rapid control of an upper limb exoskeleton actuator. We used a mathematical model and motion measurements of a human arm to estimate joint torque as a means to control the exoskeleton’s actuator. The proposed arm model is based on a two-pendulum configuration and is used to obtain instantaneous joint torques which are then passed into control law to regulate the actuator torque. Nine subjects volunteered to take part in the experimental protocol, in which inertial measurement units (IMUs) and a digital goniometer were used to measure and estimate the torque profiles. To validate the control law, a Simscape model was developed to simulate the arm model and control law in which measurem

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Publication Date
Sun Oct 15 2023
Journal Name
Bionatura
Effect of Partial Drip Irrigation Methods on Soil Moisture and Water Potential Distribution, Growth Characteristics and Yield of Maize
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A field experiment was conducted during the autumn of 2021 at the Agricultural Research Department station / Abu Ghraib to evaluate the soil moisture, water potential distribution, and growth factors of maize crops under alternating and constant partial drip irrigation methods. In the experiment, two irrigation systems were used, surface drip irrigation (DI) and subsurface irrigation (SD); under each irrigation system, five irrigation methods were: conventional irrigation (CI), and 75 and 50% of the amount of water of CI of each of the alternating partial irrigation APRI75 and APRI50 and the constant partial irrigation FPRI75 and FPRI50 respectively. The results showed that the water depth for conventional irrigation (C1) was 658.3

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Publication Date
Sun Nov 27 2022
Journal Name
Al–bahith Al–a'alami
The views of media elites on the reality of citizen journalism and its commitment to professional and ethical standards
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This article aims to identify the views of media elites on citizen journalism, a new media genre that strays away from the foundations and ethics of professional journalism, thus calling for in-depth exploration and scrutiny into the genre and its commitment to the professional standards of journalism.

For this purpose, the researcher opted for the survey method by distributing a questionnaire to a purposive sample consisting of 407 media elites. The research is also based on Habermas' public sphere theory.

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Publication Date
Fri Dec 01 2023
Journal Name
Iraqi Journal Of Physics
Study of the Symmetry Energy and the Nuclear Equation of State for 13O -13B and 13N-13C Mirror Nuclei
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In parallel with the shell model using the harmonic oscillator's single-particle wave functions, the Hartree-Fock approximation was also used to calculate the neutron skin thickness, the mirror charge radii, and the differences in proton radii for 13O-13B and 13N-13C mirror nuclei. The calculations were done for both mirror nuclei in the psdpn model space. Depending on the type of potential used, the calculated values of skin thickness are affected. The symmetry energy and the symmetry energy's slope at nuclear saturation density were also determined, and the ratio of the density to the saturation density of nuclear matter and the symmetry energy has a nearly linear correlation. The mirror ener

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Publication Date
Thu Jan 01 2015
Journal Name
كلية التربيه للعلوم الصرفه ابن الهيثم
Purification and Genetic Study of G-Protein Coupled Receptor from Saccharomyces cerevisiae and sera of Patients with Heart Thrombosis
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Publication Date
Sun Sep 29 2024
Journal Name
Journal Of Global Innovations In Agricultural Sciences
The Impact of pH and Growth Phases on Photosynthetic Pigments and Carotene of Coelastrella saipanensis N. Hanagata (Scenedsmacese, Shaerophleales)
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The present study aimed to investigate the effects of level pH and the growth phases of Coelastrella saipanensis on Chlorophyll a,b, total, and Carotene. The algae were cultured in BG11 media and grown at different pH levels. We measured chlorophyll a, b, total chlorophyll, growth phases, and carotene concentrations. The results showed that at pH 8.5, the measurements of photosynthetic pigments-chlorophyll a, Chlorophyll b, and the total chlorophyll (0.183, 0.268, and 0.433 mg L-1, respectively). The highest values of chlorophyll a (0.185 mg L-1), and b (0.339 mg L-1), and the total chlorophyll (0.492 mg L-1) were recorded in the stationary phase. In addition, the study found that at pH 8.5 and the beginning of the stationary phase,

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