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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Oct 01 2024
Journal Name
Journal Of Obstetrics Gynecology And Cancer Research
Comparison of Levels of Activin A and Follistatin in Ectopic Pregnancies and Missed Abortions Patients
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Publication Date
Mon Oct 01 2012
Journal Name
The Iraqi Journal Of Agricultural Science
EVALUATION AND PERFORMANCE COMPARISON OF MOLD BOARD AND DISC PLOW IN SOILS OF CENTRAL IRAQ
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The experiment was conducted to evaluate and performance comparison for moldboard and disk plows in central of Iraq in 2011. Three factor were used in this study included Two types of plows included moldboard and disk plows which represented main plot , three forward speeds of the tillage was second factor included 1.85, 3.75 and 5.62 km / h which represented sup plot , and three levels of soil moisture was third factor included 21 , 18 and 14 % to determined data actual plow depth , Practical productivity, Volume of disturbed soil, Field efficiency , Slippage percentage in silt clay loam soil with depth 22 cm were studied in the experiment Split – split plot design under randomized complete block design with three replications using

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Publication Date
Wed Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Salivary Immunoglobulin A Assessment in Lymphoma Patients before and after Chemotherapy
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Background: Lymphomas are group of diseases caused by malignant lymphocytes that accumulate in lymph nodes and caused the characteristics lymphadenopathy. Occasionally, they may spill over into blood or infiltrate organs outside the lymphoid tissue. The major subdivision of lymphomas is into Hodgkin lymphoma and non–Hodgkin lymphoma and this is based on the histologic presence of Reed-Sternberg cells in Hodgkin lymphoma. Salivary immunoglobulin A is the prominent immunoglobulin and is considered to be the main specific defense mechanism in oral cavity. The aim of this study was to determine the level of salivary immunoglobulin A in lymphoma patients before and after chemotherapy treatment. Subjects, materials and methods: The study i

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Publication Date
Tue Jun 01 2021
Journal Name
Baghdad Science Journal
On Blow-up Solutions of A Parabolic System Coupled in Both Equations and Boundary Conditions
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This paper is concerned with the blow-up solutions of a system of two reaction-diffusion equations coupled in both equations and boundary conditions. In order to understand how the reaction terms and the boundary terms affect the blow-up properties, the lower and upper blow-up rate estimates are derived. Moreover, the blow-up set under some restricted assumptions is studied.

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Publication Date
Fri Jan 01 2021
Journal Name
Conference: 4th International Conference On Innovative Studies Of Contemporary Sciences
An anatomical and chemical comparison study of Epipremnum aureum cultivated in soil and soilless
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The present study took up the different ways to cultivate the species Epipremnum aureum by two habitat water and soil and comber the anatomical features of the root, stem, and leaf. The results showed amazing significant anatomical features to the ecosystem. The root and stem anatomy showing decrease in all characters that studied but the leaf anatomy showing increase of palisade, spongy tissue thickness, midrib thickness, number of vessels in the xylem also the long and width of stomata of the soilless plants than soil ones. The upper epidermis empty from the stomata for the two treatment and the stoma diffuse in the lower epidermis, the type of it paracytic type. Also the total of flavonoids in the plant that were growth in soil reached 1

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Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
Correlation of blood, salivary glucose levels and bloo HbA1c% in healthy and previously diagnosed Diabetes Mellitus Type 2 in a sec ion of patients of Baghdad hospital, Iraq
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Background: Diabetes mellitus is a metabolic disorder affecting people worldwide, which require constant monitoring of their glucose levels. Commonly employed procedures include collection of blood or urine samples causing discomfort to the patients. Necessity arises to find alternative non invasive technique is required to monitor glucose levels. Saliva is one of most abundant secretions in the human body and its collection is easy, noninvasive and painless technique. Objective: The aim of this study was to determine the efficacy of saliva as a diagnostic tool by study the correlation between blood and salivary glucose levels and glycosylated hemoglobin (HbA1c%) in diabetes and non diabetes, and the comparison of salivary glucose level

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Publication Date
Wed Sep 15 2010
Journal Name
Journal Of Baghdad College Of Dentistry
Computerized measurement of bite forces for edentulous subjects with denture bases of different impression techniques
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Background: Complete denture wearers show lower levels of bite force than dentate subjects. This has a significant influence on their chewing efficiency. In this study an attempt was made to investigate the effect of the impression technique on the maximum bite force in complete denture wearers. Materials and methods: The patients selected for this research were 12 edentulous patients. Three different techniques for registering the final impression were made; the mucostatic, mucofunctional, and the selective pressure impression technique. Two sets of upper and lower denture bases and one set of upper and lower dentures were constructed for each subject. Intraoral and extraoral instruments and devices, as well as a computer program were used

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Publication Date
Sat Jun 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between some well- Known methods to estimate the parameter of the proposed method of measurement and the reliability of the distribution function with two parameters Rally by simulation
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Abstract

            Rayleigh distribution is one of the important distributions used for analysis life time data, and has applications in reliability study and physical interpretations. This paper introduces four different methods to estimate the scale parameter, and also estimate reliability function; these methods are Maximum Likelihood, and Bayes and Modified Bayes, and Minimax estimator under squared error loss function, for the scale and reliability function of the generalized Rayleigh distribution are obtained. The comparison is done through simulation procedure, t

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Publication Date
Sun Feb 15 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of regional bond strength of post space of fiber-reinforced post luted with two types of cements at different testing times
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Back ground: This in vitro study was carried out to investigate the effect of post space regions (coronal, middle and apical), Time and the mode of polymerization (dual, self-cured) of the cements used on the bond strength between translucent fiber post and root dentin by using push-out test. Materials and Methods: Forty eight extracted mandibular first premolars (single root) were instrumented with ProTaper Universal system files (for hand use) and obturated with gutta percha for ProTaper and AH26® root canal sealer following the manufacturer instructions, after 24 hours post space was prepared using FRC postec® plus drills no.3 creating 8 mm depth post space. The prepared samples were randomly divided into two main groups (24 samples ea

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Publication Date
Mon May 06 2024
Journal Name
Journal Of Pakistan Association Of Dermatologists
Assessment of tumor necrosis factor alpha and interleukinـ10 in obese psoriatic patients before and after using apremilast
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Background Psoriasis is one of the most prevalent chronic inflammatory skin conditions; its prevalence ranges from 1 to 3%. Tumor necrosis factor-alpha (TNF-α), a cytokine that enhances inflammation, is overexpressed in synovium and skin plaques in psoriasis. TNF-α plays a critical role in the pathogenesis of psoriasis. IL-10 is the most crucial cytokine for reducing excessive immune responses and decreasing pro-inflammatory reactions in all autoimmune disorders.   Objective To evaluate the effect of Apremilast on ILـ10, TNFـα, and BMI in obese psoriatic patients.   Methods Thirty patients included in this investigative study to measure the concentrations of TNFـα, ILـ10 and BMI, before and after receiving Apremilast. TNFـα and

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