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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jul 02 2026
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparison between the Horizontal Condylar and Bennett Angles of Iraqi Full Mouth Rehabilitation Patients by Using Two Different Articulator Systems (An In-Vivo Study)
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Background: Errors of horizontal condylar inclinations and Bennett angles had largely affected the articulation of teeth and the pathways of cusps. The aim of this study was to estimate and compare between the horizontal condylar (protrusive) angles and Bennett angles of full mouth rehabilitation patients using two different articulator systems. Materials and Methods: Protrusive angles and Bennett angles of 50 adult males and females Iraqi TMD-free full mouth rehabilitation patients were estimated by using two different articulator systems. Arbitrary hinge axis location followed by protrusive angles and Bennett angles, estimation was done by a semiadjustable articulator system. A fully adjustable articulator system was utilized to locate th

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Publication Date
Tue Mar 31 2026
Journal Name
Magna Scientia Advanced Research And Reviews
Bombay and para-Bombay blood group phenotypes: Molecular basis, epidemiology, diagnosis, and transfusion management: An extended review
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Bombay (Oh) and Para-Bombay are rare variants of the ABO blood group system that carry significant clinical importance. They are characterized by the absence or a marked reduction in the expression of the H antigen on red blood cells (RBCs). This deficiency leads to a failure in the synthesis of A and B antigens, predisposing patients—particularly those with the Bombay phenotype—to developing potent anti-H antibodies, which can cause severe hemolytic transfusion reactions. Objective: The primary goal is to provide clinicians and laboratory specialists with a practical and comprehensive framework to prevent avoidable blood mismatch and improve clinical outcomes for patients suffering from H-deficient phenotypes. Methods: This rev

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Publication Date
Thu Nov 01 2012
Journal Name
Journal Of The Faculty Of Medicine Baghdad
A Comparative Study of the Effects of Age and Smoking on Nail Growth Rate in Healthy Individuals
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GA Al Omran, AA Noaimi, Z Al Madfai, H Al Hamamy, Journal of the Faculty of Medicine Baghdad, 2012

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Publication Date
Sun Jul 01 2018
Journal Name
Journal Of Educational And Psychological Researches
The healthy personality and its relation to the academic achievement of school and university teacher
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Personality regard as one of the human soul pillars that has been built throughout the life of people, starting from the fertilizing process to different stages of people ages. Over time, numerous scientific studies have shown that fetus has the ability to hear and feel and he is being stereotyped since the first stages of formation. Accordingly, the process of forming human personality set up since that date. Besides, the socialization means that take different resources to enhance human personality such as holy Quran, school, social media, and social environment. The emergence of social media made the world as a small village which gives the chance for all people, over the world, to obtain the knowledge easily and limitless. Thus, the

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Controlled Release Floating Matrix Tablet of Captopril
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The present study was done to prepare a gastroretentive floating tablet of captopril (CAP) which is an angiotensin converting enzyme inhibitor (ACE-inhibitor) used in the treatment of hypertension and heart failure. CAP is mainly absorbed from the proximal intestine and to a lesser extent from the stomach, also CAP stability decreases as the pH raised above 1.2 and this makes it a suitable candidate for floating dosage form.Effervescent floating tablets of CAP were prepared in order to prolong the gastric residence time and increase the bioavailability of the drug. The floating tablets of CAP were prepared by direct compression and wet granulation technique, using the polymer hydroxypropylmethylcellulose (HPMC) as the primary retarding p

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Publication Date
Fri Jan 19 2024
Journal Name
Turkish Journal Of Pharmaceutical Sciences
Taste Masking of Steroids for Oral Formulations
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Publication Date
Sun Mar 31 2019
Journal Name
Association Of Arab Universities Journal Of Engineering Sciences
Behavior of Plain Concrete Beam Analyzed Using Extended Finite Element Method
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In this study, plain concrete simply supported beams subjected to two points loading were analyzed for the flexure. The numerical model of the beam was constructed in the meso-scale representation of concrete as a two phasic material (aggregate, and mortar). The fracture process of the concrete beams under loading was investigated in the laboratory as well as by the numerical models. The Extended Finite Element Method (XFEM) was employed for the treatment of the discontinuities that appeared during the fracture process in concrete. Finite element method with the feature standard/explicitlywas utilized for the numerical analysis. Aggregate particles were assumedof elliptic shape. Other properties such as grading and sizes of the aggr

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Publication Date
Tue Apr 30 2024
Journal Name
Iraqi Journal Of Science
An Extended Subclass of Meromorphic Multivalent Functions Involving Ruscheweyh Derivative Operator
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     In this paper, we introduce and discuss an extended subclass〖 Ą〗_p^*(λ,α,γ) of meromorphic multivalent functions involving Ruscheweyh derivative operator. Coefficients inequality, distortion theorems, closure theorem for this subclass are obtained.

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Publication Date
Fri Feb 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of estimations methods of the entropy function to the random coefficients for two models: the general regression and swamy of the panel data
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In this study, we focused on the random coefficient estimation of the general regression and Swamy models of panel data. By using this type of data, the data give a better chance of obtaining a better method and better indicators. Entropy's methods have been used to estimate random coefficients for the general regression and Swamy of the panel data which were presented in two ways: the first represents the maximum dual Entropy and the second is general maximum Entropy in which a comparison between them have been done by using simulation to choose the optimal methods.

The results have been compared by using mean squares error and mean absolute percentage error to different cases in term of correlation valu

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Publication Date
Thu Dec 31 2020
Journal Name
Indian Journal Of Public Health Research & Development
A Comparative Study of Vitamin D Levels and Some Biochemical Parameters between Healthy and Breast Cancer in Iraqi Females.
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Breast cancer is one of the most widespread cancers,depending on World Health Organization, cancer calculated for approximately 7.6 million incidences in 2008, whoever expected elevation in incidence is about 13.1 million in 2030. So that the current research investigates vitamin D role in the occurrence of this disease and explains if vitamin D has a positive effect on the incidence of disease, as well as measuring parathyroid hormone and estrogen levels. Three groups were included in this analysis: control healthy women, benign and malignant breast tumor women. All cases that were selected at the beginning of the disease diagnosis. According to statistical values vitamin D showed highly significant (P<0.001) decrease in benign (3.74±2.33

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