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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 31 2016
Journal Name
Al-kindy College Medical Journal
Comparison between Open Mini-incision Thyroidectomy and Conventional Thyroidectomy: Clinical Experience and Literatures Review
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Background: Thyroid surgery is most common endocrine surgery in general surgical practice. Objectives: the aim of this work is to evaluate the feasibility, benefits and outcomes of open mini-incision thyroidectomy and compared the results with that of conventional thyroidectomy. The comparison between the two groups was in term of incision length, amount of blood loss, time of operation, postoperative pain, hospital stay and the cosmetic outcomes.Type of the study: this is a single-blinded randomized controlled studyMethods: This study compared the advantages and outcomes of 22 patients subjected to mini-incision thyroidectomy (Group A) with the equal numbers of patients subjected to conventional thyroidectomy (Group B).Results: the oper

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Publication Date
Tue Feb 11 2025
Journal Name
Operations Research Forum
Investigation of the Optimization Numerical of the Design and Operational Conditions of Clutch System by Using the Integration of the Taguchi and Multi-criteria Decision-Making Methods
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The clutch system is essential for gently transmitting power from the engine to the gearbox, in addition to other tasks such as absorbing vibration, inertia reducing, and working as a protector against the overload for the motor and the components of power transmission. A new approach is developed for this research paper, to find a dry clutch system’s optimal design and operational parameters to improve performance and thermal behavior. Three design factors were selected to design the numerical tests based on the Taguchi method which are the friction material, the applied pressure function, and the dimensionless radius ratio R. A three-dimensional finite element model was developed, and the numerical cases were designed using the Taguchi

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Publication Date
Sun Mar 15 2020
Journal Name
Journal Of The College Of Education For Women
General Conditions of Women in Ibn al-Jawzi’s Book Safwat Al-Safwa: A Historical Study
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The research aims at the scholars’attention to the importance and role of Arab Muslim women through books and historical studies that historians and scholars have taken up like Ibn Al-Jawzi (597 AH) and his book Safwat Al-Safwa,  where he presented the conduct of worship and their words and deeds, and explained to women worshipers other aspects of their lives, such as the scientific aspect Crafts and works as well as their prominent role in preaching and religious guidance, and the impact of this on their morals and qualities. This study showed the strength of the personality of women and their high interest in worship. The importance of the study lies in knowledge.The research followed the role of Muslim women to carry t

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Publication Date
Tue Dec 15 2015
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Determination of some Optimum Conditions for Bioremediation of Some Heavy Metals by Saccharomyces cerevisiae: Determination of some Optimum Conditions for Bioremediation of Some Heavy Metals by Saccharomyces cerevisiae
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The study aimed to determine of some Optimum conditions for bioremediation and removing of seven mineral elements included hexavalent chromium, nickel, cobalt, cadmium, lead, iron and copper as either alone or in group by living and heat treated cells of baker’s yeast Saccharomyces cerevisiae. The dried baker's yeast from Aldnaamaya China Company was used in this study. Biochemical tests was used to ensure yeast belonging to S. cerevisiae and then used to remove the mentioned mineral elementes under different conditions which included incubation period, pH, and temperature. It was found that the best of these conditions was 60 minutes for duration of incubation, 6 for pH, 25 ᵒC for temperature. During the study the behavior of living

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Publication Date
Thu Feb 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Estimation of parameters of two-dimensional sinusoidal signal model by employing Deferential Evaluation algorithm and the use of Sequential approach in estimation
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Estimation the unknown parameters of a two-dimensional sinusoidal signal model is an important and a difficult problem , The importance of this model  in modeling Symmetric gray- scale texture image . In this paper, we propose employment Deferential Evaluation algorithm and the use of Sequential approach to estimate the unknown frequencies and amplitudes of the 2-D sinusoidal components when the signal is affected by noise. Numerical simulation are performed for different sample size, and various level of standard deviation to observe the performance of this method in estimate the parameters of 2-D sinusoidal signal model , This model was used for modeling  the Symmetric gray scale texture image and estimating by using

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Publication Date
Fri Oct 02 2020
Journal Name
International Development Planning Review
COMPARISON OF THE PERFORMANCE OF THE FOREHANDKICK (STRAIGHT AND ACCOMPANIED BY FORWARD ROTATION) IN TERMS OF ACCURACY AND SPEED AMONG THE PLAYERS OF THE NATIONAL TEAM (ADVANCED CATEGORY) IN TENNIS
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Publication Date
Wed Oct 02 2024
Journal Name
International Development Planning Review
COMPARISON OF THE PERFORMANCE OF THE FOREHANDKICK (STRAIGHT AND ACCOMPANIED BY FORWARD ROTATION) IN TERMS OF ACCURACY AND SPEED AMONG THE PLAYERS OF THE NATIONAL TEAM (ADVANCED CATEGORY) IN TENNIS
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Publication Date
Wed Oct 02 2024
Journal Name
International Development Planning Review
COMPARISON OF THE PERFORMANCE OF THE FOREHANDKICK (STRAIGHT AND ACCOMPANIED BY FORWARD ROTATION) IN TERMS OF ACCURACY AND SPEED AMONG THE PLAYERS OF THE NATIONAL TEAM (ADVANCED CATEGORY) IN TENNIS
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Publication Date
Wed Oct 02 2024
Journal Name
International Development Planning Review
COMPARISON OF THE PERFORMANCE OF THE FOREHANDKICK (STRAIGHT AND ACCOMPANIED BY FORWARD ROTATION) IN TERMS OF ACCURACY AND SPEED AMONG THE PLAYERS OF THE NATIONAL TEAM (ADVANCED CATEGORY) IN TENNIS
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Publication Date
Mon Jul 01 1996
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
TWO PRIMITIVE ORIBATIDS: FIRST RECORD IN IRAQ
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Cosmochthonius reticulatus Grandjean, 1947 (Acari: Oribatei: Cosmochthoniidae) and Rhysotritia ardua ardua C. L. Koch, 1841 ( Acari : Oribate : Euphthiracari¬dae), are two species of oribatids mites first recorded in Iraq from a woodland in the central part of Iraq. The two species are described and illustrated.

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