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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 15 2020
Journal Name
Journal Of Baghdad College Of Dentistry
Impact of two non-nutritive sucking patterns on the development of anterior open bite in children of two kindergartens in Baghdad city
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Background: Non-nutritive sucking habit (NNSH) is the main environmental causative factor that disturbs normal orofacial development. In spite of the harmful effect of pacifier as a NNSH, mothers aware from the other types of NNSH like thumb sucking far more than pacifier use. Open bite is one of the most challenging malocclusions in orthodontics due to the high prevalence of relapse after treatment, so preventing the causative factor of its occurrence is essential at early age of child life. This study aims to assess the impact of two non-nutritive patterns on the development of anterior open bite in primary dentition and to compare which of these habits mostly affect open bite development. Materials and Methods: The sample consisted of

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Publication Date
Mon Jul 25 2022
Journal Name
2022 Ieee 20th International Conference On Industrial Informatics (indin)
Robust Continuous Sliding Mode Controller for Uncertain Canonical Brunovsky Systems Using Reduced Order Extended State Observer
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A reduced-order extended state observer (RESO) based a continuous sliding mode control (SMC) is proposed in this paper for the tracking problem of high order Brunovsky systems with the existence of external perturbations and system uncertainties. For this purpose, a composite control is constituted by two consecutive steps. First, the reduced-order ESO (RESO) technique is designed to estimate unknown system states and total disturbance without estimating an available state. Second, the continuous SMC law is designed based on the estimations supplied by the RESO estimator in order to govern the nominal system part. More importantly, the robustness performance is well achieved by compensating not only the lumped disturbance, but also its esti

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Publication Date
Mon Apr 27 2020
Journal Name
Journal Of Mechanics Of Continua And Mathematical Sciences
A COMPARISON OF TOPOLOGICAL KRIGING AND AREA TO POINT KRIGING FOR IRREGULAR DISTRICT AREA IN IRAQ
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Publication Date
Wed Mar 30 2016
Journal Name
College Of Islamic Sciences
Graphical significance To (if) and (if) the two cops in Surat al-Maidah
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Many writers and scientists hardly differentiate between the two instruments of use
(If) and (if) to convergence in the meaning, as they perform the meaning of the penalty and condition, as the answer relates to his condition, but when linguistic meditation we find a great difference in use in terms of meaning, so this research came to reveal these meanings and was extrapolated applied in Surat al-Maidah By counting the verses in which (if) and (if) the cops were given and looking at their contexts, the connotation of the cops in most places was within the context of probability, which is the origin of its use, given in twenty places of Surat al-Ma'idah, and it had multiple connotations according to the contexts of the verses received

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Publication Date
Sat Jul 01 2000
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
BLOOD PARASITES OF TWO BEE-EATERS iN IRAQ
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Examination of 241 specimens of two bee-eater species, Merops apiaster and Merops
superciliosus persicus reveal recording of Haemoproteus meropis (Zagar, 1945) emend.
Bennett, 1978 and H. manwelli Bennett, 1978 for the first time in Iraq. A new species
Haemoproteus hudaidensis sp. nov. is described. Microfilariae are also infected the two host
species. The results are discussed with the pertinent literature and the necessary comparision
of morphometric measurements of the recorded parasites with that previously reported is
provided along with a taxonomic key including the newly described haemoproteid.

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Publication Date
Sat Sep 16 2023
Journal Name
مجلة الدراسات المستدامة
A Review Article: Use of fertilizers and their gradual release of mineral nutrients as a remedy to this problem have an adverse environmental impact.
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Throughout Agriculture has mostly relied on the use of natural fertilizers throughout human history, which are compounds that increase the nitrogen levels in the soil. Modern agriculture was made possible by the introduction of synthetic fertilizers at the end of the 19th centuryproduction of agriculture. Their application enhanced crop yields and sparked an agricultural revolution unlike anything the world had ever seen.In the near future, synthetic fertilizers are anticipated to continue to have a significant impa ct on human life, both positively and negatively. They are frequently utilized for producing all t ypes of crops and are essential to plant growth. The significance of synthetic fertilizers is their ability to provide the soil w

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Publication Date
Mon Jun 19 2023
Journal Name
Journal Of Engineering
Effect of Design Parameters and Support Conditions on Natural Frequency of Pipe Excited by a Turbulent Internal Flow
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In this study, the effect of design parameters such as pipe diameter, pipe wall thickness, pipe material and the effect of fluid velocity on the natural frequency of fluid-structure interaction in straight pipe conveying fully developed turbulent flow were investigate numerically,analytically and experimentally. Also the effect of support conditions, simply-simply and clamped-clamped was investigated. Experimentally, pipe vibrations were characterized by accelerometer mounted on the pipe wall. The natural frequencies of vibration were analyzed by using Fast Fourier Transformer (FFT). Five test sections of two different pipe diameters of 76.2
mm and 50.8 mm with two pipe thicknesses of 3.7 mm and 2.4 mm and two pipe materials,stainles

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Publication Date
Wed Feb 05 2020
Journal Name
Political Sciences Journal
“The constitutional- political structures in Iraq after 2003”
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It is obvious that the constitutional- political structures which has been emerged in Iraq after the occupation in 2003 frame worked by many sectarian, ethnic, tribal and political orientations, pushing forewords to escalating the contradictions between social- political powers, however, these changes unfortunately result not just destroy and taking apart the political regime and his authority, but the state and his institutions as well, although, did not stamped as wise and rational change for better future to new Iraq and its political, civil and military institutions. Finally, as quick as Iraq start to bisects to sectarian, ethnic and national components according to the new political – social components of Iraq. Indeed, what is req

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
Affecting factors in Yemeni - Russian Relations after 2011
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Thethesis of theresearch is to deal with relations between Russia and Yemen after 2011.That relationwas significant in different fields, historic, economic, strategic and cultural ones. There are mutual interestsbetweenRussia and Yemen, especially with the economic development and growth in Russia as an important partner to Yemen.Their has to an a great deal of progress in different types of relations, where as they were only partner in military relations. The studywasclassifiedintoto three sections: the first section dealt with strategic importance of Yemen to Russia. And second section dealt withthe military factor between Russia and Yemen. While the third section dealt with the economic factor between Russia and Yemen. In addi

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Publication Date
Mon Oct 01 2012
Journal Name
Iraqi Journal Of Physics
Comparison study of some mechanical properties of micro and nano silica EP composites
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The effect of micro-and nano silica particles (silica SiO2 (100 μm), Fused silica (12nm)) on some mechanical properties of epoxy resin was investigated (Young's modulus, Flexural strength). The micro-and nano composites were prepared by using three steps process with different volume fraction of micro-and nano particles (1, 2, 3, 4, 5, 7, 10, 15, and 20 vol. %). Flexural strength and Young's modulus of nano composites were increased at low volume fraction (max. enhancement at 4 vol.% ). However at higher volume fraction both Young's modulus and flexural strength decrease. Moreover, above, the mechanical properties are enhanced more than that of neat epoxy resin. The flexural strength decreases with increasing the volume fraction of micr

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