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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Jan 09 2023
Journal Name
Indian Journal Of Economics And Business
Evaluation of reverse logistics options for international and local companies in Iraq
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Many international companies have branches or agencies in Iraq and have large market shares, and this has contributed to the increase in the import of these companies' products. This process created an additional problem of handling a large number of expired or defective products. There are many methods that contribute significantly to reducing these problems. The most prominent of these is the activation of reverse logistics options in Iraq by international and local companies. This research aims to conduct a survey of the reverse logistics options approved by some local and international companies and compare between them. This paper found that Amaron, Hitachi, Apple, Samsung and Huawei have limited options for reverse logistics and that

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Publication Date
Wed Mar 29 2023
Journal Name
Journal Of The College Of Education For Women
Blindness and the Critique of Society: Dystopia in “Blindness” by José Saramago""
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This paper addresses the new coloring in the concept of dystopian society as represented by the positive role of one of the characters vs. the passive role of the government and its mutual effect on the people of the society. In addition, it describes how all men in the dystopian society victimize and degrade the other through unlawful acts, like: stealing, rape, and fear, which are the lowest points in a moral decay. However, it offers hope by illustrating a positive sense, as exemplified by the doctor's wife out of Saramago's optimistic view that men may be descended from good women. Accordingly, the paper aims to examine the effect of the government’s role in the lives of the people who have later turned into blind in a dystopian so

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Publication Date
Fri Sep 15 2017
Journal Name
كلية الاداب جامعة بغداد
A Contrastive study of ‘Inversion ‘ in Modern English and Modern Arabic Poetry
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The present paper respects 'inversion' as a habit of arranging the language of modern English and Arabic poetry . Inversion is a significant phenomenon generally in modern literature and particularly in poetry that it treats poetic text as it is a violator to the ordinary text. The paper displays the common patterns and functions of inversion which are spotted in modern English and Arabic poetry in order to show aspects of similarities and differences in both languages. It concludes that inversion is most commonly used in English and Arabic poetry in which it may both satisfy the demands of sound correspondence and emphasis. English and Arabic poetic languages vary in extant to their manipulation of inverted styles as they show changeable f

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Publication Date
Sat Feb 02 2019
Journal Name
Journal Of The College Of Education For Women
Research and Development Programs Effectiveness in the Central Library of Baghdad University
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Research and Development Programs Effectiveness in the Central Library of Baghdad University

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Publication Date
Mon Feb 18 2019
Journal Name
Iraqi Journal Of Physics
Preparation and characterization of colloidal CdTe nanoparticles by laser ablation in liquids
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Nanoparticles generation by laser ablation of a solid target in a liquid environment is an easy method. Cadmium Telluride (CdTe) colloidal nanoparticles have been synthesized by laser ablation Nd:YAG with wavelengths of 1064nm and double frequency at 532 nm, number of pulses 50 pulses, with pulse energy= 620mJ, 700mJ of a solid target CdTe is immersed in double distilled deionized water (DDIW) and in methanol liquid. Influences of the laser energy and different solutions on the formation and optical characterization of the CdTe nanoparticles have been studied using atomic force microscope (AFM) and the UV-Vis absorption. As a results, it leads to the absorbance in UV-Vis spectra of samples prepared in water at laser wavelength of 532nm i

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Publication Date
Sat Dec 14 2024
Journal Name
Al-anbar Journal Of Veterinary Sciences
Prenatal Histomorphological and Histochemical Study of Stomach in Indigenous Rabbit (Oryctolagus cuniculus)
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The present study was designed to investigate the normal histological features of the stomach at the prenatal stage from ten healthy pregnant rabbits at the third period of pregnancy. The stomach appeared as J-shaped situated at the left part of the abdominal cavity. It found in the front part entirely within the rib. The non-glandular region act as a reservoir, the septa prevented ingesta reflux into the esophagus. Histologically the stomach in both periods composed of four tunics', which were mucosa, tunica submucosa, tunica muscularis and tunica serosa. The stomach also has different regions cardiac, fundic and pyloric regions, glands in the cardiac region were coiled branched tubular gland and almost present of the mucous cells

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Publication Date
Wed May 15 2024
Journal Name
International Journal Of Religion
The Theory of Quantity in Measures and Scales a Comparative Jurisprudential Study
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Every body has a size and mass that distinguishes it from others and makes it different from others. Some of these bodies are huge and large in size, and some are small and light in weight. Among these masses and bodies are some that are dealt with by their size and weight, each according to its quantity, weight, and cheapness. This is why they created quantities by which these weights and quantities could be estimated, so they used measures and weights for that. Objectives: The research aims to know some measures and weights, such as the wife’s maintenance, the amount of zakat, etc.I found it to be a widely spread topic, and widely used in the folds of jurisprudence. During my reading of jurisprudence books, I found jurists using many qu

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Publication Date
Thu Oct 01 2015
Journal Name
Al-academy
Power of language and carriers meaning in communication discourse: كاظم مؤنس عزيز
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It reveals speech communication whether it is legible audible or visible on a comprehensive formula inhabited open language on the modalities for reporting cases of the source say, making communication cognitive processes, is not to produce arguments as it is about the generation of the content of communication, so the contact of any kind remains practice for the cognitive action by the language in which it operates as a way agreed to their units between the poles of communication circle in the framework of a certain socio-cultural context, and that becomes the basis of the text of the message external referrals, making it feasible for multiple readings in semantic dimensions and deliberative

 
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Publication Date
Sat Dec 01 2012
Journal Name
European Journal Of Scientific Research
Evaluation of Progesterone and Estrogen Hormonal Levels in Pregnant Women with Toxoplasmosis
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In this study the prevalence of acute, sub-acute and chronic toxoplasmosis were monitored in a group of Iraqi pregnant women according to the anti-T.gondii antibodies (IgG and IgM), as well as the levels of both progesterone and estrogen hormones were measured using mini-VIDAS®technique. This study demonstrated that there was high prevalence of chronic toxoplasmosis (31.70%) when it compared with acute and sub-acute type, results also showed that the acute toxoplasmosis always related with low concentration of both progesterone and estrogen which were (5.35 ± 7.15 ng/ml) and (70.66 ± 51.08 pg/ml) respectively

Publication Date
Tue Apr 01 2025
Journal Name
Iop Conference Series: Earth And Environmental Science
Molecular Detection and Antiserum Preparation of Begomoviruses Infecting Zucchini Squash in Iraq
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Abstract<p>Begomoviruses infecting zucchini squash were investigated. Leaf samples were collected from zucchini squash growing areas in Baghdad (Jhadryaa and Yusufiyah), Babylon (Jibela and Mahmudiyah) and Diyala (Khan Bani Saad) Provinces. Samples were screened for the presence of begomoviruses using polymerase chain reaction (PCR) and Deng genus specific primers. Sixteen out of 40 samples were begomovirus positive. Sequence analysis confirmed the detection of Tomato leaf curl Palampur virus (TLCPALV) <italic>Begomovirus solanumpalampurense</italic>, Squash leaf curl virus (SLCuV) <italic>B. cucurbitapeponis</italic> and Tomato yellow leaf curl virus (TYLCV) <italic>B. </italic></p> ... Show More
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