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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 09 2023
Journal Name
Journal Of Global Scientific Research In Business Management And Economics
The profitability index and its role in evaluating the performance of specialized banks in Iraq.
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Central banks around the world typically use various financial indicators to evaluate performance. In Iraq, the indicators used by central banks to evaluate the performance of banks are of great importance to ensure that the banks operating within the Iraqi banking system comply with the regulatory and legal requirements issued by the Central Bank of Iraq or the Ministry of Finance. Given the need to study the profitability indicator to ensure its ability to evaluate the performance of specialized banks in Iraq, these banks carry out their banking activities and businesses through capital funded by the government. The use of profitability indicators in evaluating the performance of specialized banks provides information about the profitabil

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Publication Date
Fri Apr 19 2019
Journal Name
Iraqi Journal Of Biotechnology
Impact of Age Factor in Cervical Abnormalities and Cancers Incidence in Some Iraqi Married Women
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Cervical cancer is the third most common cancer in women worldwide, and it has the fourth highest mortality rate among cancers in women. The present study aimed to reveal the impact of age factor in cervical abnormalities and cancers incidence in some Iraqi married women. 150 scraping cervical cells samples were collected from the women clinically diagnosed with cervical abnormalities and cancer who were divided into two groups; the first group included the women with abnormal pap smear which revealed 13.33% of women were less than 30 years and followed by 66.66% of women whose age between 30-50 years and 20% of them were more than 50 years old. While the second group iclude the women with normal Pap smear (Healthy women) which revealed tha

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Publication Date
Wed Nov 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
The Role of Islamic Banks and Private Commercial Banks in Increasing Financial Depth in Iraq
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The banks mobilize savings and channel them to the economy, whether commercial or Islamic banks and thus both contribute to increasing financial depth, the objective of this paper is to measure the contribution of the Islamic banks in increase financial depth in Iraq, and compared the role played by private commercial banks in contributing to increasing financial depth in Iraq. The paper has been applying the most used indicators of financial depth that used widely in the literatures, especially those applicable with the Iraqi economy.

The paper found via using the Autoregressive Distributed Lag Model (ARDL) that Islamic banks did not contribute to increasing financial depth in Iraq, as well as for the p

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Requirements of talent management in high- containment organizations/ field study in Technology and Science Ministry
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Human resources constitute the most important recourses that the organization owned today, as it may have developed financial and technology resources to achieve their goals, but they are not able to use it with required efficiency and effective and quality desired unless there is human resources that have good skills, experiences and talents that able to directing and exploited ideally that compatible  with market requirements, where today's market and business organizations which compete naturally inherent talent, so the task is to attracting and developing talented resources and preservation these talented resources from the challenges that facing organizations. 

The research seek to achieve

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Publication Date
Sun Jun 30 2013
Journal Name
College Of Islamic Sciences
 Assignment method in the Holy Quran and some of its applications in Surat Al-Anaam
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Research objective: This research aims to unveil how to use the method of referral in understanding the Holy Quran.
        The reason for choosing the research: The one that invited me to write on this topic is the importance of the referral method, so I liked the research in it, and unveiled this wonderful Qur’anic method, so that it helps to understand the intention of God Almighty in his dear book.
       The research plan: The research was divided into three topics and a conclusion.
   As for the first topic, it is divided into two requirements. The first requirement deals with the definition of referral language.
In the second re

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Publication Date
Wed May 29 2024
Journal Name
Pharmacia
Formulation, in vitro and in vivo evaluation of olanzapine nanoparticles dissolving microneedles for transdermal delivery
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Olanzapine (OLZ) is classified as a typical antipsychotic drug utilized for the treatment of schizophrenia. Its oral bioavailability is 60% due to its low solubility and pre-systemic metabolism. Hence, the present work aims to formulate and evaluate OLZ nanoparticles dissolving microneedles (MNs) for transdermal delivery to overcome the problems associated with drug administration orally. OLZ nanoparticles were prepared by the nanoprecipitation method. The optimized OLZ nanoparticle formula was utilized for the fabrication of dissolving MNs by loading OLZ nanodispersion into polydimethylsiloxane (PDMS) micromould cavities, followed by casting the polymeric solution of polyvinylpyrrolidone(PVP-K30) and polyvinyl alcohol (PVA) to form

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Publication Date
Tue Jun 30 2015
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Study the effect of ozone gas and ultraviolet radiation and microwave in the degredation of aflatoxin B1 produce by Aspergillus flavus on stored Maize grains.: Study the effect of ozone gas and ultraviolet radiation and microwave in the degredation of aflatoxin B1 produce by Aspergillus flavus on stored Maize grains.
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This study was conducted in the plant protection department/ College of Agriculture/ University of Baghdad to evaluate the efficiency of physical agents ozone, ultraviolet radiation, microwave for destroying afla produced in corn seeds. An isolate af A.flavus producing Aflatoxin B1 was obtained from plant protection dept. college of Agric. University of Baghdad. Results showed destroy toxin AFLA B1 the effect of radiation microwave in the media of Japex degree 80 and 100 co 57.14% and 85.71%, respectively, and for 20 sec, compared to the treatment comparison 0.00% as found significant differences were apparent between transactions and the treatment of comparison, as and notes the existence of a significant dif

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Publication Date
Wed Oct 02 2024
Journal Name
International Development Planning Review
EVALUATING THE EFFECTIVE CREATIVE LEADERSHIP ROLE OF THE DEAN AND HEADS OF SCIENTIFIC DEPARTMENTS IN THE COLLEGE OF PHYSICAL EDUCATION AND SPORTS SCIENCES AL-MUSTANSIRIYAUNIVERSITY
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Publication Date
Sun Jan 07 2024
Journal Name
Migration Letters
The Effect Of Preventive Physical Exercises Supported By Collagen Supplements And Vitamin D In Improving Some Of The Physical And Skill Abilities Of Handball Players
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The purpose of this paper is to preparing preventive exercises supported by collagen supplements and vitamin D for handball players, and identify the effect of preventive physical exercises supported by collagen supplements and vitamin D on some physical and skill abilities of handball players. The researchers used the experimental method and designed two groups, one experimental and the other control, with both pre- and post-tests, to suit the nature of the research. The research community was selected from handball players (specialized school players), numbering (14), and they were divided into two groups, each group numbering (7) players. One of the most important results reached by the researcher is that: The exercises prepared by the r

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Publication Date
Mon Dec 25 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Colorimetry and Indirect X-ray Fluorescence Determination of Active Ingredients in Tetracycline Hydrochloride Drug and Injection Solution of B12 Vitamin Using of Polyurethane Foam Sorbents
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The simple and available technique of colorimetry and indirect X-ray fluorescence determination of tetracycline hydrochloride (in the form of colored complex with iron(III) ions) and cyanocobalamine (in the form of the colored thiocyanate complex with cobalt(II) ions) is offered. The analytes were separated from the accompanying components by sorption to polyurethane foam based on ethers. The conditions of sorption separation and measurement of analytical signal of these substances are optimized. The obtained results of tetracycline drugs and injection solution B12 vitamin are in satisfactory agreement with data declared by the manufacturer.

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