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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 01 2024
Journal Name
Academic Science Journal
Comparison between MDDV and VADD routing protocols in VANET (Case Study)
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Routing is the process of delivering a packet from a source to a destination in the network using a routing algorithm that tries to create an efficient path. The path should be created with minimum overhead and bandwidth consumption. In literature, routing protocols in VANET were categorized in many ways, according to different aspects. In the present study, we prefer the classification based on the number of hops to reach the destination node. In literature, these are single-hop and multi-hops protocols. We first discuss the two types and then compare the MDDV (multi-hops protocol) with VADD (single-hop protocol). The comparison is theoretically and experimentally implemented by providing a network environment consisting of SUMO, VIENS and

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Publication Date
Wed Jun 01 2011
Journal Name
Al Mustansiriyah Journal Of Pharmaceutical Sciences
Comparing the clinical efficacy and safety of high doses of beclomethasone inhaler with medium doses of beclomethasone inhaler combined with oral aminophylline or montelukast tablets in persistent asthmatic Iraqi patients.
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Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The treatment guidelines recommend theuse of a second controller drug in addition to medium doses of inhaled corticosteroids (ICSs) rather than the use of high doses ICS alone in the treatment of moderate-severe persistent asthma. This study was conducted to compare the clinical efficacy and safety of three treatment regimens in Iraqi patients with moderate-severe persistent asthma.The study included three groups; each group included 15 patients. Patients were administered beclomethasone inhaler alone 1500-2000 μg/day, beclomethasone inhaler 750-1000 μg/day plus oral controlled release aminophylline tablets 450 mg/day or

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Publication Date
Thu Dec 30 2021
Journal Name
Al-kindy College Medical Journal
The Impact of COVID-19 on Healthy Related Issues, A structured Review
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Coronavirus: (COVID-19) is a recently discovered viral disease caused by a new strain of coronavirus.

The majority of patients with corona-virus infections will have a mild-moderate respiratory disease that recovers without special care. Most often, the elderly, and others with chronic medical conditions such as asthma, coronary disease, respiratory illness, and malignancy are seriously ill.

    COVID-19 is spread mostly by salivary droplets or nasal secretions when an infected person coughs or sneezes.

    COVID-19 causes severe acute respiratory illness (SARS-COV-2). The first incidence was recorded in Wuhan, China, in 2019.  Since then it spreads leading to a pandemic.

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Publication Date
Sun Feb 15 2026
Journal Name
Universum: общественные науки
POLITICAL ENVIRONMENT AND HYDROLOGICAL DECLINE: IRAQ’S WATER SECURITY TRANSFORMATION BEFORE AND AFTER 2003
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Iraq's water crisis represents one of the most pressing environmental and socioeconomic challenges facing the country today. This study examines the evolution of water resource problems in Iraq through a comprehensive historical comparison between the pre-2003 period under Saddam Hussein's regime and the post-2003 era following the U.S.-led invasion and subsequent political transformation. The research employs a mixed-method approach, analyzing quantitative data on water flow rates, infrastructure development, and qualitative assessments of policy impacts across both periods. Key findings reveal that while the pre-2003 period was characterized by deliberate environmental destruction, particularly the draining of the Mesopotamian Marshes, an

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Publication Date
Sun Jul 02 2017
Journal Name
Journal Of Educational And Psychological Researches
Prevalence of Posttraumatic Stress Symptomatology and Distribution of Attachment Patterns 1 and 5 Months after a Terrorist Attack
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As a consequence of a terrorist attack, people may experience posttraumatic stress disorder (PTSD) and lack of feeling secure in relationships. This longitudinal study aimed to examine the prevalence of PTSD symptoms over time, the relationship between adult attachment styles and PTSD, as well as their association with degree of exposure, and finally to consider the distribution and the trajectory of attachment styles. The sample consisted of 235 students (M=125, F=110) who were exposed to different levels of trauma intensity in response to a bombing attack. Participants were recruited and assessed approximately 1 month and 5 months after the attack using a battery of questionnaires. Findings revealed, as expected, that 79.5% of the part

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Publication Date
Sat Dec 01 2018
Journal Name
Future Dental Journal
Studying some mechanical properties of maxillofacial silicone elastomer before and after incorporation of intrinsic pigments and artificial aging
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Objective Advantageous properties of silicone elastomer made it one of the favorable materials in maxillofacial prosthesis construction, but these properties may change after months of usage or after pigments addition. This study aimed to define the optimum concentration for a mixture of two types of intrinsic pigments that added to VST-50 maxillofacial silicone material and study their effects on mechanical properties before and after artificial aging. Methods After the pilot study was conducted, 0.1% by weight of rayon flocking and 0. 2% by weight of burnt sienna intrinsic pigment concentration was selected because of improvement in tested mechanical properties of VST-50 maxillofacial silicone. A total of one hundred and eighty samples we

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Publication Date
Fri Aug 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
The phenomenon of Corruption and its impact on the growing problem of Unemployment in Iraq after a year ( 2003 ).
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        Corruption is a phenomenon that exists in all times and places, they appear in the developing countries and in developed countries, and in all political systems. And its repercussions and economic repercussions on the society in which it is rampant, and lead to the undermining of economic development and obstruction, is also working on increasing poverty and unemployment, as well as its role in the worsening of social problems, and political instability. And corruption is deviant behavior is illegal and contrary to the teachings of the religious and moral values. The emergence of this phenomenon is due to several reasons, including political, economic, social and cultura

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Publication Date
Wed Jan 01 2014
Journal Name
Journal Of The College Of Languages (jcl)
A comparison between Objective and subjective tests
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This paper aims at presenting a comparison between objective and subjective tests . This paper attemptsto shed light on these two aspects of tests and make do a compression by using suitable techniques for objective and subjective tests .

     The paper compares between the two techniques used by the objective and subjective tests respectively, the time and efforts required by each type, the extent to which each type can be reliable, and the skills each type is suitable to measure.

     The paper shows that objective tests, on the contrary of the subjective ones, encourages guess> Objective tests are used to test specific areas of langua

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Publication Date
Thu Mar 20 2025
Journal Name
Osol Journal Of Medical Sciences (ojms)
Thyroid Function Variations in Critically Ill Neonates A Comparative Study with Healthy Controls
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Normal thyroid function is essential for neonatal growth and brain development. In a newborn infant with severe disease, endocrine regulation of hormones can be affected by abnormal metabolism. The assessment of thyroid parameters results in the recognition of a dysfunction and its association with disease severity

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Publication Date
Sun Mar 02 2025
Journal Name
Osol Journal Of Medical Sciences (ojms)
Thyroid Function Variations in Critically Ill Neonates: A Comparative Study with Healthy Controls
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Background: Normal thyroid function is essential for neonatal growth and brain development. In a newborn infant with severe disease, endocrine regulation of hormones can be affected by abnormal metabolism. The assessment of thyroid parameters results in the recognition of a dysfunction and its association with disease severity. Objective: This study aimed to assess thyroid function profiles in critically ill neonates in the neonatal intensive care unit (NICU) compared with healthy controls. Additionally, we aimed to detect the presence of TD and its possible association with critical illness. Methods: A case-control study was performed in 100 neonates, comprising 50 sick neonates and 50 healthy controls. We measured thyroid functio

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