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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 08 2021
Journal Name
Baghdad Science Journal
Impact the quality of the food in the rates of malnutrition in the city of Baghdad and Baquba - Iraq
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This research aims to identify the nutritional status of the individual's relationship to malnutrition using anthropometric measurements such as weight, height and impact on the values ??of the blood study sample included 200 male and 200 female of the inhabitants of the cities of Baghdad and Baquba reviewers Central Mahtbrat

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Publication Date
Thu Sep 15 2022
Journal Name
Al-academy
The philosophy of physical and sensory communication in the dramatic show
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Modern critical theories revealed polemical views about the reality of the existence of communication - as a necessity for building a deliberative discourse - in the theater or not. To the theory of communication with all the conditions it imposes on thinking, interaction, and emancipation of selves in different contexts.
Therefore, the current research included four chapters, the first chapter dealt with the research problem, which was represented in (the philosophy of sensory and physical communication in theatrical performance), and the first chapter included the importance of the research, its goal and its limits, and ended with defining the terminology, and the second chapter included (theoretical framework) the first topic (ph

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Publication Date
Mon Feb 01 2021
Journal Name
Neuroquantology
Study and Investigation of Hard Photons Emission in Heavy Ion Collisions
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This work involves hard photon rate production from quark -gluon plasma QGP interaction in heavy ion collision. Using a quantum chromodynamic model to investigate and calculation of photons rate in 𝑐𝑔 → 𝑠𝑔𝛾 system due to strength coupling, photons rate, temperature of system, flavor number and critical. The photons rate production computed using the perturbative strength models for QGP interactions. The strength coupling was function of temperature of system, flavor number and critical temperature. Its influenced by force with temperature of system, its increased with decreased the temperature and vice versa. The strength coupling has used to examine the confinement and deconfinement of quarks in QGP properties and inf

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Publication Date
Tue Mar 28 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Prescribing Pattern and Rational use of Drugs in Maysan Governorate, Iraq
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This study was designed to investing the drug prescribing pattern which is the important point in the rational or irrational use of drugs among patients dispensing their prescriptions from the private pharmacies in Maysan governorate, Iraq for a period of 1 month. The data collected from prescriptions were calculated and analyzed according to the WHO prescribing guidelines. The data showed that the mean of drugs included in single prescription was 3.4, and 12% of prescribed drugs were written as generic names; moreover, the percentage of antibiotics, corticosteroids and anxiolytics were 33.3%, 11.4% and 23.8% respectively. Those results indicate the irrational use of drugs when compared with the world health organization standard values

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Publication Date
Mon Sep 30 2019
Journal Name
College Of Islamic Sciences
Irrigated Women News   In the historical and literary fluorescence of Andalusia
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Andalusian women enjoyed much historical news in the fluorescence of Andalusia, describing it as beautiful and good cohabitation, as the men were involved in conquests, including those who were wives of the caliphs, including scientists, singers, and adept writers Hassan and tongue, in addition to the acquisition of masters in slave markets in Cordoba, Seville and many cities, In addition, Andalusian women enjoy freedom in their relationship with men and have been reflected in the historical fluorescence of Andalusia, such as the book of the history of Ibn Abdul Malik bin Habib al-Alberi (d. And the collar of the dove repented in intimacy and thousands of Ibn Hazm al-Qurtubi (d. 456 AH / 1065 CE), the book of Hilla al-Sayra of Ibn al-Wel

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Publication Date
Tue Apr 30 2024
Journal Name
Iraqi Journal Of Science
Diagnostic Potential Role of CXCL3 and Leptin Levels in Breast Cancer
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The risk of breast cancer development is believed to be attributed to the alterations of a number of key biological components. Within this context, elevated levels of some chemokines that act as growth factors and can promote cancer development. The current study was designed to evaluate CXCL3 (a chemokine C-X-C Motif Ligand 3) and leptin (a peptide hormone synthesized by adipose tissue with cytokine activity) serum of Iraqi breast cancer patients in comparison to healthy controls. A total of 90 participants consisted of 60 patients diagnosed with breast cancer and 30 healthy women as control group were enrolled into this case-control study. Venous blood samples were collected from all participants to evaluate CXCL3 and leptin serum levels

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Publication Date
Mon Jan 01 2024
Journal Name
Bio Web Of Conferences
Concepts of statistical learning and classification in machine learning: An overview
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Statistical learning theory serves as the foundational bedrock of Machine learning (ML), which in turn represents the backbone of artificial intelligence, ushering in innovative solutions for real-world challenges. Its origins can be linked to the point where statistics and the field of computing meet, evolving into a distinct scientific discipline. Machine learning can be distinguished by its fundamental branches, encompassing supervised learning, unsupervised learning, semi-supervised learning, and reinforcement learning. Within this tapestry, supervised learning takes center stage, divided in two fundamental forms: classification and regression. Regression is tailored for continuous outcomes, while classification specializes in c

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Publication Date
Thu Dec 15 2022
Journal Name
Al-academy
Philosophy of values and its epistemological representations in industrial product design
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The research dealt with the concepts of the philosophy of values ​​and its epistemological variables according to specific propositions represented in their scientific approaches to value theory in the field of industrial design. As the epistemological propositions of the theory of values ​​were dealt with based on the epistemological fields that dealt with the concept and what values ​​are, starting with the modernist propositions and postmodern, passing through the propositions of sociological and psychological thought, which was a prelude to extracting the concepts of value theory and adopting it in the field of industrial product design. The epistemological approaches to value theory in industrial product design were repr

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Publication Date
Wed Nov 17 2021
Journal Name
7th International Conference On Multidisciplinary Sciences (7th Icomus)
A Critical Pragmatic Study of Sarcasms in American and British Interviews
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APDBN Rashid, 7th International Conference on Multidisciplinary Sciences (7th ICOMUS), 2021

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Publication Date
Fri Mar 12 2021
Journal Name
Medico Legal Update
Knowledge, Awareness and Attitude of Pharmacy Students towards Epilepsy in Iraq
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Background: The undergraduate students in pharmacy colleges represent a well-educated group of thecommunity according to the use of drugs and they are required to hold the appropriate knowledge of druguse and have positive attitudes toward health problems, this good knowledge about the diseases and theirtreatment will give good pharmacists in the future and this will reflect positively on patient knowledge, andtheir compliance with treatment, this due to direct contact of pharmacists with the patients.Aim: To know the knowledge, Awareness and Attitude of a sample of Iraqi pharmacy students towardsepilepsy.Method: Cross-sectional study used a structured questionnaire validated by previous studies to collectdata about knowledge, Aware

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