Preferred Language
Articles
/
bijps-367
Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
...Show More Authors

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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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.

Crossref
View Publication Preview PDF
Quick Preview PDF
Publication Date
Tue Jun 14 2016
Journal Name
Al-academy
Idealism and Realism in The Design: A Comparative Study
...Show More Authors

At the beginning of the twentieth century distorting handling totalitarian phenomena of art, which can be called the stage of the test, transition from the theory of ideal theory and other realistic is not cushy, since it requires vision and reading and other concepts, and in light of this dialectic manifested research problem by asking the following Is affected by the design idealism and realism. Through the above mentioned questions, the researcher found rationale for addressing this problem, the study through his research, which is marked (idealism and realism in a comparative study design). And demonstrated the importance of research in the identification of the concept and the effectiveness of the two theories idealism and realism a

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Dec 16 2018
Journal Name
Al-academy
Graphic Design and Functional Applications in the Interior Space
...Show More Authors

The overlap between science and knowledge is a feature of the 21st century. This integration, which crosses the traditional boundaries between academic disciplines, has occurred because of the emergence of new needs and new professions. This overlap has overshadowed the arts in general and design in particular. The Design achievements have not been far away from the attempts of integration of more than one type or design application to produce new outputs unique in its functional and aesthetic character, including the terms of internal graphic design.

The researcher raises the question of the functional dimension of graphic design in the internal space, in order to answer it through the methodological framework, which includes th

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Jun 20 2018
Journal Name
Al-academy
Spatial transformations and visual construction in the contemporary theater
...Show More Authors

The current research deals with the subject of spatial transformations and visual construction in contemporary theater. How the visual system works to create spatial diversity in the contemporary Iraqi theater performance and how visual construction contributes to a spatial development process capable of building a tourism system that creates an architectural architecture that leaves the topography of the scriptural architecture. And the production of various indications and patterns in the scene of theatrical presentation in order to produce the new foundational meaning by creating a new structure that leads to diversity and diversity in the visual system and the beginning of visual constructions and their applications. Knowledge and te

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri Sep 15 2023
Journal Name
Al-academy
Space suitability and its functional implications in interior design
...Show More Authors

The current research dealt with the study of space compatibility and its role in enhancing the functional aspect of the design of the interior spaces of isolation hospitals by finding a system or format that is compatible with the nature of the changes occurring in the structure and function of the space system, as well as contributing to enhancing compatibility between the functional aspect and the interior space. Therefore, the designer must The interior is the study of the functional and spatial aspects as they are the basic aspects for achieving suitability, and through the interaction between the person and the place, the utilitarian performance characteristics are generated that the interior designer is interested in and tries to d

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Tue Mar 10 2020
Journal Name
Open Access Macedonian Journal Of Medical Sciences
Maternal Anemia Prevalence and Subsequent Neonatal Complications in Iraq
...Show More Authors

BACKGROUND: Anemia during pregnancy is still a challenge throughout the world, and it may cause severe health consequences in the maternal and fetal sides. AIM: This study aims to find out the prevalence of maternal anemia and potential adverse outcomes in Iraq. METHODS: In Medical City Tertiary Center in Baghdad, singleton pregnant ladies came for delivery were involved over 6 months’ period. Based on hemoglobin (Hb) readings; they were divided into no anemia group (Hb>11 g/l) and anemia group which were further subdivided into mild, moderate, and severe (Hb =10–10.9, =7.1–9.9, and <7 g/l, respectively). Full history and examination were performed by attending obstetrician and pediatrician for the upcoming b

... Show More
View Publication Preview PDF
Scopus (12)
Crossref (10)
Scopus Crossref
Publication Date
Wed Nov 13 2024
Journal Name
Aip Conference Proceedings
On Sδ.derived and Sδ.isolated sets in supra topological spaces
...Show More Authors

The topic of supra.topological.spaces considered one of the important topics because it is a generalization to topological.spaces. Many researchers have presented generalizations to supra open sets such as supra semi.open and supra pre.open sets and others. In this paper, the concept of δ∼open sets was employed and introduced in to the concept of supra topology and a new type of open set was extracted, which was named S∼δ∼open. Our research entails the utilization of this category of sets to form a new concepts in these spaces, namely S∼δ∼limit points and S∼δ∼derive points, and examining its relationship with S∼open and S∼reg∼open. Based on this class of sets, we have introduced other new concepts such as S∼isolate

... Show More
View Publication
Scopus (2)
Scopus Crossref
Publication Date
Tue Mar 10 2020
Journal Name
Open Access Macedonian Journal Of Medical Sciences
Maternal Anemia Prevalence and Subsequent Neonatal Complications in Iraq
...Show More Authors

BACKGROUND: Anemia during pregnancy is still a challenge throughout the world, and it may cause severe health consequences in the maternal and fetal sides. AIM: This study aims to find out the prevalence of maternal anemia and potential adverse outcomes in Iraq. METHODS: In Medical City Tertiary Center in Baghdad, singleton pregnant ladies came for delivery were involved over 6 months’ period. Based on hemoglobin (Hb) readings; they were divided into no anemia group (Hb>11 g/l) and anemia group which were further subdivided into mild, moderate, and severe (Hb =10–10.9, =7.1–9.9, and <7 g/l, respectively). Full history and examination were performed by attending obstetrician and pediatrician for the upcoming babies. RE

... Show More
View Publication
Scopus (12)
Crossref (10)
Scopus Crossref
Publication Date
Fri Mar 23 2018
Journal Name
Entropy
Methods and Challenges in Shot Boundary Detection: A Review
...Show More Authors

View Publication
Scopus (66)
Crossref (59)
Scopus Clarivate Crossref
Publication Date
Wed Mar 15 2023
Journal Name
Al-academy
Decorative aesthetic aspects and their use in Islamic architecture
...Show More Authors

The architecture of the richly decorated mosques demonstrated that the Islamic culture is one of the most significant and greatest civilizations in the history of humanity. The plant decorative units are one of the key areas in which the Muslim artist excelled. As a result, he created various plant forms that he took from nature, which led him to invent the arabesque art consisting of plant motifs with curved and rounded lines or wrapped between them. These shapes with curved borders include leaves, twigs, and flowers. Buildings and artefacts from the nineteenth century AD have this shape. they achieved their objectives during the twelfth and thirteenth centuries. There was another kind of vegetable decorative unit, made up of stems and

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Tue Dec 29 2020
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The role of the auditor in measuring social and environmental performance indicators in light of the implementation of the GRI standards: (Applied research at the Iraqi General Cement Company)
...Show More Authors

This study measures the indicators of social and environmental performance of the contents of the administration's prepared reports on its social and environmental performance by comparing the actual performance with the indicators set within the standards of the Global Reports Initiative (GRI), In preparing this research, the researchers relied on studying the criteria of the Global Reporting Initiative, which aims to achieve a high level of performance disclosure under sustainability, In light of contemporary global trends towards achieving sustainable development and its disclosure and the orientations of economic institutions and units in different countries towards emphasizing the extent of commitment during practicing its a

... Show More
View Publication Preview PDF