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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2019
Journal Name
Current Research In Microbiology And Biotechnology
Detection of Anti-rubella virus, Cytomegalovirus and Chlamydia pneumonia antibodies in patients with type I diabetes mellitus
...Show More Authors

Type-1 diabetes is defined as destruction of pancreatic beta cell, virus and bacteria are some environmental factor for this disease. The study included 25 patients with type-1 diabetes mellitus aged between 8 – 25 years from Baghdad hospital and 20 healthy persons as control group. Anti-rubella IgG and IgM, anti-Chlamydia pneumonia IgG and IgM were measured by ELISA technique while anti-CMV antibody were measured by immunofluorescence technique. The aim of current study was to know the trigger factor for type-1 diabetes. There were significant differences (P<0.05) between studied groups according to parameters and the results lead to suggest that Chlamydia pneumonia, CMV and rubella virus may trigger type-1 diabetes mellitus in Iraqi pat

... Show More
Publication Date
Wed Aug 17 2022
Journal Name
Aip Conference Proceedings
The effect of using Gaussian, Kurtosis and LogCosh as kernels in ICA on the satellite classification accuracy
...Show More Authors

This study focusses on the effect of using ICA transform on the classification accuracy of satellite images using the maximum likelihood classifier. The study area represents an agricultural area north of the capital Baghdad - Iraq, as it was captured by the Landsat 8 satellite on 12 January 2021, where the bands of the OLI sensor were used. A field visit was made to a variety of classes that represent the landcover of the study area and the geographical location of these classes was recorded. Gaussian, Kurtosis, and LogCosh kernels were used to perform the ICA transform of the OLI Landsat 8 image. Different training sets were made for each of the ICA and Landsat 8 images separately that used in the classification phase, and used to calcula

... Show More
View Publication Preview PDF
Scopus Crossref
Publication Date
Tue Dec 15 2020
Journal Name
Al-academy
Methods of Acting Performance and Watching Industry in Street Theatre- Play (Sold) - A Model: بهاء زهير كاظم
...Show More Authors

  The audience is one of the important practical elements in the theatrical show and its importance is not confined to its static activity as a receiver element only, rather it went beyond that issue as an effective and influential element in the proceedings of the show and the process of meaning construction, that it gains an active role in the construction and production of the connotation that influences and is influenced by the actor, where the communication channels are open between the two sides, consequently a kind of watching and joint interaction happens between them. Thus, it has become necessary for the actor to create a suitable environment for the onlookers in order for it to be an essential part of the show system. The

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu Oct 13 2022
Journal Name
Plant Archives
ISOLATION AND SERODIGNOSTIC OF VIBRIO CHOLERAE FROM PATIENTS SUFFERED FROM WATERY DIARRHEA IN SUWAYRAH, WASIT GOVERNORATE, IRAQ
...Show More Authors

Background: Cholera has been recognized as a killer disease since earliest time. The disease is caused by infection of the small intestine by Vibrio cholerae O1 and O1391 which is characterized by severe dehydrating diarrheal condition and is one disease in modern times that is epidemic, endemic and pandemic in nature. Objective: This study was carried out to detect and isolate V. cholerae from patients suffered from watery diarrhea, which may cause severe complications such as dehydration, shock followed by death. Materials and methods: stool specimens were collected from 308 patients with watery diarrhea. These samples were tested with many criteria such as TCBS agar, gram stain, biochemical tests and VITEK-2 system to improve the isolati

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Sep 01 2014
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Analysis of the relationship between inflation and the tax revenue in Iraq for the period 1990-2010
...Show More Authors

The Iraqi economy has suffered for a long period of inflation because of the Iraq war and the resolutions and the sanctions that were imposed on Iraq, this phenomenon overshadowed at various aspects of the economy including the tax revenue that the State seeks to optimize the total income for the budget, the research covers the years 1990-2010, these years have been divided according to the country's economic variables.

The research  adopted on econometrics analysis that is based on the information and data available on topics and has been using statistical methods to test functions are formulated.

Research concluded that rates of inflation and GDP impact is limited to direct taxation and indirect in current prices a

... Show More
View Publication Preview PDF
Publication Date
Mon Jul 27 2015
Journal Name
Iranian Journal Of Parasitology
Abnormalities of endocytosis, phagocytosis, and development process in Dictyostelium cells that over-express Acanthamoeba castellanii metacaspase protein
...Show More Authors

Scopus (2)
Scopus
Publication Date
Wed Jan 30 2019
Journal Name
Journal Of The College Of Education For Women
Job satisfaction in motivating potential energy of youth charged and non-enforcement officials' relationship newly administrative work
...Show More Authors

The good preparation for a class of young people is the great importance requirement.
This case on the state role to put exceptional philosophy bench form which the entire category
through group of experienced educators to prepare different and distinct programs to suit
every specialty of this class. This base of this role can draw upon, including state institutions
need of young people add urges the mental and physical abilities, scientific and cognitive
specialties and carry it from the levee in the academic certification .And we must not lose the
lose sight of the link that pilot projects in which to invest the energies of youth programs and
curricula attractions including incentives .It's become the subject of jo

... Show More
View Publication Preview PDF
Publication Date
Sun Aug 30 2015
Journal Name
Statistical Analysis Of The Relations Between Api,specific Gravity And Sulfur Content In The Universal Crude Oil
Statistical Analysis of the Relations between API, Specific Gravity and Sulfur Content in the Universal Crude Oil
...Show More Authors

Publication Date
Mon Feb 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
International variables and their impact on the flow of foreign direct investment in Gulf Cooperation Council (GCC)
...Show More Authors

Abstract:

The six Arab Gulf states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE) play a vital role, especially with its geographical location and natural  resources (oil and gas) as well as other cultural and civilizational elements, in achieving  global economic balance and more specifically global energy security, naturally  because of  these countries have a comparative advantage in the field of fossil energy (oil and gas), thus this sector becomes more attractive for local and international investments alike. Being  the energy sector a leader sector in the economic development process, and the basic factor to achieve savings and financial surpluses in thes

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Jan 23 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The importance of cash flow statement in reducing credit risk and liquidity: بحث تطبيقي في مصرف الرشيد
...Show More Authors

Banks face different types of banking risks that limit the performance of its functions and achieve its objectives, including the financial risk that is based on current research into two types including a credit and liquidity risks. And established credit risk due to the possibility of delaying the borrowers to fulfill their obligations to the bank when due or non-payments on according to the terms agreed upon, while liquidity risk arises as a result of the inability of the bank to fund the financial needs, any inability to provide cash to pay its obligations short on credit without achieving tangible loss or the inability to employ the funds properly and show the liquidity risk in the event of inadequate cash inflows to the bank for an

... Show More
View Publication Preview PDF
Crossref