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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 01 2020
Journal Name
Al-khwarizmi Engineering Journal
Two-Stage Classification of Breast Tumor Biomarkers for Iraqi Women
...Show More Authors

Objective: Breast cancer is regarded as a deadly disease in women causing lots of mortalities. Early diagnosis of breast cancer with appropriate tumor biomarkers may facilitate early treatment of the disease, thus reducing the mortality rate. The purpose of the current study is to improve early diagnosis of breast by proposing a two-stage classification of breast tumor biomarkers fora sample of Iraqi women.

Methods: In this study, a two-stage classification system is proposed and tested with four machine learning classifiers. In the first stage, breast features (demographic, blood and salivary-based attributes) are classified into normal or abnormal cases, while in the second stage the abnormal breast cases are

... Show More
View Publication Preview PDF
Publication Date
Thu Jan 31 2019
Journal Name
Engineering Journa
Flexural Moment Capacity Evaluation of Reinforced RPC Two-way Slabs
...Show More Authors

The aim of this paper is to determine the flexural moment capacity of Reactive Powder Concrete (RPC) two-way slabs based on three models proposed by previous studies (Model 1, Model 2, and Model 3). The results obtained from these models were compared with those obtained from experimental work to check the accuracy and the applicability of the adopted theoretical models. The experimental program included the testing of three simply supported RPC two-way slabs (1000x1000x70) mm each. The tested specimens had identical properties except their steel fibres volume ratios (0.5 %, 1 %, and 1.5 %). The comparison with the experimental data showed that (Model 3) is the most suitable one among the three models. Model 1 was found to underestimate the

... Show More
Crossref (1)
Crossref
Publication Date
Sun Jun 06 2010
Journal Name
Baghdad Science Journal
Comparison between the efficiency of serological tests for Identification of Brucellosis
...Show More Authors

Five serological methods for detection of Brucella were compaired in this study, Four of the methods are commonely used in the detections:- 1-Rose-Bengal: as primary screening test which depends on detecting antibodies in the blood serum. 2-IFAT: which detects IgG and IgM antibodies in the serum. 3-ELISA test: which detects IgG antibodies in the serum. 4-2ME test: which detects IgG antibodies The fifth methods. It was developed by a reasercher in one of the health centers in Baghdad. It was given the name of spot Immune Assay (SIA). Results declares that among (100) samples of patients blood, 76, 49, 49, 37, and 28. samples were positive to Rose Bengal, ELISA, SIA, 2ME and IFAT tests, respectively. When efficiency, sensitivity and specific

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu Mar 01 2018
Journal Name
2018 International Conference On Computing Sciences And Engineering (iccse)
Comparison between Epsilon Normalized Least Means Square (ϵ-NLMS) and Recursive Least Squares (RLS) Adaptive Algorithms
...Show More Authors

There is an evidence that channel estimation in communication systems plays a crucial issue in recovering the transmitted data. In recent years, there has been an increasing interest to solve problems due to channel estimation and equalization especially when the channel impulse response is fast time varying Rician fading distribution that means channel impulse response change rapidly. Therefore, there must be an optimal channel estimation and equalization to recover transmitted data. However. this paper attempt to compare epsilon normalized least mean square (ε-NLMS) and recursive least squares (RLS) algorithms by computing their performance ability to track multiple fast time varying Rician fading channel with different values of Doppler

... Show More
View Publication
Scopus (3)
Crossref (1)
Scopus Crossref
Publication Date
Sat Jan 01 2022
Journal Name
The 2nd Universitas Lampung International Conference On Science, Technology, And Environment (ulicoste) 2021
A comparison between IRI-2016 and ASAPS models for predicting foF2 ionospheric parameter over Baghdad city
...Show More Authors

View Publication
Scopus (1)
Crossref (2)
Scopus Crossref
Publication Date
Mon Jan 01 2024
Journal Name
Aip Conference Proceedings
A comparison between banana peel powder and gel for removing methylene blue dye from aqueous solution
...Show More Authors

This research aims to removes dyes from waste water by adsorption using banana peels. The conduct experiment done by banana powder and banana gel to compare between them and find out which one is the most efficient in adsorption. Studying the effects different factors on adsorption material and calculate the best removal efficiency to get rid of the methylene blue dye (MB).

View Publication
Scopus Crossref
Publication Date
Fri Apr 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
A Comparison Between Classic Local Least Estimatop And Bayesian Methoid For Estimating Semiparametric Logistic Regression Model
...Show More Authors

Semi-parametric models analysis is one of the most interesting subjects in recent studies due to give an efficient model estimation. The problem when the response variable has one of two values either 0 ( no response) or one – with response which is called the logistic regression model.

We compare two methods Bayesian and . Then the results were compared using MSe criteria.

A simulation had been used to study the empirical behavior for the Logistic model , with  different sample sizes and variances. The results using represent that the Bayesian method is better than the   at small samples sizes.

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Jul 09 2023
Journal Name
Journal Of Engineering
Comparison between Linear and Non-linear ANN Models for Predicting Water Quality Parameters at Tigris River
...Show More Authors

In this research, Artificial Neural Networks (ANNs) technique was applied in an attempt to predict the water levels and some of the water quality parameters at Tigris River in Wasit Government for five different sites. These predictions are useful in the planning, management, evaluation of the water resources in the area. Spatial data along a river system or area at different locations in a catchment area usually have missing measurements, hence an accurate prediction. model to fill these missing values is essential.
The selected sites for water quality data prediction were Sewera, Numania , Kut u/s, Kut d/s, Garaf observation sites. In these five sites models were built for prediction of the water level and water quality parameters.

... Show More
View Publication Preview PDF
Crossref (3)
Crossref
Publication Date
Wed Nov 01 2023
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
After Introducing Artificial Intelligence, can Pharmacists Still Find a Job?
...Show More Authors

View Publication Preview PDF
Scopus (1)
Crossref (1)
Scopus Crossref
Publication Date
Tue Jan 10 2017
Journal Name
South Asian Journal Of Life Sciences
Comparison the effect of fungi (Beauveria bassiana) and bacteria Bacillus thuringiensis (is-raelensis) on a cumulative mortality of culex quinquefasciatus (Diptera: Culicidae).
...Show More Authors

Mosquitoes play a serious role on public health transmitting several dangerous diseases such as malaria, filariasis and Encephalitis. So it consider as a vector diseases. Therefor it is important to control its spread using ecology friend’s factors like bacteria Bacillus thuringiensis var. israelensis and fungi Beauveria bassiana. Results revealed that the direct effect of Bacillus thuringiensis on the larvae led to the high mortality (100%) during 3 days while Beauveria bassiana have a cumulative effect on the Mosquito stage lifecycle; 7.3 X 104 more significant effect in the first day but there was no significant in the other days of treatment. In the end period of lifecycle there was no adult emergence and the adult which emergence up

... Show More