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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 03 2009
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of repetitive estimation methodsSelf-data
...Show More Authors

In this study, we review the ARIMA (p, d, q), the EWMA and the DLM (dynamic linear moodelling) procedures in brief in order to accomdate the ac(autocorrelation)  structure of data .We consider the recursive estimation and prediction algorithms based on Bayes and KF (Kalman filtering) techniques for correlated observations.We investigate the effect on the MSE of  these procedures and compare them using generated data.

View Publication Preview PDF
Crossref
Publication Date
Wed Jun 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
...Show More Authors

Through recent years many researchers have developed methods to estimate the self-similarity and long memory parameter that is best known as the Hurst parameter. In this paper, we set a comparison between nine different methods. Most of them use the deviations slope to find an estimate for the Hurst parameter like Rescaled range (R/S), Aggregate Variance (AV), and Absolute moments (AM), and some depend on filtration technique like Discrete Variations (DV), Variance versus level using wavelets (VVL) and Second-order discrete derivative using wavelets (SODDW) were the comparison set by a simulation study to find the most efficient method through MASE. The results of simulation experiments were shown that the performance of the meth

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Tue Jun 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
...Show More Authors

Publication Date
Mon Jun 01 2015
Journal Name
International Journal Of Advanced Research In Computer Science And Software Engineering
Performance Comparison of Transport Layer Protocols
...Show More Authors

Transport layer is responsible for delivering data to the appropriate application process on the host computers. The two most popular transport layer protocols are Transmission Control Protocol (TCP) and User Datagram Protocol (UDP). TCP is considered one of the most important protocols in the Internet. UDP is a minimal message-oriented Transport Layer protocol. In this paper we have compared the performance of TCP and UDP on the wired network. Network Simulator (NS2) has been used for performance Comparison since it is preferred by the networking research community. Constant bit rate (CBR) traffic used for both TCP and UDP protocols.

View Publication
Publication Date
Thu Jun 01 2017
Journal Name
Journal Of Huazhong University Of Science And Technology [medical Sciences]
New mini dental implant attachments versus O-ring attachment after cyclic aging: Analysis of retention strength and gap space
...Show More Authors

View Publication
Crossref (2)
Crossref
Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
The natural courses of keratometric, pachymetric and visual acuity outcomes during 1year follow up after corneal collagen cross-linking
...Show More Authors

Background: As photochemical reaction that can stiffen the cornea, CXL is the only promising method of preventing progression of keratectasia such as KC and secondary ectasia following refractive surgery. The aim of CXL is to stabilize the underlying condition with a small chance of visual improvement. Objective: To show the sequences of changes in visual acuity and topographic outcomes during 1 year post CXL for patients with progressive Keratoconus.Type of the study: Cross sectional studyMethods: CXL procedure was done for 45 eyes with progressive KC. The following parameters had been monitored pre operatively, 1, 3, 6 and 12 months postoperatively: K apex, K2, corneal thickness at thinnest location, anterior and posterior elevation po

... Show More
View Publication Preview PDF
Publication Date
Sun Sep 02 2012
Journal Name
Baghdad Science Journal
Study the expression level of beta 2 microglobulin gene on hepatitis C patients before and after treatment with interferon
...Show More Authors

This study has been carried out to evaluate the expression level of beta 2 microglobulin gene on patients infected by hepatitis C virus before and after treatment with interferon. The study included 117 hepatitis C patients comprising as 63 pre-treated patients, the range of age was between 20-65 year with a mean age of 48.12 ± 16.1 and 54 post-treated patients with age range was between 23-63 year with the mean of 46.1 ± 18.1. Also it was found that more than half of patients were located within third and fourth decade i.e. 30-49 year, with a percentage of 52.4% and 55.6 % for pre-treatment and post-treatment patients respectively. Moreover , regarding both groups, males are more than females with the ratio of ( 3.2:1) among p

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri Aug 15 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Enamel defect of primary and permanent teeth in relation to nutrients daily intake among Down's syndrome children in comparison to normal children
...Show More Authors

Background: Any child with Down's syndrome does not develop in the same manner as normal child. Therefore, the child should not be viewed as being like everyone else. Developmental enamel defects in primary teeth have been found at least twice as frequently in disabled children as in control children. Down's syndrome consumed protein more than the recommended daily allowance compared to other disabled groups. Therefore, the aim of this study was to investigate developmental defects of enamel and their relations to nutrient intake among Down's syndrome children in comparison to normal children. Materials and Methods: A sample consisted of fifty institutionalized Down's syndrome children (study group) and 50 normal children (control group)

... Show More
View Publication Preview PDF
Publication Date
Sat Oct 01 2022
Journal Name
Al–bahith Al–a'alami
ETHICAL JOURNALISM IN IRAQ AFTER 2003: Baghdad edition as a model
...Show More Authors

The fact of having Journalism being open to people from different orientations professions, working as journalists requiring protection just to spread corruption, is one of the biggest threats faced by journalism.

Journalists noticed the spread of unprincipled journalists with no journalistic ethics amongst them, they tried to protect their profession from these corrupt outsiders who might annihilate the mighty of journalism. The principles of the journalism profession known as journalistic ethics, are one the most important formulations of the law concluded by the journalists and those concerned by the the profession, they were then published in public in order to prove their professionalism, especially for those who don’t und

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri May 01 2015
Journal Name
Journal Of Nuclear Medicine
Comparison of in vivo uptake of radioactive gold nanoparticles formulated using phytochemicals
...Show More Authors

1267 Objectives Aim to evaluate 198Au nanoparticles (AuNP) biodistribution and uptake in a human prostate model for treatment. Many phytochemicals are known to have anti-tumor properties but have short half-lives in vivo. We hypothesized that using these phytochemicals to formulate and coat AuNP would inhibit enzyme cleavage and enhance their anti-tumor properties. Initial evaluations were performed in SCID mice bearing PC3 tumors. Methods : 198AuNP were formulated with the following gum Arabic, epigalocatechin gallate (EGCg) pomegranate extract and mangiferin extract. The resultant nanoparticles were evaluated in normal mice and in human prostate bearing SCID mice. The tumor bearing mice were injected intratumorally with 3-5 uCi of 198A

... Show More
View Publication