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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Dec 29 2024
Journal Name
Muthanna Journal Of Pure Science
Two-Fold Cryptography: Enhancing Image Security with Henon Map
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This paper introduces an innovative method for image encryption called "Two-Fold Cryptography," which leverages the Henon map in a dual-layer encryption framework. By applying two distinct encryption processes, this approach offers enhanced security for images. Key parameters generated by the Henon map dynamically shape both stages of encryption, creating a sophisticated and robust security system. The findings reveal that Two-Fold Cryptography provides a notable improvement in image protection, outperforming traditional single-layer encryption techniques.

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Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Engineering And Development
Comparison Study of (urinary & serum) AST Activity from Patients with type 2 diabetes
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Aspartate aminotransferase was purified from urine and serum of patients with type 2 diabetes in a 2 steps procedure involving dialysis bag and sephadex G-25 gel filtration (column chromatography). The enzyme was purified 346.23 fold with 1467% yield and 3.46 fold with 142.85% yield in urine and serum of patients with type 2 diabetes respectively. The purified enzyme showed single peak. The results of this study revealed that AST activity of type 2 diabetes urine and serum increased significantly (p<0.001) compared with control group.

Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
A comparison Some of Methods for Estimating Survival Function for Truncated Exponential Distribution
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Exponential distribution is one of most common distributions in studies and scientific researches with wide application in the fields of reliability, engineering and in analyzing survival function therefore the researcher has carried on extended studies in the characteristics of this distribution.

In this research, estimation of survival function for truncated exponential distribution in the maximum likelihood  methods and Bayes first and second method, least square method and Jackknife dependent in the first place on the maximum likelihood method, then on Bayes first method then comparing then using simulation, thus to accomplish this task, different size samples have been adopted by the searcher us

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Publication Date
Sat Jan 24 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Dissolution of inorganic phosphorous ion from human enamel treated with different concentration of Siwak aqueous extract in comparison with sodium fluoride
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Background: The use of Miswak, chewing sticks (salvadorapersica) can be traced back to Babylonians some 7000 years ago. It is commonly used throughout the world especially for the purpose of oral hygiene. Muslims are using as the religious view. Current study aimed to test the ability of aqueous siwak extract to increase the resistance of enamel surface against acid dissolution compared to sodium fluoride. Materials and Method: Twenty maxillary first premolars were treated with the selected solutions included two aqueous siwak extract concentration(5%,10%) and sodium fluoride(0.05%)as control positive for 2 minutes once daily for 20days interval, de ionized water was used as control negative. The concentration of the dissolved phosphorus i

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Publication Date
Mon Jul 24 2023
Journal Name
Journal Of University Of Kerbala
The occurrence of two species of the genus Myxobolus Bütschli, 1882 (Myxozoa: Myxosporea) for the first time in Iraq from freshwater fishes.
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The occurrence of two species of the genus Myxobolus Bütschli, 1882 (Myxozoa: Myxosporea) for the first time in Iraq from freshwater fishes.

Publication Date
Sat Jan 24 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of regional bond strength among different types of posts luted with different types of cement
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Background: This in vitro study was carried out to investigate the effect of post space regions (coronal, middle and apical), the effect of post types ( Manually Milled Zirconia post, Prefabricated Fiber post, prefabricated Zirconia post) and the type of cement used (GIC, self-adhesive resin cement) on the bond strength between the posts and root dentin by using push-out test. Material and methods: Forty eight mandibular premolars extracted for orthodontic reasons (single rooted) were instrumented with ProTaper system (hand use) and obturated with gutta percha for ProTaper using AH26® root canal sealer following the manufacturer instructions. After 24 hours, post space was prepared using Zirix and Glassix drills no.3 creating 8 mm dept

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Publication Date
Sun Mar 02 2014
Journal Name
Baghdad Science Journal
Comparison of Properties of Various Heat Storage Fluids used with Evacuated Tube of Solar Water Heater
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The aim of this work was to capture solar radiation and convert it into solar thermal energy by using a storage material and the heat transfer fluid like oil and water and comparison between them, we used the evacuated tube as a receiver for solar radiation, The results showed that the oil better than water as storage material and the heat transfer fluid and the effective thermal conductivity material and good for power level, rates and durations of charge and discharge cycles.

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Publication Date
Thu Jun 27 2019
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
TWO NEW RECORDS OF THE GENUS APHODIUS ILLIGE, 1798 (COLEOPTERA: APHODIIDAE) IN IRAQTWO NEW RECORDS OF THE GENUS APHODIUS ILLIGE, 1798 (COLEOPTERA: APHODIIDAE) IN IRAQ
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    In this study, the dung beetles Aphodius (Bodilus) ictericus (Laicharting, 1781) and Aphodius (Planolinellus) vittatus Say, 1825 which belongs to the family of Aphodiidae (Order: Coleoptera) are redscribed here as to being found for the first time in Iraq.

 

    The specimens were collected from different regions in the middle of Iraq; the main diagnostic characters and some morphological features of males were drawn and pictured.

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Publication Date
Wed Jan 01 2020
Journal Name
Periodicals Of Engineering And Natural Sciences
Comparison between the estimated of nonparametric methods by using the methodology of quantile regression models
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This paper study two stratified quantile regression models of the marginal and the conditional varieties. We estimate the quantile functions of these models by using two nonparametric methods of smoothing spline (B-spline) and kernel regression (Nadaraya-Watson). The estimates can be obtained by solve nonparametric quantile regression problem which means minimizing the quantile regression objective functions and using the approach of varying coefficient models. The main goal is discussing the comparison between the estimators of the two nonparametric methods and adopting the best one between them

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Publication Date
Sun Jan 01 2023
Journal Name
مجلة ميسان للدراسات الأكاديمية
Bond Strength Of 3D Printed Acrylic Resin With Silicone Soft Liner After Ethyl Acetate Surface Treatment:, A Review Of Literature
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