BIOEQUIVALENCE OF CLOSANTEL MANUFACTURED WITH RAW MATERIALS FROM TWO DIFFERENT SOURCES

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JAHANNIA M.; ARAB H.A.; RASOULI A.; SHAMS GHOLAM REZA

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Seminar Paper

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Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Year:2007 | Issue:18

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Title

BIOEQUIVALENCE OF CLOSANTEL MANUFACTURED WITH RAW MATERIALS FROM TWO DIFFERENT SOURCES

Author(s)

JAHANNIA M. | ARAB H.A. | RASOULI A. | SHAMS GHOLAM REZA

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Abstract

Bioequivalence study is a scientific and practical method that is used to compare a generic drug quality with a reference product. This study aimed to examine the bioequivalence of two closantel made by a domestic company. The study carried out by a parallel method, due to long half- life of closantel. Thirty sheep, the same in bread, weight and age divided in 2 groups. In the first group (test), each sheep received a 500mg bolus of closantel made with raw material purchased from Spanish company and the sheep in second group (reference) received 500mg bolus of closantel produced with raw material from Belgium Company. Blood samples were collected on 0, 4, 8, 12, 16, 20, 24, 32, 48 and 72 hours after drug administration. An HPLC system was used to determine the amount of closantel in blood. Different pharmacokinetic parameters including area under curve (AUC), Cmax, and Tmax of closantel were determined in each sheep. A T-student and F test with 90% confidence interval were used to analyze and compare the results. The average of Cmax in reference group was 56.38±14.28 µgr/ml while in test it was 51.44±10.55. The average of Tmax in reference group was 22.63±2.81 hours and in test was 23.72±1.83. AUC (0-72) in reference and test drugs were 2037.87±423.65 and 2785.00±427.72 respectively. He results of this study showed that there was not significant difference between reference and test group, which is suggesting that this two product are bioequivalent.

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APA: Copy

JAHANNIA, M., ARAB, H.A., RASOULI, A., & SHAMS, GHOLAM REZA. (2007). BIOEQUIVALENCE OF CLOSANTEL MANUFACTURED WITH RAW MATERIALS FROM TWO DIFFERENT SOURCES. IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY. SID. https://sid.ir/paper/904563/en

Vancouver: Copy

JAHANNIA M., ARAB H.A., RASOULI A., SHAMS GHOLAM REZA. BIOEQUIVALENCE OF CLOSANTEL MANUFACTURED WITH RAW MATERIALS FROM TWO DIFFERENT SOURCES. 2007. Available from: https://sid.ir/paper/904563/en

IEEE: Copy

M. JAHANNIA, H.A. ARAB, A. RASOULI, and GHOLAM REZA SHAMS, “BIOEQUIVALENCE OF CLOSANTEL MANUFACTURED WITH RAW MATERIALS FROM TWO DIFFERENT SOURCES,” presented at the IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY. 2007, [Online]. Available: https://sid.ir/paper/904563/en

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