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KMID : 0369819940240020049
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Jorunal of Korean Pharmaceutical Sciences
1994 Volume.24 No. 2 p.49 ~ p.55
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Bioequivalence Test of Rifampicin Preparations (Ⅱ )
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장일효/Chang IH
범진필/최준식/Burm JP/Choi JS
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Abstract
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Bioequivalence test of commercially available rifampicin capsules was performed. Sixteen volunteers were divided into 2 groups and the reference and test drug were given orally (450 mg) by cross-over design. Statistical evaluation of AUC, CmaxandTmax involved an analysis of variance (ANOVA). The differences of mean value in AUC, CmaxandTmax between the reference and test drug were within 20% with reference drug. ANOVA showed no significant differences for ‘between group’, ‘drug’ and ‘period’, but not for ‘between subjects’. The power of test (1?β)ofAUCandC_{max}$ was larger than 0.8 and the confidence of bioavailability was within±20. From these results, it was concluded that the two preparations were bioequivalent for AUC and Cmax, but was not for Tmax.
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KEYWORD
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Bioequivalence, Rifampicin, Cross-over design
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