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Bioequivalence evaluation of two brands of amoxicillin/clavulanic acid 250/125 mg combination tablets in healthy human volunteers: Use of replicate design approach

✍ Scribed by Nasir M. Idkaidek; Ahmad Al-Ghazawi; Naji M. Najib

Book ID
101702054
Publisher
John Wiley and Sons
Year
2004
Tongue
English
Weight
76 KB
Volume
25
Category
Article
ISSN
0142-2782

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✦ Synopsis

Abstract

The purpose of this study was to apply a replicate design approach to a bioequivalence study of amoxicillin/clavulanic acid combination following a 250/125 mg oral dose to 23 subjects, and to compare the analysis of individual bioequivalence with average bioequivalence. This was conducted as a 2‐treatment 2‐sequence 4‐period crossover study. Average bioequivalence was shown, while the results from the individual bioequivalence approach had no success in showing bioequivalence. In conclusion, the individual bioequivalence approach is a strong statistical tool to test for intra‐subject variances and also subject‐by‐formulation interaction variance compared with the average bioequivalence approach. Copyright © 2004 John Wiley & Sons, Ltd.

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Bioequivalence evaluation of two brands
Bioequivalence evaluation of two brands of gliclazide 80 mg tablets (Glyzide® & Diamicron®) — in healthy human volunteers
✍ Naji Najib; Nasir Idkaidek; M. Beshtawi; Mohammed Bader; Isra' Admour; S. Mahmoo 📂 Article 📅 2002 🏛 John Wiley and Sons 🌐 English ⚖ 91 KB 👁 2 views

A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of gliclazide 80 mg tablets, Glyzide (Julphar, UAE) as test and Diamicron (Servier Industries, France) as reference product. The study was performed at the International