In vitro bioequivalence testing
- 1 January 2002
- journal article
- research article
- Published by Wiley in Statistics in Medicine
- Vol. 22 (1) , 55-68
- https://doi.org/10.1002/sim.1345
Abstract
A statistical test is proposed for in vitro bioequivalence testing between drug products such as nasal aerosols and nasal sprays. The proposed test generalizes the one recommended in the FDA 1999 guidance to the situation where replicated observations obtained from each sampled canister or bottle of the drug product are available. The technique developed by Hyslop, Hsuan and Holder is used so that the proposed test is asymptotically accurate. The type I error probability and power of the proposed test are investigated through a simulation study. A method for determining the required sample size to achieve a desired power is also proposed. A numerical example is given for illustration. Copyright © 2003 John Wiley & Sons, Ltd.Keywords
This publication has 2 references indexed in Scilit:
- A small sample confidence interval approach to assess individual bioequivalenceStatistics in Medicine, 2000
- Design and Analysis of Bioavailability and Bioequivalence StudiesPublished by Taylor & Francis ,1999