In vitro bioequivalence testing.

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Shao, J; Wang, H

Published Date

  • January 15, 2003

Published In

Volume / Issue

  • 22 / 1

Start / End Page

  • 55 - 68

PubMed ID

  • 12486751

International Standard Serial Number (ISSN)

  • 0277-6715

Digital Object Identifier (DOI)

  • 10.1002/sim.1345

Language

  • eng

Conference Location

  • England