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In vitro bioequivalence testing
Author(s) -
Chow SheinChung,
Shao Jun,
Wang Hansheng
Publication year - 2002
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.1345
Subject(s) - bioequivalence , type i and type ii errors , statistics , statistical power , computer science , statistical hypothesis testing , mathematics , reliability engineering , medicine , engineering , pharmacology , bioavailability
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.