In vitro bioequivalence testing.
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.
Chow
Shein-Chung
SC
Statplus Inc, Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA.
Shao
Jun
J
Wang
Hansheng
H
D000281:Administration, Intranasal; D000336:Aerosols / Q000008:administration & dosage; D003198:Computer Simulation; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010599:Pharmacokinetics; D018401:Sample Size; D013223:Statistics as Topic / Q000379:methods* / Q000592:standards; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D000336:Aerosols; D004364:Pharmaceutical Preparations