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OJVRTM
Online Journal of Veterinary
Research ©
Volume 25 (1) : 28-34, 2021.
Jihao Zhou, PhD1§,
1Department of Clinical
Biostatistics, Pfizer Global Research and Development, La Jolla Laboratories,
11085 Torreyana Road, San Diego, California, 92121,
USA. 2Department of Biostatistics, The
Zhou J, He Y,
Yuan Y., Schuirmann’s two 1-sided and nonparametric tests for non-normal
pharmacokinetic drug interactions, Onl J Vet Res., 25(1):
28-34, 2021. Schuirmann’s two one-sided tests (TOST)
approach is widely used in clinical drug-drug interaction studies. However, it
requires normality assumption, which may not hold in practice. We report
statistical performance of Schuirmann’s TOST
procedure for non-normal data compared with nonparametric TOSTs. Monte Carlo
simulations were used to generate non-normal data with different skewness and
kurtosis. The statistical performances of Schuirmann’s
TOST and nonparametric method-based TOSTs were compared in terms of empirical
power, size and coverage probability. The nonparametric TOST approaches were
based on Wilcoxon signed-rank test, Jackknife and
Bootstrap methods. Our simulations show that Schuirmann’s
TOST is fairly robust to slightly skewed data, but may have poor performance
when data are heavily skewed. In contrast, Bootstrap-T approach consistently
yields the best coverage probabilities and reasonable empirical sizes.