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OJB©

Online Journal of Bioinformatics©

Onl J Bioinform©


Established 1995

ISSN  1443-2250

 

Volume 25 (2) :86-93, 2024.


One and 2 side nonparametric Schuirmann’s tests for non-normal pharmacokinetic data.

 

Jihao Zhou PhD, Yulei He MS, Ying Yuan, MA MS.

 

1Clinical Biostatistics, Pfizer Global Research and Development, La Jolla Laboratories,, San Diego, California, University of Michigan, Ann Arbor, Michigan, USA..

 

Abstract

 

Zhou J, He Y,  Yuan Y, One and 2 side nonparametric Schuirmann’s tests for non-normal pharmacokinetic data, Onl J Bioinform.,  25 (2) :86-93, 2024. Schuirmann’s two one-sided tests (TOST) for clinical drug-drug interaction assume data normality which may not occur in practice. We describe statistical tests for non-normal data compared with nonparametric ones. We used Monte Carlo simulations for non-normal skewed data and Schuirmann’s TOST and nonparametric tests compared by empirical power, size and coverage probability. The nonparametric TOST was based on Wilcoxon signed-rank, Jackknife and Bootstrap tests. We found that Schuirmann’s TOST is robust for slightly skewed data, but poor when heavily skewed, whereas Bootstrap yielded high probability and empirical size.

 

Key words: drug-drug interaction, two-one sided tests, nonparametric, clinical trial.


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