A nonparametric test for similarity of marginals-With applications to the assessment of population bioequivalence

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Abstract

In this paper we suggest a completely nonparametric test for the assessment of similar marginals of a multivariate distribution function. This test is based on the asymptotic normality of Mallows distance between marginals. It is also shown that the n out of n bootstrap is weakly consistent, thus providing a theoretical justification to the work in Czado, C. and Munk, A. [2001. Bootstrap methods for the nonparametric assessment of population bioequivalence and similarity of distributions. J. Statist. Comput. Simulation 68, 243-280]. The test is extended to cross-over trials and is applied to the problem of population bioequivalence, where two formulations of a drug are shown to be similar up to a tolerable limit. This approach was investigated in small samples using bootstrap techniques in Czado, C., Munk, A. [2001. Bootstrap methods for the nonparametric assessment of population bioequivalence and similarity of distributions. J. Statist. Comput. Simulation 68, 243-280], showing that the bias corrected and accelerated bootstrap yields a very accurate and powerful finite sample correction. A data example is discussed.

Original languageEnglish
Pages (from-to)697-711
Number of pages15
JournalJournal of Statistical Planning and Inference
Volume137
Issue number3
DOIs
StatePublished - 1 Mar 2007

Keywords

  • Bioequivalence
  • Cross-over trials
  • Hadamard derivative
  • Limit law
  • Multivariate empirical process
  • Pre-post comparison

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