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W 47: Testing for Bioequivalence in Higher-Order Crossover Designs: Two-at-a-Time Principle Versus Pooled ANOVA
Senior Director, Scientific Affairs
Novum Pharmaceutical Research Services United States
The objective of this research is to determine which method of statistical analysis is more appropriate to conclude bioequivalence in higher-order crossover studies.
Empirical data from three-way crossover bioequivalence studies were examined using 1) the two-at-a-time principle and 2) a pooled approach using one ANOVA. Simulations will also be performed to control and compare the type I and II errors resulting from both methods of analyses.
The method of statistical analysis of higher-order crossover studies can affect the bioequivalence conclusions of each formulation being tested. Empirical results show that using a two-at-a-time principle or a pooled ANOVA approach may produce different bioequivalence conclusions for the targeted comparison owing to the influence of the other formulations on those results. Simulations where type I and II errors are controlled will show which method of analysis produces less bias and more accurate bioequivalence conclusions.