Assessment of Bioequivalence with Dropout Subjects in 3$\times$3 and 3$\times$2 Crossover Design

  • Ko, seoung-gon (Department of Applied Statistics, Kyungwon University) ;
  • Oh, Hyun-Sook (Department of Applied Statistics, Kyungwon University)
  • Published : 2000.06.01

Abstract

Oh et al.(1999) 3$\times$2 crossover design for assessing bioequivalence when two new generic drug formulations and innovator are simultaneously considered. This design is not only more efficient than 3$\times$3 one, proposed by Lee et al.(1998), in practical sense, but also more ethical in medical sense. However, the general statistical methods are not directly applicable to both designs when subjects are dropped out in the experiment, even though it is always possible in bioavailability and bioequivalence studies because of some administrative and economic reasons. In this research we propose an inference to drug effects when subjects are dropped out in the planed-for 3$\times$3 and 3$\times$2 crossover experiments. An example is given for illustration.

Keywords

References

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