No abstract

No abstract

Efficacy and safety study is of practical importance in modern drug development. It is a key component in evaluating the safety of food additives or pesticides, and assessing the effectiveness and safety of drugs. In most of the various statistical procedures, homogeneity of variances among different dose levels was required. This paper without a need for multiplicity adjustment proposes a stepwise confidence set procedure for estimating Minimum Effective Dose (MED) of drugs based on ratio of population means for normally distributed data under heteroscedasticity. The procedure employed Fieller’s (1954) method and obtained individual confidence intervals for identification of MED. The procedure is applied to a data of an experiment that was published by Ruberg (1989) where the effect of a new compound is measured by an increase in the weight of a particular organ in mice. Simulation study was carried out and results indicate that the procedure controls the family-wise error rate (FWER) strongly. Power of the procedure increases with increasing ratio of means and sample size.

We propose a stepwise confidence procedure for identifying minimum effective dose (MED) without multiplicity adjustment.Stepwise procedures strongly control the familywise error rate (FWER) which is a critical requirement for statistical methodologies in identification of MED. The partitioning principle is invoked to validate the control of the FWER. Our simulation study indicates that the FWER was properly controlled in the case with balanced design but failed in some cases of sample sizes for situations of unbalanced design. In addition, the power of the procedure increases with increasing mean of ratio differences and the sample sizes.