Bioequivalence and Bioavailability Forum

Dear Helmut,

Could you please explain how to analyze the following design and how to combine two groups? Which test we have to use for combining two groups?

A two-stage approach is acceptable when attempting to demonstrate bioequivalence. An initial group of subjects can be treated and their data analysed.If bioequivalence has not been demonstrated an additional group can be recruited and the results from both groups combined in a final analysis. If this approach is taken appropriate steps must be taken to preserve the overall type I error of the experiment. The analysis of the first stage data should be treated as an interim analysis and both analyses conducted at adjusted significance levels (with the confidence intervals accordingly using an adjusted coverage probability which will be higher than 90%). An appropriate statistical test will be used for combining the data of two groups.

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Edit: Category changed. [Helmut]