Bioequivalence and Bioavailability Forum

Hi,

For higher order studies (i.e. 3x3, 4x4 etc) I understand that the PKWP want us to make comparisons using a data subset (e.g. T2 vs T1) excluding the data from the treatments that are not relevant for the comparison in question (e.g. T1).

So, the analysis done is basically a 2-way crossover study for each treatment comparison.

However, how are the the order of treatments incorporated into the statistical model? Are the actual periods ignored hence recoded e.g. for the comparison between R and T2 for a subject assigned to R|T1|T2 treatment sequence, is Period 1 data regarded as “period 1” data and Period 3 data regarded as “period 2” data in the analysis or can the original Period be used in the model?

Thanks!