Bioequivalence and Bioavailability Forum

dear KR !

you may set up your study as a randomized complete block design.

In a randomized complete block design, experimental subjects are first divided into homogeneous blocks (i.e. males; females) before they are randomly assigned to a treatment group (i.e. sequence of your cross-over setting). Randomized complete block designs are used to split an experiment into a number of “mini-experiments” to increase precision and/or take account of some natural structure of the experiment.

in an randomized complete block design all treatments (i.e. sequences in your design) occur in each block (i.e. sex in your design). for this reason you have to randomize subjects to sequences stratified by sex.

you can model your data using an ANOVA model taking the block factor sex into account - in addition to the other commonly used factors for modelling data from a cross-over design.

hope this helps

martin