Bioequivalence and Bioavailability Forum

Hi,

We are currently in the planning stages of a BE trial for a HVD. The current proposed study design is a 2x2x4. We are planning on performing a RSABE analysis.

My question has two parts. First, how are analysis sets defined for a RSABE analysis? Must subjects complete all 4 periods in order to be included in the analysis population? How are dropouts and missing values handled.

For example, what if a subject drops from the study after completing periods 1 & 2. Or, what if a subject vomits during one of the periods?

Any guidance or suggestions is greatly appreciated.

Thanks!