An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review
This paper provides a detailed example of how one should write the statistical section of a bioequivalence study protocol for FDA review. Three forms of bioequivalence are covered: average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE). The method of analysis is based on Jones and Kenward (2003) and a modification of their SAS Macro is provided.
McCarthy, William F., "An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review" (July 2007). COBRA Preprint Series. Working Paper 30.